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 UNITED STATES

 SECURITIES AND EXCHANGE COMMISSION

 Washington, D.C. 20549

 FORM 10-K

 (Mark One)

 ANNUAL
REPORT PURSUANT TO SECTION 13 OR 15(d) OF THE SECURITIES EXCHANGE ACT
 OF 1934

 For the fiscal year ended December 31, 2024

 TRANSITION
REPORT PURSUANT TO SECTION 13 OR 15(d) OF THE SECURITIES EXCHANGE ACT OF 1934

 For the transition period from to

 Commission File No. 001-41097

 (Exact name of registrant as specified in its charter)

 Delaware

 87-0925574

 (State or Other Jurisdiction of

 Incorporation or Organization)

 (I.R.S. Employer Identification No.)

 311 West Superior Street, Suite 444

 Chicago, IL 60654

 (Address of principal executive offices and Zip Code)

 ( 855) 226-9991

 (Registrant's telephone number, including area
code)

 Securities registered pursuant to Section 12(b) of
the Exchange Act

 Title of each class

 Trading Symbol(s)

 Name of each exchange on which registered

 Common Stock, par value $0.00001

 CDIO

 The Nasdaq Stock Market LLC

 Redeemable warrants, each warrant exercisable for one
 share of common stock

 CDIOW

 The Nasdaq Stock Market LLC

 Securities registered pursuant to Section 12(g) of
the Securities Exchange Act: NONE

by check mark if the registrant is a well-known seasoned issuer, as defined in Rule 405 of the Securities Act. Yes No

by check mark if the registrant is not required to file reports pursuant to Section 13 or 15 (d) of the Securities Exchange Act. Yes No

by check mark whether the registrant (1) has filed all reports required to be filed by Section 13 or 15(d) of the Securities Exchange
Act during the preceding 12 months (or for such shorter period that the registrant was required to file such reports), and (2) has been
subject to such filing requirements for the past 90 days. Yes No

by check mark whether the registrant has submitted electronically every Interactive Data File required to be submitted pursuant to Rule
405 of Regulation S-T (§ 232.405 of this chapter) during the preceding 12 months (or for such shorter period that the registrant
was required to submit such files). Yes No

 Indicate by check mark whether the registrant is a large accelerated
filer, an accelerated filer, a non-accelerated filer, smaller reporting company, or an emerging growth company. See the definitions of
"large accelerated filer," "accelerated filer," "smaller reporting company," and "emerging growth
company" in Rule 12b-2 of the Exchange Act.

 Large accelerated filer

 Accelerated filer

 Non-accelerated filer

 Smaller reporting company

 Emerging growth company

 If
an emerging growth company, indicate by check mark if the registrant has elected not to use the extended transition period for complying
with any new or revised financial accounting standards provided pursuant to Section 13(a) of the Exchange Act.

by check mark whether the registrant has filed a report on and attestation to its management's assessment of the effectiveness
of its internal control over financial reporting under Section 404(b) of the Sarbanes-Oxley Act (15 U.S.C. 7262(b)) by the registered
public accounting firm that prepared or issued its audit report.

 If
securities are registered pursuant to Section 12(b) of the Act, indicate by check mark whether the financial statements of the registrant
included in the filing reflect the correction of an error to previously issued financial statements.

by check mark whether any of those error corrections are restatements that required a recovery analysis of incentive-based compensation
received by any of the registrant's executive officers during the relevant recovery period pursuant to § 240.10D-1(b).

by check mark whether the registrant is a shell company (as defined in Rule 12b-2 of the Act). Yes
 No

 As of
June 30, 2024, the aggregate market value of shares held by non-affiliates of the registrant (based upon the closing sale prices of such
shares on the Nasdaq Capital Market on June 30, 2024) was approximately $ 10.7 million. For purposes of calculating the aggregate market
value of shares held by non-affiliates, we have assumed that all outstanding shares are held by non- affiliates, except for shares held
by each of our executive officers, directors, and 5% or greater stockholders. In the case of 5% or greater stockholders, we have not
deemed such stockholders to be affiliates unless there are facts and circumstances which would indicate that such stockholders exercise
any control over our company, or unless they hold 10% or more of our outstanding common stock. These assumptions should not be deemed
to constitute an admission that all executive officers, directors, and 5% or greater stockholders are, in fact, affiliates of our company,
or that there are not other persons who may be deemed to be affiliates of our company.

2025, there were 52,145,416 shares of common stock, par value $0.00001 issued and outstanding. Documents Incorporated by Reference: None.

 Page

 PART 1

 Item 1. Business

 Item 1A. Risk Factors

 Item 1B. Unresolved Staff Comments

 Item 1C. Cybersecurity

 Item 2. Properties

 Item 3. Legal Proceedings

 Item 4. Mine Safety Disclosures

 Item 5. Market for Registrant's Common Equity, Related Stockholder Matters and Issuer Purchases of Equity Securities

 Item 6. Reserved

 Item 7. Management's Discussion and Analysis of Financial Condition and Results of Operations

 Item 7A. Quantitative and Qualitative Disclosures About Market Risk

 Item 8. Financial Statements and Supplemental Data

 Item 9. Changes in and Disagreements with Accountants on Accounting and Financial Disclosure

 Item 9A. Controls and Procedures

 Item 9B. Other Information

 Item 9C. Disclosure Regarding Foreign Jurisdictions that Prevent Inspections

 Item 10. Directors, Executive Officers and Corporate Governance

 Item 11. Executive Compensation

 Item 12. Security Ownership of Certain Beneficial Owners and Management and Related
 Stockholder Matters

 Item 13. Certain Relationships and Related Transactions, and Director Independence

 Item 14. Principal Accounting Fees and Services

 Item 15. Exhibits, Financial Statement Schedules

 Item 16. Form 10-K Summary

 i

 INTRODUCTORY
 NOTE

 Unless
the context dictates otherwise, references in this Annual Report on Form 10-K to the "Company," "Cardio," "we,"
"us," "our," and similar words are references to Cardio Diagnostics Holdings, Inc., a Delaware corporation, and
its consolidated subsidiary. "Legacy Cardio" refers to Cardio Diagnostics, Inc. prior to the October 2022 Business Combination,
which became our wholly-owned subsidiary as a result of that transaction.

 Trade
names and trademarks of Cardio referred to herein, and their respective logos, are our property. This Annual Report on Form 10-K may
contain additional trade names and/or trademarks of other companies, which are the property of their respective owners. We do not intend
our use or display of other companies' trade names and/or trademarks, if any, to imply an endorsement or sponsorship of us by such
companies, or any relationship with any of these companies.

 CAUTIONARY NOTE REGARDING FORWARD LOOKING STATEMENTS

 This Annual
Report on Form 10-K contains forward-looking statements within the meaning of Section 27A of the Securities Act of 1933, or the "Securities
Act," and Section 21E of the Securities Exchange Act of 1934, or the Exchange Act. The statements contained in this report that
are not purely historical are forward-looking statements. Our forward-looking statements include, but are not limited to, statements
regarding our or our management's expectations, hopes, beliefs, intentions or strategies regarding the future. In addition, any
statements that refer to projections, forecasts or other characterizations of future events or circumstances, including any underlying
assumptions, are forward-looking statements. The words "anticipates," "believe," "continue," "could,"
"estimate," "expect," "intends," "may," "might," "plan," "possible,"
"potential," "predicts," "project," "should," "would" and similar expressions
may identify forward- looking statements, but the absence of these words does not mean that a statement is not forward-looking. Forward-looking
statements in this Form 10-K may include, for example, statements such as the following:

 the possibility that we may be adversely impacted by economic, business, and/or competitive
 factors;

 our limited operating history makes it difficult to evaluate our business and prospects;

 the success, cost and timing of our product development and commercialization
activities, including the degree to which Epi+Gen CHD and PrecisionCHD, our currently-available tests, are accepted and
adopted by patients, healthcare professionals and other participants in other key channels may not meet our current expectations;

 changes in applicable laws or regulations could negatively impact our current business plans,
in particular with respect to regulation of laboratory-developed tests;

 we may be unable to obtain and maintain regulatory clearance or approval
for our tests, and any related restrictions and limitations of any cleared or approved product could negatively impact our financial condition;

 the pricing of our products and services and reimbursement for medical
tests conducted using our products and services may not be sufficient to achieve our financial goals;

 we may be unable to successfully compete with other companies currently
marketing or engaged in the development of products and services that could serve the same or similar functions as our products and services;

 the size and growth potential of the markets for our products and services,
and our ability to serve those markets, either alone or in partnership with others may not meet our current expectations;

 we may be unable to maintain our existing or future licenses, or manufacturing,
supply and distribution agreements;

 we may be unable to identify, in-license or acquire additional technology
needed to develop new products or services;

 our estimates regarding expenses, future revenue, capital requirements
and needs for additional financing may not be accurate;

 we may be unable to raise needed financing in the future on acceptable
terms, if at all;

 we may be unable to maintain our listing on The Nasdaq Stock Market;

 the ongoing or future impact from the coronavirus disease or other global
health crises could cause significant economic and social disruption, and such impact on our business is uncertain; and

 there are other risks and uncertainties indicated in this prospectus
or included in any prospectus supplement, including those under the section entitled "Risk Factors" that will be included
in any prospectus supplement, and other filings that have been made or will be made with the SEC by us that could materially alter our
current expectations.

 The forward-looking statements
contained in this Form 10-K are based on our current expectations and beliefs concerning future developments and their potential effects
on us. There can be no assurance that future developments affecting us will be those that we have anticipated. These forward-looking statements
involve a number of risks, uncertainties (some of which are beyond our control) or other assumptions that may cause actual results or
performance to be materially different from those expressed or implied by these forward-looking statements. Should one or more of these
risks or uncertainties materialize, or should any of our assumptions prove incorrect, actual results may vary in material respects from
those projected in these forward-looking statements. We undertake no obligation to update or revise any forward-looking statements, whether
as a result of new information, future events or otherwise, except as may be required under applicable securities laws.

 Risk
Factor Summary

 Our
business is subject to numerous risks and uncertainties, including those highlighted in the section titled "Risk Factors,"
which represent challenges that we face in connection with the successful implementation of our strategy and growth of our business.
The occurrence of one or more of the events or circumstances described in the section titled "Risk Factors," alone or in
combination with other events or circumstances, may have an adverse effect on our business, cash flows, financial condition and results
of operations. Such risks include, but are not limited to:

 Risks
Related to Our Business, Industry and Business Operations

 We have a limited operating history that makes it impossible to reliably predict future growth and operating
 results.

 We have an unproven business model, have not generated significant revenues and can provide no assurance
of generating significant revenues or operating profit.

 The market for epigenetic tests is fairly new and unproven, and it may
decline or experience limited growth, which would adversely affect our ability to fully realize the potential of our business plan.

 The estimates of market opportunity and forecasts of market growth included
in this Annual Report on Form 10-K may prove to be inaccurate, and even if the market in which we compete achieves the forecasted growth,
our business could fail to grow at similar rates, if at all.

 If we are not able to enhance or introduce new products that achieve market
acceptance and keep pace with technological developments, our business, results of operations and financial condition could be harmed.

 The success of our business depends on our ability to expand into new vertical markets and attract new
customers in a cost-effective manner.

 Our growth strategy may not prove viable and expected growth and value may not be realized.

 Our future growth could be harmed if we lose the services of our key personnel.

 We may face intense competition, which could limit our ability to maintain
or expand market share within our industry, and if we do not maintain or expand our market share, our business and operating results will
be harmed.

 Our business depends on customers increasing their use of our existing and future products, and we may
experience loss of customers or a decline in their use of our solutions.

 We rely on a limited number of suppliers, contract manufacturers, and
logistics providers, and our tests are currently performed by a single contract high complexity Clinical Laboratory Improvement Amendments
(CLIA) laboratory.

 We may be unable to scale our operations successfully.

 As we grow the size of our organization, we may experience difficulties in managing this growth.

 Our success depends upon our ability to adapt to a changing market and our continued development of
additional tests and services.

 Our Board of Directors may change our strategies, policies, and procedures without stockholder approval.

 We may need to seek alternative business opportunities and change the nature of our business.

 We may be subject to general litigation that may materially adversely affect us and our operations.

 Our management expects to continue to devote substantial time to maintaining
and improving its internal controls over financial reporting and the requirements of being a public company which may, among other things,
strain our resources, divert management's attention and affect our ability to accurately report our financial results and prevent
fraud.

 Risks Related to Our Intellectual Property

 Certain of our core technology is licensed, and that license may be terminated if we were to breach
our obligations under the license.

 Our license agreement with University of Iowa Research Foundation (UIRF)
includes a non-exclusive license of "technical information" that potentially could grant unaffiliated third parties access
to materials and information considered derivative work made by us, which could be used by such licensees to develop competitive products.

 Risks Related to Government Regulation

 We conduct business in a heavily regulated industry, and if we fail to
comply with these laws and government regulations, we could incur penalties or be required to make significant changes to our operations
or experience adverse publicity, which could have a material adverse effect on our business, financial condition, and results of operations.

 If the U.S. Food and Drug Administration ("FDA") were to implement
actively regulating our tests, we could incur substantial costs and delays associated with trying to obtain premarket clearance or approval
and incur costs associated with complying with post-market controls.

 If our products do not receive adequate coverage and reimbursement from
third-party payors, our ability to expand access to our tests beyond our initial sales channels will be limited and our overall commercial
success will be limited.

 Risks
Related to Our Common Stock

 The price of our Common Stock likely will be volatile like the stocks of other early-stage companies.

 Because a substantial number of our currently outstanding shares of Common Stock are registered for
resale, we may have difficulty raising additional capital when and if needed.

 A significant number of shares of our Common Stock are subject to issuance
upon exercise of outstanding warrants and options, which upon such exercise may result in dilution to our security holders.

 We have never paid dividends on our Common Stock, and we do not anticipate paying any cash dividends
on our Common Stock in the foreseeable future.

 Sales of a substantial number of shares of our Common Stock in the public market by our existing stockholders
could cause our stock price to decline.

 Item 1.
 Business

 References
in this report to "Cardio," "we," "us" or the "Company" refer to Cardio Diagnostics Holdings,
Inc. References to our "management" or our "management team" refer to the officers and directors of Cardio Diagnostics
Holdings, Inc.

 Our
 Company

 Cardio Diagnostics, Inc. ("Legacy
Cardio") was founded in 2017 in Coralville, Iowa by Meeshanthini (Meesha) Dogan, PhD, and Robert (Rob) Philibert, MD PhD. It was
formed in January 2017 as an Iowa LLC and was subsequently incorporated as a Delaware C Corp in September 2019.

 Cardio was formed to further develop and commercialize a series of products for
major types of cardiovascular disease and associated co-morbidities, including coronary heart disease ("CHD"), stroke, heart
failure and diabetes, by leveraging our Artificial Intelligence ("AI")-driven Integrated Genetic-Epigenetic Engine.
As a company, we aspire to give every American adult insight into their unique risk for various cardiovascular diseases. Cardio aims
to become one of the leading medical technology companies for enabling improved prevention, detection, treatment and management of cardiovascular
disease and associated co-morbidities. Cardio is transforming the approach to cardiovascular medicine from reactive to proactive and
hopes to accelerate the adoption of Precision Cardiovascular Medicine for all. We believe that incorporating our solutions into routine
clinical practice in and prevention efforts can help alter the trajectory that nearly one in two Americans is expected to develop some
form of cardiovascular disease by 2035.

 Cardio believes
that it is the first company to develop and commercialize epigenetics-based clinical tests for cardiovascular disease that
have clear value propositions for multiple stakeholders including (1) patients, (2) clinicians, (3) hospitals/health systems, (4) employers
and (5) payors. According to the CDC, epigenetics is the study of how a person's behaviors and environment can cause changes that
affect the way a person's genes work. Unlike genetic changes, epigenetic changes are reversible and do not change one's DNA
sequence, but they can change how a person's body reads a DNA sequence.

 Cardio launched its
first clinical test, Epi+Gen CHD, a three-year symptomatic CHD risk assessment clinical blood test targeting CHD events, including
heart attacks, in 2021 during the Covid-19 pandemic. As a result, the initial strategy for commercialization involved launching the test
via telemedicine and in smaller provider practices such as concierge medicine practices. The volume of tests through these channels were
minimal, and as the circumstances around Covid-19 pandemic improved, management re-vamped the Company's go-to-market strategy to
include other healthcare verticals and stakeholders beyond patients and small providers, including larger provider organizations, group
purchasing organizations, employers, payors and life insurers. This new approach allowed Cardio to expand the reach of our solutions
beyond the initial focus areas. Beyond the launch of Epi+Gen CHD, in March 2023, we announced the launch of our second product, PrecisionCHD,
an integrated epigenetic-genetic clinical blood test for the detection of coronary heart disease. The Epi+Gen CHD and PrecisionCHD
tests are coupled to Actionable Clinical Intelligence ("ACI"), a platform that offers new epigenetic and genetic insights
to clinicians prescribing the to personalize patient management and help improve chronic care management. In May 2023, we launched CardioInnovate360,
a research-use-only ("RUO") solution to support the discovery, development and validation of novel biopharmaceuticals for
the assessment and management of cardiovascular diseases. In February 2024, we announced the launch of HeartRisk, a cardiovascular
disease risk intelligence platform. We believe that our Epi+Gen CHD and PrecisionCHD tests are categorized as laboratory-developed
tests, or "LDTs." The new go-to-market strategy is also being implemented for these products.

 As a company in the early stages
of its development, the Company continuously reevaluates its business, the market in which it operates and potential new opportunities.
The Company may seek other alternatives within the healthcare field in order to grow its business and increase revenues. Such alternatives
may include, but not be limited to, combinations or strategic partnerships with other laboratory companies or with medical practices such
as hospitalists or behavioral health.

 Key recent developments include:

 Increased revenue in 2024;

 Recommended pricing for our two Current Procedural Terminology ("CPT")
Proprietary Laboratory Analysis ("PLA") codes from the American Medical Association, 0440U for PrecisionCHD and 0439U
for Epi+Gen CHD, at the Centers for Medicare and Medicaid Services' ("CMS") Clinical Laboratory Fee Schedule
(CLFS) annual meeting;

 Expanded the availability of our Epi+Gen CHD test to Family Medicine Specialists'
retail clinical location at Meijer Supercenter;

 Received Medicare pricing determination from Centers for Medicare and Medicaid
Services (CMS) for PrecisionCHD and Epi+Gen CHD; and

 We have entered into partnerships with seven new provider organizations. The new
partners include specialized practices in Michigan, Illinois, Texas, Florida, California, and Connecticut, representing various medical
specialties including concierge medicine, primary care, and precision medicine

 Cardio
expects that sales and partnership cycles will continue to be long. Our ongoing strategy for expanding our business operations and increasing
revenue generation include the following:

 Develop additional products, including clinical tests for stroke, congestive heart
failure and diabetes;

 Expand clinical and health economics evidence portfolio to continue to demonstrate
value of products and increase reach;

 Leverage our newly-awarded CPT PLA codes;

 Expand the adoption of our products across key channels, including health systems
and self-insured employers, including for HeartRisk, Cardio's new SaaS product;

 Scale our internal operations capabilities with a focus on improving efficiency
and reducing our cost of goods sold; and

 Pursue potential strategic partnership(s) and acquisition(s) of one or more synergistic
companies.

 Industry Background

 According to the American
Heart Association ("AHA"), even though an estimated 80% of cardiovascular disease ("CVD") is preventable, it remains
the leading cause of death in the United States and globally. The AHA also reported that over 650,000 deaths in the United States each
year are attributable to heart disease, which amounts to one in every four deaths. The Centers for Disease Control and Prevention ("CDC")
estimates that in the United States, one person dies every 36 seconds from CVD. Unfortunately, the incidence of CVD is expected to continue
to rise with the AHA projecting that by 2035, nearly half of Americans will have some form of CVD.

 CVD represents conditions that
affect the heart and blood vessels such as coronary heart disease ("CHD"), stroke, and congestive heart failure ("CHF").
CHD is the most common type of heart disease and according to the CDC, was responsible for nearly 370,000 deaths in 2019. The National
Center for Health Statistics reported that the prevalence of CHD is approximately 6.7%, and according to the AHA, over 20 million adults
aged 20 or older in the United States have CHD. CHD is also the major cause of heart attacks. According to the AHA, every 40 seconds,
someone in the United States has a heart attack, with over 800,000 Americans having a heart attack each year. The CDC reported that in
2020, stroke was responsible for one in six CVD-related deaths. The AHA estimates that every year, nearly 800,000 Americans have a stroke
which is the leading cause of major long-term disability, with a stroke-related death occurring every 3.5 minutes. According to the AHA,
over six million adults have heart failure and nearly 380,000 deaths in 2018 were attributable to heart failure. There are numerous risk
factors that could increase an individual's risk for CVD. Several key risk factors include diabetes, high blood cholesterol, and
high blood pressure. For example, according to the CDC, over 34 million adults have diabetes and according to Johns Hopkins Medicine,
those with diabetes are two to four times more likely to develop CVD. Alongside genetics, age, sex, and ethnicity, lifestyle factors such
as smoking, unhealthy diet, physical inactivity, and being overweight can also increase the risk for CVD.

 In addition
to the enormous morbidity and mortality associated with CVD, the economic burden of CVD is also staggering as depicted in the figure below
from the Cardiovascular Disease: A Costly Burden For America, Projections Through 2035 report by the AHA. CVD is the costliest disease
in the United States and the economic burden associated with CVD is expected to continue to soar. According to the CDC Foundation, every
year, one in six United States healthcare dollars is expended on CVD.

 The AHA reports that in 2016, the
cost of CVD was $555 billion and is expected to rise to over $1 trillion by 2035. Of the $555 billion, $318 billion was associated with
medical costs, and the remaining $237 billion with indirect costs such as lost productivity. By 2035, the medical costs associated with
CVD are expected to increase 135% to $749 billion, while the indirect costs are expected to rise by 55% to $368 billion. Currently, among
the various types of CVD, the medical costs of CHD are the highest at $89 billion and are expected to rise to $215 billion by 2035 as
depicted in the figure below from the Cardiovascular Disease: A Costly Burden For America, Projections Through 2035 report by the AHA.

 To address
this expected significant rise in human health and economic burdens, the United States healthcare market is seeking more efficient and
effective methods to better prevent, detect, manage, and treat CVD. This same trend is playing out across developed nations around the
globe as the burden of CVD continues to grow due to a rise in major risk factors such as obesity, poor diet and Type 2 diabetes.

 This is consistent with the cardiovascular diagnostic
testing market trends reported by Research and Markets in their Outlook on the Cardiovascular Diagnostic Testing Global Market to 2027
- Increasing Number of Insurance Providers Presents Opportunities press release published on July 4, 2022. They estimate that the Global
Cardiovascular Diagnostic Testing Market is estimated to grow from $8.47 billion in 2022 to $12.41 billion by 2027, with a CAGR of 7.94%.

 There are several healthcare tailwinds that are driving this
expected growth and are expected to support the large-scale adoption of our solutions:

 The aging population: According to the Population
Reference Bureau, by 2060, the number of Americans aged 65 and over is projected to more than double from 46 million to over 98 million.
This demographic shift will result in increased demand for healthcare services in general and for CVD specifically because the risk for
CVD increases with age. According to the AHA, the risk for CVD at age 24 is about 20% and more than doubles to 50% by age 45, with 90%
of those over the age of 80 having some form of CVD.

 The rise of chronic diseases: Chronic diseases such as heart disease,
cancer, and diabetes are rising in the United States. The rise of these conditions is further driven by less-than-ideal lifestyle choices
such as smoking, an unhealthy diet, and sedentary behavior. As a result, better predictive and diagnostic tools are needed to get ahead
of these conditions alongside the need for improved treatment and management of these conditions.

 The rise of costs associated with chronic diseases: Chronic diseases,
including heart disease and cancer continue to drive up healthcare costs, placing a growing financial burden on employers, insurers, and
the healthcare system at large. In the United States, the direct and indirect costs associated with CVD is expected to climb as prevalence
increases. The financial strain is particularly evident in employer-sponsored health plans, where CVD is a leading driver of high-cost
claims, absenteeism, and reduced productivity. As healthcare costs rise, self-insured employers, benefits consultants, payers, and providers
are actively seeking cost-effective solutions to mitigate the impact of CVD. This includes early detection strategies, precision diagnostics,
and personalized prevention programs that can identify at-risk individuals before costly acute events occur.

 The shift to value-based care: The shift to value-based care drives
healthcare providers to focus on quality rather than quantity of care. The shift to value-based care is a crucial driver of growth for
Cardio because it incentivizes health care providers to focus on providing quality care rather than simply providing more care. Cardio
believes providers can tackle the costliest and deadliest disease category with its solutions while reducing costs.

 The growth of telemedicine: Driven largely by the COVID-19 pandemic,
telemedicine is a growing trend in healthcare, as it allows patients to receive care from providers remotely. Remote, telemedicine-based
preventative programs and tests can serve those who are already undergoing routine screening, but more importantly, expand reach to most
Americans who currently are not receiving preventative healthcare, including rural and underserved populations. our evidence-based solutions
can be deployed remotely, which is expected to further drive adoption by patients and clinicians.

 The adoption of Artificial Intelligence (AI): AI is increasingly
incorporated into many aspects of healthcare, including administrative tasks, diagnosis and treatment. AI has the potential to improve
the quality of care while reducing costs. Machine learning, which is a type of AI, is instrumental to our cutting-edge solutions, powering
their clinical performance and differentiating them from other technologies for CVD.

 The rise of patient engagement: Thanks to technology, patients are
becoming more engaged in their healthcare. They use online tools to research their conditions and treatments and are more likely to participate
in their care. This includes demanding cutting-edge clinical tests that can help them better prevent chronic diseases such as CVD while
improving the length and quality of life. As a result, healthcare providers and organizations that offer such services including our solutions
are likely to have an edge over those who do not.

 Our
 Strategy

 Building compelling evidence. Our AI-driven Integrated Genetic-Epigenetic
Engine enables rapid design, development, and launch of diagnostic solutions resulting from over
a decade of research studies. Our solutions that result from this technology, including our Epi+Gen CHD test for coronary
heart disease event risk assessment and PrecisionCHD for the earlier detection of coronary heart disease, were developed through
rigorous studies that are peer-reviewed and published and others that are being prepared for peer-reviewed publication in collaboration
with leading healthcare and research institutions. In addition to the superior sensitivity of the Epi+Gen CHD and PrecisionCHD
tests, the evidence bases for both the PrecisionCHD and Epi+Gen CHD tests also
include an economic case to drive a more holistic and compelling argument for adoption.

 Engaging experts and key stakeholders. At Cardio, we understand
that engaging experts and key healthcare stakeholders is critical to realizing our solutions' full potential and ensuring that these
solutions reach as many people as possible.

 Prioritizing and executing strategic acquisitions. Our expertise
at several intersections across biology, machine learning, lab assay development, and cardiovascular disease, provide an array of strategic
acquisition opportunities to better serve the cardiovascular disease market by horizontally and vertically integrating across the cardiac
care continuum.

 Prioritizing payor coverage. We believe that to continue to grow
the market traction of our solutions, it would require pursuing additional payor coverage. We are engaging the appropriate experts, building
necessary evidence, and have a roadmap in place for this. As part of this priority, we are pursuing pilots and strategic collaborations.
We expect that it will take six to twelve months to engage additional payors and potentially longer to secure additional coverage for
our solutions.

 Evaluating FDA pathway. Cardio is evaluating an FDA regulatory pathway to enable broader access
to our tests.

 Targeting multiple revenue channels. To ensure that our revenue
stream is diversified, Cardio has and will continue to target multiple revenue channels for which our solutions have compelling value
propositions. This strategy includes, but is not limited to providers, health systems, and employers.

 Launching synergistic products. To more fully address cardiovascular
health, Cardio is leveraging our AI-driven Integrated Genetic-Epigenetic Engine to develop a series of clinical tests for major
types of cardiovascular disease and associated co-morbidities, including stroke, congestive heart failure and diabetes. We have also started
to develop additional synergistic products other than new clinical blood tests. Our first such product, HeartRisk, is a cardiovascular
disease risk intelligence platform, designed to augment our clinical blood tests.

 Our
 Technology

 At the core of Cardio is our proprietary
AI-driven Integrated Genetic-Epigenetic Engine, an engine invented and built by three key employees/officers for
 over a decade. Our technology enables rapid design, development and launch of new diagnostic solutions through the identification
of robust integrated genetic-epigenetic biomarkers and their translation into clinical tests for cardiovascular disease and associated
co-morbidities. This Engine consists of multiple layers. It begins with genome-wide genetic (single nucleotide polymorphisms or SNPs),
genome-wide epigenetic (DNA methylation) and clinical data points. Using high-performance computing, ML/AI techniques and deep domain
expertise in medicine, molecular biology and engineering, a panel of SNP-DNA methylation biomarkers and mined, modeled and translated
into standalone laboratory assays.

 As a result, our products, which
are clinical tests, consist of two components. The first is a laboratory component, which involves epigenetic DNA biomarkers. Genetic
biomarkers ("SNPs") represent an individual's inherited risk for the disease, have been reported to drive less than
20% of the risk for cardiovascular disease (Hou, K et al, Aug 2019, Nature Genetics) and do not change with intervention ( i.e.,
static). Epigenetic biomarkers (DNA methylation) represent an individual's acquired risk for the disease that is influenced by lifestyle
and environment which is a larger driver for cardiovascular risk compared to genetics, is largely confounded by genetics and has been
shown to change over time with intervention or changes in one's lifestyle and environment ( i.e., dynamic). The second is
an analytical component, which involves applying a proprietary interpretive predictive machine learning model to predict risk and provide
personalized insights to help clinicians tailor patient management. The combination of biomarkers and predictive machine learning model
is unique to each clinical test we develop.

 Our
Products and Services

 We have and will continue
to leverage our AI-driven Integrated Genetic-Epigenetic Engine to develop a series of clinical tests for cardiovascular disease.
As of March 2025, we have leveraged this Engine to develop two clinical products: Epi+Gen CHD and PrecisionCHD.

 We believe that our first product,
Epi+Gen CHD, is the first epigenetics-based clinical blood test capable of assessing near-term (three-year) risk for a
 coronary heart disease ("CHD") event, including heart attacks, and our
second product, PrecisionCHD, is the first epigenetics-based clinical blood test for the detection of CHD.

 Both Epi+Gen CHD and PrecisionCHD
are accompanied by our provider-facing Actionable Clinical Intelligence platform, which maps a patient's unique biomarker
profile and other information onto modifiable factors such as diabetes, hypertension, hypercholesterolemia, and smoking, known to be critical
drivers of coronary heart disease.

 CardioInnovate360 is a
research use only (RUO) solution we launched to support the discovery, development and validation of novel biopharmaceuticals for the
assessment and management of cardiovascular diseases.

 In 2024, we launched our first software
product, HeartRisk. HeartRisk is a cardiovascular disease risk intelligence platform that combines insights from HIPAA-compliant
anonymized and aggregated clinical cardiovascular data obtained through our Epi+Gen CHD and PrecisionCHD clinical blood
tests, with industry and geographic data to enable real-time population-level cardiovascular disease ("CVD") risk insights.
These insights are customized for the stakeholder implementing our clinical solutions.

 Clinicians' Current Approach to Cardiovascular Disease

 Currently, a patient's risk for CVD is generally assessed
using two common lipid-based clinical tests known as Framingham Risk Score (FRS) and ASCVD Pooled Cohort Equation (PCE).

 FRS and PCE are 10-year CVD risk calculators
that aggregate common clinical variables such as cholesterol and diabetes, demographics and subjective, self-reported information such
as smoking status. For the early detection of CHD, tests that are routinely used in a provider setting include stress echocardiograms.
These tests have several limitations and are less effective for several reasons:

 In a peer-reviewed published study by Cardio in collaboration with Intermountain
Healthcare (Dogan, Meeshanthini & Knight, Stacey & Dogan, Timur & Knowlton, Kirk & Philibert, Robert. (2021). External
validation of integrated genetic-epigenetic biomarkers for predicting incident coronary heart disease. Epigenomics. 13. 10.2217/epi-2021-0123),
we found that for predicting the three-year risk for
a coronary heart disease event such as a heart attack, the average sensitivity of FRS and PCE was 44% in men and 32% in women.
This means that for every 100 men and 100 women deemed "at-risk" for a coronary heart disease event, the test only correctly
identifies 44 men and 32 women.

 In a peer-reviewed published study by Cardio in collaboration with Intermountain
Healthcare and University of Iowa Hospitals and Clinics (Philibert, Robert & Dogan, Timur & Knight, Stacey & Ahmad, Ferhaan
& Lau, Stanley & Miles, George & Knowlton, Kirk & Dogan, Meeshanthini. (2023). Validation of integrated genetic-epigenetic
test for the assessment of coronary heart disease. Journal of American Heart Association. 12:e030934. DOI: 10.1161/JAHA.123.030934), we
found that the overall average area under the curve, sensitivity, and specificity in three independent test cohorts for detecting coronary
heart disease were 82%, 79%, and 76%, respectively.

 In a peer-reviewed published study by Cardio in collaboration with Intermountain
Healthcare and University of Iowa Hospitals and Clinics (Philibert, Robert & Dogan, Timur & Knight, Stacey & Ahmed, Ferhaan
& Lau, Stanley & Miles, George & Knowlton, Kirk & Dogan, Meeshanthini. (2023). Validation of an
 integrated genetic-epigenetic test for the assessment of coronary heart disease. Jounal of American Heart Association. 10.1161/JAHA.123.030934),
we found that for predicting the presence of coronary heart disease, PrecisionCHD
had an 80% sensitivity for men and 76% sensitivity for women.

 The fasting requirement for current tests could be cumbersome for patients to comply, and the lack of
fasting could affect test results.

 The patient care plan that results from these tests generally lack personalization.

 Lipid-based risk assessment tests depend on self-reported, subjective
information such as smoking status from patients, and inaccurate information could affect the accuracy of test results.

 Undergoing these tests requires an in-person clinic visit to collect blood
samples and other necessary data points such as blood pressure, which may delay or prevent access to primary prevention, e.g., for those
who are unable to make time for the visit, have transportation issues or live in rural areas are likely to delay primary prevention altogether.
Similarly, to undergo a stress echocardiogram for instance, an in-person visit is required, and such a visit can take weeks to schedule
that could delay care for patients especially if they are experiencing symptoms such as chest pain.

 Commonly used risk assessment tests were also developed predominantly using data from men and therefore,
may be less effective for women.

 Epi+Gen
CHD is the Only Epigenetics-based Clinical Test for Coronary Heart Disease Event Risk
 Assessment

 Epi+Gen CHD
is a scientifically backed clinical blood test that is based on an individual's objective genetic and epigenetic DNA biomarkers
for assessing the three-year risk for a coronary heart disease event such as a heart attack. In a peer-reviewed study done in collaboration
with Intermountain Healthcare (Dogan, Meeshanthini & Knight, Stacey & Dogan, Timur & Knowlton, Kirk & Philibert, Robert.
(2021). External validation of integrated genetic-epigenetic biomarkers for predicting incident coronary heart disease. Epigenomics.
13. 10.2217/epi-2021-0123), this test demonstrated a 76% and 78% sensitivity for men and women, respectively, for three-year CHD risk.
This means that for every 100 men and 100 women deemed "at-risk" for a coronary heart disease event, the test correctly identifies
76 men and 78 women. In comparison, the average sensitivity of the Framingham Risk Score and the ASCVD Pooled Cohort Equation was found
to be 44% and 32% for men and women, respectively. The performance of the test in this study was evaluated across two cohorts that were
independent of each other. One cohort was used for the development of this test and the other was used to independently validate the
performance of the test, showing Epi+Gen CHD to be approximately 1.7 times and 2.4 times more sensitive than the current lipid-based
clinical risk estimators in men and women, respectively. In another peer-reviewed study focusing on the cost utility of Epi+Gen CHD
(Jung, Younsoo & Frisvold, David & Dogan, Timur & Dogan, Meeshanthini & Philibert, Robert. (2021). Cost-utility analysis
of an integrated genetic/epigenetic test for assessing risk for coronary heart disease. Epigenomics. 13. 10.2217/epi-2021-0021), this
test was associated with up to $42,000 in cost savings per quality adjusted life year and improved survival compared to the ASCVD Pooled
Cohort Equation. In another peer-reviewed study, (Philibert, Willem & Andersen, Allan & Hoffman, Eric & Philibert, Robert
& Dogan, Meeshanthini. (2021). The reversion of DNA methylation at coronary heart disease risk loci in response to prevention therapy.
Processes. 9, 699.  DNA methylation of this test was shown to change within 90 days of intervention
in the form of smoking cessation, demonstrating that this test could potentially also be leveraged to evaluate the effectiveness of interventions.

 The blood-based version of this
test was introduced for market testing in 2021 The pricing of the test varies based on factors such as organization type and test volume.
The price of the test and revenue streams could change in the future depending on market forces and payor requirements, as well as on
the customer and the region in which the test is being sold. We are continuing to build additional clinical and health economics evidence
to pursue payor coverage. A key first step in expanding critical payor coverage is to have this test be assigned a CPT PLA code, and the
American Medical Association awarded the Epi+Gen CHD a CPT PLA code, 0439U.

 We believe
that the Epi+Gen CHD test can benefit numerous healthcare stakeholders. For instance, we believe that this test will enable clinicians
to identify patients at-risk in the near-term for CHD-related events, including a heart attack, and utilize actionable insights from
this test to provide more personalized care for their patients to help prevent the event and improve outcomes. These actionable insights
are conveyed via our provider-facing Actionable Clinical Intelligence platform, which maps a patient's unique biomarker
profile and other information onto pathways and modifiable drivers of coronary heart disease. In addition to clinicians, we believe that
this test can enable healthcare organizations and payors to reduce the cost of care, and employers to understand and better manage business
risks including healthcare costs. Insights for these stakeholders upon leveraging the Epi+Gen CHD test are provided via our new
software product, HeartRisk, which is a cardiovascular disease risk intelligence platform. The pricing for this platform will
be customized based on the organization type and size, and use case.

 PrecisionCHD is the Only Epigenetics-based Clinical
Test for the Early Detection of Coronary Heart Disease

 PrecisionCHD is a scientifically
backed clinical blood test that is based on an individual's objective genetic and epigenetic DNA biomarkers for the detection of
coronary heart disease. In a peer-reviewed published study by Cardio in collaboration with Intermountain Healthcare and University of
Iowa Hospitals and Clinics (Philibert, Robert & Dogan, Timur & Knight, Stacey & Ahmad, Ferhaan & Lau, Stanley & Miles,
George & Knowlton, Kirk & Dogan, Meeshanthini. (2023). Validation of integrated genetic-epigenetic test for the assessment of
coronary heart disease. Journal of American Heart Association. 12:e030934. DOI: 10.1161/JAHA.123.030934), this test demonstrated an overall
average area under the curve, sensitivity, and specificity in three independent test cohorts for detecting coronary heart disease of 82%,
79%, and 76%, respectively. The average sensitivity for men and women were 80% and 76%, respectively. This means that for every 100 men
and 100 women deemed "to have" coronary heart disease, the test correctly identifies 80 men and 76 women. In comparison, the
most commonly used and least invasive test for detecting coronary heart disease, exercise ECG, has a sensitivity of only 58%. The performance
of the test in this study was evaluated across three cohorts that were independent of each other. One cohort was used for the development
of this test and the other two were used to independently validate the performance of the test. Based on the known sensitivity of exercise
ECG, PrecisionCHD is approximately 1.4 times and 1.3 times more sensitive than an exercise ECG in men and women, respectively,
for detecting coronary heart disease. In another peer-reviewed study, (Broyles, Damon & Philibert, Robert. (2023). Precision epigenetics
provides a scalable pathway for improving coronary heart disease care globally. Epigenomics. 10.2217/epi-2023-0233), the global scalability
of PrecisionCHD was outlined in comparison to commonly used coronary heart disease tests such as exercise ECG and CCTA. Similar to the
Epi+Gen CHD test, a peer-reviewed study was conducted to evaluate if the DNA methylation biomarkers of PrecisionCHD could be potentially
leveraged to evaluate the effectiveness of interventions. In this peer-reviewed study, (Philibert, Robert & Moody, Joanna & Philibert,
Willem & Dogan, Meeshanthini & Hoffman, Eric. (2023). The reversion of epigenetic signature of coronary heart disease in response
to smoking cessation. Genes. 14, 1233.  DNA methylation of this test was shown to change within
90 days of intervention in the form of smoking cessation.

 The blood-based version of this
test was introduced for market testing in 2023. The pricing of the test varies based on factors such as organization type and test volume.
The American Medical Association awarded the PrecisionCHD a CPT PLA code, 0440U. The price of the test and revenue streams could
change in the future depending on market forces and payor requirements, as well as on the customer and the region in which the test is
being sold. We are continuing to build additional clinical and health economics evidence to pursue payor coverage.

 We believe
that the PrecisionCHD test can benefit numerous healthcare stakeholders. For instance, we believe that this test will enable clinicians
to identify patients with CHD with a simple blood test and utilize actionable insights from this test to provide more personalized care
for their patients to help improve outcomes. These actionable insights are conveyed via our provider-facing Actionable Clinical Intelligence
platform, which maps a patient's unique biomarker profile and other information onto modifiable factors such as diabetes, inflammation,
hypercholesterolemia, and smoking, known to be critical drivers of coronary heart disease. In addition to clinicians, we believe that
this test can enable healthcare organizations and payors to reduce the cost of care, and employers to understand and better
 manage business risks including healthcare cost. Insights for these stakeholders upon leveraging the PrecisionCHD test
are provided via our new software product, HeartRisk, which is a cardiovascular disease risk
intelligence platform. The pricing for this platform will be customized based on the organization type and size, and use case.

 Cardio intends to accelerate the
adoption of Epi+Gen CHD and PrecisionCHD by:

 developing strategic clinical partnerships to reach as many patients as possible;

 leveraging industry organizations to engage and educate providers;

 launching a piloting program to for innovative providers and key strategic partners;

 developing strategic partnerships with other healthcare stakeholders such as payors and employers; and

 developing a customized customer portal to reduce transaction friction.

 Cardio foresees potential opportunities to increase the
gross margin of the Epi+Gen CHD and PrecisionCHD by:

 establishing a laboratory to potentially reduce cost associated with processing samples;

 processing patient samples in the laboratory in larger batches;

 shipping sample collection kits in larger batches; and

 increasing the level of automation to reduce manual processing.

 We have completed
a pre-submission with the FDA pertaining to our PrecisionCHD product and have received feedback from the FDA on that submission. We may
complete additional pre- submissions to the FDA as we continue to evaluate FDA's feedback and further develop our regulatory strategy.
We have engaged outside expertise for this process.

 Product Pipeline

 In March 2023, we announced the
debut of the PrecisionCHD test, our second clinical blood test for the detection of CHD. In May 2023, we launched CardioInnovate360
a research-use- only (RUO) solution to support the discovery, development and validation of novel biopharmaceuticals for the assessment
and management of cardiovascular diseases. In February 2024, we announced the launch of HeartRisk, our first software product that
is a cardiovascular disease risk intelligence platform. We have several other tests in our product pipeline at various stages of development
for congestive heart failure, stroke and diabetes. However, as a company in the early stages of its development, we continuously reevaluate
our business, the market in which we operate and potential new opportunities. We may modify our product pipeline, seek other alternatives
within the healthcare field in order to grow the Company's business and increase revenues. Such alternatives may include, but not
be limited to, combinations or strategic partnerships with other laboratory companies or with medical practices such as hospitalists or
behavioral health.

 Our
Market Opportunity

 Cardiovascular disease ("CVD")
is the leading cause of death in the United States, accounting for one in four deaths. Despite being largely preventable, the American
Heart Association projects that by 2035, nearly 45% of Americans will have some form of CVD. One of the key ways to address the prevalence
of CVD is to shift the approach for CVD from reactive treatment to proactive prevention and earlier detection. As such, technologies that
can more precisely assess the risk for and detect CVD before symptoms emerge or a catastrophic cardiac event occurs becomes even more
critical.

 According to Research and
Markets in their Outlook on the Cardiovascular Diagnostic Testing Global Market to 2027 - Increasing Number of Insurance Providers Presents
Opportunities press release published on July 4, 2022, the Global Cardiovascular Diagnostic Testing Market is estimated to grow from $8.47
billion in 2022 to $12.41 billion by 2027, with a CAGR of 7.94%. The increasing prevalence of cardiovascular diseases, technological advancements
in cardiovascular disease diagnostics, and the growing number of initiatives to promote cardiovascular disease testing are the major factors
driving the growth of this market.

 Our principal
mission is to enable better detection of the presence and risk of major cardiovascular diseases through a series of clinical tests developed
by leveraging our proprietary AI-driven Integrated Genetic-Epigenetic Engine. Our initial product, Epi+Gen CHD, is a highly
sensitive and accessible clinical test for three-year coronary heart disease ("CHD") event
 risk assessment, including risk for a heart attack. Our second product, PrecisionCHD, is a highly sensitive and accessible
clinical test for the detection of CHD.

 Using data
from the US Census Bureau, Cardio estimates that 146 million adults could potentially benefit from our Epi+Gen CHD test, 157 million
adults for our PrecisionCHD test, 152 million adults for the congestive heart failure test, 153 million adults for the stroke test and
140 million adults for the diabetes test. The pricing of each of our tests may vary, but the US addressable market equates to $51 billion
for Epi+Gen CHD, assuming a pricing of $350/test, $134 billion for PrecisionCHD, assuming a price of $850/test, $53 billion
for congestive heart failure, assuming a pricing of $350/test, $53 billion for stroke, assuming a pricing of $350/test and $49 billion
for diabetes, assuming a pricing of $350/test for a total US addressable market of $340 billion. This total addressable market evaluation
also assumes that one patient could be tested with multiple tests, and each test is administered to each patient a single time in a year
although some patients may benefit from being re-tested in less than a year.

 Go-To-Market
Strategy for Epi+Gen CHD and PrecisionCHD

 Our current go-to-market
("GTM") strategy is predominantly a product-led innovation growth strategy that emphasizes enterprise-wide adoption across
key healthcare sub-verticals with a particular emphasis on deeply centralized key opinion and health trend leaders like innovative providers,
health systems, and employers. This strategy is augmented with a bottom-up consumer- led sales focused on directly acquiring and retaining
savvy and health-conscious consumers interested in using the latest technologies to address their cardiovascular disease concerns.

 Healthcare Sub-Vertical Priorities for Epi+Gen CHD
and PrecisionCHD

 By assessing the risk for a heart
attack early and/or detecting CHD early to potentially avert a heart attack, we believe that the clinical and economic utility of the
Epi+Gen CHD and PrecisionCHD tests will support their commercial adoption. We believe that Epi+Gen CHD and PrecisionCHD
can address a significant addressable market opportunity even before these tests are covered and reimbursed by payors. While we believe
that such coverage and reimbursement would be necessary to gain widespread adoption, obtaining such coverage and reimbursement from federal
and private payors may take several years, if it is obtained at all. We intend to focus on the following key channels as part of our GTM
strategy:

 Innovative Health Systems

 As
innovative health systems diversify their business models and care delivery pathways, there is a renewed emphasis on using precision
medical technologies to better manage expensive and chronic conditions, including CHD. By assessing the risk for a CHD event including
a heart attack before it occurs, Epi+Gen CHD has the potential to improve population health. We believe that the improved performance
of our test compared to other risk calculators, coupled with evidence of cost savings and enhanced survival, will drive the adoption
of Epi+Gen CHD by health systems to continue improving the health of their patients. Similarly, with PrecisionCHD, innovative
health systems are able to help test their patients detect CHD earlier with a simple blood test, potentially leading to better patient
outcomes.

 Physician-Directed Channels, Including Concierge Practices

 Early adoption is driven by practices
committed to innovation in medicine for patients who are more focused on preventive health and wellness and have the financial means to
pay out-of- pocket for concierge subscription services. There is a convergence in innovative providers, health-conscious consumers, and
best-in-class tests and technologies in concierge medicine practices or other similar practices
to provide on-demand elite personalized and readily accessible healthcare. With an estimated 2,000 to 5,000 concierge practices
in the United States, there is robust growth in high-end healthcare services with an equal demand for innovative diagnostic tools. Additionally,
concierge practices are not price-sensitive, so reimbursement is not a top priority.

 Employers

 Early adoption in the employer space
is likely to be driven by self-insured employers and employers looking to provide employee perks relevant to health. Self-insured employers
are consistently seeking solutions to help manage their biggest cost centers such as heart disease. In a post-pandemic world, the health
and wellbeing of employees are also top-of-mind for many employers to ensure that their employees are healthy and productive. Employers
view healthcare investments as another investment in the business. Employers leveraging innovative diagnostic solutions can connect better
health for employees to drive overall business objectives and have a competitive advantage in managing business risks while attracting
and retaining talent.

 Telemedicine and Marketplaces

 Many Americans
are concerned about being proactive with their health needs. Understanding their personalized risk with tests at the forefront of medicine
is crucial for those with financial resources. According to the U.S. Census Bureau based on the 2020 census, there are nearly 44 million
households that earn $100,000 or more annually. We expect high-earning Americans who are proactive about their health to constitute the
initial attainable market.

 Sales and Marketing for Epi+Gen CHD and PrecisionCHD
with a Focus on Strategic Channel Partnerships

 While our overall sales and
marketing initiatives will span the gamut across traditional, print, and digital media, our primary sales and marketing strategy consists
of the branding, collaboration, co-marketing, and co-sales opportunities involved in strategic channel partnerships. By prioritizing strategic
channel partnerships, we believe we can accelerate our market penetration into the key healthcare sub-verticals we intend to prioritize
for our growth. The key to our efforts is a well-defined and executed channel partnership integration strategy that will serve to accelerate
the sales cycles for each of our distribution channels. The sales cycles are generally defined as the period in which such distribution
channel will turn over its inventory of our tests, which may vary for each distribution channel. Utilizing and developing such strategic
channel partnerships, we believe, will generate revenue in a myriad of ways including larger contracts for our Epi+Gen CHD and
PrecisionCHD clinical blood tests, and bundling our solutions alongside other synergistic technologies, services, and products.

 Strategic
channel partnerships are key for the growth of our solutions. There are several key revenue and strategy benefits to developing a robust
channel partnership strategy, including:

 Defensibility and Displacement

 Strategic channel partners may have exclusivity agreements for
Epi+Gen CHD and PrecisionCHD, which forecloses distribution channels to potential competitors.

 Distribution and Network Effects

 Channel partners under consideration
for Epi+Gen CHD and PrecisionCHD strategic partnerships have large, related healthcare and life science networks that we
expect to leverage as part of the relationship.

 Bi-Directional Value

 The cardiovascular disease space is
of paramount concern to stakeholders across the healthcare continuum; the scale of the disease across the population and the associated
costs ensures that addressing cardiovascular disease from a payment, cost, patient outcome, and prevention standpoint for stakeholders
across the spectrum.

 Pricing Differentiation

 The economics of each channel partnership can be crafted independently
to offer each strategic partner a per-unit cost relevant to the size of their network.

 Complementary Goods

 Bundling Epi+Gen CHD, PrecisionCHD,
HeartRisk and future Cardio solutions alongside complementary clinical, analytics, treatment pathways, and services-consulting
for primary prevention optimization with key partners expands the ROI of the investment in our solutions.

 Hiring and Talent to Accelerate Growth

 Our growth strategy will require
investment in internal and external healthcare enterprise sales, marketing and deep customer insights. By combining best-in-class revenue
operations technologies with seasoned healthcare sales and marketing experts, we believe we can quickly scale the selling approaches we
have outlined and validated to transform the cardiovascular healthcare experience, driving revenue and increased margins. New hires will
be targeting the entire continuum of revenue needs, including opportunity identification, campaign design, and execution.

 Manufacture/Supply
 Chain

 The content of the sample collections
kits for both Epi+Gen CHD and PrecisionCHD are identical, and we rely on third-party suppliers for kit contents required
to collect and transport a blood sample to the lab for processing. These are commonly used supplies that are and can be sourced from multiple
distributors. Upon sourcing these contents, they are assembled into lancet- based and vacutainer-based sample collection kits internally
and fulfilled. We intend to maintain an inventory of fully assembled kits to meet expected demand for at least six months. However, since
there are no particular or unique assembly protocols and assembly is handled internally, the lead time to assemble additional sample collection
kits would be minimal after the contents are sourced.

 Proprietary genetic and DNA methylation
components are sourced from large manufacturers and manufactured under good manufacturing practices ("cGMP"). There are alternative
manufacturers for each of these components, and no additional lead time is expected. Laboratory assays that are manufactured under cGMP
to specifications are expected to be available to meet anticipated demand for at least six months.

 Both the Epi+Gen CHD and PrecisionCHD
clinical blood tests currently are offered as LDTs through an experienced laboratory with the appropriate Clinical Laboratory Improvement
Amendments of 1988 ("CLIA") certification and state licensure. However, we are currently setting up an internal operational
hub that includes a CLIA laboratory. We anticipate completing this process in 2025. However, we are moving at a measured pace in order
to preserve resources, so the timing of completion of the internal CLIA laboratory could be delayed. We will continue to use the services
of our outside laboratory without interruption until our laboratory is operational.

 Our
Competitive Strengths

 Innovation is the key to success.
In the rapidly moving cardiac diagnostics space, we believe that we have the team, differentiated technology, and deep technical and business
expertise to deliver a market differentiating suite of products for our customers to address unmet clinical needs in the cardiovascular
space and help us dominate our market.

 The pillar of our strategy has
been innovation, from the onset with our technology development and intellectual property that account for future growth, to our commercialization
and partnership efforts that bring together key healthcare stakeholders.

 We believe that, among other reasons, the future belongs
to Cardio based on the following competitive strengths:

 Technology and products are strongly backed by science.

 Our technology and products stem
from over a decade of rigorous scientific research by the founding team in collaboration with other clinical and research experts from
leading organizations. Our founding team consist of experts in machine learning approaches in healthcare and in epigenetics with highly-cited
peer-reviewed publications. The technology and products are developed and validated with extensive clinical data. The key findings have
been published after undergoing stringent independent third-party peer review.

 Broad intellectual property portfolio protects our current and future products and their applications.

 As of March 2025,
our patent portfolio includes six patent families, which encompasses two issued patents in the U.S., as well as issued patents in United
Kingdom, France, Germany, Italy, Switzerland, Ireland, Hong Kong, Australia, China, and India, four pending U.S. patent applications,
two pending PCT International applications, and almost forty patent applications pending worldwide, and which are generally directed to
methods and compositions for detecting biomarkers associated with cardiovascular disease and diabetes for diagnosis and other applications.
In addition, we have extensive trade secrets and know-how, including algorithms and assay designs, that are critical for the continued
development and improvement of our current and future products.

 Big data and artificial intelligence (machine learning) expertise drive future product development.

 Our expertise in processing billions of clinical genotypic,
epigenetic and phenotypic data points to generate critical insights allows us to continue to develop innovative products.

 Proprietary cutting-edge AI-driven Integrated Genetic-Epigenetic Engine accelerates product
 development.

 We have built a proprietary
AI-driven Integrated Genetic-Epigenetic Engine that is made up of layers of big data, our algorithms informed by biology and its
expert domain knowledge that was designed and built over the past decade and can be leveraged to enable rapid design, development and
launch of new diagnostic solutions.

 Multiple potential product offerings with strong value propositions for key healthcare stakeholders.

 We have built a robust product
pipeline for various types of cardiovascular disease and other indications that leverage our AI-driven Integrated Genetic-Epigenetic Engine
to continue to build market traction. We believe that our current and future products have strong value propositions for various key stakeholders
in healthcare. As a result, we believe that our customers will adopt and champion our products.

 Products that can potentially drive value in multiple ways.

 We believe that our tests are
the first epigenetics-based clinical tests for heart disease. Unlike genetic biomarkers that are static, the DNA methylation (epigenetic)
biomarkers included in our products are generally dynamic. Therefore, DNA methylation biomarkers can change over time and as a result,
in addition to initial assessment, our products could potentially be used to personalize interventions and help monitor the effectiveness
of these interventions.

 Commercial processes that are inherently scalable to meet demand.

 Our commercial pipeline is inherently
scalable. Laboratory testing kits consist of easy to synthesize oligonucleotide products, readily available PCR reagents, and can be kitted
months in advance. Our lancet and vacutainer-based sampling kits incorporate readily available components that can be sourced from several
vendors. Our propriety algorithms can be scaled and automated to process data from thousands of samples. In addition, the laboratory processes
can be automated and scaled by adding existing commercial equipment.

 A leadership team of seasoned healthcare professionals and executives that is led by a visionary
 founder.

 Cardio is led by a management team with experience in inventing
innovative technologies, developing and commercializing clinical products, and building high growth companies.

 Competition

 Even though we believe that our
solutions provide significant advantages over solutions that are currently available from other sources, we expect continued intense competition.
This includes companies that are entering the cardiovascular diagnostics market or existing companies that are looking to capitalize on
the same or similar opportunities as Cardio is in the clinical and non-clinical spaces. Some of our potential and current competitors
have longer operating histories and have, or will have, substantially greater financial, technical, research, and other resources than
we do, along with larger, more established marketing, sales, distribution, and service organizations. This could enable our competitors
to respond more quickly or efficiently than it can to capture a larger market share, respond to changes in the regulatory landscape or
adapt to meet new trends in the market. Having access to more resources, these competitors may undertake more extensive research and development
efforts, substantially reduce the time to introducing new technologies, accelerate key hires to drive adoption of their technologies,
deploy more far-reaching marketing campaigns and implement a more aggressive pricing policy to build larger customer bases than we have.
In some cases, we are competing for the same resources our customers allocate for purchasing cardiovascular diagnostics products or for
establishing strategic partnerships. We expect new competitors to emerge and the intensity of competition to increase. There is a likelihood
that our competitors may develop solutions that are similar ours and ones that could achieve greater market acceptance than ours. This
could attract customers away from our solutions and reduce our market share. To compete effectively, we must scale our organization and
infrastructure appropriately and demonstrate that our products have superior value propositions, cost savings, and clinical performance.

 The clinical cardiovascular diagnostic
space is perhaps the most intensely competitive market space in clinical medicine. Even though we believe our solutions offer significant
advantages to existing methods, we expect alternative biomarker assessment approaches to continue to exist and to be developed. With respect
to coronary heart disease (CHD) risk assessment and early detection, our competitors use a variety of technologies including genetic,
serum lipid-based, imaging, proteomic and "people tracking" approaches.

 Genetic testing, both whole genome
and more focused panel modalities, is the first type of biomarker assessment and is used by many clinicians to assess lifetime risk for
CHD. However, whereas the scientific tenets for this approach are generally accepted, it does not identify when CHD might develop, and
we believe that the relative power of this method for predicting CHD as compared to its Epi+Gen CHD test is limited. In addition,
whereas the use of this test may divert revenues for testing, this approach is in some respects complementary, and it is conceivable that
some clinicians may elect to get both forms of testing to have a more holistic assessment of both short term and lifetime risk.

 The best-known biomarker approach
is that embodied by the American Heart Association/American College of Cardiology Atherosclerotic Cardiovascular Risk Calculator (referred
to ASCVD risk calculator or Pooled Cohort Equation). This method integrates laboratory assessment of serum lipids, blood pressure and
self-reported health variables to impute 10-year risk for all forms of atherosclerotic cardiovascular disease (mainly CHD, but also stroke
and peripheral artery disease) using a standard algebraic equation. This is the most commonly used method of assessing CHD risk and enjoys
general acceptance by the medical community. It is perhaps the most direct competitor for our Epi+Gen CHD test. We believe that
our test has superior performance, does not require overnight fasting and will eventually provide greater information to the clinician
than this current market standard. In addition, we note that our test assesses risk over a three-year window rather than a 10-year window
which it believes is a more relevant period of time for patient management.

 Imaging modalities are also used
to assess risk for and detect CHD. Perhaps the most commonly used imaging method for predicting risk for CHD is Coronary Artery Calcium
("CAC") screening. In this method, a low intensity computed tomography ("CT") scan is taken of the heart. Then
using this data, the amount of calcium laden plaque is determined and the result used to assess 10-year risk for CHD. Strengths of this
approach include the general acceptance of the medical community. Weaknesses include the necessity of exposing patients to x-ray radiation
and the inability of the CAC test to monitor patient response. In many ways, this test competes with our test. At the same time, we note
that this test is not yet recommended as a primary method for screening low risk individuals, uses a longer risk assessment window, and
could actually be used as secondary testing to evaluate patients who are not found to be at low risk using Epi+Gen CHD or who are
flagged for CHD by the PrecisionCHD test.

 Proteomic methods, as exemplified by
serologic assessments of individual proteins such as c-reactive protein or of entire protein panels, such as that for the HART CADhs or
CVE tests from Prevencio are another risk assessment tool. The CADhs test is a good example of a proteomic competitor and predicts the
one-year risk for having 70% stenosis in a major coronary artery while another Prevencio test HART CVE, predicts one year risk for
individuals at risk for developing a major adverse cardiovascular event. Important differences between our tests and their offerings include
the window of prediction (three-year vs one-year), the type of technology employed (AI-guided interpretation of genotype and methylation
sensitive digital PCR results compared to algorithm interpretation of results from Luminex bead immunoassays). Because we believe that
digital PCR based methods are more scalable testing solutions than Luminex bead platforms, we believe that our approach has an advantage.

 Finally, researchers have described
methods to use wearable devices, such as the Huami wrist device, to predict risk for cardiovascular disease. Although people doubtlessly
use these and similar methods derived from wearable devices to assess risk, their exact clinical market penetrance is currently low, and
whether they would pose as a direct competitor for our test remains uncertain.

 However, the aforementioned is
only a snapshot of the current market space in which we currently compete and which we intend to compete in the future. Our intellectual
property claims include methods to develop tests for coronary heart disease, as well as incident and prevalent heart failure, stroke and
diabetes. The test for prevalent coronary heart disease, whose basis was published in 2018, is well underway, and we expect this test
to become a strong competitor for other methods of establishing current CHD, such as exercise treadmill testing, and for monitoring response
to CHD treatment.

 In summary, the cardiovascular
diagnostic space is extremely competitive and fast moving. We believe that the serum lipid, proteomic and to a certain extent, imaging-based
modalities are direct competitors for customers and enjoy both large existing market share and substantial financial backing. In addition,
it is clear that these existing alternative assessment strategies have significant degrees of scientific literature supporting their use,
enjoy backing from key medical constituencies for their use in certain circumstances, and have established strategies for obtaining third
party reimbursement. As the population ages, this competition is likely to increase. At the same time, we believe that there are important
differences between the current tests offered and our solutions with respect to clinical performance, window of clinical assessment, scalability,
capacity for assisting with interventions and response monitoring. However, the other technologies are not static, and we expect refinements
and/or combination of existing approaches to vigorously compete for customers in our business space. We will need to scale our efforts,
orient our organization appropriately and demonstrate that our products provide better value for our customers.

 Intellectual
 Property

 We have made broad
pending intellectual property ("IP") claims with respect to the use of epigenetic and gene-methylation interactions for the
assessment and monitoring of cardiovascular disease, specifically coronary heart disease, congestive heart failure and stroke, as well
as diabetes. Our portfolio falls into six patent families. The members of these patent families have been filed in the United States and
a number of foreign jurisdictions including Europe Union, Japan, India, Australia, United Arab Emirates, Saudi Arabia, Canada and China.
U.S., Patent Nos. 11,414,704 and 12,043,869, titled Compositions and Methods for Detecting Predisposition to Cardiovascular Disease, were
issued in 2022 and 2024, respectively, to the University of Iowa Research Foundation ("UIRF"), the co-inventors of which are
Dr. Dogan and Dr. Philibert, our Chief Executive Officer and Chief Medical Officer, respectively. The original patent family also includes
issued patents in Europe, China, Australia, India, and a number of other pending applications. We have a worldwide exclusive license agreement
with UIRF. Under UIRF's Inventions Policy, inventors are generally entitled to 25% of income from earnings from their inventions.
Consequently, Dr. Dogan and Dr. Philibert will benefit from this policy.

 Our issued and
pending patents cover general methods as well as key technological steps that enable these core approaches while facilitating the continued
patenting of material included in the patent applications. In addition to the technology licensed from UIRF, we have other patent applications
pending relating to improvements to our technology, which are potentially valuable and of possible strategic importance to the Company.
We expect to continue to file new patent applications to protect additional products and methodologies as they emerge.

 The initial work
on our AI-driven Integrated Genetic-Epigenetic Engine is derived from work done by our founders while at the University of Iowa.
Follow-on work on our core technology also is derived from work done by our founders while at the University of Iowa but was furthered
by our founders and Cardio's Chief Technology Officer independent of the University of Iowa. The follow-on work is described in
our second, third, fourth, fifth and sixth families of patent applications.

 The initial work
is described in the first family of patents and patent applications and is generally directed to a number of single nucleotide polymorphism
("SNP") biomarkers and a number of methylation site biomarkers that are associated with the presence or the early onset of
a number of cardiovascular diseases. The first family of patents and patent applications is owned solely by UIRF and is exclusively licensed
by Cardio. As of March 2025, this family includes twelve granted patents and eight pending patent applications. Any and all patents issuing
in this family will be solely owned by UIRF and, barring any changes to the UIRF exclusive license agreement, will fall under the exclusive
license to Cardio.

 The first family
is generally directed to biomarkers associated with cardiovascular disease. This family includes two issued patents in the US as well
as issued patents in the United Kingdom, France, Germany, Italy, Switzerland, Ireland, Hong Kong, Australia, China and India, and pending
applications in Australia, Canada, China, Europe, Hong Kong, Japan, and the US. The issued claims in the original US patent and in Australia,
China and India are directed to methods and/or compositions (e.g., kits) for determining the methylation status of at least one CpG dinucleotide
and the genotype of at least one single-nucleotide polymorphism (SNP) that use or include at least one primer for detecting the presence
or absence of methylation in a particular region of the genome (referred to as cg12586707) and at least one primer for detecting the presence
or absence of a SNP in a particular region of the genome (referred to as rs11597065). The issued claims in the EP patent are similarly
directed to compositions (e.g., a kit) for determining the methylation status of at least one CpG dinucleotide and a genotype of at least
one SNP that includes at least one primer that detects the presence or absence of methylation in a particular region of the genome (referred
to as cg26910465) and at least one primer that detects a SNP in a particular region of the genome (referred to as rs10275666) or another
SNP in linkage disequilibrium with the first SNP. The claims that issued in the second U.S. patent are directed to methods for determining
the methylation status of at least one CpG dinucleotide and the genotype of at least one SNP that includes at least one primer that detects
the presence or absence of methylation in a particular region of the genome (referred to as cg11964099) and at least one primer that detects
a SNP in a particular region of the genome (referred to as rs9988960). This family of patents is in-licensed under an exclusive license
agreement with UIRF, and is expected to expire in 2037, absent any applicable patent term adjustments or extensions.

 The second family
is generally directed to biomarkers associated with diabetes. This family includes pending applications in the U.S., Australia, United
Arab Emirates, Canada, China, Europe, Hong Kong, India, Japan, Saudi Arabia, and Singapore, with original claims directed to compositions
(e.g., a kit) that include at least one primer for determining the methylation status of at least one CpG dinucleotide from a group of
five different methylation sites, or a different CpG dinucleotide in linkage disequilibrium with one of the listed CpG dinucleotides,
and at least one primer for determining the genotype of at least one SNP from a group of five different SNPs, or a different SNP in linkage
disequilibrium with one of the listed SNPs. The pending applications also included original claims to methods of determining the presence
of biomarkers associated with diabetes, claims to a computer-readable medium for performing such methods, and claims to a system for determining
the methylation status of at least one CpG dinucleotide and the genotype of at least one SNP. This family is co-owned by Cardio Diagnostics
and UIRF, and the UIRF-owned portion is in-licensed under the same exclusive license agreement as the first family. Patents issuing from
this second family are expected to expire in 2041, absent any applicable patent term adjustments or extensions.

 The second family
of patent applications is co-owned by UIRF and Cardio, since Cardio expanded on and further refined the original research that was done
at the University of Iowa. The ownership of any and all patents that ultimately issue in this family will depend on the specific subject
matter that is claimed in each issued patent. For example, depending upon the specific biomarkers claimed and when those biomarkers were
identified ( e.g., during the initial work at the University of Iowa or during the follow-on work at Cardio), ownership could lie
solely with UIRF or Cardio, or ownership could be shared between UIRF and Cardio ( e.g., if a claimed biomarker was initially identified
at the University of Iowa and its significance with respect to diabetes was further refined by Cardio; or if one of the claimed biomarkers
was identified at the University of Iowa and another one of the claimed biomarkers was identified at Cardio).

 The third family
is generally directed to biomarkers associated with predicting a three-year incidence of cardiovascular disease. This family includes
applications pending in the U.S., Australia, United Arab Emirates, Canada, China, Europe, Hong Kong, India, Japan, Saudi Arabia, and Singapore,
with original claims directed to compositions (e.g., a kit) that include at least one primer for determining the methylation status of
at least one CpG dinucleotide from a group of three different methylation sites, or a different CpG dinucleotide in linkage disequilibrium
with one of the listed CpG dinucleotides, and at least one primer for determining the genotype of at least one SNP from a group of five
different SNPs, or a different SNP in linkage disequilibrium with one of the listed SNPs. The pending applications also included original
claims to methods of determining the presence of biomarkers associated with three-year incidence of cardiovascular disease, claims to
a computer-readable medium for performing such methods, and claims to a system for determining the methylation status of at least one
CpG dinucleotide and the genotype of a SNP. This family of patents is owned exclusively by Cardio Diagnostics. Patents issuing from this
third family are expected to expire in 2041, absent any applicable patent term adjustments or extensions.

 The fourth family
is generally directed to computer resources (e.g., a dashboard) designed by Cardio Diagnostics for use by their stakeholders (e.g., patients,
physicians, researchers, insurance companies, etc.). The computer resources are designed to provide results as well as information and
context related to Cardio Diagnostics tests and the specific biomarkers that are used. The pending claims are directed to methods of displaying
relevant information including genetic marker test results as well as probability analysis (based on, e.g., the population, age, and/or
gender of patients), and hyperlinks to relevant literature. The pending application also includes claims to computer-readable media containing
instructions for performing such methods and computer systems for executing such instructions. This family currently includes an International
PCT application and is solely owned by Cardio. Patents issuing from this fourth family are expected to expire in 2044, absent any applicable
patent term adjustments or extensions.

 The fifth family
is generally directed to biomarkers associated with detecting cardiovascular disease. The pending claims are directed to compositions
(e.g., a kit) that include at least one primer for determining the methylation status of at least one CpG dinucleotide from a group of
six different methylation sites, or a different CpG dinucleotide in linkage disequilibrium with one of the listed CpG dinucleotides, and
at least one primer for determining the genotype of at least one SNP from a group of ten different SNPs, or a different SNP in linkage
disequilibrium with one of the listed SNPs. The pending application also includes claims to methods of determining the presence of biomarkers
associated with detecting cardiovascular disease, claims to a computer- readable medium for performing such methods, and claims to a system
for determining the methylation status of at least one CpG dinucleotide and the genotype of a SNP. This family currently includes an International
PCT application, a U.S. utility application, and an Indian application and is solely owned by Cardio. Patents issuing from this fifth
family are expected to expire in 2044, absent any applicable patent term adjustments or extensions.

 The sixth family
is generally directed to an algorithm that can be used to predict mortality based on the methylation status of at least one CpG dinucleotide
and/or information obtained from cardio-imaging. The pending claims are directed to methods for predicting mortality based on the presence
of cardiovascular disease that include obtaining epigenetic data and/or image data and generating an output that includes a mortality
risk assessment for the subject. This family currently includes a pending US provisional application, which is owned solely by Cardio.
Patents issuing from the sixth family are expected to expire in 2045, absent any applicable patent term adjustments or extensions.

 The Exclusive License
Agreement entered into with UIRF and those licenses granted under that license agreement terminate on the expiration of the patent rights
licensed under the license agreement, unless certain proprietary, non-patented technical information is still being used by Cardio, in
which case the license agreement will not terminate until the date of termination of such use. The licenses under the license agreement
could terminate prior to the expiration of the licensed patent rights if we materially breach our obligations under the license agreement,
including failing to pay the applicable license fees and any interest on such fees, and failing to fully remedy such breach within the
period specified in the license agreement, or if we enter liquidation, have a receiver or administrator appointed over any assets related
to the license agreement, or if we cease to carry on business, file for bankruptcy or if an involuntary bankruptcy petition is filed against
Cardio.

 Additionally, we have considerable
IP in the form of trade secrets, including bioinformatics and high-performance computing techniques and artificial intelligence and machine
learning algorithms used to identify genetic and epigenetic biomarkers for various products and to interpret genetic and epigenetic data
from patient samples to generate clinically actionable information, as well as the methods to develop new methylation sensitive assays.
We protect our proprietary information, which includes, but is not limited to, trade secrets, know-how, and copyrights. Our future success
depends on protecting that knowledge, obtaining trademarks on our products, copyright on key materials, and avoiding infringing on the
IP rights of others. Where appropriate, we will assess the operating space and acquire licenses for critical technologies that we do not
possess or cannot create. We continue to invest in technological innovation and will seek mutualistic and symbiotic licensing opportunities
to promote and maintain our competitive position.

 In order to provide our products,
we currently use a variety of third party technologies including, for example, genotyping, digital methylation assessment and data processing
technologies. The terms of these agreements for the non-exclusive use of these technologies are subject to change without notice and could
affect our ability to deliver our solutions. In addition, from time to time, we may face claims from third parties asserting ownership
of, or demanding release of, the open-source software or derivative works that we developed using such software (which could include our
proprietary source code), or otherwise seeking to enforce the terms of the applicable open-source license. These claims could result in
litigation that could be costly to defend, have a negative effect on our operating results and financial condition or require us to devote
additional research and development resources to change our existing or future solutions. Responding to any infringement or noncompliance
claim by an open-source vendor, regardless of its validity, discovering certain open-source software code in our products, or a finding
that we have breached the terms of an open-source software license, could harm our business, results of operations and financial condition.
In each case, we would be required to either seek licenses to software or services from other parties and redesign our products to function
with such other parties' software or services or develop these components internally, which would result in increased costs and
could result in delays to product launches. Furthermore, we might be forced to limit the features available in our current or future solutions.

 Government
 Regulation

 The laboratory testing and
healthcare industry and the practice of medicine are extensively regulated at both the state and federal levels, and additionally, the
practice of medicine is similarly extensively regulated by the various states. Our ability to operate profitably will depend in part upon
its ability, and that of its vendor partners, to maintain all necessary licenses and to operate in compliance with applicable laws and
rules. Those laws and rules continue to evolve, and therefore we devote significant resources to monitoring relevant developments in FDA,
CLIA, healthcare and medical practice regulation. Those laws and rules include, but are not limited to, ones that govern the regulation
of clinical laboratories in general and the regulation of LDTs in particular. As discussed below, legislation has been introduced in Congress
that, if enacted, would substantially alter federal regulation of diagnostic tests, including LDTs. As the applicable laws and rules change,
we are likely to make conforming modifications in our business processes from time to time. In many jurisdictions where we operate, neither
our current nor our anticipated business model has been the subject of judicial or administrative interpretation. We cannot be assured
that a review of our business by courts or regulatory authorities will not result in determinations that could adversely affect our operations
or that the laboratory and healthcare regulatory environment will not change in a way that restricts our operations.

 State
and Federal Regulatory Issues

 Clinical Laboratory Improvement Amendments of 1988 and State
 Regulation

 Clinical laboratories are required
to hold certain federal and state licenses, certifications and permits to conduct our business. As to federal certifications, in 1988,
Congress passed the Clinical Laboratory Improvement Amendments of 1988, or ("CLIA"), establishing more rigorous quality standards
for all commercial laboratories that perform testing on human specimens for the purpose of providing information for the diagnosis, prevention,
or treatment of disease or the assessment of the health of human beings. CLIA requires such laboratories to be certified by the federal
government and mandates compliance with various operational, personnel, facilities administration, validation, quality and proficiency
testing requirements intended to ensure the accuracy, reliability and timeliness of patient test results. CLIA certification is also a
prerequisite to be eligible to bill state and federal healthcare programs, as well as many commercial third- party payers, for laboratory
testing services. The Centers for Medicare & Medicaid Services ("CMS") regulates laboratories that perform testing on
individuals in the U.S. through CLIA.

 Laboratories must comply with
all applicable CLIA requirements. If a clinical laboratory is found not to comply with CLIA standards, the government may impose sanctions,
limit or revoke the laboratory's CLIA certificate (and prohibit the owner, operator or laboratory director from owning, operating,
or directing a laboratory for two years following license revocation), subject the laboratory to a directed plan of correction, on-site
monitoring, civil monetary penalties, civil actions for injunctive relief, criminal penalties, or suspension or exclusion from the Medicare
and Medicaid programs.

 CLIA provides that a state
may adopt laboratory licensure requirements and regulations that are more stringent than those under federal law and requires compliance
with such laws and regulations. New York State in particular, has implemented its own more stringent laboratory regulatory requirements.
State laws may require the laboratory to obtain state licensure and/or laboratory personnel to meet certain qualifications, specify certain
quality control procedures or facility requirements, or prescribe record maintenance requirements. Moreover, several states impose the
same or similar state requirements on out-of-state laboratory testing specimens collected or received from, or test results reported back
to, residents within that state. Therefore, the laboratory is required to meet certain laboratory licensing requirements for those states
in which we offer services or from which we accept specimens and that have adopted regulations beyond CLIA. For more information on state
licensing requirements, see "— California Laboratory Licensing," "— New York Laboratory Licensing" and
"— Other State Laboratory Licensing Laws."

 California Laboratory Licensing

 In addition
to federal certification requirements for laboratories under CLIA, the laboratory is required under California law to maintain a California
state license and comply with California state laboratory laws and regulations. Similar to the federal CLIA regulations, the California
state laboratory laws and regulations establish standards for the operation of a clinical laboratory and performance of test services,
including the education and experience requirements of the laboratory director and personnel (including requirements for documentation
of competency), equipment validations, and quality Management practices. All testing personnel must maintain a California state license
or be supervised by licensed personnel.

 Clinical laboratories are subject
to both routine and complaint-initiated on-site inspections by the state. If a clinical laboratory is found to be out of compliance with
California laboratory standards, the California Department of Public Health ("CDPH"), may suspend, restrict or revoke the
California state laboratory license to operate the clinical laboratory (and exclude persons or entities from owning, operating, or directing
a laboratory for two years following license revocation), assess civil money penalties, and/or impose specific corrective action plans,
among other sanctions. Clinical laboratories must also provide notice to CDPH of any changes in the ownership, directorship, name or location
of the laboratory. Failure to provide such notification may result in revocation of the state license and sanctions under the CLIA program.
Any revocation of a CLIA certificate or exclusion from participation in Medicare or Medicaid programs may result in suspension of the
California state laboratory license.

 New York Laboratory Licensing

 We currently
do not conduct tests on specimens originating from New York State. In order to test specimens originating from, and return results to
New York State, a clinical laboratory is required to obtain a New York state laboratory permit and comply with New York state laboratory
laws and regulations. The New York state laboratory laws, regulations and rules are equal to or more stringent than the CLIA regulations
and establish standards for the operation of a clinical laboratory and performance of test services, including education and experience
requirements of a laboratory director and personnel, physical requirements of a laboratory facility, equipment validations, and quality
Management practices. The laboratory director(s) must maintain a Certificate of Qualification issued by the New York State Department
of Health ("NYS DOH") in the permitted test categories.

 A clinical
laboratory conducting tests on specimens originating in New York is subject to proficiency testing and on-site survey inspections conducted
by the Clinical Laboratory Evaluation Program ("CLEP") under the NYS DOH. If a laboratory is found to be out of compliance
with New York's CLEP standards, the NYS DOH, may suspend, limit, revoke or annul the New York laboratory permit, censure the holder
of the license or assess civil money penalties. Statutory or regulatory noncompliance may result in a laboratory's operator, owners
and/or laboratory director being found guilty of a misdemeanor under New York law. Clinical laboratories must also provide notice to
CLEP of any changes in ownership, directorship, name or location of the laboratory. Failure to provide such notification may result in
revocation of the state license and sanctions under the CLIA program. Any revocation of a CLIA certificate or exclusion from participation
in the Medicare or Medicaid programs may result in suspension of the New York laboratory permit.

 The NYS DOH also must approve each LDT before that test
is offered to patients located in New York.

 Other
State Laboratory Licensing Laws

 In addition to New York and California,
certain other states require licensing of out-of-state laboratories under certain circumstances. We have obtained licenses in the states
that we believe require us to do so and believe we are in compliance with applicable state laboratory licensing laws, including Maryland
and Pennsylvania. We currently do not conduct tests on specimens originating from Rhode Island.

 Potential sanctions for violation
of state statutes and regulations can include significant monetary fines, the rejection of license applications, the suspension or loss
of various licenses, certificates and authorizations, and in some cases criminal penalties, which could harm our business. CLIA does not
preempt state laws that have established laboratory quality standards that are more stringent than federal law.

 Laboratory-Developed
Tests

 The FDA generally considers an
LDT to be a test that is designed, manufactured, and used within a single laboratory that is certified under CLIA and meets the regulatory
requirements under CLIA to perform high complexity testing. LDTs are performed using a variety of laboratory instruments and reagents
and may also incorporate FDA-authorized in vitro diagnostics ("IVDs") that the laboratory modifies in some way and validates
for its new use. The FDA has historically taken the position that it has the authority to regulate LDTs as medical devices under the Federal
Food, Drug and Cosmetic Act ("FDC Act"), but it has generally exercised enforcement discretion with regard to LDTs. This means
that even though the FDA believes it can impose regulatory requirements on LDTs, such as requirements to obtain premarket approval, de
novo authorization, or 510(k) clearance of LDTs, it has generally chosen not to enforce those requirements to date. Although FDA has generally
exercised enforcement discretion for LDTs, the FDA has stated it retains discretion to require compliance with premarket when FDA deems
it appropriate to address significant public health concerns.

 On May 6,
2024, FDA published a final rule amending the definition of an in vitro diagnostic ("IVD") device to include tests manufactured
by a clinical laboratory. Pursuant to the rule, laboratory developed tests ("LDTs"), i.e., tests designed, manufactured,
and used within a single CLIA-certified high complexity laboratory, are medical devices subject to FDA regulation under the Federal Food,
Drug, and Cosmetic Act. The final rule also announced FDA's intention to apply its medical device requirements to LDTs. Under the
final rule, all LDTs, unless subject to a specific exemption, will be subject to premarket authorization requirements (510(k), de novo
classification, or PMA) for each LDT performed by the laboratory, and to postmarket registration and listing, medical device reporting,
correction, removal, and recall, complaint handling, labeling, investigational device, and quality system requirements. FDA intends to
phase in these requirements beginning May 6, 2025. The final rule states that certain categories of LDTs will be subject to enforcement
discretion with respect to some or all of these requirements. For example, FDA will apply enforcement discretion to currently marketed
LDTs that were first offered prior to May 6, 2024, with respect to most quality system requirements and the requirement for premarket
authorization if they are not modified or modified in only limited ways. Laboratories performing these tests are subject to other requirements,
including the requirement to submit the labeling for the LDT to FDA for review. FDA will similarly exercise enforcement discretion with
respect to premarket authorization for LDTs approved by the New York State Clinical Laboratory Evaluation Program ("NYS-CLEP").

 Unless overturned
by a court or Congress, or stayed or withdrawn by the new Administration, the final rule will substantially increase costs and regulatory
burdens for many clinical laboratories in ways that may adversely affect their ability to develop, perform, and offer LDTs. Two lawsuits
challenging FDA's authority to regulate LDTs have been filed in federal court: the American Clinical Laboratory Association filed
a lawsuit against FDA on May 29, 2024 in the Eastern District of Texas, while the Association for Molecular Pathology filed a lawsuit
on August 19, 2024 in the Southern District of Texas. The ultimate success of these lawsuits, which were subsequently consolidated, or
any future lawsuits that may be brought against the FDA challenging the LDT rule, is uncertain. It is also unclear whether a court would
delay the implementation of the final rule while the litigation is ongoing, which means we may need to initiate steps to comply with
the final rule even if it is ultimately overturned.

 Legislative
proposals addressing the FDA's oversight of LDTs have been previously introduced. In June 2021, Congress introduced the VALID Act,
which would have established a new risk-based regulatory framework for in vitro clinical tests ("IVCTs"), a category which
would have included IVDs, LDTs, collection devices and instruments used with such tests. FDA's new LDT final rule may renew attention
to the VALID Act or other legislation and may lead to the introduction of new proposals to limit the FDA's regulatory authority.
On July 12, 2024, the House Appropriations Committee issued a Report accompanying a FY 2025 appropriations bill in which it directed
the FDA to suspend efforts to implement the LDT final rule and to continue working with Congress to modernize the regulatory approach
for LDTs. This directive is not binding on the FDA.

 The change
in Administration and in Congress could significantly affect FDA's ability to implement the final rule or to otherwise regulate
LDTs. For example, the Department of Health and Human Services, which oversees FDA, could stay enforcement of the rule or seek to rescind
the final rule, or could direct FDA to not regulate LDTs as medical devices. Separately, Congress could enact legislation aimed at preventing
FDA from regulating LDTs and/or assigning oversight of LDTs to a different agency.

 As mentioned
above, separately, CMS oversees clinical laboratory operations through the CLIA program.

 Regulation by the U.S. Food and Drug Administration

 Should the FDA decide to no longer
exercise enforcement discretion for LDTs, LDTs would be subject to extensive regulation as medical devices under the FDC Act and its implementing
regulations, which govern, among other things, medical device development, testing, labeling, storage, premarket clearance or approval,
advertising and promotion and product sales and distribution. To be commercially distributed in the United States, medical devices, including
some collection devices used to collect samples for testing, and certain types of software, must receive from the FDA prior to marketing,
unless subject to an exemption, clearance of a premarket notification ("510(k) clearance"), premarket approval ("PMA"),
or a de novo authorization.

 IVDs are a type of medical device
that are intended to be used in the diagnosis or detection of diseases or conditions, including a determination of the state of health,
through collection, preparation and examination of specimens taken from the human body. IVDs may be used to detect the presence of certain
chemicals, genetic information or other biomarkers related to diagnosis or detection of diseases or conditions. IVDs may include tests
for disease prediction, prognosis, diagnosis, and screening.

 The FDC Act classifies medical
devices into one of three categories based on the risks associated with the device and the level of control necessary to provide reasonable
assurance of safety and effectiveness. Class I devices are deemed to be low risk and are subject to the fewest regulatory controls. Many
Class I devices are exempt from FDA premarket review requirements. Class II devices, including some software products to the extent that
they qualify as a device, are deemed to be moderate risk, and generally require clearance through the premarket notification, or 510(k)
clearance, process. Class III devices are generally the highest risk devices and are subject to the highest level of regulatory control
to provide reasonable assurance of the device's safety and effectiveness. Class III devices typically require a PMA by the FDA before
they are marketed. A clinical trial is almost always required to support a PMA application or de novo authorization and is sometimes required
for 510(k) clearance. All clinical studies of investigational devices must be conducted in compliance with any applicable FDA and Institutional
Review Board requirements. Devices that are exempt from FDA premarket review requirements must nonetheless comply with post-market general
controls as described below, unless the FDA has indicated otherwise.

 510(k) clearance pathway.
 To obtain 510(k) clearance, a manufacturer must submit a premarket notification demonstrating to the FDA's satisfaction that
the new device is substantially equivalent to a "predicate device." A predicate device is a legally marketed device to which
a new device may be compared to for a determination regarding substantial equivalence. A legally marketed device is a device that was
previously 510(k)-cleared, a device that received de novo authorization, or a device that was in commercial distribution before May 28,
1976 for which the FDA has not called for submission of a PMA application. The FDA's 510(k) clearance pathway usually takes from
three to 12 months from submission, but it can take longer, particularly for a novel type of product.

 PMA pathway. The PMA pathway
requires proof of the safety and effectiveness of the device to the FDA's satisfaction. The PMA pathway is costly, lengthy, and
uncertain. A PMA application must provide extensive preclinical and clinical trial data as well as information about the device and its
components regarding, among other things, device design, manufacturing, and labeling. As part of its PMA review process, the FDA will
typically inspect the manufacturer's facilities for compliance with QSR requirements, which impose extensive testing, control, documentation,
and other quality assurance procedures. The PMA review process typically takes one to three years from submission but can take longer.

 De novo
pathway. If no predicate device can be identified, a device is automatically classified as Class III, requiring a PMA application. However,
the FDA can reclassify, either on its own initiative or in response to a request for de novo classification, for a device for which there
was no predicate device if the device is low- or moderate-risk. If the device is reclassified as Class II, the FDA will identify special
controls that the manufacturer must implement, which may include labeling, testing, performance standards, or other requirements. Subsequent
applicants can rely upon the de novo device as a predicate for a 510(k) clearance, unless the FDA exempts subsequent devices from the
need for a 510(k). The de novo route is intended to be less burdensome than the PMA process.

 Post-market general controls.
After a device, including a device exempt from FDA premarket review, is placed on the market, numerous regulatory requirements apply.
These include: the QSR, labeling regulations, registration and listing, the Medical Device Reporting regulation (which requires that manufacturers
report to the FDA if their device may have caused or contributed to a death or serious injury or malfunctioned in a way that would likely
cause or contribute to a death or serious injury if it were to recur), and the Reports of Corrections and Removals regulation (which requires
manufacturers to report to the FDA corrective actions made to, or removal of, products in the field, if such actions were initiated to
reduce a risk to health posed by the device or to remedy a violation of the FDC Act which may present a health risk). Depending on the
severity of the legal violation that led to correction or removal, the FDA may classify the manufacturer's action as a recall.

 The FDA enforces compliance with
its requirements through inspection and market surveillance. If the FDA finds a violation, it can institute a wide variety of actions,
ranging from an untitled or warning letter sent to manufacturers to enforcement actions such as fines, injunctions, and civil penalties;
recall or seizure of products; operating restrictions, partial suspension or total shutdown of production; refusing requests for 510(k)
clearance or PMA approval of new products; withdrawal of PMAs already granted; and criminal prosecution.

 The FDA has become increasingly
active in addressing the regulation of software used to support clinical decision making. In 2016, the 21st Century Cures Act, (the "Cures
Act"), among other things, amended the medical device definition in the FDC Act to exclude certain software from FDA regulation,
including clinical decision support ("CDS software") that meets certain criteria. CDS software is exempt from the medical
device definition if it: (a) displays, analyzes or prints medical information about a patient or other medical information; (b) is intended
for the purpose of supporting or providing recommendations about a patient's care to a health care professional, ("HCP"),
user; and (c) provides sufficient information about the basis for the recommendations to the HCP user, so that the HCP user does not rely
primarily on any of the recommendations to make a clinical decision about an individual patient; unless (d) the software function acquires,
processes, or analyzes a medical image, a signal from an in vitro diagnostic device, or a pattern or signal from a signal acquisition
system.

 On September 28, 2022, the
FDA issued a final guidance document interpreting the Cures Act as it pertains to CDS software. Among other views expressed, the final
guidance stated that software functions that assess or interpret the clinical implications or clinical relevance of a signal or pattern,
such as those that process or analyze an electrochemical or photometric response generated by an assay and instrument to generate a clinical
test result, are not exempt from medical device regulation. The final guidance also stated that software functions that generate risk
probabilities or risk scores are not exempt because they provide a specific diagnostic, preventive, or treatment output.

 Corporate
Practice of Medicine; Fee- Splitting

 We contract with various healthcare
companies to deliver services to patients. This contractual relationship is subject to various state laws, including those of New York,
Texas and California, that prohibit fee-splitting or the practice of medicine by lay entities or persons and are intended to prevent unlicensed
persons from interfering with or influencing the physician's professional judgment. In addition, various state laws also generally
prohibit the sharing of professional services income with nonprofessional or business interests. Activities other than those directly
related to the delivery of healthcare may be considered an element of the practice of medicine in many states. Under the corporate practice
of medicine restrictions of certain states, decisions and activities such as scheduling, contracting, setting rates and the hiring and
management of non-clinical personnel may implicate the restrictions on the corporate practice of medicine.

 State corporate practice of medicine
and fee-splitting laws vary from state to state and are not always consistent among states. In addition, these requirements are subject
to broad powers of interpretation and enforcement by state regulators. Some of these requirements may apply to any telemedicine company
or provider organization we contract with. Failure to comply with regulations could lead to adverse judicial or administrative action
against us and/or the providers we work with, civil or criminal penalties, receipt of cease-and-desist orders from state regulators, loss
of provider licenses, the need to make changes to the terms of engagement with any telemedicine company or provider organization we contract
with that interfere with our business and other materially adverse consequences.

 Federal
and State Fraud and Abuse Laws

 Healthcare Laws Generally

 The federal Health Insurance Portability
and Accountability Act of 1996, as amended by the Health Information Technology for Economic and Clinical Health Act, or HITECH, and their
implementing regulations, which is collectively referred to as HIPAA, established several separate criminal penalties for making false
or fraudulent claims to insurance companies and other non- governmental payors of healthcare services. Under HIPAA, these two additional
federal crimes are: "Healthcare Fraud" and "False Statements Relating to Healthcare Matters." The Healthcare Fraud
statute prohibits knowingly and recklessly executing a scheme or artifice to defraud any healthcare benefit program, including private
payors. A violation of this statute is a felony and may result in fines, imprisonment or exclusion from government-sponsored programs.
The False Statements Relating to Healthcare Matters statute prohibits knowingly and willfully falsifying, concealing or covering up a
material fact by any trick, scheme or device or making any materially false, fictitious or fraudulent statement in connection with the
delivery of or payment for healthcare benefits, items or services. A violation of this statute is a felony and may result in fines or
imprisonment. This statute could be used by the government to assert criminal liability if a healthcare provider knowingly fails to refund
an overpayment. These provisions are intended to punish some of the same conduct in the submission of claims to private payors as the
federal False Claims Act covers in connection with governmental health programs.

 In addition, the Civil Monetary
Penalties Law imposes civil administrative sanctions for, among other violations, inappropriate billing of services to federally funded
healthcare programs and employing or contracting with individuals or entities who are excluded from participation in federally funded
healthcare programs. Moreover, a person who offers or transfers to a Medicare or Medicaid beneficiary any remuneration, including waivers
of co-payments and deductible amounts (or any part thereof), that the person knows or should know is likely to influence the beneficiary's
selection of a particular provider, practitioner or supplier of Medicare or Medicaid payable items or services may be liable for civil
monetary penalties of up to $10,000 for each wrongful act. Moreover, in certain cases, providers who routinely waive copayments and deductibles
for Medicare and Medicaid beneficiaries can also be held liable under the Anti-Kickback Statute and civil False Claims Act, which can
impose additional penalties associated with the wrongful act. One of the statutory exceptions to the prohibition is non-routine, unadvertised
waivers of copayments or deductible amounts based on individualized determinations of financial need or exhaustion of reasonable collection
efforts. The OIG emphasizes, however, that this exception should only be used occasionally to address special financial needs of a particular
patient. Although this prohibition applies only to federal healthcare program beneficiaries, the routine waivers of copayments and deductibles
offered to patients covered by commercial payers may implicate applicable state laws related to, among other things, unlawful schemes
to defraud, excessive fees for services, tortious interference with patient contracts and statutory or common law fraud.

 Federal Stark Law

 We are subject to the federal
self-referral prohibitions, commonly known as the Stark Law. Where applicable, this law prohibits a physician from referring Medicare
patients to an entity providing "designated health services" if the physician or a member of such physician's immediate
family has a "financial relationship" with the entity, unless an exception applies. The penalties for violating the Stark Law
include the denial of payment for services ordered in violation of the statute, mandatory refunds of any sums paid for such services,
civil penalties of up to $15,000 for each violation and twice the dollar value of each such service and possible exclusion from future
participation in the federally-funded healthcare programs. A person who engages in a scheme to circumvent the Stark Law's prohibitions
may be fined up to $100,000 for each applicable arrangement or scheme. The Stark Law is a strict liability statute, which means proof
of specific intent to violate the law is not required. In addition, the government and some courts have taken the position that claims
presented in violation of the various statutes, including the Stark Law can be considered a violation of the federal False Claims Act
(described below) based on the contention that a provider impliedly certifies compliance with all applicable laws, regulations and other
rules when submitting claims for reimbursement. A determination of liability under the Stark Law could have a material adverse effect
on our business, financial condition and results of operations.

 Federal Anti-Kickback Statute

 We are also subject to the federal
Anti-Kickback Statute. The Anti-Kickback Statute is broadly worded and prohibits the knowing and willful offer, payment, solicitation
or receipt of any form of remuneration in return for, or to induce, (i) the referral of a person covered by Medicare, Medicaid or other
governmental programs, (ii) the furnishing or arranging for the furnishing of items or services reimbursable under Medicare, Medicaid
or other governmental programs or (iii) the purchasing, leasing or ordering or arranging or recommending purchasing, leasing or ordering
of any item or service reimbursable under Medicare, Medicaid or other governmental programs. Certain federal courts have held that the
Anti-Kickback Statute can be violated if "one purpose" of a payment is to induce referrals. In addition, a person or entity
does not need to have actual knowledge of this statute or specific intent to violate it to have committed a violation, making it easier
for the government to prove that a defendant had the requisite state of mind or "scienter" required for a violation. Moreover,
the government may assert that a claim including items or services resulting from a violation of the Anti-Kickback Statute constitutes
a false or fraudulent claim for purposes of the False Claims Act, as discussed below. Violations of the Anti- Kickback Statute can result
in exclusion from Medicare, Medicaid or other governmental programs as well as civil and criminal penalties, including fines of $50,000
per violation and three times the amount of the unlawful remuneration. Imposition of any of these remedies could have a material adverse
effect on our business, financial condition and results of operations. In addition to a few statutory exceptions, the U.S. Department
of Health and Human Services Office of Inspector General, or OIG, has published safe-harbor regulations that outline categories of activities
that are deemed protected from prosecution under the Anti-Kickback Statute provided all applicable criteria are met. The failure of a
financial relationship to meet all of the applicable safe harbor criteria does not necessarily mean that the particular arrangement violates
the Anti-Kickback Statute. However, conduct and business arrangements that do not fully satisfy each applicable safe harbor may result
in increased scrutiny by government enforcement authorities, such as the OIG.

 False Claims Act

 Both federal and state government
agencies have continued civil and criminal enforcement efforts as part of numerous ongoing investigations of healthcare companies and
their executives and managers. Although there are a number of civil and criminal statutes that can be applied to healthcare providers,
a significant number of these investigations involve the federal False Claims Act. These investigations can be initiated not only by the
government but also by a private party asserting direct knowledge of fraud. These "qui tam" whistleblower lawsuits may be initiated
against any person or entity alleging such person or entity has knowingly or recklessly presented, or caused to be presented, a false
or fraudulent request for payment from the federal government or has made a false statement or used a false record to get a claim approved.
In addition, the improper retention of an overpayment for 60 days or more is also a basis for a False Claim Act action, even if the claim
was originally submitted appropriately. Penalties for False Claims Act violations include fines ranging from $5,500 to $11,000 for each
false claim, plus up to three times the amount of damages sustained by the federal government. A False Claims Act violation may provide
the basis for exclusion from the federally-funded healthcare programs. In addition, some states have adopted similar fraud, whistleblower
and false claims provisions.

 State
Fraud and Abuse Laws

 Several states in which we
operate have also adopted similar fraud and abuse laws as described above. The scope of these laws and the interpretations of them vary
from state to state and are enforced by state courts and regulatory authorities, each with broad discretion. Some state fraud and abuse
laws apply to items or services reimbursed by any third-party payor, including commercial insurers, not just those reimbursed by a federally-funded
healthcare program. A determination of liability under such state fraud and abuse laws could result in fines and penalties and restrictions
on our ability to operate in these jurisdictions.

 State
and Federal Health Information Privacy and Security Laws

 There are numerous U.S. federal
and state laws and regulations related to the privacy and security of personally identifiable information, or PII, including health information.
In particular, HIPAA establishes privacy and security standards that limit the use and disclosure of protected health information, or
PHI, and require the implementation of administrative, physical, and technical safeguards to ensure the confidentiality, integrity and
availability of individually identifiable health information in electronic form. Since the effective date of the HIPAA Omnibus Final Rule
on September 23, 2013, HIPAA's requirements are also directly applicable to the independent contractors, agents and other "business
associates" of covered entities that create, receive, maintain or transmit PHI in connection with providing services to covered
entities. Although Cardio is a covered entity under HIPAA, Cardio is also a business associate of other covered entities when Cardio is
working on behalf of our affiliated medical groups.

 Violations of HIPAA may result in civil
and criminal penalties. The civil penalties range from $100 to $50,000 per violation, with a cap of $1.5 million per year for violations
of the same standard during the same calendar year. However, a single breach incident can result in violations of multiple standards.
Cardio must also comply with HIPAA's breach notification rule. Under the breach notification rule, covered entities must notify
affected individuals without unreasonable delay in the case of a breach of unsecured PHI, which may compromise the privacy, security or
integrity of the PHI. In addition, notification must be provided to the HHS and the local media in cases where a breach affects more than
500 individuals. Breaches affecting fewer than 500 individuals must be reported to HHS on an annual basis. The regulations also require
business associates of covered entities to notify the covered entity of breaches by the business associate.

 State attorneys general also
have the right to prosecute HIPAA violations committed against residents of their states. While HIPAA does not create a private right
of action that would allow individuals to sue in civil court for a HIPAA violation, its standards have been used as the basis for the
duty of care in state civil suits, such as those for negligence or recklessness in misusing personal information. In addition, HIPAA mandates
that HHS conduct periodic compliance audits of HIPAA covered entities and their business associates for compliance. It also tasks HHS
with establishing a methodology whereby harmed individuals who were the victims of breaches of unsecured PHI may receive a percentage
of the Civil Monetary Penalty fine paid by the violator. In light of the HIPAA Omnibus Final Rule, recent enforcement activity, and statements
from HHS, we expect increased federal and state HIPAA privacy and security enforcement efforts.

 HIPAA also required HHS to adopt
national standards establishing electronic transaction standards that all healthcare providers must use when submitting or receiving certain
healthcare transactions electronically. On January 16, 2009, HHS released the final rule mandating that everyone covered by HIPAA must
implement ICD-10 for medical coding on October 1, 2013, which was subsequently extended to October 1, 2015 and is now in effect.

 Many states in which we operate
and in which patients reside also have laws that protect the privacy and security of sensitive and personal information, including health
information. These laws may be similar to or even more protective than HIPAA and other federal privacy laws. For example, the laws of
the State of California, in which we operate, are more restrictive than HIPAA. Where state laws are more protective than HIPAA, we must
comply with the state laws we are subject to, in addition to HIPAA. In certain cases, it may be necessary to modify our planned operations
and procedures to comply with these more stringent state laws. Not only may some of these state laws impose fines and penalties upon violators,
but also some, unlike HIPAA, may afford private rights of action to individuals who believe their personal information has been misused.
In addition, state laws are changing rapidly, and there is discussion of a new federal privacy law or federal breach notification law,
to which we may be subject.

 In addition to HIPAA, state
health information privacy and state health information privacy laws, we may be subject to other state and federal privacy laws, including
laws that prohibit unfair privacy and security practices and deceptive statements about privacy and security and laws that place specific
requirements on certain types of activities, such as data security and texting.

 In recent years, there have been
a number of well-publicized data breaches involving the improper use and disclosure of PII and PHI. Many states have responded to these
incidents by enacting laws requiring holders of personal information to maintain safeguards and to take certain actions in response to
a data breach, such as providing prompt notification of the breach to affected individuals and state officials. In addition, under HIPAA
and pursuant to the related contracts that we enter into with our business associates, we must report breaches of unsecured PHI to our
contractual partners following discovery of the breach. Notification must also be made in certain circumstances to affected individuals,
federal authorities and others.

 State
Privacy Laws

 Various states have enacted laws
governing the privacy of personal information collected and used by businesses online. For example, California adopted the California
Consumer Privacy Act of 2018 ("CCPA"), which went into effect on January 1, 2020 and was recently amended by the California
Privacy Rights Act of 2020 which significantly modified the CCPA in ways that affect businesses. This law, in part, requires that companies
make certain disclosures to consumers via their privacy policies, or otherwise at the time the personal data is collected. We will have
to determine what personal data it is collecting from individuals and for what purposes, and to update its privacy policy every 12 months
to make the required disclosures, among other things.

 Employees
and Human Capital Resources

2025 we had 13 full-time employees and two part-time employees. Three of our employees hold Ph. D. or M.D. degrees. We also engage contractors
and consultants from time to time. None of our employees are represented by a labor union or covered under a collective bargaining agreement.

 Our human capital
resources objectives include, identifying, recruiting, retaining, incentivizing and integrating our existing and additional employees
into our collaborative culture. Our compensation program is designed to retain, motivate and attract highly qualified executives and talented
employees and consultants. We are committed to fostering a culture that supports diversity and an environment of mutual respect, equity
and collaboration that helps drive our business and our mission to become one of the leading medical technology companies for enabling
improved prevention, detection, treatment and management of cardiovascular disease.

 Corporation Information

 Our corporate headquarters
is located at 311 W. Superior St. Suite 444, Chicago IL. Our telephone number is (855) 226-9991 and our website address is cdio.ai. The
information contained on, or that can be accessed through, our website is not incorporated by reference in this Annual Report on Form
10-K and does not form a part of this Annual Report on Form 10-K. The reference to our website address does not constitute incorporation
by reference of the information contained at or available through our website, and you should not consider it to be a part of this registration
statement.

 Emerging
Growth Status

 We are an "emerging
growth company, " as defined in Section 2(a) of the Securities Act, as modified by the Jumpstart Our Business Startups Act
of 2012 (the "JOBS Act"), and we may take advantage of certain exemptions from various reporting requirements that are applicable
to other public companies that are not emerging growth companies, including, but not limited to, not being required to comply with the
auditor attestation requirements of Section 404 of the Sarbanes-Oxley Act of 2002, as amended (the "Sarbanes-Oxley Act"),
reduced disclosure obligations regarding executive compensation in our periodic reports and proxy statements, and exemptions from the
requirements of holding a nonbinding advisory vote on executive compensation and stockholder approval of any golden parachute payments
not previously approved.

 Further, Section 102(b)(1)
of the JOBS Act exempts emerging growth companies from being required to comply with new or revised financial accounting standards until
private companies (that is, those that have not had a registration statement under the Securities Act declared effective or do not have
a class of securities registered under the Securities Exchange Act of 1934, as amended the "Exchange Act"), are required to
comply with the new or revised financial accounting standards. The JOBS Act provides that a company can elect to opt out of the extended
transition period and comply with the requirements that apply to non-emerging growth companies but any such an election to opt out is
irrevocable. We have elected not to opt out of such extended transition period which means that when a standard is issued or revised and
it has different application dates for public or private companies, we, as an emerging growth company, can adopt the new or revised standard
at the time private companies adopt the new or revised standard. This may make comparison of our financial statements with another public
company which is neither an emerging growth company nor an emerging growth company which has opted out of using the extended transition
period difficult or impossible because of the potential differences in accounting standards used.

 We will
remain an emerging growth company until the earlier of (1) the last day of the fiscal year (a) following the fifth anniversary of the
completion of the IPO, (b) in which we have total annual gross revenue of at least $1.07 billion, or (c) in which we are deemed to be
a large accelerated filer, which means the market value of our Common Stock held by non-affiliates equaled or exceeded $700 million as
of the prior June 30, and (2) the date on which we have issued more than $1.0 billion in non-convertible debt securities during the prior
three-year period.

 Additionally, we are a "smaller
reporting company" as defined in Item 10(f)(1) of Regulation S-K. Smaller reporting companies may take advantage of certain reduced
disclosure obligations, including, among other things, providing only two years of audited financial statements. We will remain a smaller
reporting company until the last day of the fiscal year in which (1) the market value of our Common Stock held by non-affiliates equaled
or exceeded $250 million as of the end of the prior June 30th, or (2) our annual revenues equaled or exceeded $100 million during such
completed fiscal year and the market value of our Common Stock held by non-affiliates equaled or exceeded $700 million as of the prior
June 30th.

 Available
Information

 We are required
to file Annual Reports on Form 10-K and Quarterly Reports on Form 10-Q with the SEC on a regular basis, and are required to disclose
certain material events in a Current Report on Form 8-K. The SEC maintains an Internet website that contains reports, proxy and information
statements and other information regarding issuers that file electronically with the SEC. The SEC's Internet website is located
at www.sec.gov. In addition, the Company will provide copies of these documents without charge upon request from us in writing at 311
West Superior Street, Suite 444, Chicago IL 60654.

 Item
 1A. Risk Factors

 RISK FACTORS

 Investing in our securities
involves risks. You should carefully consider the risks and uncertainties described below and the other information in this Annual Report
on Form 10-K before making an investment in our Common Stock. Our business, financial condition, results of operations, or prospects could
be materially and adversely affected if any of these risks occurs, and as a result, the market price of our Common Stock could decline
and you could lose all or part of your investment. This Annual Report on Form 10-K also contains forward-looking statements that involve
risks and uncertainties. See "Cautionary Statement Regarding Forward-Looking Statements." Our actual results could differ
materially and adversely from those anticipated in these forward-looking statements as a result of certain factors, including those set
forth below.

 Risks
Related to Our Limited Operating History and Early Stage of Growth

 We are a medical diagnostic testing company
with a limited operating history and have not yet generated significant revenue from product sales. We have incurred operating losses
since our inception and may never achieve or maintain profitability.

 We have generated
only nominal revenue in 2023 and 2024, including $17,065 in revenue generated in 2023 and $34,890 in revenue generated in 2024. Our net
losses totaled $8,376,834 and $8,383,453 for the years ended December 31, 2023 and 2024, respectively, and we have an accumulated deficit
of $22,751,833 at December 31, 2024. We expect losses to continue as a result of our ongoing activities to increase the adoption of our
products, to gain market recognition and acceptance of our products, to expand our marketing channels and otherwise position ourselves
to grow our revenue opportunities, all of which will require hiring additional employees as well as other significant expenses. We are
unable to predict when we will become profitable, and it is possible that we may never become profitable. We may encounter unforeseen
expenses, difficulties, complications, delays, and other unknown factors that may adversely affect our business. The size of our future
net losses will depend, in part, on the rate of future growth of our expenses, which we expect to increase substantially as a public company,
and on our ability to generate revenue. Even if we achieve profitability in the future, we may not be able to sustain profitability in
subsequent periods. If additional capital is not available when required, if at all, or is not available on acceptable terms, we could
be forced to modify or abandon our current business plan.

 We believe our long-term value as a company will be greater
if we focus on growth, which may negatively impact our results of operations in the near term.

 We believe our long-term value
as a company will be greater if we focus on longer-term growth over short-term results. As a result, our results of operations may be
negatively impacted in the near term relative to a strategy focused on maximizing short-term profitability. Significant expenditures on
marketing efforts, potential acquisitions and other expansion efforts may not ultimately grow our business or lead to expected long-term
results.

 Our business and the markets in which we operate are new
and rapidly evolving, which makes it difficult to evaluate our future prospects and the risks and challenges we may encounter.

 Our business and the markets in which
we operate are new and rapidly evolving, which make it difficult to evaluate and assess the success of our business to date, our future
prospects and the risks and challenges that we may encounter. These risks and challenges include our ability to:

 attract new customers for our tests through patient awareness, sales and marketing campaigns, as well
as through key channel partners;

 gain market acceptance of our current and future tests and services with key constituencies and maintain
and expand such relationships;

 comply with existing and new laws and regulations applicable to our business and in our industry;

 anticipate and respond to changes in payor reimbursement rates and the markets in which we operate;

 react to challenges from existing and new competitors;

 maintain and enhance our reputation and brand;

 effectively manage our growth and business operations, including new geographies;

 accurately forecast our revenue and budget for, and manage, our expenses, including capital expenditures;
 and

 hire and retain talented individuals at all levels of our organization;

 If we fail to understand fully
or adequately address the challenges that we are currently encountering or that we may encounter in the future, including those challenges
described here and elsewhere in this "Risk Factors" section, our business, financial condition and results of operations could
be adversely affected. If the risks and uncertainties that we plan for when operating our business are incorrect or change, or if we fail
to manage these risks successfully, our results of operations could differ materially from our expectations and our business, financial
condition and results of operations could be adversely affected.

 Our limited
operating history make it difficult to evaluate our future prospects and the risks and challenges we may encounter.

 We were established in 2017 and
we are continuing to grow our marketing and management capabilities. Consequently, predictions about our future success or viability may
not be as accurate as they could be if we had a longer operating history. The evolving nature of the medical diagnostics industry increases
these uncertainties. If our growth strategy is not successful, we may not be able to continue to grow our revenue or operations. Our limited
operating history, evolving business and growth make it difficult to evaluate our future prospects and the risks and challenges we may
encounter.

 In addition, as a business with a limited
operating history, we may encounter unforeseen expenses, difficulties, complications, delays and other known and unknown challenges. We
are not be successful at commercialization, sales and marketing and, as a result, our business may be adversely affected.

 Our quarterly results may fluctuate significantly and may
not fully reflect the underlying performance of our business.

 Our results of operations and
key metrics discussed elsewhere in this Annual Report on Form 10-K may vary significantly in the future and period-to-period comparisons
of our operating results and key metrics may not provide a full picture of our performance. Accordingly, the results of any one quarter
or year should not be relied upon as an indication of future performance. Our quarterly financial results and metrics may fluctuate as
a result of a variety of factors, many of which are outside of our control, and as a result they may not fully reflect the underlying
performance of our business. These quarterly fluctuations may negatively affect the value of our securities. Factors that may cause these
fluctuations include, without limitation:

 the level of demand for our tests and services, which may vary significantly from period to period;

 our ability to attract new customers, whether patients or strategic channel partners or other customers;

 the timing of recognition of revenues;

 the amount and timing of operating expenses;

 general economic, industry and market conditions, both domestically and
internationally, including any economic downturns and adverse impacts resulting from the COVID- 19 pandemic and/or the military conflict
between Russia and Ukraine;

 the timing of our billing and collections;

 adoption rates by participants in our key channels;

 increases or decreases in the number of patients, providers and organizations
that use our tests or pricing changes upon any signing and renewals of agreements with healthcare sub-vertical channel partners;

 changes in our pricing policies or those of our competitors;

 the timing and success of new offerings by us or our competitors or
 any other change in the competitive dynamics of our industry, including consolidation among competitors, practitioners, clinics or
 outsourcing facilities; extraordinary expenses such as litigation or other dispute-related expenses or settlement payments;

 extraordinary expenses such as litigation or other dispute-related expenses or settlement payments;

 sales tax and other tax determinations by authorities in the jurisdictions in which we conduct business;

 the impact of new accounting pronouncements and the adoption thereof;

 fluctuations in stock-based compensation expenses;

 expenses in connection with mergers, acquisitions or other strategic transactions;

 changes in regulatory and licensing requirements;

 the amount and timing of expenses related to our expansion to markets outside the United States; and

 the timing of expenses related to the development or acquisition of technologies
or businesses and potential future charges for impairment of goodwill or intangibles from acquired companies.

 Further, in any future period,
our revenue growth could slow or our revenues could decline for a number of reasons, including slowing demand for our tests and services,
increasing competition, a decrease in the growth of our overall market, or our failure, for any reason, to continue to capitalize on growth
opportunities. In addition, our growth rate may slow in the future as our market penetration rates increase. As a result, our revenues,
operating results and cash flows may fluctuate significantly on a quarterly basis and revenue growth rates may not be sustainable and
may decline in the future, and we may not be able to achieve or sustain profitability in future periods, which could harm our business
and cause the market price of our Common Stock to decline.

 We expect
to need to raise additional capital to fund our existing operations or develop and commercialize new services or expand our operations.

 We expect to spend significant
amounts to expand our existing operations, including expansion into new geographies, to make additional key hires, to expand our sales
channels and constituencies and to develop new tests and services. If we are unable to raise additional capital, we may need to delay
the timing of, or scale back, certain aspects of our business plan and operations. The estimate and our expectation regarding the sufficiency
of funds to continue our business plan and operations are based on assumptions that may prove to be wrong, and we could use our available
capital resources sooner than we currently expect. Until such time, if ever, as we can generate sufficient revenues, we may finance our
cash needs through a combination of equity offerings and debt financings or other sources. In addition, we may seek additional capital
due to favorable market conditions or strategic considerations, even if we believe that we have sufficient funds for our current or future
operating plans.

 Our present and future funding requirements will depend on many
factors, including:

 our ability to achieve revenue growth;

 our ability to effectively manage our expenses and burn;

 the cost of expanding our operations, including our geographic scope, and our offerings, including our
marketing efforts;

 our rate of progress in launching, commercializing and establishing adoption of our tests and services;
 and

 the effect of competing technological and market developments.

 To the extent that we raise
additional capital through the sale of equity or convertible debt securities, your ownership interest will be diluted, and the terms of
these securities may include liquidation or other preferences that adversely affect your rights as a securityholder. In addition, debt
financing and preferred equity financing, if available, may involve agreements that include covenants limiting or restricting our ability
to take specific actions, such as incurring additional debt, making capital expenditures or declaring dividends. If we raise additional
funds through collaborations, strategic alliances or marketing, distribution or licensing arrangements with third parties, we may be required
to relinquish valuable rights to our technologies, intellectual property, or future revenue streams or grant licenses on terms that may
not be favorable to us. Furthermore, any capital raising efforts may divert our management from their day-to-day activities, which may
adversely affect our ability to advance development activities. If we need additional capital and cannot raise it on acceptable terms,
or at all, we may not be able to, among other things:

 invest in our business and continue to grow our brand and expand our customer and patient bases;

 hire and retain employees, including scientists and medical professionals, operations personnel, financial
and accounting staff, and sales and marketing staff;

 respond to competitive pressures or unanticipated working capital requirements; or

 pursue opportunities for acquisitions of, investments in, or strategic alliances and joint ventures
with complementary businesses.

 We may invest in or acquire other businesses, and our
business may suffer if we are unable to successfully integrate an acquired business into our company or otherwise manage the growth associated
with multiple acquisitions.

 From time to time, we may acquire,
make investments in, or enter into strategic alliances and joint ventures with, complementary businesses. These transactions may involve
significant risks and uncertainties, including:

 In the case of an acquisition:

 The potential for the acquired business to underperform relative to our expectations and the acquisition
 price;

 The potential for the acquired business to cause our financial results to differ from expectations in
any given period, or over the longer- term;

 Unexpected tax consequences from the acquisition, or the tax treatment
of the acquired business's operations going forward, giving rise to incremental tax liabilities that are difficult to predict;

 Difficulty in integrating the acquired business, its operations, and its employees in an efficient and
effective manner;

 Any unknown liabilities or internal control deficiencies assumed as part of the acquisition; and

 The potential loss of key employees of the acquired businesses.

 In the case of an investment, alliance, joint venture, or other
 partnership:

 Our ability to cooperate with our co- venturer;

 Our co-venturer having economic, business, or legal interests or goals that are inconsistent with ours;
 and

 The potential that our co-venturer may be unable to meet is economic or other obligations, which may
require us to fulfill those obligations alone or find a suitable replacement.

 Any such transaction may
involve the risk that our senior management's attention will be excessively diverted from our other operations, the risk that our
industry does not evolve as anticipate, and that any intellectual property or personnel skills acquired do not prove to be those needed
for our future success, and the risk that our strategic objectives, cost savings or other anticipate benefits are otherwise not achieved.

 We may
experience difficulties in managing our growth and expanding our operations.

 We expect to experience significant
growth in the scope of our operations. Our ability to manage our operations and future growth will require us to continue to improve our
operational, financial and management controls, compliance programs and reporting systems. We may not be able to implement improvements
in an efficient or timely manner and may discover deficiencies in existing controls, programs, systems and procedures, which could have
an adverse effect on our business, reputation and financial results. Additionally, rapid growth in our business may place a strain on
our human and capital resources.

 Risks
Related to our Business and Industry

 We have an unproven business model with no assurance of significant
revenues or operating profit.

 Our current business model is
unproven and the profit potential, if any, is unknown at this time. We are subject to all of the risks inherent in the creation of a new
business. Our ability to achieve profitability is dependent, among other things, on our initial marketing and accompanying product acceptance
to generate sufficient operating cash flow to fund current operations and future expansion. There can be no assurance that our results
of operations or business strategy will achieve significant revenue or profitability.

 The market
for epigenetic tests is fairly new and unproven, and it may decline or experience limited growth, which would adversely affect our ability
to fully realize the potential of our platform.

 Epigenetics is at the heart of
our technology, products and services. According to the CDC, epigenetics is the study of how a person's behaviors and environment
can cause changes that affect the way a person's genes work. Unlike genetic changes, epigenetic changes are reversible and do not
change one's DNA sequence, but they can change how a person's body reads a DNA sequence. The market for epigenetic tests is
relatively new and evaluating the size and scope of the market is subject to a number of risks and uncertainties. We believe that our
future success will depend in large part on the growth of this market. The utilization of our solution is still relatively new, and customers
may not recognize the need for, or benefits of, our tests and services, which may prompt them to cease use of our tests and services or
decide to adopt alternative products and services to satisfy their healthcare requirements. In order to expand our business and extend
our market position, we intend to focus our marketing and sales efforts on educating customers about the benefits and technological capabilities
of our tests and services and the application of our tests and services to specific needs of customers in different market verticals.
Our ability to access and expand the market that our tests and services are designed to address depends upon a number of factors, including
the cost, performance and perceived value of the tests and services. Market opportunity estimates are subject to significant uncertainty
and are based on assumptions and estimates. Assessing the market for our solutions in each of the vertical markets we are competing in,
or planning to compete in, is particularly difficult due to a number of factors, including limited available information and rapid evolution
of the market. The market for our tests and services may fail to grow significantly or be unable to meet the level of growth we expect.
As a result, we may experience lower-than-expected demand for our products and services due to lack of customer acceptance, technological
challenges, competing products and services, decreases in expenditures by current and prospective customers, weakening economic conditions
and other causes. If our market share does not experience significant growth, or if demand for our solution does not increase, then our
business, results of operations and financial condition will be adversely affected.

 The estimates of market opportunity and forecasts
of market growth included in this Annual Report on Form 10-K may prove to be inaccurate, and even if the market in which we compete achieves
the forecasted growth, our business could fail to grow at similar rates, if at all.

 Market opportunity
estimates and growth forecasts are subject to significant uncertainty and are based on assumptions and estimates that may not prove to
be accurate. The estimates and forecasts in this Annual Report on Form 10-K relating to the size and expected growth of the cardiovascular
diagnostics market may prove to be inaccurate. Even if the market in which we compete meets our size estimates and forecasted growth,
our business could fail to grow at similar rates, if at all.

 If we are not able to enhance or introduce new
products that achieve market acceptance and keep pace with technological developments, our business, results of operations and financial
condition could be harmed.

 Our ability to attract new customers
and increase revenue from existing customers depends in part on our ability to enhance and improve our solutions, increase adoption and
usage of our products and introduce new products and features. The success of any enhancements or new products depends on several factors,
including timely completion, adequate quality testing, actual performance quality, market-accepted pricing levels and overall market acceptance
and demand. Enhancements and new products that we develop may not be introduced in a timely or cost-effective manner, may contain defects,
may have interoperability difficulties with our solutions, or may not achieve the market acceptance necessary to generate significant
or any revenue. If we are unable to successfully enhance our existing solutions and capabilities to meet evolving customer requirements,
increase adoption and usage of our solutions, develop new products, or if our efforts to increase the usage of our products are more expensive
than we expect, then our business, results of operations and financial condition could be harmed.

 The success of our business depends on our ability to expand
into new vertical markets and attract new customers in a cost-effective manner.

 In order to grow our business,
we plan to drive greater awareness and adoption of our tests and services from customers across new vertical markets. We intend to increase
our investment in sales and marketing, as well as in technological development, to meet evolving customer needs in these and other markets.
There is no guarantee, however, that we will be successful in gaining new customers from existing and new markets. We have limited experience
in marketing and selling our products and services generally, and in particular in new markets, which may present unique and unexpected
challenges and difficulties. Furthermore, we may incur additional costs to modify our current solutions to conform to the customer's
requirements, and we may not be able to generate sufficient revenue to offset these costs. We may also be required to comply with certain
regulations required by government customers, which will require us to incur costs, devote management time and modify our current solutions
and operations. If we are unable to comply with those regulations effectively and in a cost-effective manner, our financial results could
be adversely affected.

 If the costs of the new marketing
channels we use or plan to pursue increase dramatically, then we may choose to use alternative and less expensive channels, which may
not be as effective as the channels we currently use or have plans to use. As we add to or change the mix of our marketing strategies,
we may need to expand into more expensive channels than those we are currently in, which could adversely affect our business, results
of operations and financial condition. In addition, we have limited experience marketing our products and services and we may not be successful
in selecting the marketing channels that will provide us with exposure to customers in a cost-effective manner. As part of our strategy
to penetrate the new vertical markets, we expect to incur marketing expenses before we are able to recognize any revenue in such markets,
and these expenses may not result in increased revenue or brand awareness. We expect to make significant expenditures and investments
in new marketing activities, and these investments may not lead to the cost-effective acquisition of additional customers. If we are unable
to maintain effective sales and marketing programs, then our ability to attract new customers or enter into new vertical markets could
be adversely affected.

 Consolidation in the health care industry could have a
material adverse effect on our business, financial condition and results of operations.

 Many health care industry participants
and payers are consolidating to create larger and more integrated health care delivery systems with greater market power. We expect regulatory
and economic conditions to result in additional consolidation in the health care industry in the future. As consolidation accelerates,
the economies of scale of our customers' organizations may grow. If a customer experiences sizable growth following consolidation,
that customer may determine that it no longer needs to rely on us and may reduce its demand for our products and services. In addition,
as health care providers consolidate to create larger and more integrated health care delivery systems with greater market power, these
providers may try to use their market power to negotiate price reductions for our products and services. Finally, consolidation may also
result in the acquisition or future development by our customers of products and services that compete with our products and services.
Any of these potential results of consolidation could have a material adverse effect on our business, financial condition and results
of operations.

 If we
are not able to compete effectively, our business and operating results will be harmed.

 The market for our tests
and services is increasingly competitive, rapidly evolving and fragmented, and is subject to changing technology and shifting customer
needs. Although we believe that the solutions that we offer are unique, many companies develop and market products and services that compete
to varying extents with our offerings, and we expect competition in our market to continue to intensify. Moreover, industry consolidation
may increase competition.

 While the clinical epigenetics
market is still fairly new, we face competition from various sources, including large, well-capitalized technology companies such as Cleerly
and Prevencio. These competitors may have better brand name recognition, greater financial and engineering resources and larger sales
teams than we have. As a result, our competitors may be able to develop and introduce competing solutions and technologies that may have
greater capabilities than our solutions or that are able to achieve greater customer acceptance, and they may be able to respond more
quickly and effectively than we can to new or changing opportunities, technologies, standards or customer requirements. In addition, we
may also compete with smaller companies, who may develop their own platforms that perform similar services as our platform. We expect
that competition will increase and intensify as we continue to expand our serviceable markets and improve our tests and services. If we
are unable to provide our tests and services on terms attractive to the customer, the prospective customer may be unwilling to utilize
our solutions. If our competitors' products, services or technologies become more accepted than our solutions, if they are successful
in bringing their products or services to market earlier than we do, or if their products or services are more technologically capable
than ours, then our revenue could be adversely affected. In addition, increased competition may result in pricing pressures and require
us to incur additional sales and marketing expenses, which could negatively impact our sales, profitability and market share.

 Our business depends on customers increasing their use of
our solutions, and we may experience loss of customers or decline in their use of our solutions.

 Our ability to grow and generate
revenue depends, in part, on our ability to maintain and grow our relationships with existing customers and convince them to increase
their usage of our tests and services. If our customers do not increase their use of our tests and services, then our revenue may not
grow, and our results of operations may be harmed. It is difficult to accurately predict customers' usage levels and the loss of
customers or reductions in their usage levels may have a negative impact on our business, results of operations and financial condition.
If a significant number of customers cease using, or reduce their usage of our tests and services, then we may be required to expend significantly
more on sales and marketing than we currently plan to expend in order to maintain or increase revenue from customers. These additional
expenditures could adversely affect our business, results of operations and financial condition.

 Our technologies and products leverage and incorporate
AI and machine learning, and their development, maintenance, and operational success are subject to various risks and uncertainties,
some of which are beyond our control and may adversely affect our business, results of operations and financial condition, and may also
result in reputational harm and liability.

 One of the key components
of our technology and solutions is the use of machine learning/artificial intelligence ("ML/AI"). While we have made, and
expect to continue to make, investments in the continued development of AI capabilities, adoption of fast changing AI technology presents
risks, challenges and potential unintended consequences. Also, the markets for our solutions and services are rapidly evolving and are
highly competitive, and many of our competitors are also seeking to incorporate AI into their products. Competing firms may be able to
develop and embed AI in their products more quickly than we can. If our competitors are better able to incorporate AI in their products
and we are unable to compete effectively with them, our business, results of operations and financial condition could be adversely affected.

 Our ML/AI powering our technology
and products, there are known risks of with the use of ML/AI including accuracy, bias, toxicity, privacy, security and data provenance.
Developing, testing and deploying ML/AI systems may also increase the cost of our offerings. Our failure to adequately address potential
risks relating to the use of ML/AI in our technology and solutions could result in litigation regarding, among other things, intellectual
property, privacy and other claims that could result in liability for our company. It may also result in new or increased governmental
or regulatory scrutiny, which could result in regulatory action, legal liabilities, regulatory penalties, and damage to our reputation,
potentially harming our business and financial condition. The use of our AI capabilities could raise ethical or social concerns and our
failure to adequately address these concerns or the failure of our competitors, clients or other end users to do so could negatively impact
our brand and reputation.

 Our success in ML/AI technologies depends significantly
on the continued service of our key technical personnel especially our Chief Technology Officer and our Chief Executive Officer, and our
ability to attract and retain skilled professionals in a competitive market. The loss of key personnel or the inability to hire and retain
the necessary talent could adversely affect our technological competitiveness and operational capabilities.

 Interruptions or performance problems associated with
our technology and infrastructure may adversely affect our business and operating results.

 Our continued growth depends
in part on the ability of customers to access its tests and services at any time and within an acceptable amount of time. We may in the
future experience disruptions, outages and other performance problems due to a variety of factors, including challenges with suppliers,
infrastructure changes, introductions of new applications and functionality, software errors and defects, capacity constraints due to
an increasing number of customers or security related incidents. In addition, from time-to-time, we or our vendors may experience limited
periods of equipment downtime, server downtime due to server failure or other technical difficulties (as well as maintenance requirements).
It may become increasingly difficult to maintain and improve our performance, especially during high volume times and as our solution
becomes more complex and our customer demand and traffic increases. If our solution is unavailable or if our customers are unable to access
our solutions within a reasonable amount of time or at all, our business would be adversely affected, and its brand could be harmed. In
the event of any of the factors described above, or certain other failures of our infrastructure, customer or patient data may be permanently
lost. To the extent that we do not effectively address capacity constraints, upgrade our systems, as needed, and continually develop our
technology and network architecture to accommodate actual and anticipated changes in technology, customers may cease to use our solutions
and our business and operating results may be adversely affected.

 We rely
on a limited number of suppliers, contract manufacturers, and logistics providers, and our test is performed by a single contract high
complexity Clinical Laboratory Improvement Amendments (CLIA) laboratory.

 For our Epi+Gen CHD and
PrecisionCHD tests, we and our vendors rely on a limited number of suppliers for laboratory reagents and sampling kit supplies,
contract manufacturers, and logistics providers. For example, certain proprietary reagents are manufactured under Good Manufacturing Practice
(GMP) by a single contract manufacturer located in Michigan; the blood collection tubes included in the sample collection kits are manufactured
by a single manufacturer; and the tests are performed in one high complexity CLIA laboratory located in Missouri. The reliance on a limited
number of suppliers and a sole contract manufacturer and laboratory present various risks. These include the risk that in the event of
an interruption from any part of our supply chain for any reason, such as a natural catastrophe, labor dispute, or system interruption.
We may not be able to develop an alternate source without incurring material additional costs and substantial delays. For example, during
2021, the Coronavirus pandemic impacted the ability to conduct in-person training of personnel at the laboratory, which delayed the launch
of Epi+Gen CHD by approximately two and a half months. As a public company, the delay of a product launch by a nearly a fiscal
quarter could cause our reported results of operations to fail to meet market expectations, which, in turn, and could negatively impact
our stock price.

 The security of our solutions, networks or computer systems
may be breached, and any unauthorized access to our customer data will have an adverse effect on our business and reputation.

 The use of our solutions involves
the storage, transmission and processing of our customers' private data, and this data may contain confidential and proprietary
information of our customers or their customers, patients, employees, business partners or other persons ("customer personnel")
or other personal or identifying information regarding our customers and customer personnel. Individuals or entities may attempt to penetrate
our network or platform security, or that of our third-party hosting and storage providers, and could gain access to our customer and
customer personnel private data, which could result in the destruction, disclosure or misappropriation of proprietary or confidential
information of our customers and customer personnel. If any of our customers' or customer personnel's private data is leaked,
obtained by others or destroyed without authorization, it could harm our reputation, we could be exposed to civil and criminal liability,
and we may lose our ability to access private data, which will adversely affect the quality and performance of our solutions.

 In addition,
our platform and services may be subject to computer malware, viruses and computer hacking, fraudulent use attempts and phishing attacks,
all of which have become more prevalent in our industry. Though it is difficult to determine what, if any, harm may directly result from
any specific interruption or attack, they may include the theft or destruction of data owned by us or our customers or customer personnel,
and/or damage to our platform. Any failure to maintain the performance, reliability, security and availability of our products and technical
infrastructure to the satisfaction of our customers may harm our reputation and our ability to retain existing customers and attract
new customers.

 While we have implemented and
is continuing to implement procedures and safeguards that are designed to prevent security breaches and cyber attacks, they may not be
able to protect against all attempts to breach our systems, and we may not become aware in a timely manner of any such security breach.
Unauthorized access to or security breaches of our platform, network or computer systems, or those of our technology service providers,
could result in the loss of business, reputational damage, regulatory investigations and orders, litigation, indemnity obligations, damages
for contract breach, civil and criminal penalties for violation of applicable laws, regulations or contractual obligations and significant
costs, fees and other monetary payments for remediation. If customers believe that our platform does not provide adequate security for
the storage of sensitive information or its transmission over the Internet, our business will be harmed. Customers' concerns about
security or privacy may deter them from using our solutions for activities that involve personal or other sensitive information.

 We maintain cybersecurity coverage;
however, this coverage may not continue to be available on acceptable terms, may not be available in sufficient amounts to cover one or
more large claims against us, and may include larger self-insured retentions or certain exclusions. In addition, the insurer might disclaim
coverage as to any future claim. A successful claim not fully covered by our insurance could have a material adverse impact on our liquidity,
financial condition, and results of operations.

 Any failure to offer high-quality customer support may adversely
affect our relationships with our customers.

 Our ability to retain existing
customers and attract new customers depends in part on our ability to maintain a consistently high level of customer service and technical
support. Our current and future customers depend on our customer support team to assist them in utilizing our tests and services effectively
and to help them to resolve issues quickly and to provide ongoing support. If we are unable to hire and train sufficient support resources
or are otherwise unsuccessful in assisting our customers effectively, it could adversely affect our ability to retain existing customers
and could prevent prospective customers from adopting our solutions. We may be unable to respond quickly enough to accommodate short-term
increases in demand for customer support. We also may be unable to modify the nature, scope and delivery of our customer support to compete
with changes in the support services provided by our competitors. Increased demand for customer support, without corresponding revenue,
could increase our costs and adversely affect our business, results of operations and financial condition. Our sales are and will be highly
dependent on our business reputation and on positive recommendations from customers. Any failure to maintain high-quality customer support,
or a market perception that we do not maintain high-quality customer support, could adversely affect our reputation, business, results
of operations and financial condition.

 The information
that we provide to our customers could be inaccurate or incomplete, which could harm our business reputation, financial condition, and
results of operations.

 We aggregate, process, and analyze
customers'/patients' healthcare-related data and information for use by our customers. Because data in the healthcare industry
is fragmented in origin, inconsistent in format, and often incomplete, the overall quality of data received or accessed in the healthcare
industry is often poor, the degree or amount of data which is knowingly or unknowingly absent or omitted can be material. If the test
results that we provide to our customers are based on incorrect or incomplete data or if we make mistakes in the capture, input, or analysis
of these data, our reputation may suffer, and our ability to attract and retain customers may be materially harmed.

 In addition, in the future, we
may assist our customers with the management and submission of data to governmental entities, including CMS. These processes and submissions
are governed by complex data processing and validation policies and regulations. If we fail to abide by such policies or submits incorrect
or incomplete data, we may be exposed to liability to a client, court, or government agency that concludes that its storage, handling,
submission, delivery, or display of health information or other data was wrongful or erroneous.

 Our proprietary
applications may not operate properly, which could damage our reputation, give rise to a variety of claims against us, or divert our
resources from other purposes, any of which could harm our business and operating results.

 Proprietary software, product
and application development is time-consuming, expensive, and complex, and may involve unforeseen difficulties. We may encounter technical
obstacles, and it is possible that we discover additional problems that prevent our proprietary solutions from operating properly. If
our solutions and services do not function reliably or fail to achieve customer expectations in terms of performance, customers could
assert liability claims against us and attempt to cancel their contracts with us. Moreover, material performance problems, defects, or
errors in our existing or new solutions may arise in the future and may result from, among other things, the lack of interoperability
of our applications with systems and data that we did not develop and the function of which is outside of our control or undetected in
our testing. Defects or errors in our solutions might discourage existing or potential customers from purchasing products and services
from us. Correction of defects or errors could prove to be time consuming, costly, impossible, or impracticable. The existence of errors
or defects in our solutions and the correction of such errors could divert our resources from other matters relating to its business,
damage our reputation, increase our costs, and have a material adverse effect on our business, financial condition, and results of operations.

 If we
do not keep pace with technological changes, our solutions may become less competitive, and our business may suffer.

 The clinical epigenetic testing,
artificial intelligence/machine learning-based solutions and the cardiovascular diagnostics markets are undergoing rapid technological
change, frequent product and service innovation and evolving industry standards. If we are unable to provide enhancements and new features
for our existing tests and services or additional tests and services that achieve market acceptance or that keep pace with these technological
developments, our business could be adversely affected. The success of enhancements, new tests and services depends on several factors,
including the timely completion, introduction and market acceptance of the innovations. Failure in this regard may significantly impair
our revenue growth. In addition, because our solutions are designed to operate on existing cloud software and technologies, we will need
to continuously modify and enhance our solutions to keep pace with changes in internet-related hardware, software, communication, browser
and database technologies, alongside changes in laboratory technologies. We may not be successful in either developing these modifications
and enhancements or in bringing them to market in a timely fashion. Furthermore, uncertainties about the timing and nature of new diagnostic
tests, network platforms or technologies, including laboratory technologies, or modifications to existing tests, platforms or technologies,
could increase our research and development expenses. Any failure of our solutions to keep pace with technological changes or operate
effectively with future network platforms and technologies, including laboratory technologies, could reduce the demand for our solutions,
result in customer dissatisfaction and adversely affect our business.

 Our growth strategy may not prove viable and expected
growth and value may not be realized.

 While our overall sales and marketing
initiatives will span the gamut across traditional, print and digital mediums, our primary sales and marketing strategy consists of the
branding, collaboration, co-marketing, and co-sales opportunities involved in strategic channel partnerships. By prioritizing strategic
channel partnerships, we believe we can accelerate our market penetration into the key healthcare sub-verticals we intend to prioritize
for our growth. The key to our efforts is a well-defined and executed channel partnership integration strategy that we believe will serve
to accelerate the sales cycle. Although there is no assurance, we believe such strategic channel partnerships will generate revenue in
a myriad of ways, including larger contracts for our Epi+Gen CHD and PrecisionCHD tests, our HeartRisk platform, and bundling
our solutions alongside other synergistic technologies, services, and products. There can be no assurance that we will be successful in
acquiring customers through these and other strategies.

 Market and economic conditions may negatively impact
our business, financial condition and stock price.

 Concerns over inflation,
energy costs, geopolitical issues, including the ongoing conflict between Russian and Ukraine, unstable global credit markets and financial
conditions, and volatile oil prices could lead to periods of significant economic instability, diminished liquidity and credit availability,
declines in consumer confidence and discretionary spending, diminished expectations for the global economy and expectations of slower
global economic growth going forward. For example, in March 2022, the U.S. Consumer Price Index ("CPI"), which measures a
wide-ranging basket of goods and services, rose 8.5% from the same month a year ago, which represents the largest CPI increase since December
of 1981. Our general business strategy may be adversely affected by any such inflationary fluctuations, economic downturns, volatile business
environments and continued unstable or unpredictable economic and market conditions.

 Additionally, rising costs of goods and services
purchased by us, including raw materials used in manufacturing our tests, may have an adverse effect on our gross margins and profitability
in future periods. If economic and market conditions continue to deteriorate or do not improve, it may make any necessary debt or equity
financing more difficult to complete, more costly and more dilutive to our stockholders. Failure to secure any necessary financing in
a timely manner or on favorable terms could have a material adverse effect on our financial performance and stock price or could require
us to delay or abandon development other business plans. In addition, there is a risk that one or more of our current and future service
providers, manufacturers, suppliers, other partners could be negatively affected by such difficult economic factors, which could adversely
affect our ability to attain our operating goals on schedule and on budget or meet our business and financial objectives.

 Our success depends upon our ability to adapt to a changing
market and our continued development of additional tests and services.

 Although we believe that we will
provide a competitive range of tests and services, there can be no assurance of acceptance by the marketplace. The procurement of new
contracts by us may be dependent upon the continuing results achieved with current and future customers, upon pricing and operational
considerations, as well as the potential need for continuing improvement to existing products and services. Moreover, the markets for
such services may not develop as expected nor can there be any assurance that we will be successful in our marketing of any such products
and services.

 Compliance with changing regulation of corporate governance
and public disclosure will result in significant additional expenses.

 Changing laws, regulations, and
standards relating to corporate governance and public disclosure for public companies, including the Sarbanes-Oxley Act of 2002 and various
rules and regulations adopted by the SEC, are creating uncertainty for public companies. Our management will need to invest significant
time and financial resources to comply with both existing and evolving requirements for public companies, which will lead, among other
things, to significantly increased general and administrative expenses and a certain diversion of management time and attention from revenue
generating activities to compliance activities.

 Risks
Related to our Business Operations

 We could
experience losses or liability not covered by insurance.

 Our business exposes us to risks
that are inherent in the provision of testing services that assist clinical decision-making. If customers or customer personnel assert
liability claims against us, any ensuing litigation, regardless of outcome, could result in a substantial cost to the Company, divert
management's attention from operations, and decrease market acceptance of our solutions. The limitations of liability set forth
in any contracts we may enter into now or in the future may not be enforceable or may not otherwise protect us from liability for damages.
Additionally, we may be subject to claims that are not explicitly covered by a contract. We also maintain general liability coverage;
however, this coverage may not continue to be available on acceptable terms, may not be available in sufficient amounts to cover one or
more large claims against us, and may include larger self-insured retentions or exclusions for certain products. In addition, the insurer
might disclaim coverage as to any future claim. A successful claim not fully covered by our insurance could have a material adverse impact
on our liquidity, financial condition, and results of operations.

 Our future growth could be harmed if we lose the services
of our key personnel.

 We are highly dependent upon the
talents and services of a number of key employees, specifically Meeshanthini Dogan, PhD and Robert Philibert, MD PhD and other senior
technical and management personnel, including our other executive officers, all of whom would be difficult to replace. In 2022, we entered
into multi-year employment agreements with each of our executive officers and a consulting agreement with our non-executive chairman.
The loss of the services of one or more of these key employees would disrupt our business and harm its results of operations. As competition
is intense for the type of highly skilled scientific and medical professionals our business requires, we may not be able to successfully
attract and retain senior leadership necessary to grow our business.

 If we are unable to hire, retain and motivate qualified
personnel, our business will suffer.

 Our future success depends, in
part, on our ability to continue to attract and retain highly skilled personnel. We believe that there is, and will continue to be, intense
competition for highly skilled management, medical, engineering, data science, sales and other personnel with experience in our industry.
We must provide competitive compensation packages and a high-quality work environment to hire, retain and motivate employees. If we are
unable to retain and motivate our existing employees and attract qualified personnel to fill key positions, we may be unable to manage
our business effectively, including the development, marketing and sale of our products, which could adversely affect our business, results
of operations and financial condition. To the extent we hire personnel from competitors, we also may be subject to allegations that they
have been improperly solicited or that they have divulged proprietary or other confidential information. If we are unable to retain our
employees, our business, results of operations and financial condition could be adversely affected.

 If we cannot maintain our corporate culture as it grows,
we could lose the innovation, teamwork, passion and focus on execution that it believes contribute to its success, and its business may
be harmed.

 We believe that our corporate
culture is a critical component to our success. We have and will continue to invest substantial time and resources in building our team.
As we grow and develop the infrastructure of a public company, we may find it difficult to maintain our corporate culture. Any failure
to preserve our culture could negatively affect our future success, including our ability to retain and recruit personnel and effectively
focus on and pursue our corporate objectives.

 We may be unable to manage our growth.

 Currently, we have less than 16
full and part-time employees. Our ability to manage our growth effectively will require us to continue to improve our operational, financial
and management controls and information systems to accurately forecast sales demand, to manage our operating costs, manage our marketing
programs in conjunction with an emerging market, and attract, train, motivate and manage our employees effectively. Our growth strategy
will place significant demands on our management team and our financial, administrative and other resources. Operating results will depend
substantially on the ability of our officers and key employees to manage changing business conditions and to implement and improve its
financial, administrative and other resources. If management fails to manage the expected growth, our results of operations, financial
condition, business and prospects could be adversely affected. In addition, our growth strategy may depend on effectively integrating
future entities, which requires cooperative efforts from the managers and employees of the respective business entities. If we are unable
to respond to and manage changing business conditions, or the scale of our operations, then the quality of our products and services,
our ability to retain key personnel, and our business could be harmed, which in turn, could adversely affect our results of operations,
financial condition, business and prospects.

 Our Board of Directors may change its strategies, policies,
and procedures without stockholder approval, and we may become highly leveraged, which may increase our risk of default under our existing
or future obligations.

 Our investment, financing, leverage,
and dividend policies, and our policies with respect to all other activities, including growth, capitalization, and operations, are determined
exclusively by our board of directors, and may be amended or revised at any time by our board of directors without notice to or a vote
of our stockholders. This could result in the Company conducting operational matters, making investments, or pursuing different business
or growth strategies than those contemplated in this Annual Report on Form 10-K. Further, our charter and bylaws do not limit the amount
or percentage of indebtedness, funded or otherwise, that we may incur. High leverage also increases the risk of default on our obligations.
In addition, a change in our investment policies, including the manner in which we allocate our resources across our portfolio or the
types of assets in which we seek to invest, may increase our exposure to interest rate risk and liquidity risk. Changes to our policies
with regards to the foregoing could materially adversely affect our financial condition, results of operations, and cash flow.

 Our business
is subject to the risks of earthquakes, fire, floods, pandemics and other natural catastrophic events, and to interruption by man-made
problems, such as power disruptions, computer viruses, data security breaches or terrorism.

 A significant natural disaster,
such as a tornado, hurricane or a flood, occurring at our headquarters or where a business partner is located could adversely affect our
business, results of operations and financial condition. Further, if a natural disaster or man-made problem were to affect our network
service providers or Internet service providers, this could adversely affect the ability of our customers to use our products and platform.
In addition, health epidemics or pandemics, natural disasters and acts of terrorism could cause disruptions in our business, or the businesses
of our customers or service providers. We also rely, and will continue to rely, on our network and third-party infrastructure and enterprise
applications and internal technology systems for our engineering, sales and marketing and operations activities. In the event of a major
disruption caused by a health epidemic or pandemic, natural disaster or man-made problem, we may be unable to continue our operations
and may endure system interruptions, reputational harm, delays in our development activities, lengthy interruptions in service, breaches
of data security and loss of critical data, any of which could adversely affect our business, results of operations and financial condition.

 We may need to seek alternative business opportunities and
change the nature of our business.

 As a company
in the early stages of its development, we continuously reevaluate our business, the market in which we operate and potential new opportunities.
We may seek other alternatives within the healthcare field in order to grow our business and increase revenues. Such alternatives may
include, but not be limited to, combinations or strategic partnerships with laboratory companies or with medical practices such as hospitalists
or behavioral health. Pursuing alternative business opportunities could increase our expenses, may require us to obtain additional financing,
which may not be available on favorable terms or at all, and result in potentially dilutive issuances of our equity securities or the
incurrence of debt that may be burdensome to service, any of which could have a material adverse effect on our business and operations.
In addition, pursuing alternative business opportunities may never be successful and may divert significant management time and attention.
Moreover, accomplishing and integrating any business opportunity that is pursued by us may disrupt the existing business and may be a
complex, risky and costly endeavor and could have a material adverse effect on our business, results of operations, financial condition
and prospects.

 Any legal proceedings or claims against us could be costly
and time-consuming to defend and could harm our reputation regardless of the outcome.

 We may in the future become subject
to legal proceedings and claims that arise in the ordinary course of business, including intellectual property, collaboration, licensing
agreement, product liability, employment, class action, whistleblower and other litigation claims, and governmental and other regulatory
investigations and proceedings. Such matters can be time-consuming, divert management's attention and resources, cause us to incur
significant expenses or liability, or require us to change our business practices. In addition, the expense of litigation and the timing
of this expense from period to period are difficult to estimate, subject to change, and could adversely affect our financial condition
and results of operations. Because of the potential risks, expenses, and uncertainties of litigation, we may, from time to time, settle
disputes, even where we have meritorious claims or defenses, by agreeing to settlement agreements. Any of the foregoing could adversely
affect our business, financial condition, and results of operations.

 Risks
Related to our Intellectual Property

 Our license agreement with the University of Iowa
Research Foundation includes a non-exclusive license of "technical information" that potentially could grant unaffiliated
third parties access to materials and information considered derivative work made by us, which could be used by such licensees to develop
competitive products.

 The University
of Iowa Research Foundation, or UIRF, license agreement grants to us a worldwide, exclusive, non-transferable license under the Patent
Rights, as defined in the agreement, to make, have made, use, sell, offer for sale and import the Licensed Products(s) and/or Licensed
Processes, as defined in the agreement, in the field of research tools and clinical diagnostics for cardiovascular disease, stroke, congestive
heart failure and diabetes in humans. However, the agreement also confers a non-exclusive license as to Technical Information. Technical
Information is defined as certain research and development information, materials, confidential information, technical data, unpatented
inventions, know-how and supportive information owned and controlled by the licensor that was not in the public domain as of May 2, 2017
and that describes the Invention, as defined in the agreement, its manufacture and/or use and selected by the licensor to provide to
us for use in or with the development, manufacture or use of the Licensed Products and/or Licensed Processes. Technical Information further
includes materials, all progeny and derivatives of the materials made by us or our sublicensees, as well as software or other copyrightable
work, all derivatives of such software and other copyrightable work made by us and our sublicensees. The ability of UIRF to grant non-exclusive
licenses to third parties in and to this broad definition of Technical Information raises the possibility that unaffiliated third parties
could use such Technical Information, including Technical Information used by the Company, to make, use, sell, offer to sell and import
products and/or processes that compete with the Company's exclusively-licensed products and/or processes or are positioned in markets
that the Company may enter in the future. Increased competition could result in reduced demand for the Company's products and/or
processes, slow its growth and materially adversely affect its business, operating results and financial condition.

 We could
incur substantial costs in protecting or defending our intellectual property rights, and any failure to protect or defend our intellectual
property could adversely affect our business, results of operations and financial condition.

 Our success depends, in part,
on our ability to protect our brand and the proprietary methods and technologies that we develop under patent and other intellectual property
laws of the United States and foreign jurisdictions so that we can prevent others from using our inventions and proprietary information.
Any patents that have been issued or that may be issued in the future may not provide significant protection for our intellectual property.
If we fail to protect our intellectual property rights adequately, our competitors might gain access to our technology and our business,
results of operations and financial condition may be adversely affected.

 The particular forms of intellectual
property protection that we seek, or our business decisions about when to file patent applications and trademark applications, may not
be adequate to protect our business. We could be required to expend significant resources to monitor and protect our intellectual property
rights. Litigation may be necessary in the future to enforce our intellectual property rights, determine the validity and scope of our
proprietary rights or those of others, or defend against claims of infringement or invalidity. Such litigation could be costly, time-consuming
and distracting to management, result in a diversion of significant resources, lead to the narrowing or invalidation of portions of our
intellectual property and have an adverse effect on our business, results of operations and financial condition. Our efforts to enforce
our intellectual property rights may be met with defenses, counterclaims and countersuits attacking the validity and enforceability of
our intellectual property rights or alleging that we infringe the counterclaimant's own intellectual property. Any of our patents,
copyrights, trademarks or other intellectual property rights could be challenged by others or invalidated through administrative process
or litigation.

 We also rely, in part, on confidentiality
agreements with our business partners, employees, consultants, advisors, customers and others in our efforts to protect our proprietary
technology, processes and methods. These agreements may not effectively prevent disclosure of our confidential information, and it may
be possible for unauthorized parties to copy our software or other proprietary technology or information, or to develop similar technology
independently without our having an adequate remedy for unauthorized use or disclosure of our confidential information. In addition, others
may independently discover our trade secrets and proprietary information, and in these cases, we would not be able to assert any trade
secret rights against those parties. Costly and time-consuming litigation could be necessary to enforce and determine the scope of our
proprietary rights, and the failure to obtain or maintain trade secret protection could adversely affect our competitive business position.

 In addition, the laws of some countries
do not protect intellectual property and other proprietary rights to the same extent as the laws of the United States. To the extent we
expand into international activities, our exposure to unauthorized copying, transfer and use of our proprietary technology or information
may increase.

 Our means of protecting
our intellectual property and proprietary rights may not be adequate or our competitors could independently develop similar technology.
If we fail to meaningfully protect our intellectual property and proprietary rights, our business, results of operations and financial
condition could be adversely affected.

 Assertions by third parties of infringement or other violations
by us of its intellectual property rights could result in significant costs and harm our business and operating results.

 Our success depends upon our ability
to refrain from infringing upon the intellectual property rights of others. Some companies, including some of our competitors, own large
numbers of patents, copyrights and trademarks, which they may use to assert claims against us. As we grow and enter new markets, we will
face a growing number of competitors. As the number of competitors in our industry grows and the functionality of products in different
industry segments overlaps, we expect that software and other solutions in our industry may be subject to such claims by third parties.
Third parties may in the future assert claims of infringement, misappropriation or other violations of intellectual property rights against
us. We cannot assure investors that infringement claims will not be asserted against us in the future, or that, if asserted, any infringement
claim will be successfully defended. A successful claim against us could require that we pay substantial damages or ongoing royalty payments,
prevent us from offering our products and services, or require that we comply with other unfavorable terms. We may also be obligated to
indemnify our customers or business partners or pay substantial settlement costs, including royalty payments, in connection with any such
claim or litigation and to obtain licenses, modify applications or refund fees, which could be costly. Even if we were to prevail in such
a dispute, any litigation regarding our intellectual property could be costly and time-consuming and divert the attention of our management
and key personnel from our business operations.

 Certain of our core technology is licensed, and that license
may be terminated if we were to breach our obligations under the license.

 The initial work on our core technology
is derived from work done by our founders while at the University of Iowa, around which there is currently a family of patent applications,
the rights of which are owned by the University of Iowa Research Foundation (UIRF) and exclusively licensed to us. In addition, certain
follow-on work on our core technology also is derived from work done by our founders while at the University of Iowa but was furthered
by our founders. Therefore, certain follow-on work is co-owned by UIRF and us, and exclusively licensed to us under the license agreement
with UIRF. That license agreement and those licenses granted under the license agreement terminate on the expiration of the patent rights
licensed under the license agreement, unless certain proprietary, non-patented technical information is still being used by us, in which
case the license agreement will not terminate until the date of termination of such use. The licenses under the license agreement could
terminate prior to the expiration of the licensed patent rights if we materially breach our obligations under the license agreement, including
failing to pay the applicable license fees and any interest on such fees, and if we fail to fully remedy such breach within the period
specified in the license agreement, or if we enter liquidation, have a receiver or administrator appointed over any assets related to
the license agreement, or cease to carry on business, or file for bankruptcy or if an involuntary bankruptcy petition is filed against
us. The license agreement can also be terminated by either party as a result of any material breach of the license which is not remedied
within 30 days after receiving written notice thereof or by UIRF as a result of any breach of the license which has not been cured within
90 days after UIRF provides written notice of such breach.

 Some of our technologies incorporate "open-source"
software or other similar licensed technologies, which could become unavailable or subject us to increased costs, delays in production
or assessment or litigation.

 In order to provide our products,
we currently use a variety of technologies including, for example, genotyping, digital methylation assessment and data processing technologies
owned by third parties. The terms of these agreements, and any other "open source" software agreements we may rely upon in
the future, are subject to change without notice and may increase our costs. Moreover, our failure to comply with the terms of one or
more of these agreements could expose us to business disruption because the license may be terminated automatically due to non- compliance.

 The use and distribution of open-source
software may also entail greater risks than the use of third-party commercial software, as open-source licensors generally do not provide
warranties or other contractual protections regarding infringement claims or the quality of the code. Many of the risks associated with
use of open-source software cannot be eliminated and could negatively affect our business.

 In addition, the wide availability
of open-source code used in our current and future products could expose us to security vulnerabilities. From time to time, we may face
claims from third parties asserting ownership of, or demanding release of, the open-source software or derivative works that we developed
using such software (which could include our proprietary source code), or otherwise seeking to enforce the terms of the applicable open-source
license. These claims could result in litigation that could be costly to defend, have a negative effect on our operating results and financial
condition or require us to devote additional research and development resources to change our existing or future proprietary source code.
Responding to any infringement or noncompliance claim by an open-source vendor, regardless of its validity, discovering certain open-source
software code in our products, or a finding that we have breached the terms of an open- source software license, could harm our business,
results of operations and financial condition. In each case, we would be required to either seek licenses to software or services from
other parties and redesign our products to function with such other parties' software or services or develop these components internally,
which would result in increased costs and could result in delays to product launches. Furthermore, we might be forced to limit the features
available in our current or future solutions. If these delays and feature limitations occur, our business, results of operations and financial
condition could be adversely affected.

 Intellectual property that is in-licensed may have been made
using government funding and, thus, may be subject to federal regulations under the Bayh-Dole Act.

 The intellectual property Cardio has licensed
from UIRF is indicated as having been discovered through government funded programs and thus, may be subject to federal regulations under
the Bayh-Dole Act. In general, the Bayh-Dole Act provides the U.S. government certain rights in inventions developed using government
funding, such as a right to a non-exclusive, non-transferable, irrevocable worldwide license to use inventions for any governmental purpose.
In addition, intellectual property generated with government funding is also subject to certain reporting requirements, and the Bayh-Dole
Act requires that any products subject to the Bayh-Dole Act be manufactured substantially in the United States, although this manufacturing
requirement can be waived if the owner of the patents and applications can show that reasonable efforts to manufacture the product substantially
in the United States were unsuccessful, or that under the circumstances, domestic manufacture is not commercially feasible.

 Under the Bayh-Dole Act, the U.S. government has
the right to take title to inventions developed using a U.S. government funded program, referred to as "march-in rights,"
for a number of reasons including, for example, failure to disclose the invention to the government or failure to file an application
within specified time limits. In addition, under the Bayh-Dole Act, the U.S. government has the right to require any invention developed
using U.S. government funding to be granted exclusive, partially exclusive, or non-exclusive licenses to any of these inventions to a
third party if it determines that (i) adequate steps have not been taken to commercialize the invention (ii) government action is necessary
to meet public health or safety needs or (iii) government action is necessary to meet requirements for public use under federal regulations.

 Compliance with such regulations may limit Cardio's
exclusive rights, subject Cardio to expenditure of resources with respect to reporting requirements and limit Cardio's ability to
contract with non-U.S. manufacturers. In addition, any exercise by the government of any of the foregoing rights under the Bayh-Dole Act
may affect Cardio's competitive position, business, financial condition, results of operations, and prospects.

 Risks
Related to Government Regulation

 We conduct business in a heavily regulated industry,
and if we fail to comply with these laws and government regulations, we could incur penalties or be required to make significant changes
to our operations or experience adverse publicity, which could have a material adverse effect on our business, financial condition, and
results of operations.

 The healthcare
industry is heavily regulated and closely scrutinized by federal, state and local governments. Comprehensive statutes and regulations
govern the manner in which we provide and bill for our products services and collect reimbursement from governmental programs and private
payors, our contractual relationships with providers, vendors and customers, our marketing activities and other aspects of our operations.
Of particular importance are:

 the federal physician self-referral law, commonly referred to as the Stark Law;

 the federal Anti-Kickback Act;

 the criminal healthcare fraud provisions of HIPAA;

 the federal False Claims Act;

 reassignment of payment rules that prohibit certain types of billing and collection;

 similar state law provisions pertaining to anti-kickback, self-referral and false claims issues;

 state laws that prohibit general business corporations, such as us, from practicing medicine; and

 laws that regulate debt collection practices as applied to our debt collection practices.

 Because of the breadth of these
laws and the narrowness of the statutory exceptions and safe harbors available, it is possible that some of our business activities could
be subject to challenge under one or more of such laws. Achieving and sustaining compliance with these laws may prove costly. Failure
to comply with these laws and other laws can result in civil and criminal penalties such as fines, damages, overpayment recoupment loss
of enrollment status and exclusion from the Medicare and Medicaid programs. The risk of us being found in violation of these laws and
regulations is increased by the fact that many of them have not been fully interpreted by the regulatory authorities or the courts, and
their provisions are sometimes open to a variety of interpretations. Our failure to accurately anticipate the application of these laws
and regulations to our business or any other failure to comply with regulatory requirements could create liability for us and negatively
affect our business. Any action against us for violation of these laws or regulations, even if we successfully defend against it, could
cause us to incur significant legal expenses, divert management's attention from the operation of our business and result in loss
of customers and adverse publicity.

 To enforce compliance with the
federal laws, the U.S. Department of Justice and the Office of the Inspector General (OIG) have recently increased their scrutiny of healthcare
providers, which has led to a number of investigations, prosecutions, convictions and settlements in the healthcare industry. Dealing
with investigations can be time- and resource-consuming and can divert management's attention from the business. Any such investigation
or settlement could increase our costs or otherwise have an adverse effect on our business. In addition, because of the potential for
large monetary exposure under the federal False Claims Act, which provides for treble damages and mandatory minimum penalties of $5,500
to $11,000 per false claim or statement, healthcare providers often resolve allegations without admissions of liability for significant
and material amounts to avoid the uncertainty of treble damages that may be awarded in litigation proceedings. Such settlements often
contain additional compliance and reporting requirements as part of a consent decree, settlement agreement or corporate integrity agreement.
Given the significant size of actual and potential settlements, it is expected that the government will continue to devote substantial
resources to investigating healthcare providers' compliance with the healthcare reimbursement rules and fraud and abuse laws.

 The laws, regulations and
standards governing the provision of healthcare services may change significantly in the future. We cannot assure investors that any new
or changed healthcare laws, regulations or standards will not materially adversely affect our business. We cannot assure investors that
a review of our business by judicial, law enforcement, regulatory or accreditation authorities will not result in a determination that
could adversely affect our operations.

 The U.S.
Food and Drug Administration's ("FDA's") newly-issued rule for laboratory developed tests ("LDTs"),
which will be phased in over a period of four years, will significantly change the regulatory landscape for LDTs. Unless the rule is
overturned by a court or Congress, our currently marketed LDTs and those we develop in the future will be subject to new requirements
which may include, for some tests, premarket clearance, de novo authorization or premarket approval. We will incur substantial costs
and delays associated with complying with the new rule.

 We believe
our Epi+Gen CHD and PrecisionCHD tests are LDTs. The FDA generally considers an LDT to be a test that is designed, manufactured,
and used within a single laboratory that is certified under CLIA and meets the regulatory requirements under CLIA to perform high complexity
testing

 The FDA has
historically taken the position that it has the authority to regulate LDTs as in-vitro diagnostics ("IVDs") under the Federal
Food, Drug, and Cosmetic Act ("FDC Act"), although it has generally exercised enforcement discretion with regard to LDTs.
This means that even though the FDA believes it can impose regulatory requirements on LDTs, such as requirements to obtain premarket
approval, de novo authorization or clearance of LDTs, it has generally chosen not to enforce those requirements.

 On May 6,
2024, FDA published a final rule amending the definition of an in vitro diagnostic ("IVD") device to include tests manufactured
by a clinical laboratory. Pursuant to the rule LDTs, i.e., tests designed, manufactured, and used within a single CLIA-certified high
complexity laboratory, are medical devices subject to FDA regulation under the Federal Food, Drug, and Cosmetic Act. The final rule also
announced FDA's intention to apply its medical device requirements to LDTs. Under the final rule, all LDTs, unless subject to a
specific exemption, will be subject to premarket authorization requirements (510(k), de novo classification, or PMA) for each LDT performed
by the laboratory, and to postmarket registration and listing, medical device reporting, correction, removal, and recall, complaint handling,
labeling, investigational device, and quality system requirements. FDA intends to phase in these requirements beginning May 6, 2025.
The final rule states that certain categories of LDTs will be subject to enforcement discretion with respect to some or all of these
requirements. For example, FDA will apply enforcement discretion to currently marketed LDTs that were first offered prior to May 6, 2024,
with respect to most quality system requirements and the requirement for premarket authorization if they are not modified or modified
in only limited ways. Laboratories performing these tests are subject to other requirements, including the requirement to submit the
labeling for the LDT to FDA for review. FDA will similarly exercise enforcement discretion with respect to premarket authorization for
LDTs approved by the New York State Clinical Laboratory Evaluation Program ("NYS-CLEP").

 Unless overturned
by a court or Congress, or stayed or withdrawn by the new Administration, the final rule will substantially increase costs and regulatory
burdens for many clinical laboratories in ways that may adversely affect their ability to develop, perform, and offer LDTs. Two lawsuits
challenging FDA's authority to regulate LDTs have been filed in federal court: the American Clinical Laboratory Association filed
a lawsuit against FDA on May 29, 2024 in the Eastern District of Texas, while the Association for Molecular Pathology filed a lawsuit
on August 19, 2024 in the Southern District of Texas. The ultimate success of these lawsuits, which were subsequently consolidated, or
any future lawsuits that may be brought against the FDA challenging the LDT rule, is uncertain. It is also unclear whether a court would
delay the implementation of the final rule while the litigation is ongoing, which means we may need to initiate steps to comply with
the final rule even if it is ultimately overturned.

 Legislative
proposals addressing the FDA's oversight of LDTs have been previously introduced. In June 2021, Congress introduced the VALID Act,
which would have established a new risk-based regulatory framework for in vitro clinical tests ("IVCTs"), a category which
would have included IVDs, LDTs, collection devices and instruments used with such tests. FDA's new LDT final rule may renew attention
to the VALID Act or other legislation and may lead to the introduction of new proposals to limit the FDA's regulatory authority.
On July 12, 2024, the House Appropriations Committee issued a Report accompanying a FY 2025 appropriations bill in which it directed
the FDA to suspend efforts to implement the LDT final rule and to continue working with Congress to modernize the regulatory approach
for LDTs. This directive is not binding on the FDA.

 The change
in Administration and in Congress could significantly affect FDA's ability to implement the final rule or to otherwise regulate
LDTs. For example, the Department of Health and Human Services, which oversees FDA, could stay enforcement of the rule or seek to rescind
the final rule, or could direct FDA to not regulate LDTs as medical devices. Separately, Congress could enact legislation aimed at preventing
FDA from regulating LDTs and/or assigning oversight of LDTs to a different agency.

 Various bills
have been introduced in Congress seeking to substantially revamp the regulation of both LDTs and IVDs, but no legislation has been enacted
thus far.

 If our products do not receive adequate
coverage and reimbursement from third-party payors, our ability to expand access to our tests beyond the initial sales channels will be
limited and our overall commercial success will be limited.

 We currently do not have broad-based
coverage and reimbursement for the Epi+Gen CHD and PrecisionCHD tests. However, our strategy is to expand access to our
tests by pursuing coverage and reimbursement by third-party payors, including government payors. Coverage and reimbursement by third-party
payors, including managed care organizations, private health insurers, and government healthcare programs, such as Medicare and Medicaid
in the United States and similar programs in other countries, for the types of risk assessment and detection tests we perform can be limited
and uncertain. Healthcare providers may not order our products unless third-party payors cover and provide adequate reimbursement for
a substantial portion of the price of the products. If we are not able to obtain adequate coverage and an acceptable level of reimbursement
for our products from third-party payors, there could be a greater co-insurance or co- payment obligation for any individual for whom
a test is ordered. The individual may be forced to pay the entire cost of a test out-of-pocket, which could dissuade physicians from ordering
our products and, if ordered, could result in delay in or decreased likelihood of collection of payment.

 Medicare is the single largest
U.S. payor and a particularly important payor for many cardiac-related laboratory services, given the demographics of the Medicare population.
Generally, traditional Medicare fee-for-service will not cover screening tests that are performed in the absence of signs, symptoms, complaints,
personal history of disease, or injury except when there is a statutory provision that explicitly covers the test. Epi+Gen CHD
could be considered a screening test under Medicare and, accordingly, may not be eligible for traditional Medicare fee-for- service coverage
and reimbursement unless we pursue substantial additional measures, which would require significant investments, and may ultimately be
unsuccessful or may take several years to achieve.

 If eligible for reimbursement,
laboratory tests such as ours generally are classified for reimbursement purposes under CMS's Healthcare Common Procedure Coding
System ("HCPCS") and the American Medical Association's ("AMA") Current Procedural Terminology ("CPT")
coding systems. We and payors must use those coding systems to bill and pay for our diagnostic tests, respectively. These HCPCS and CPT
codes are associated with the particular product or service that is provided to the individual. Accordingly, without a HCPCS or CPT code
applicable to our products, the submission of claims could be a significant challenge. Once CMS creates an HCPCS code or the AMA establishes
a CPT code, CMS establishes payment rates and coverage rules under traditional Medicare, and private payors establish rates and coverage
rules independently. Under Medicare, payment for laboratory tests is generally made under the Clinical Laboratory Fee Schedule ("CLFS")
with payment amounts assigned to specific HCPCS and CPT codes. In addition, effective January 1, 2018, a new Medicare payment methodology
went into effect for clinical laboratory tests, under which laboratory-reported private payor rates are used to establish Medicare payment
rates for tests reimbursed via the CLFS. The new methodology implements Section 216 of the Protecting Access to Medicare Act of 2014 ("PAMA")
and requires laboratories that meet certain requirements related to volume and type of Medicare revenues to report to CMS their private
payor payment rates for each test they perform, the volume of tests paid at each rate, and the HCPCS code associated with the test. CMS
uses the reported information to set the Medicare payment rate for each test at the weighted median private payor rate. The full impact
of the PAMA rate-setting methodology and its applicability to our products remains uncertain at this time.

 Coverage and reimbursement by
a third-party payor may depend on a number of factors, including a payor's determination that a product is appropriate, medically
necessary, and cost- effective. Each payor will make its own decision as to whether to establish a policy or enter into a contract to
cover our products and the amount it will reimburse for such products. Obtaining approvals from third-party payors to cover our products
and establishing adequate coding recognition and reimbursement levels is an unpredictable, challenging, time-consuming, and costly process,
and we may never be successful. If third-party payors do not provide adequate coverage and reimbursement for our products, our ability
to succeed commercially will be limited.

 Even if we establish relationships
with payors to provide our products at negotiated rates, such agreements would not obligate any healthcare providers to order our products
or guarantee that we would receive reimbursement for our products from these or any other payors at adequate levels. Thus, these payor
relationships, or any similar relationships, may not result in acceptable levels of coverage and reimbursement for our products or meaningful
increases in the number of billable tests we sell to healthcare providers. We believe it may take at least several years to achieve coverage
and adequate reimbursement with a majority of third-party payors, including with those payors offering negotiated rates. In addition,
we cannot predict whether, under what circumstances, or at what payment levels payors will cover and reimburse for our products. We do
not expect Epi+Gen CHD or PrecisionCHD to have Medicare or other third-party coverage or reimbursement in the near term.
However, if we fail to establish and maintain broad-based coverage and reimbursement for our products, our ability to expand access to
our products, generate increased revenue, and grow our test volume and customer base will be limited, and our overall commercial success
will be limited.

 Our products may fail to achieve the degree of market acceptance
necessary for commercial success.

 The failure of our products,
once introduced, to be listed in physician guidelines or of our studies to produce favorable results or to be published in peer-reviewed
journals could limit the adoption of our products. In addition, healthcare providers and third-party payors, including Medicare, may rely
on physician guidelines issued by industry groups, medical societies, and other key organizations, before utilizing or reimbursing the
cost of any diagnostic or screening test. Although we have published a study showing the Epi+Gen CHD and PrecisionCHD tests
are associated with cost saving, it is not yet, and may never be, listed in any such guidelines.

 Further, if our products or the technology
underlying them do not receive sufficient favorable exposure in peer-reviewed publications, the rate of physician and market acceptance
of our products and positive reimbursement coverage decisions for our products could be negatively affected. The publication of clinical
data in peer-reviewed journals is an important step in commercializing and obtaining reimbursement for products, such as Epi+Gen CHD
and PrecisionCHD, and our inability to control when, if ever, results are published may delay or limit our ability to derive sufficient
revenues from any product that is developed using data from a clinical study.

 Failure to
achieve broad market acceptance of our products, including Epi+Gen CHD and PrecisionCHD, would materially harm our business,
financial condition, and results of operations.

 Risks
Related to Customer Privacy, Cybersecurity and Data

 Our use and disclosure of personally identifiable information,
including health information, is subject to federal and state privacy and security regulations, and our failure to comply with those regulations
or to adequately secure the information we hold could result in significant liability or reputational harm and, in turn, a material adverse
effect on our customer base and revenue.

 Numerous state and federal laws
and regulations govern the collection, dissemination, use, privacy, confidentiality, security, availability and integrity of Personally
Identifiable Information ("PII"), including protected health information. These laws and regulations include the Health Insurance
Portability and Accountability Act of 1996 ("HIPAA"). HIPAA establishes a set of basic national privacy and security standards
for the protection of protected health information, ("PHI"), by health plans, healthcare clearinghouses and certain healthcare
providers, referred to as covered entities, and the business associates with whom such covered entities contract for services, which includes
Cardio.

 HIPAA
requires healthcare providers like Cardio to develop and maintain policies and procedures with respect to PHI that is used or disclosed,
including the adoption of administrative, physical and technical safeguards to protect such information. HIPAA also implemented the use
of standard transaction code sets and standard identifiers that covered entities must use when submitting or receiving certain electronic
healthcare transactions, including activities associated with the billing and collection of healthcare claims.

 HIPAA imposes mandatory penalties
for certain violations. Penalties for violations of HIPAA and its implementing regulations start at $100 per violation and are not to
exceed $50,000 per violation, subject to a cap of $1.5 million for violations of the same standard in a single calendar year. However,
a single breach incident can result in violations of multiple standards. HIPAA also authorizes state attorneys general to file suit on
behalf of their residents. Courts will be able to award damages, costs and attorneys' fees related to violations of HIPAA in such
cases. While HIPAA does not create a private right of action allowing individuals to sue us in civil court for violations of HIPAA, its
standards have been used as the basis for duty of care in state civil suits such as those for negligence or recklessness in the misuse
or breach of PHI.

 In addition,
HIPAA mandates that the Secretary of Health and Human Services, or HHS, conduct periodic compliance audits of HIPAA-covered entities or
business associates for compliance with the HIPAA Privacy and Security Standards. It also tasks HHS with establishing a methodology whereby
harmed individuals who were the victims of breaches of unsecured PHI may receive a percentage of the Civil Monetary Penalty fine paid
by the violator.

 HIPAA further requires that patients
be notified of any unauthorized acquisition, access, use or disclosure of their unsecured PHI that compromises the privacy or security
of such information, with certain exceptions related to unintentional or inadvertent use or disclosure by employees or authorized individuals.
HIPAA specifies that such notifications must be made "without unreasonable delay and in no case later than 60 calendar days after
discovery of the breach." If a breach affects 500 patients or more, it must be reported to HHS without unreasonable delay, and HHS
will post the name of the breaching entity on its public web site. Breaches affecting 500 patients or more in the same state or jurisdiction
must also be reported to the local media. If a breach involves fewer than 500 people, the covered entity must record it in a log and notify
HHS at least annually.

 Numerous other federal and state
laws protect the confidentiality, privacy, availability, integrity and security of personally identifiable information, or PII, including
PHI. These laws in many cases are more restrictive than, and may not be preempted by, the HIPAA rules and may be subject to varying interpretations
by courts and government agencies, creating complex compliance issues for us, and our customers and potentially exposing us to additional
expense, adverse publicity and liability.

 New health information standards,
whether implemented pursuant to HIPAA, congressional action or otherwise, could have a significant effect on the manner in which we must
handle healthcare related data, and the cost of complying with standards could be significant. If we do not comply with existing or new
laws and regulations related to PHI, it could be subject to criminal or civil sanctions.

 Because of the extreme sensitivity
of the PII that we store and transmit, the security features of our technology platform are very important. If our security measures,
some of which are managed by third parties, are breached or fail, unauthorized persons may be able to obtain access to sensitive customer
and patient data, including HIPAA-regulated PHI. As a result, our reputation could be severely damaged, adversely affecting customer and
patient confidence. Customers may curtail their use of or stop using our services or our customer base could decrease, which would cause
our business to suffer. In addition, we could face litigation, damages for contract breach, penalties and regulatory actions for violation
of HIPAA and other applicable laws or regulations and significant costs for remediation, notification to individuals and for measures
to prevent future occurrences. Any potential security breach could also result in increased costs associated with liability for stolen
assets or information, repairing system damage that may have been caused by such breaches, incentives offered to customers or other business
partners in an effort to maintain our business relationships after a breach and implementing measures to prevent future occurrences, including
organizational changes, deploying additional personnel and protection technologies, training employees and engaging third-party experts
and consultants. While we maintain insurance covering certain security and privacy damages and claims expenses, we may not carry insurance
or maintain coverage sufficient to compensate for all liability and in any event, insurance coverage would not address the reputational
damage that could result from a security incident.

 We outsource important aspects
of the storage and transmission of customer and customer personnel information, and thus rely on third parties to manage functions that
have material cyber- security risks. We attempt to address these risks by requiring outsourcing subcontractors who handle customer and
customer personnel information to sign business associate agreements contractually requiring those subcontractors to adequately safeguard
personal health data to the same extent that applies to us and in some cases by requiring such outsourcing subcontractors to undergo third-party
security examinations. In addition, we periodically hire third-party security experts to assess and test our security posture. However,
we cannot assure investors that these contractual measures and other safeguards will adequately protect us from the risks associated with
the storage and transmission of client and patient's proprietary and protected health information.

 In addition, U.S. states
are adopting new laws or amending existing laws and regulations, requiring attention to frequently changing regulatory requirements applicable
to data related to individuals. For example, California has enacted the California Consumer Privacy Act ("CCPA"). The CCPA
gives California residents expanded rights to access and delete their personal information, opt out of certain personal information sharing
and receive detailed information about how their personal information is used by requiring covered companies to provide new disclosures
to California consumers (as that term is broadly defined and which can include any of our current or future employees who may be California
residents or any other California residents whose data we collect or process) and provide such residents new ways to opt out of certain
sales of personal information. The CCPA provides for civil penalties for violations, as well as a private right of action for data breaches
that is expected to increase data breach litigation. As we expand our operations and customer base, the CCPA may increase our compliance
costs and potential liability. Additionally, the California Privacy Rights Act ("CPRA"), which was approved by California
voters in the election in November 2020, created obligations relating to consumer data with implementing regulations that, although delayed,
did take effect during 2024. The CPRA modifies the CCPA significantly, potentially resulting in further uncertainty and requiring us to
incur additional costs and expenses in an effort to comply. Additionally, other U.S. states continue to propose, and in certain cases
adopt, privacy-focused legislation such as Colorado, Virginia, Utah and Connecticut. Aspects of these state laws remain unclear, resulting
in further uncertainty and potentially requiring us to modify our data practices and policies and to incur substantial additional costs
and expenses in an effort to comply.

 Privacy
and data security laws and regulations could require us to make changes to our business, impose additional costs on us and reduce the
demand for our tests and services.

 Our business model contemplates
that we will store, process and transmit both public data and our customers' and customer personnel's private data. Our customers
may store and/or transmit a significant amount of personal or identifying information through our platform. Privacy and data security
have become significant issues in the United States and in other jurisdictions where we may offer our solutions. The regulatory framework
relating to privacy and data security issues worldwide is evolving rapidly and is likely to remain uncertain for the foreseeable future.
Federal, state and foreign government bodies and agencies have in the past adopted, or may in the future adopt, laws and regulations regarding
the collection, use, processing, storage and disclosure of personal or identifying information obtained from customers and other individuals.
In addition to government regulation, privacy advocates and industry groups may propose various self- regulatory standards that may legally
or contractually apply to our business. Because the interpretation and application of many privacy and data security laws, regulations
and applicable industry standards are uncertain, it is possible that these laws, regulations and standards may be interpreted and applied
in a manner inconsistent with our existing privacy and data management practices. As we expand into new jurisdictions or verticals, we
will need to understand and comply with various new requirements applicable in those jurisdictions or verticals.

 To the extent applicable to our
business or the businesses of our customers, these laws, regulations and industry standards could have negative effects on our business,
including by increasing our costs and operating expenses, and delaying or impeding our deployment of new core functionality and products.
Compliance with these laws, regulations and industry standards requires significant management time and attention, and failure to comply
could result in negative publicity, subject us to fines or penalties or result in demands that we modify or cease existing business practices.
In addition, the costs of compliance with, and other burdens imposed by, such laws, regulations and industry standards may adversely affect
our customers' ability or desire to collect, use, process and store personal information using our solutions, which could reduce
overall demand for them. Even the perception of privacy and data security concerns, whether or not valid, may inhibit market acceptance
of our solutions in certain verticals. Furthermore, privacy and data security concerns may cause our customers' customers, vendors,
employees and other industry participants to resist providing the personal information necessary to allow our customers to use our applications
effectively. Any of these outcomes could adversely affect our business and operating results.

 General
Risks Affecting Our Company

 A pandemic,
epidemic or outbreak of an infectious disease in the United States or worldwide, including the re-emergence of the novel strain of coronavirus
disease, COVID-19, could adversely affect our business.

 If a pandemic, epidemic or outbreak
of an infectious disease occurs in the United States or worldwide, our business may be adversely affected. If the COVID-19 virus and its
potentially more contagious variants cause an additional resurgence of infection of COVID-19, or if new variants continue to develop resistance
to government approved COVID-19 vaccinations, or if an influenza or other pandemic were to occur, our business, results of operations,
financial condition and liquidity could be negatively impacted.

 As a result of public health
emergencies, we experienced, and in the future could experience, supply chain disruptions, including shortages, delays and work stoppages
among some vendors and suppliers, travel restrictions and cancellation of events, among other effects, thereby significantly and negatively
impacting our operations. In addition, our results and financial condition may be adversely affected by future federal or state laws,
regulations, orders, or other governmental or regulatory actions addressing public health emergencies such as a COVID-19 or the U.S. health
care system, which, if adopted, could result in direct or indirect restrictions to its business, financial condition, results of operations
and cash flow.

 Changes
in accounting standards and subjective assumptions, estimates and judgments by management related to complex accounting matters could
significantly affect our financial results or financial condition.

 Generally accepted accounting
principles and related accounting pronouncements, implementation guidelines and interpretations with regard to a wide range of matters
that are relevant to our business, including but not limited to revenue recognition, allowance for doubtful accounts, content asset amortization
policy, valuation of our Common Stock, stock-based compensation expense and income taxes, are highly complex and involve many subjective
assumptions, estimates and judgments. Changes in these rules or their interpretation or changes in underlying assumptions, estimates or
judgments could significantly change or increase volatility of our reported or expected financial performance or financial condition.
Refer to Note 3, "Summary of Significant Accounting Policies" to the Audited Financial Statements included elsewhere in this
Annual Report on Form 10-K for a description of recent accounting pronouncements.

 Risks
Related to Our Securities

 We are an "emerging growth company" and "smaller
reporting company" within the meaning of the Securities Act, and if we take advantage of certain exemptions from disclosure requirements
available to emerging growth companies, it could make our securities less attractive to investors and may make it more difficult to compare
our performance to the performance of other public companies.

 We are an "emerging growth
company" as defined in Section 2(a)(19) of the Securities Act, as modified by the JOBS Act. As such, we are eligible for and intend
to take advantage of certain exemptions from various reporting requirements applicable to other public companies that are not emerging
growth companies for as long as we continue to be an emerging growth company, including, but not limited to, (a) not being required to
comply with the auditor attestation requirements of Section 404 of the Sarbanes-Oxley Act, (b) reduced disclosure obligations regarding
executive compensation in our periodic reports and proxy statements and (c) exemptions from the requirements of holding a nonbinding advisory
vote on executive compensation and stockholder approval of any golden parachute payments not previously approved. As a result, our stockholders
may not have access to certain information they may deem important. We will remain an emerging growth company until the earliest of (i)
the last day of the fiscal year in which the market value of shares of Common Stock that are held by non-affiliates exceeds $700 million
as of June 30 of that fiscal year, (ii) the last day of the fiscal year in which we have total annual gross revenue of $1.07 billion or
more during such fiscal year (as indexed for inflation), (iii) the date on which we have issued more than $1 billion in non-convertible
debt in the prior three-year period or (iv) December 31, 2026, which is the last day of the fiscal year following the fifth anniversary
of the date of the first sale of Common Stock in Mana's initial public offering. We cannot predict whether investors will find our
securities less attractive because it will rely on these exemptions. If some investors find our securities less attractive as a result
of our reliance on these exemptions, the trading prices of our securities may be lower than they otherwise would be, there may be a less
active trading market for our securities and the trading prices of our securities may be more volatile.

 Further, Section 102(b)(1)
of the JOBS Act exempts emerging growth companies from being required to comply with new or revised financial accounting standards until
private companies (that is, those that have not had a Securities Act registration statement declared effective or do not have a class
of securities registered under the Exchange Act) are required to comply with the new or revised financial accounting standards. The JOBS
Act provides that a company can elect to opt out of the extended transition period and comply with the requirements that apply to non-
emerging growth companies but any such election to opt out is irrevocable. We have elected not to opt out of such extended transition
period, which means that when a standard is issued or revised and it has different application dates for public or private companies,
we, as an emerging growth company, can adopt the new or revised standard at the time private companies adopt the new or revised standard.
This may make comparison of our financial statements with another public company that is neither an emerging growth company nor an emerging
growth company that has opted out of using the extended transition period difficult or impossible because of the potential differences
in accounting standards used.

 Additionally,
we are a "smaller reporting company" as defined in Item 10(f)(1) of Regulation S-K. Smaller reporting companies may take
advantage of certain reduced disclosure obligations, including, among other things, providing only two years of audited financial statements.
We expect that we will remain a smaller reporting company until the last day of any fiscal year for so long as either (a) the market
value of our Common Stock held by non-affiliates does not equal or exceed $250 million as of the prior June 30th, or (b) our annual revenues
did not equal or exceed $100 million during such completed fiscal year and the market value of our Common Stock held by non-affiliates
did not equal or exceed $700 million as of the prior June 30th. To the extent we take advantage of such reduced disclosure obligations,
it may also make comparison of our financial statements with other public companies difficult or impossible.

 Our stock price may be volatile and may decline regardless
of our operating performance.

 The market
price of our Common Stock may fluctuate significantly in response to numerous factors and may continue to fluctuate for these and other
reasons, many of which are beyond our control, including:

 actual or anticipated fluctuations in our revenue and results of operations;

 failure of securities analysts to maintain coverage of the Company, changes
in financial estimates or ratings by any securities analysts who follow us or our failure to meet these estimates or the expectations
of investors;

 announcements by us or our competitors of significant technical innovations, acquisitions, strategic
partnerships, joint ventures, results of operations or capital commitments;

 changes in operating performance and stock market valuations of other healthcare-related companies generally,
or those in the medical diagnostics industry in particular;

 price and volume fluctuations in the overall stock market, including as a result of trends in the economy
as a whole;

 trading volume of our Common Stock;

 the inclusion, exclusion or removal of our Common Stock from any indices;

 changes in the Board or management;

 transactions in our Common Stock by directors, officers, affiliates and other major investors;

 lawsuits threatened or filed against us;

 changes in laws or regulations applicable to our business;

 changes in our capital structure, such as future issuances of debt or equity securities;

 short sales, hedging and other derivative transactions involving our capital stock;

 general economic conditions in the United States;

 pandemics or other public health crises, including, but not limited to, the COVID-19 pandemic (including
additional variants such as the Omicron variant);

 other events or factors, including those resulting from war, incidents of terrorism or responses to
these events; and

 the other factors described in this "Risk Factors" section.

 The stock market has recently
experienced extreme price and volume fluctuations. The market prices of securities of companies have experienced fluctuations that often
have been unrelated or disproportionate to their operating results. In the past, stockholders have sometimes instituted securities class
action litigation against companies following periods of volatility in the market price of their securities. Any similar litigation against
us could result in substantial costs, divert management's attention and resources, and harm its business, financial condition, and
results of operations.

 An active
trading market for our Common Stock may not be created or sustained.

 We have listed our Common Stock
and Warrants on Nasdaq under the symbols "CDIO" and "CDIOW," respectively. We cannot assure you that an active
trading market for its Common Stock will be created or sustained. Accordingly, we cannot assure you of the liquidity of any trading market,
your ability to sell your shares of our Common Stock when desired or the prices that you may obtain for your shares.

 Future
sales of Common Stock in the public market could cause our share price to decline significantly, even if our business is doing well.

 We have filed, and the SEC has
declared effective, registration statements covering (i) the resale of Common Stock underlying Public Warrants issued in the Company's
initial public offering and a substantial number of shares of Common Stock and shares underlying warrants issued in private placements
we completed prior to our Business Combination; (ii) up to $17 million in securities on a shelf registration statement that was used for
an at-the-market offering of up to $17 million; (iii) up to $9,476,508 in securities on a shelf registration statement that we are currently
using for an at-the-market offering of up to $9,476,508; and (iii) a registration statement on Form S-8 covering our 2022 Equity Incentive
Plan. Public sales of securities can continue to be made under these registration statements. We also plan to file a registration statement
covering the resale of Common Stock and shares underlying warrants that we recently sold in a private placement. In addition, all of the
shares we issued in the Business Combination to holders of Legacy Cardio securities are available for resale under Rule 144 without restriction,
subject to certain limitations that apply to our affiliates.

 The total number of shares available
for resale under these registration statements and/or under Rule 144 represents a significant percentage of our outstanding shares. The
resale, or expected or potential resale, of a substantial number of our shares of Common Stock in the public market could adversely affect
the market price for our shares of Common Stock and make it more difficult for investors to sell their shares of Common Stock at times
and prices that they feel are appropriate. In particular, we expect that, because there are a substantial number of shares registered
pursuant to various registration statements, the applicable selling securityholders can continue to offer such covered securities for
a significant period of time, the precise duration of which cannot be predicted. Accordingly, the adverse market and price pressures resulting
from an offering pursuant to a registration statement or Rule 144 may continue for an extended period of time.

 Sales of Common Stock pursuant
to these registration statements or pursuant to Rule 144 may make it more difficult for us to sell equity securities in the future at
a time and at a price that we deem appropriate. These sales also could cause the trading price of our Common Stock to fall and make it
more difficult for investors to sell shares of our Common Stock at a time and price that they deem appropriate.

 If securities
or industry analysts either do not publish research about us or publish inaccurate or unfavorable research about us, our business, or
our market, or if they change their recommendations regarding our Common Stock adversely, the trading price or trading volume of our
Common Stock could decline.

 The trading market for our Common
Stock is influenced in part by the research and reports that securities or industry analysts may publish about us, our business, our market,
or our competitors. If one or more of the analysts initiate research with an unfavorable rating or downgrade our Common Stock, provide
a more favorable recommendation about our competitors, or publish inaccurate or unfavorable research about our business, the trading price
of our Common Stock would likely decline. In addition, we currently expect that securities research analysts will establish and publish
their own periodic projections for our business. These projections may vary widely and may not accurately predict the results we actually
achieve. Our stock price may decline if our actual results do not match the projections of these securities research analysts. Furthermore,
if no analysts commence coverage of our Company, the trading price and volume for our Common Stock could be adversely affected. If any
analyst who may cover us were to cease coverage of the Company or fail to regularly publish reports on us, we could lose visibility in
the financial markets, which in turn could cause the trading price or trading volume of our Common Stock to decline.

 Delaware law and provisions in our Charter and Bylaws could
make a merger, tender offer, or proxy contest difficult, thereby depressing the trading price of its Common Stock.

 Our Charter and Bylaws contain
provisions that could depress the trading price of our Common Stock by acting to discourage, delay, or prevent a change of control of
the Company or changes in our management that our stockholders may deem advantageous. These provisions include the following:

 the right of the board of directors to establish the number of directors and fill any vacancies and
newly created directorships;

 director removal solely for cause;

 "blank check" preferred stock that the Board could use to implement a stockholder rights
 plan;

 the right of the Board to issue our authorized but unissued Common Stock and preferred stock without
stockholder approval;

 no ability of our stockholders to call special meetings of stockholders;

 no right of our stockholders to act by written consent, which requires all stockholder actions to be
taken at a meeting of our stockholders;

 limitations on the liability of, and the provision of indemnification to, our director and officers;

 the right of the board of directors to make, alter, or repeal the Bylaws; and

 advance notice requirements for nominations for election to the Board or for proposing matters that
can be acted upon by stockholders at annual stockholder meetings.

 Any provision of the Charter or
Bylaws that has the effect of delaying or deterring a change in control could limit the opportunity for our stockholders to receive a
premium for their shares of our Common Stock, and could also affect the price that some investors are willing to pay for our Common Stock.

 Our Bylaws provide that the Court of Chancery of
the State of Delaware will be the exclusive forum for substantially all disputes between the Company and our stockholders, which could
limit our stockholders' ability to obtain a favorable judicial forum for disputes with the Company or our directors, officers or
employees.

 The Bylaws provide that the Court
of Chancery of the State of Delaware is the exclusive forum for any derivative action or proceeding brought on our behalf, any action
asserting a breach of fiduciary duty, any action asserting a claim against us arising pursuant to the DGCL, the Charter or Bylaws or any
action asserting a claim against us that is governed by the internal affairs doctrine. These choice of forum provisions may limit a stockholder's
ability to bring a claim in a judicial forum that it finds favorable for disputes with us or our directors, officers or other employees
and may discourage these types of lawsuits. This provision would not apply to claims brought to enforce a duty or liability created by
the Exchange Act or any other claim for which the federal courts have exclusive jurisdiction. The Bylaws provide further that, to the
fullest extent permitted by law, the federal district courts of the United States will be the exclusive forum for resolving any complaint
asserting a cause of action arising under the Securities Act. However, Section 22 of the Securities Act provides that federal and state
courts have concurrent jurisdiction over lawsuits brought under the Securities Act or the rules and regulations thereunder. To the extent
the exclusive forum provision restricts the courts in which claims arising under the Securities Act may be brought, there is uncertainty
as to whether a court would enforce such a provision. We note that investors cannot waive compliance with the federal securities laws
and the rules and regulations thereunder. Furthermore, the enforceability of similar choice of forum provisions in other companies'
certificates of incorporation has been challenged in legal proceedings, and it is possible that a court could find these types of provisions
to be inapplicable or unenforceable. While the Delaware courts have determined that such choice of forum provisions are facially valid,
a stockholder may nevertheless seek to bring a claim in a venue other than those designated in the exclusive forum provisions, and there
can be no assurance that such provisions will be enforced by a court in those other jurisdictions. If a court were to find the exclusive-forum
provision contained in the Bylaws to be inapplicable or unenforceable in an action, we may incur additional costs associated with resolving
such action in other jurisdictions, which could harm our business.

 We do not intend to pay dividends for the foreseeable
 future.

 We currently intend to retain any
future earnings to finance the operation and expansion of its business and we do not expect to declare or pay any dividends in the foreseeable
 future.

 Moreover, the terms of any
revolving credit facility into which we or any of our subsidiaries enters may restrict our ability to pay dividends, and any additional
debt we or any of our subsidiaries may incur in the future may include similar restrictions. As a result, stockholders must rely on sales
of their Common Stock after price appreciation as the only way to realize any future gains on their investment.

 We may
issue additional shares of our Common Stock or other equity securities without your approval, which would dilute your ownership interests
and may depress the market price of our Common Stock.

 On January 26,
2024, the Company entered into an At-the-Market Issuance Sales Agreement (the "Sales Agreement") with Craig-Hallum Capital
Group LLC ("Craig-Hallum"). Sales of our Common Stock pursuant to the Sales Agreement were made under the Company's
Registration Statement on Form S-3 filed on January 26, 2024 (File No. 333-276725) declared effective by the SEC on February 1, 2024 and
will be made under the Company's Registration Statement on Form S-3 filed on February 7, 2025 (File No. 333-284775) declared effective
by the SEC on February 14, 2025. As of March 20, 2025, we have sold 30,959,434 shares of our Common Stock under the Sales Agreement and
may sell up to $9,476,508 of our Common Stock through Craig-Hallum under the Sales Agreement.

2025, we have Warrants outstanding to purchase 8,528,766 shares of our Common Stock. We will also have the ability to initially issue
an aggregate of 4,325,974 shares of our Common Stock under the Cardio Equity Incentive Plan, of which 3,594,202 options have been granted
and are currently exercisable and 387,327 RSUs have been granted. To the extent Warrants and options are exercised, and RSUs vest, additional
shares of Common Stock could be issued, which will result in dilution to our then existing stockholders and increase the number of shares
eligible for resale in the public market. Sales of substantial numbers of such shares in the public market could depress the market price
of our Common Stock.

 At a special meeting of stockholders
held on November 15, 2024, our stockholders approved the future issuance of shares of Common Stock and/or securities convertible into
or exercisable for Common Stock equal to 20% or more of the Common Stock outstanding in one or more non-public transactions as required
by Nasdaq Marketplace Listing Rule 5635(d) (the "Share Issuance Proposal"). Any non-public financing transaction undertaken
in connection with this approval will be conducted within the parameters set forth in the Share Issuance Proposal described in the proxy
statement for the Annual Meeting.

 We may issue additional shares
of our Common Stock or other equity securities of equal or senior rank in the future in connection with, among other things, future acquisitions
or repayment of outstanding indebtedness, without stockholder approval, in a number of circumstances.

 The issuance of additional shares of Common Stock or other equity
securities of equal or senior rank would have the following effects:

 our existing stockholders' proportionate ownership interest in the Company will decrease;

 the amount of cash available per share, including for payment of dividends (if any) in the future, may
 decrease;

 the relative voting strength of each previously outstanding share of Common Stock may be diminished;
 and

 the market price of our shares of Common Stock may decline.

 We may
redeem the Public Warrants and the Sponsor Warrants prior to their exercise at a time that is disadvantageous to you, as a warrant holder,
thereby making your Public Warrants or Sponsor Warrants worthless.

 We have the ability to redeem
outstanding Public Warrants and Sponsor Warrants at any time after they become exercisable and prior to their expiration, at a price of
$0.01 per warrant, provided that the last reported sales price of our Common Stock equals or exceeds $18.00 per share (as adjusted for
stock splits, stock dividends, reorganizations, recapitalizations and the like) for any 20 trading days within a 30 trading-day period
ending on the third trading day prior to the date on which we give proper notice of such redemption and provided certain other conditions
are met. Trading prices of our Common Stock have not historically exceeded the $18.00 per share redemption threshold. If and when the
Public Warrants and Sponsor Warrants become redeemable, we may not exercise our redemption right unless there is a current registration
statement in effect with respect to the shares of Common Stock underlying the Warrants. While we have registered the Common Stock issuable
upon the exercise of the Public Warrants and Sponsor Warrants on a registration statement on Form S-1 that was declared effective by the
SEC on January 24, 2023, it must remain current and effective by future filings. There can be no assurance that the registration statement
will still be effective at the time that we would like to exercise our redemption rights.

 In the event we have determined
to redeem the Public Warrants and the Sponsor Warrants, holders would be notified of such redemption as described in the Warrant Agreement.
Specifically, we would be required to fix a date for the redemption (the "Redemption Date"). Notice of redemption would be
mailed by first class mail, postage prepaid, by the Company not less than 30 days prior to the Redemption Date to the registered holders
of the Public Warrants and the Sponsor Warrants to be redeemed at their last addresses as they appear on the registration books. In addition,
beneficial owners of the redeemable Public Warrants and the Sponsor Warrants will be notified of such redemption via the Company's
posting of the redemption notice to DTC. Redemption of the Public Warrants and the Sponsor Warrants could force you (i) to exercise your
Public Warrants and the Sponsor Warrants and pay the exercise price therefor at a time when it may be disadvantageous for you to do so,
(ii) to sell your Public Warrants and the Sponsor Warrants at the then-current market price when you might otherwise wish to hold your
Public Warrants and the Sponsor Warrants or (iii) to accept the nominal redemption price which, at the time the outstanding Public Warrants
and the Sponsor Warrants are called for redemption, is likely to be substantially less than the market value of your Public Warrants and
the Sponsor Warrants. None of the Private Placement Warrants will be redeemable.

 Exercise of our Warrants is dependent upon
the trading price of our Common Stock. Because of the disparity between the current stock price and the respective Warrant exercise prices,
the Warrants may never be in the money and may expire worthless.

 The exercise prices
of our currently outstanding Warrants range from a high of $11.50 to a low of $1.78 per share. We believe the likelihood that warrant
holders will exercise the Warrants, and therefore, the amount of cash proceeds that we would receive, is dependent upon the trading price
of our Common Stock, the last reported sales price for which was $0.4630 per share on March 17, 2025. If the trading price for our Common
Stock is less than the applicable exercise price of our Warrants, we believe holders of those Warrants will be unlikely to exercise their
Warrants.

 There is no guarantee that the Warrants will be in the
money prior to their expiration, and, as such, the Warrants may expire worthless, and we may receive no proceeds from the exercise of
the Warrants.

 The Warrant
Agreement designates the courts of the State of New York or the United States District Court for the Southern District of New York as
the sole and exclusive forum for certain types of actions and proceedings that may be initiated by holders of the Warrants, which could
limit the ability of warrant holders to obtain a favorable judicial forum for disputes with our Company.

 The Warrant Agreement provides
that, subject to applicable law, (i) any action, proceeding or claim against us arising out of or relating in any way to the Warrant Agreement,
including under the Securities Act, will be brought and enforced in the courts of the State of New York or the United States District
Court for the Southern District of New York, and (ii) that we irrevocably submit to such jurisdiction, which jurisdiction shall be the
exclusive forum for any such action, proceeding or claim. We will waive any objection to such exclusive jurisdiction and that such courts
represent an inconvenient forum. Notwithstanding the foregoing, these provisions of the Warrant Agreement will not apply to suits brought
to enforce any liability or duty created by the Exchange Act or any other claim for which the federal district courts of the United States
of America are the sole and exclusive forum.

 Any person or entity purchasing
or otherwise acquiring any interest in Warrants shall be deemed to have notice of and to have consented to the forum provisions in the
Warrant Agreement. If any action, the subject matter of which is within the scope the forum provisions of the Warrant Agreement, is filed
in a court other than a court of the State of New York or the United States District Court for the Southern District of New York (a "foreign
action") in the name of any holder of Warrants, such holder shall be deemed to have consented to: (x) the personal jurisdiction
of the state and federal courts located in the State of New York in connection with any action brought in any such court to enforce the
forum provisions (an "enforcement action"), and (y) having service of process made upon such warrant holder in any such enforcement
action by service upon such warrant holder's counsel in the foreign action as agent for such warrant holder.

 This choice-of-forum provision may limit a warrant holder's
ability to bring a claim in a judicial forum that it finds favorable for disputes with us, which may discourage such lawsuits.

 Alternatively, if a court were to find this provision
of the Warrant Agreement inapplicable or unenforceable with respect to one or more of the specified types of actions or proceedings, we
may incur additional costs associated with resolving such matters in other jurisdictions, which could materially and adversely affect
our business, financial condition and results of operations and result in a diversion of the time and resources of our management and
board of directors.

 Financial reporting obligations of being a public company
in the United States are expensive and time-consuming, and our management will be required to devote substantial time to compliance matters.

 As a publicly traded company,
we will incur significant additional legal, accounting and other expenses that we did not incur as a privately company. The obligations
of being a public company in the United States require significant expenditures and will place significant demands on our management and
other personnel, including costs resulting from public company reporting obligations under the Exchange Act and the rules and regulations
regarding corporate governance practices, including those under the Sarbanes-Oxley Act of 2002 ("Sarbanes-Oxley") the Dodd-Frank
Wall Street Reform and Consumer Protection Act, and the listing requirements of the stock exchange on which our securities are listed.
These rules require the establishment and maintenance of effective disclosure and financial controls and procedures, internal control
over financial reporting and changes in corporate governance practices, among many other complex rules that are often difficult to implement,
monitor and maintain compliance with. Moreover, despite recent reforms made possible by the JOBS Act, the reporting requirements, rules,
and regulations will make some activities more time-consuming and costly, particularly after we are no longer an "emerging growth
company." In addition, we expect these rules and regulations to make it more difficult and more expensive for us to obtain director
and officer liability insurance. Our management and other personnel will need to devote a substantial amount of time to ensure that we
comply with all of these requirements and to keep pace with new regulations, otherwise we may fall out of compliance and risk becoming
subject to litigation or being delisted, among other potential problems.

 If we fail to comply with the rules under Sarbanes-Oxley
related to accounting controls and procedures in the future, or, if we discover material weaknesses and other deficiencies in our internal
control and accounting procedures, our stock price could decline significantly and raising capital could be more difficult.

 Section 404 of Sarbanes-Oxley
requires annual management assessments of the effectiveness of our internal control over financial reporting. If we fail to comply with
the rules under Sarbanes-Oxley related to disclosure controls and procedures in the future, or, if we discover material weaknesses and
other deficiencies in our internal control and accounting procedures, our stock price could decline significantly and raising capital
could be more difficult. If material weaknesses or significant deficiencies are discovered or if we otherwise fail to achieve and maintain
the adequacy of our internal control, we may not be able to ensure that we can conclude on an ongoing basis that we have effective internal
controls over financial reporting in accordance with Section 404 of Sarbanes-Oxley. Moreover, effective internal controls are necessary
for us to produce reliable financial reports and are important to helping prevent financial fraud. If we cannot provide reliable financial
reports or prevent fraud, our business and operating results could be harmed, investors could lose confidence in our reported financial
information, and the trading price of our Common Stock could drop significantly.

 We have incurred and will continue
to incur additional costs to remediate material weaknesses in our internal control over financial reporting, as described in Item 9A.
"Controls and Procedures." The additional reporting and other obligations imposed by these rules and regulations will increase
legal and financial compliance costs and the costs of related legal, accounting and administrative activities. These increased costs will
require us to divert a significant amount of money that could otherwise be used to expand the business and achieve strategic objectives.

 We will need to grow the size of our organization and may
experience difficulties in managing this growth.

 As our expansion plans and strategies
develop, and as we continue to operate as a public company, we expects needing additional managerial, operational, sales, marketing, financial
and other personnel. Future growth would impose significant added responsibilities on members of management, including:

 identifying, recruiting, compensating, integrating, maintaining and motivating additional employees;

 coping with demands on Management related to the increased size of its business;

 assimilating different corporate cultures and business practices;

 converting other entities' books and records and conforming their practices to ours;

 integrating operating, accounting and information technology systems of
other entities with ours and in maintaining uniform procedures, policies and standards, such as internal accounting controls; and

 improving our operational, financial and management controls, reporting systems and procedures.

 Our future
financial performance and our ability to expand our business will depend, in part, on our ability to effectively manage any future growth,
and our management may also have to divert a disproportionate amount of its attention away from day-to-day activities in order to devote
a substantial amount of time to managing these growth activities.

 If we are not able to effectively expand
our organization by hiring new employees and expanding our groups of consultants and contractors, we may not be able to successfully implement
the tasks necessary to further develop and commercialize our product candidates and, accordingly, may not achieve our research, development
and commercialization goals.

 We are an "emerging growth company," and
we cannot be certain that the reduced disclosure requirements applicable to "emerging growth companies" will not make our
Common Stock less attractive to investors.

 We are an "emerging growth
company," as defined under the JOBS Act and will continue to be after the Business Combination is completed. For so long as we are
an emerging growth company, we intend to take advantage of certain exemptions from reporting requirements that are applicable to other
public companies that are not emerging growth companies, including, but not limited to, compliance with the auditor attestation requirements
of Section 404 of the Sarbanes-Oxley Act, reduced disclosure obligations regarding executive compensation in our periodic reports and
proxy statements, and exemptions from the requirements of holding a nonbinding advisory vote on executive compensation and stockholder
approval of any golden parachute payments not previously approved.

 We could be an emerging growth
company for up to five years from the end of our most recently completed fiscal year, although we may lose such status earlier, depending
on the occurrence of certain events, including when we have generated total annual gross revenue of at least $1.07 billion or when we
are deemed to be a "large accelerated filer" under the Exchange Act, which means that the market value of our Common Stock
that is held by non-affiliates exceeds $700 million as of December 31st of the prior year, or when we have issued more than $1.0 billion
in nonconvertible debt securities during the prior three-year period.

 We cannot predict if investors will
not find our Common Stock less attractive or our company less comparable to certain other public companies because we rely on these exemptions.
If some investors find our Common Stock less attractive as a result, there may be a less active trading market for our Common Stock,
and our stock price may be more volatile.

 Under the JOBS Act, emerging
growth companies can delay adopting new or revised accounting standards issued subsequent to the enactment of the JOBS Act until such
time as those standards apply to private companies. We have irrevocably elected not to avail ourselves of this exemption from new or revised
accounting standards and, therefore, will be subject to the same new or revised accounting standards as other public companies that are
not emerging growth companies.

 As a "smaller
reporting company" we are permitted to provide less disclosure than larger public companies which may make our Common Stock less
attractive to investors.

 We are currently a "smaller
reporting company," as defined by Rule 12b-2 of the Exchange Act. As a smaller reporting company, we are eligible to take advantage
of certain exemptions from various reporting requirements applicable to other public companies. Consequently, it may be more challenging
for investors to analyze our results of operations and financial prospects which may result in less investor confidence. Investors may
find our Common Stock less attractive as a result of our smaller reporting company status. If some investors find our Common Stock less
attractive, there may be a less active trading market for our Common Stock and our stock price may be more volatile.

 There
can be no assurance that we will be able to comply with the continued listing standards of Nasdaq.

 Our Common
Stock is listed on The Nasdaq Capital Market ("Nasdaq"). In order to maintain that listing, we must satisfy minimum financial
and other requirements including, without limitation, a requirement that the closing bid price of our Common Stock be at least $1.00
per share. On June 3, 2024 (the "First Nasdaq Bid Price Letter"), we received a letter from Nasdaq indicating that, for the
previous 30 consecutive business days, the bid price for the Company's common stock had closed below the minimum $1.00 per share
requirement for continued listing on Nasdaq under Nasdaq Listing Rule 5550(a)(2). In accordance with Nasdaq Listing Rule 5810(c)(3)(A),
the Company was provided an initial period of 180 calendar days, or until December 2, 2024, to regain compliance. As reported on our
Current Report on Form 8-K dated December 4, 2024, Nasdaq notified the Company that Nasdaq's Staff has determined that the Company
is eligible for an additional 180 calendar day period, or until June 2, 2025, to regain compliance (the "Second Compliance Period").
As of the date of this report the Common Stock has not regained compliance with the Minimum Bid Price Requirement. If the Company chooses
to implement a reverse stock split, it must complete the split no later than ten business days prior to the end of the Second Compliance
Period in order to timely regain compliance. If we fail to regain compliance with the minimum bid requirement within the extended cure
period, or if we fail to continue to meet all applicable continued listing requirements for Nasdaq in the future, Nasdaq could delist
our securities.

 If Nasdaq delists our shares of Common Stock and Public Warrants
for failure to meet the listing standards, we and our securityholders could face significant material adverse consequences including:

 a limited availability of market quotations for our securities;

 reduced liquidity for our securities;

 a determination that our common stock is a "penny stock," which will require brokers trading in our common stock to adhere to more stringent rules, possibly resulting in a reduced level of trading activity in the secondary trading market for shares of our common stock;

 a limited amount of analyst coverage; and

 a decreased ability to issue additional securities or obtain additional financing in the future.

 We may acquire other companies or technologies,
which could divert our management's attention, result in dilution to our stockholders and otherwise disrupt our operations and adversely
affect our operating results.

 We may in the future seek to
acquire or invest in businesses, applications and services or technologies that we believe could complement or expand our services, enhance
our technical capabilities or otherwise offer growth opportunities. The pursuit of potential acquisitions may divert the attention of
management and cause us to incur various expenses in identifying, investigating and pursuing suitable acquisitions, whether or not they
are consummated.

 In addition, we do not have any
experience in acquiring other businesses. If we acquire additional businesses, we may not be able to integrate the acquired personnel,
operations and technologies successfully, or effectively manage the combined business following the acquisition. We also may not achieve
the anticipated benefits from the acquired business due to a number of factors, including:

 inability to integrate or benefit from acquired technologies or services in a profitable manner;

 unanticipated costs or liabilities associated with the acquisition;

 difficulty integrating the accounting systems, operations, and personnel of the acquired

 difficulties and additional expenses associated with supporting legacy products and hosting infrastructure
of the acquired business;

 difficulty converting the customers of the acquired business onto the
Platform and contract terms, including disparities in the revenue, licensing, support, or professional services model of the acquired
company;

 diversion of management's attention from other business concerns;

 adverse effects to our existing business relationships with business partners and customers as a result
of the acquisition;

 the potential loss of key employees;

 use of resources that are needed in other parts of our business; and

 use of substantial portions of our available cash to consummate the acquisition.

 In addition, a significant portion
of the purchase price of companies we acquire may be allocated to acquired goodwill and other intangible assets, which must be assessed
for impairment at least annually. In the future, if our acquisitions do not yield expected returns, we may be required to take charges
to our operating results based on this impairment assessment process, which could adversely affect our results of operations.

 Acquisitions
could also result in dilutive issuances of equity securities or the incurrence of debt, which could adversely affect our operating results.
In addition, if an acquired business fails to meet our expectations, our operating results, business and financial position may suffer.

 Item
 1B. Unresolved Staff Comments

 Not applicable.

 Item
 1C. Cybersecurity

 Risk
Management and Strategy

 We have established policies and processes
for assessing, identifying, and managing material risk from cybersecurity threats, and we have integrated these processes into our overall
risk management program. We assess material risks from cybersecurity threats, including any potential unauthorized occurrence on or conducted
through our information systems that may result in adverse effects on the confidentiality, integrity, or availability of our information
systems or any information residing therein.

 We have adopted as the governance framework
for our cybersecurity program the Service Organization Control Type 2 (SOC2) and the Health Insurance Portability and Accountability Act
(HIPAA). We use this framework as a guide to help us identify, assess, respond to, and manage cybersecurity risks relevant to our business.
Our cybersecurity risk management program includes:

 •
 periodic risk assessments designed to help identify material cybersecurity risks to our critical systems,
information, and our broader enterprise information technology environment;

 •
 skilled information security and data privacy personnel, who support our cybersecurity risk assessment
processes, our security controls, and our response to cybersecurity incidents;

 •
 external service providers, where appropriate, to monitor, assess, test, or otherwise assist with aspects
of our security controls, and to support risk mitigation efforts;

 •
 training for our employees on cybersecurity awareness and the importance of protecting information assets.

 •
 periodic reviews of key cybersecurity policies, and updating as needed;

 •
 a cybersecurity incident response plan that includes procedures for responding to cybersecurity incidents.

 We have not
identified any risks from known cybersecurity threats, including as a result of any prior cybersecurity incidents, that have materially
affected or are reasonably likely to materially affect us, including our business strategy, results of operations, or financial condition.

 Governance

 Our Board considers cybersecurity
risk as part of its risk oversight function and management expects to keep the Board informed of any material cybersecurity threats and
expects to provide a report to the Board on a periodic basis and the Board will consider and oversee.

 Our management team is responsible
for assessing and managing our material risks from cybersecurity threats. Our Chief Technology Officer leads a team of information security
professionals who have primary responsibility for our overall cybersecurity risk management program and supervises both our internal personnel
and our external cybersecurity consultants.

 Our management
team oversees efforts to prevent, detect, mitigate, and remediate cybersecurity risks and incidents through various means, which may
include threat briefings from internal personnel and external service providers, as well as alerts and reports produced by security tools
deployed in the information technology environment.

 Item 2.
 Properties

 We do not own any real estate
or other physical properties materially important to our operations. We currently maintain our principal executive offices at 311 W. Superior
St, Ste 444, Chicago, IL 60654 pursuant to a Lease Agreement. The cost for this space is approximately $13,000 per month with an unaffiliated
third party commencing on December 1, 2023 and is on a three year term. We also maintain a lab at 2565 N. Dodge, Suite D, Iowa City, IA
52245 pursuant to a Lease Agreement. The cost for this space is approximately $8,505 per month with an unaffiliated third party commencing
on December 1, 2023 and is on a five year term. We consider our current office space, combined with the other office space otherwise available
to our executive officers, adequate for our current operations.

 Item 3.
 Legal Proceedings

 We are not currently a party to any material litigation or other
legal proceedings brought against us.

 Item 4.
 Mine Safety Disclosures

 Not applicable.

 PART
 II

 Item 5.
 Market for Registrant's Common Equity, Related Shareholder Matters and Issuer Purchases of Equity Securities

 Market Information

 Our publicly traded Common Stock and warrants are currently
listed on the Nasdaq Capital Market under the symbols "CDIO" and "CDIOW," respectively.

 Holders

2025, there were 42 holders of record of our common stock and six holders of record of our Public Warrants and Sponsor Warrants. In addition,
we have approximately 74 holders of private placement warrants, the majority of which have been registered for resale on a registration
statement on Form S-1 that the SEC declared effective on January 24, 2023.

 The number of record
holders of our Common Stock and Public Warrants was determined from the records of our transfer agent and does not include beneficial
owners of any of our securities whose securities are held in the names of various security brokers, dealers, and registered clearing agencies.

 The transfer agent
for our common stock and warrant agent for our warrants is Continental Stock Transfer & Trust Company.

 Dividends

 We have not declared
or paid any cash dividends on our common stock. To date we have utilized all available cash to finance our operations. Payment of cash
dividends in the future will be at the discretion of our Board of Directors and will depend upon our earnings levels, capital requirements,
any restrictive loan covenants and other factors the Board considers relevant.

 Warrants

2025, there were 8,528,766 warrants outstanding for the purchase of Company Common Stock. Refer to Note 10 to the consolidated financial
statements included in this Annual Report on Form 10-K for additional information relating to outstanding warrants.

 Securities
Authorized for Issuance Under Equity Compensation Plans

 See Part III, Item 11, "Executive Compensation,"
for information about securities authorized for issuance under the Company's equity compensation plan.

 Sales of Unregistered Securities

 We did not sell any equity securities
that were not registered under the Securities Act during the fiscal year ended December 31, 2024 that were not otherwise disclosed in
our Quarterly Reports on Form 10-Q or our Current Reports on Form 8-K.

 Issuer Purchases of Equity Securities

 We do not
currently have any plans under which the Company is able to repurchase shares of our equity securities from our stockholders.

 Item 6.
 [Reserved]

 Item 7.
 Management's Discussion and Analysis of Financial Condition and Results of Operations

 As a result of the closing
of the Business Combination, which was accounted for as a reverse recapitalization in accordance with U.S. GAAP as discussed in Note 2
– Merger Agreement and Reverse Recapitalization, the consolidated financial statements of Cardio Diagnostics, Inc., a Delaware corporation
and our wholly owned subsidiary, are now the financial statements of the Company. You should read the following discussion and analysis
of our financial condition and results of operations together with our audited consolidated financial statements as of December 31, 2024
and 2023 and for each of the two years in the period ended December 31, 2024 and the related notes included in Part II, Item 8 of this
Annual Report.

 Some of the information contained
in this discussion and analysis or set forth elsewhere in this Annual Report, including information with respect to our plans, estimates
and strategy for our business, includes forward-looking statements based upon current expectations that involve risks and uncertainties.
You should read the sections titled "Risk Factors" and "Cautionary Note Regarding Forward Looking Statements"
for a discussion of important factors that could cause actual results to differ materially from the results described in or implied by
the forward-looking statements contained in the following discussion and analysis. Our historical results are not necessarily indicative
of the results that may be expected for any period in the future.

 Unless
the context requires otherwise, references to "Cardio," the "Company," "we," "us" and
"our" refer to Cardio Diagnostics Holdings, Inc., a Delaware corporation, together with its consolidated subsidiary.

 Overview

 Cardio was formed to further develop
and commercialize a series of products for major types of cardiovascular disease and associated co-morbidities, including coronary heart
disease ("CHD"), stroke, heart failure and diabetes, by leveraging our Artificial Intelligence ("AI")-driven Integrated
Genetic-Epigenetic Engine. As a company, we aspire to give every American adult insight into their unique risk for various cardiovascular
diseases. Cardio aims to become one of the leading medical technology companies for enabling improved prevention, early detection and
treatment of cardiovascular disease. Cardio is transforming the approach to cardiovascular disease from reactive to proactive and hope
to accelerate the adoption of Precision Medicine for all. We believe that incorporating Cardio's solutions into routine practice
in primary care and prevention efforts can help alter the trajectory that nearly one in two Americans is expected to develop some form
of cardiovascular disease by 2035.

 Cardio believes that it is the
first company to develop and commercialize epigenetics-based clinical tests for cardiovascular disease that have clear value propositions
for multiple stakeholders including (1) patients, (2) clinicians, (3) hospitals/health systems, (4) employers and (5) payors. According
to the CDC, epigenetics is the study of how a person's behaviors and environment can cause changes that affect the way a person's
genes work. Unlike genetic changes, epigenetic changes are reversible and do not change one's DNA sequence, but they can change
how a person's body reads a DNA sequence.

 Cardio launched its first clinical test, Epi+Gen CHD,
a three-year symptomatic CHD risk assessment clinical blood test targeting CHD events, including heart attacks, in 2021 during the Covid-19
pandemic. As a result, the initial strategy for commercialization involved launching the test via telemedicine and in smaller provider
practices such as concierge medicine practices. The volume of tests through these channels were minimal, and as the circumstances around
Covid-19 pandemic improved, management re-vamped the Company's go-to-market strategy to include other healthcare verticals and
stakeholders beyond patients and small providers, including larger provider organizations, group purchasing organizations, employers,
payors and life insurers. This new approach allowed Cardio to expand the reach of our solutions beyond the initial focus areas. Beyond
the launch of Epi+Gen CHD, in March 2023, we announced the launch of our second product, PrecisionCHD, an integrated epigenetic-genetic
clinical blood test for the detection of coronary heart disease. The Epi+Gen CHD and PrecisionCHD tests are coupled to
Actionable Clinical Intelligence ("ACI"), a platform that offers new epigenetic and genetic insights to clinicians prescribing
the to personalize patient management and help improve chronic care management. In May 2023, we launched CardioInnovate360, a
research-use-only ("RUO") solution to support the discovery, development and validation of novel biopharmaceuticals for the
assessment and management of cardiovascular diseases. In February 2024, we announced the launch of HeartRisk, a cardiovascular
disease risk intelligence platform. We believe that our Epi+Gen CHD and PrecisionCHD tests are categorized as laboratory-developed
tests, or "LDTs." The new go-to-market strategy is also being implemented for these products. Despite long partnership and
sales cycles, in some instance as long as 14 months, Cardio was able to increase the reach of its solutions in 2024, generating revenue
from provider organizations and has continued the development of a more robust sales and partnership pipeline. To further increase reach
and potentially accelerate partnerships and sales cycles, more seasoned sales personnel in the provider and employer verticals were hired.
In addition to increased revenue and number of tests in 2024 compared to 2023, other key developments in 2024 and recently, include:

 Recommended pricing for our two Current Procedural Terminology ("CPT") Proprietary Laboratory Analysis ("PLA") codes from the American Medical Association, 0440U for PrecisionCHD and 0439U for Epi+Gen CHD, at the Centers for Medicare and Medicaid Services' ("CMS") Clinical Laboratory Fee Schedule (CLFS) annual meeting;

 Expanded the availability of our Epi+Gen CHD test to Family Medicine Specialists' retail clinical location at Meijer Supercenter;

 Received Medicare pricing determination from Centers for Medicare and Medicaid Services (CMS) for PrecisionCHD and Epi+Gen CHD; and

 We have entered into partnerships with seven new provider organizations. The new partners include specialized practices in Michigan, Illinois, Texas, Florida, California, and Connecticut, representing various medical specialties including concierge medicine, primary care, and precision medicine.

 Cardio expects that sales and
partnership cycles will continue to be long. Our ongoing strategy for expanding our business operations and increasing revenue generation
include the following:

 Develop additional products, including clinical tests for stroke, congestive heart failure and diabetes;

 Expand clinical and health economics evidence portfolio to continue to demonstrate value of products
and increase reach;

 Leverage our newly awarded CPT PLA codes;

 Expand the adoption of our products across key channels, including health systems and self-insured employers,
including for HeartRisk, Cardio's new SaaS product;

 Scale our internal operations capabilities with a focus on improving efficiency and reducing our cost
of goods sold; and

 Pursue potential strategic partnership(s) and acquisition(s) of one or more synergistic companies.

 Recent
 Developments

 At the
Market Sales Agreement

 On January 26, 2024, the Company
entered into the Sales Agreement with Craig-Hallum. Pursuant to the Sales Agreement, the Company
may sell, at its option, shares of its Common Stock through Craig-Hallum, as sales agent. Sales of the Common Stock were
made pursuant to the Sales Agreement initially up to an aggregate of $17 million under the Company's Registration Statement
on Form S-3 filed on January 26, 2024 (File No. 333-276725), declared effective by the SEC on February 1, 2024 (the "Initial Registration
Statement"), and will be made pursuant to the Sales Agreement up to an aggregate of $9,476,508 under the Company's Registration
Statement on Form S-3 filed on February 7, 2025 (File No. 333-284775), declared effective by the SEC on February 14, 2025 (the "Additional
Registration Statement"). Subject to the terms and conditions of the Sales Agreement, Craig-Hallum may sell the shares, if any,
only by methods deemed to be an "at the market" offering as defined in Rule 415 promulgated under the Securities Act. The
Company has agreed to pay Craig-Hallum a sales commission of 2.5% of the gross proceeds for
sales under the Sales Agreement and to provide Craig-Hallum with customary indemnification and contribution rights, including for liabilities
under the Securities Act. In addition, the Company is required to reimburse Craig-Hallum for certain specified expenses in connection
with entering into the Sales Agreement.

2025, the Company sold 30,959,434 shares of its Common Stock under the Sales Agreement resulting in proceeds to the Company of $14,681,556,
net of offering costs. The Company has paid Craig-Hallum $376,450 in sales commissions. As of March 20, 2025, the Company has not sold
any additional shares of Common Stock under the Additional Registration Statement.

 Recent
Regulatory Developments

 On May
6, 2024, FDA published a final rule amending the definition of an in vitro diagnostic ("IVD") device to include tests manufactured
by a clinical laboratory. Pursuant to the rule, laboratory developed tests ("LDTs"), i.e., tests designed, manufactured, and
used within a single CLIA-certified high complexity laboratory, are medical devices subject to FDA regulation under the Federal Food,
Drug, and Cosmetic Act. The final rule also announced FDA's intention to apply its medical device requirements to LDTs. Under the
final rule, all LDTs, unless subject to a specific exemption, will be subject to premarket authorization requirements (510(k), de novo
classification, or PMA) for each LDT performed by the laboratory, and to postmarket registration and listing, medical device reporting,
correction, removal, and recall, complaint handling, labeling, investigational device, and quality system requirements. FDA intends to
phase in these requirements beginning May 6, 2025. The final rule states that certain categories of LDTs will be subject to enforcement
discretion with respect to some or all of these requirements. For example, FDA will apply enforcement discretion to currently marketed
LDTs that were first offered prior to May 6, 2024, with respect to most quality system requirements and the requirement for premarket
authorization if they are not modified or modified in only limited ways. Laboratories performing these tests are subject to other requirements,
including the requirement to submit the labeling for the LDT to FDA for review. FDA will similarly exercise enforcement discretion with
respect to premarket authorization for LDTs approved by the New York State Clinical Laboratory Evaluation Program ("NYS-CLEP").

 Unless
overturned by a court or Congress, or stayed or withdrawn by the new Administration, the final rule will substantially increase costs
and regulatory burdens for many clinical laboratories in ways that may adversely affect their ability to develop, perform, and offer
LDTs. Two lawsuits challenging FDA's authority to regulate LDTs have been filed in federal court: the American Clinical Laboratory
Association filed a lawsuit against FDA on May 29, 2024 in the Eastern District of Texas, while the Association for Molecular Pathology
filed a lawsuit on August 19, 2024 in the Southern District of Texas. The ultimate success of these lawsuits, which were subsequently
consolidated, or any future lawsuits that may be brought against the FDA challenging the LDT rule, is uncertain. It is also unclear whether
a court would delay the implementation of the final rule while the litigation is ongoing, which means we may need to initiate steps to
comply with the final rule even if it is ultimately overturned.

 Legislative
proposals addressing the FDA's oversight of LDTs have been previously introduced. In June 2021, Congress introduced the VALID Act,
which would have established a new risk-based regulatory framework for in vitro clinical tests ("IVCTs"), a category which
would have included IVDs, LDTs, collection devices and instruments used with such tests. FDA's new LDT final rule may renew attention
to the VALID Act or other legislation and may lead to the introduction of new proposals to limit the FDA's regulatory authority.
On July 12, 2024, the House Appropriations Committee issued a Report accompanying a FY 2025 appropriations bill in which it directed
the FDA to suspend efforts to implement the LDT final rule and to continue working with Congress to modernize the regulatory approach
for LDTs. This directive is not binding on the FDA.

 The change
in Administration and in Congress could significantly affect FDA's ability to implement the final rule or to otherwise regulate
LDTs. For example, the Department of Health and Human Services, which oversees FDA, could stay enforcement of the rule or seek to rescind
the final rule, or could direct FDA to not regulate LDTs as medical devices. Separately, Congress could enact legislation aimed at preventing
FDA from regulating LDTs and/or assigning oversight of LDTs to a different agency.

 Results
of Operations

 The results of operations presented
below should be reviewed in conjunction with the consolidated financial statements and notes included elsewhere in this Annual Report
on Form 10-K. The following table sets forth Cardio's results of operations data for the periods presented:

 Comparisons
for the years ended December 31, 2024 and 2023:

 Years
 Ended December 31,

 Revenue

 2024

 2023

 Revenue

 $
 34,890

 $
 17,065

 Operating Expenses

 Sales and marketing

 182,446

 158,514

 Research and development

 29,125

 145,182

 General and administrative expenses

 8,169,458

 6,936,646

 Amortization

 19,738

 19,182

 Total operating expenses

 (8,400,767
)

 (7,259,524
)

 Other (expense) income

 (17,576
)

 (1,134,375
)

 Net (loss)

 $
 (8,383,453
)

 $
 (8,376,834
)

 Cardio's
net loss for the year ended December 31, 2024, was $8,383,453 as compared to $8,376,834 for the year ended December 31, 2023, an increase
of $6,619 primarily as a result of an increase in General and Administrative expenses.

 Revenue

 Cardio has earned only nominal
revenue since inception. Revenue for the year ended December 31, 2024, was $34,890 compared to $17,065 for the year ended December 31,
2023.

 Sales and Marketing

 Expenses
related to sales and marketing for the year ended December 31, 2024, were $182,446 as compared to $ 158,514
for the year ended December 31, 2023, an increase of $23,932. The overall increase was due to an increase in sales and marketing activity
in 2024 due to tradeshow attendance.

 Research and Development

 Research
and development expense for the year ended December 31, 2024, was $29,125 as compared to $145,182 for the year ended December 31,
2023, a decrease of $116,057. The decrease was attributable to the decrease in laboratory runs performed in 2024 on new product
offerings in the pipeline as compared to laboratory runs performed in 2023.

 General and Administrative
 Expenses

 General and
administrative expenses for the year ended December 31, 2024, were $8,169,458 as compared to $ $6,936,646 for the year ended December
31, 2023, an increase of $1,232,812. The overall increase is primarily due to an increase in stock compensation expenses (mainly
as a result of new stock options issued in the first quarter of 2024), offset by the decrease in D&O insurance expense.

 Amortization

 Amortization expense
for the year ended December 31, 2024, was $19,738, as compared to $19,182 for the year ended December 31, 2023. The total amortization
expense for the year ended December 31, 2024 includes the amortization of intangible assets of $16,000 and patent costs of $3,738, respectively,
as compared to $16,000 for intangible assets and $3,182 for patent costs for the year ended December 31, 2023.

 Other income
(expenses)

 Total other expenses
for the year ended December 31, 2024, was $(17,576) as compared to $(1,134,375) for the year ended December 31, 2023. The total other
expenses for the year ended December 31, 2024 consists of interest expense of $18,640 net of interest income of $1,064. The total other
expenses for the year ended December 31, 2023 consists of interest expense of $6,735,013 offset by gain on extinguishment of debt of $193,350,
change in fair value of derivative liability of $5,406,220 and interest income of $1,068.

 Liquidity and Capital Resources

 Liquidity
describes the ability of a company to generate sufficient cash flows in the short- and long-term to meet the cash requirements of its
business operations, including working capital needs, debt service, acquisitions and investments, and other commitments and contractual
obligations. We consider liquidity in terms of cash flows from operations and other sources, and their sufficiency to fund our operating
and investing activities.

 Historically, our principal sources of liquidity
have been proceeds from the issuance of equity.

 On January 26, 2024, we entered
into the Sales Agreement with Craig-Hallum. Pursuant to the Sales Agreement, we may sell,
at our option, shares of our Common Stock through Craig-Hallum, as sales agent. Sales of our Common Stock were
made pursuant to the Sales Agreement initially up to an aggregate of $17 million under the Initial Registration Statement, and
will be made pursuant to the Sales Agreement up to an aggregate of $9,476,508 under the Additional Registration Statement.

2025, we sold 30,959,434 shares of our Common Stock under the Sales Agreement resulting in proceeds to us of $14,681,556, net of offering
costs. The Company has paid Craig-Hallum $376,450 in sales commissions. As of March 20, 2025, the Company has not sold any additional
shares of Common Stock under the Additional Registration Statement.

 On February 2,
2024, we closed a private placement with seven accredited investors, whereby we issued a total of 561,793 units ("Units"),
with each Unit consisting of (i) one share of our Common Stock and (ii) one six-year Common Stock purchase warrant having an exercise
price of $1.78 per share, subject to adjustment (the "Private Placement"). The Private Placement resulted in the issuance to
investors of 561,793 shares of Common Stock and 561,793 warrants in an unregistered offering of securities. The purchase price of the
securities was $1.78 per Unit, resulting in gross proceeds to the Company of $1,000,000, before deducting placement agent fees (10% or
$100,000) and other offering expenses. We used the net proceeds from the Private Placement for working capital and general corporate purposes.
We have subsequently registered the Private Placement Common Stock and the Common Stock issuable upon the exercise of the Private Placement
Warrants on a registration statement on Form S-1 that was declared effective by the SEC on December 3, 2024.

 We have had, and expect that
we will continue to have, an ongoing need to raise additional cash from outside sources to fund our operations and grow our business.
We expect that our primary cash needs in 2025 and for the foreseeable future will be for funding day-to-day operations and working capital
requirements, funding our growth strategy, paying the setup expenses of our internal laboratory and paying expenses incurred in connection
with our ongoing FDA submission activities. We explore our financing options on an ongoing basis. However, given recent stock prices
and the extreme volatility of our stock, it continues to be challenging to balance cash that could be raised and the dilution that might
be required to close a particular transaction. We expect that for the remainder of 2025, we will rely primarily on the ongoing ATM Offering,
provided that market conditions are favorable.

 At our annual stockholders
meetings in December 2023 and November 2024, we obtained stockholder approval to offer and sell up to $10,000,000 in securities (up to
50,000,000 shares of Common Stock, subject to adjustment for stock splits, reverse stock splits and other similar recapitalization events)
in a transaction or series of transactions not involving a public offering for a three-month period together with the potential to obtain
Nasdaq's consent, which we cannot guarantee, for an additional three-month period thereafter, resulting in a possible six-month
period to conduct a financing within the parameters of the stockholder authority, if granted. We currently have no specific plans for
such an offering but believed having that option available provided our Board of Directors with added flexibility in meeting the Company's
liquidity needs.

 Our long-term future capital
requirements will depend on many factors, including revenue growth rate, the timing and the amount of cash received from customers, the
expansion of sales and marketing activities, the timing and extent of spending to support investments, including research and development
efforts, and the continuing market adoption of our products. In each fiscal year since our inception, we have incurred losses from operations
and generated negative cash flows from operating activities. We expect this trend to continue in future periods for the foreseeable future.

 Unless we are able to generate
significant cash flows from operations, which we do not foresee happening in the near term, we will need to finance our operations through
the issuance of additional equity and/or convertible debt securities. Looking forward, we expect we will need to raise additional capital
and generate revenues to meet long-term operating requirements. If we raise additional funds through the issuance of equity or convertible
debt securities, the percentage ownership of our equity holders could be significantly diluted, particularly at current stock price levels,
and these newly-issued securities may have rights, preferences or privileges senior to those of existing equity holders. If we raise additional
funds by obtaining loans from third parties, the terms of those financing arrangements may include negative covenants or other restrictions
on our business that could impair our operating flexibility and also require us to incur interest expense.

 Working capital requirements
are expected to increase in line with the growth of the business. We have no lines of credit or other bank financing arrangements. We
anticipate that our principal sources of liquidity, including existing funds and issuances of equity and/or debt, will be sufficient to
fund our activities over the next 12 months. In order to have sufficient cash to fund our operations beyond the next 12 months and grow
our business, we will need to raise additional funds through the issuance of equity and/or debt. We cannot provide any assurance that
we will be successful in doing so.

 If we are unable to raise
additional capital when desired, our business, financial condition and results of operations would be harmed. Successful transition to
attaining profitable operations depends upon achieving a level of revenue adequate to support our business plan, balanced against ongoing
expenses. There is no assurance that we will be successful in reaching and sustaining profitability.

 The exercise prices
of our currently outstanding warrants range from a high of $11.50 to a low of $1.78 (subject to adjustment) per share of Common Stock.
The likelihood that warrant holders will exercise their Warrants, and therefore the amount of cash proceeds that we might receive, is
dependent upon the trading price of our Common Stock, the last reported sales price for which was $0.4630 on March 17, 2025. If the trading
price of our Common Stock is less than the respective exercise prices of our outstanding Warrants, which has been the case for a substantial
period of time, we believe holders of any of our Warrants will be unlikely to exercise their Warrants. There is no guarantee that the
Warrants will be in the money prior to their respective expiration dates, and as such, the Warrants may expire worthless, and we may receive
no proceeds from the exercise of Warrants. Given the current differential between the trading price of our Common Stock and the Warrant
exercise prices and the volatility of our stock price, we are not making strategic business decisions based on an expectation that we
will receive any cash from the exercise of Warrants. However, we will use any cash proceeds received from the exercise of Warrants for
general corporate and working capital purposes, which would increase our liquidity. We will continue to evaluate the probability of Warrant
exercises and the merit of including potential cash proceeds from the exercise of the Warrants in our future liquidity projections.

 Cash at December 31, 2024
totaled $7,827,487 as compared to $1,283,523 at December 31, 2023, a n in crease of $6,543,964.
The following table shows our cash flows from operating activities, investing activities and financing activities for the stated periods:

 2024

 2023

 Net cash used in operating activities

 $
 4,993,104

 $
 5,672,175

 Net cash used in investing activities

 404,190

 794,291

 Net cash provided by financing activities

 11,941,258

 3,632,468

 Cash Used in Operating Activities

 Cash used in operating
activities for the year ended December 31, 2024, was $4,993,104, as compared to $5,672,175 for the year ended December 31, 2023. The cash
used in operations during the year ended December 31, 2024, is a function of net loss of $8,383,453, adjusted for the following non-cash
operating items: depreciation of $113,777, amortization of $162,568, and stock based compensation of $2,591,168. Operating assets and
liabilities fluctuated as follows: an increase in accounts receivable of $13,652, a decrease of $915,969 in prepaid expenses and other
current assets, a decrease of $155,552 in accounts payable and accrued expenses and a decrease in lease liability of $223,929.

 The cash used in
operations during the year ended December 31, 2023, is a function of net loss of $8,376,834, adjusted for the following non-cash operating
items: depreciation of $3,790, amortization of $107,830, stock based compensation of $1,279,273, and non-cash interest expense of $6,704,522,
offset by a change in fair value of derivative liability of $5,406,220, and a gain on extinguishment of debt of $193,350. Operating assets
and liabilities fluctuated as follows: an increase in accounts receivable of $4,960, a decrease of $758,669 in prepaid expenses and other
current assets, an increase in deposits of $7,900, a decrease of $781,500 in accounts payable and accrued expenses and an increase in
lease liability of $244,505.

 Cash Used
in Investing Activities

 Cash used in investing
activities for the year ended December 31, 2024, was $404,190 compared to $794,291 for the year ended December 31, 2023. The cash used
in investing activities for the year ended December 31, 2024, was due to $214,765 for purchase of property and equipment and $189,425
in patent costs incurred. The cash used in investing activities for the year ended December 31, 2023, was due to $575,663 for purchase
of property and equipment, $21,352 payments for right of use asset and $197,276 in patent and trademark costs incurred.

 Cash Provided
by Financing Activities

 Cash provided
by financing activities for the year ended December 31, 2024, was $11,941,258 as compared to $3,632,468 for the year ended December 31,
2023. This change was due to $12,546,949 in proceeds from the sale of common stock and warrants
offset by $450,691 in payments pursuant to a finance agreement, and $155,000 in payments of placement agent fees during the year ended
December 31, 2024. Cash provided by financing activities for the year ended December 31, 2023 was due to $4,500,000 in proceeds from
convertible notes payable, net of original issue discount of $500,000, $390,000 in proceeds from exercise of warrants, offset by $942,532
in payments of finance agreement and $315,000 in payments of placement agent fees during the year ended December 31, 2023.

 Off-Balance Sheet Financing Arrangements

 We did not have any off-balance sheet arrangements as of December
31, 2024.

 Contractual
 Obligations

 As of December 31, 2024, we do
not have any ongoing contractual obligations that would have a negative impact on liquidity and cash flows. However, if one or more of
the following potential claims that arise from contracts we have entered into were pursued against us, there is the potential that we
could see a negative impact on liquidity and cash flows, depending on the outcome.

 Prior Relationships of Cardio with Boustead Securities, LLC

 At the commencement
of efforts to pursue what ultimately ended in the terminated business acquisition, Legacy Cardio entered into a Placement Agent and Advisory
Services Agreement (the "Placement Agent Agreement"), dated April 12, 2021, with Boustead Securities, LLC ("Boustead
Securities"). This agreement was terminated in April 2022, when Legacy Cardio terminated the underlying agreement and plan of merger
and the accompanying escrow agreement relating to that proposed business acquisition after efforts to complete the transaction failed,
despite several extensions of the closing deadline.

 Under the terminated Placement
Agent Agreement, Legacy Cardio agreed to certain future rights in favor of Boustead Securities, including (i) a two-year tail period during
which Boustead Securities would be entitled to compensation if Cardio were to close on a transaction (as defined in the Placement Agent
Agreement) with any party that was introduced to Legacy Cardio by Boustead Securities; and (ii) a right of first refusal to act as the
Company's exclusive placement agent for 24-months from the end of the term of the Placement Agent Agreement (the "right of
first refusal"). Cardio has taken the position that due to Boustead Securities' failure to perform as contemplated by the
Placement Agent Agreement, these provisions purporting to provide future rights are null and void.

 Boustead Securities responded to
the termination of the Placement Agent Agreement by disputing Legacy Cardio's contention that it had not performed under the Placement
Agent Agreement because, among other things, Boustead Securities had never sought out prospective investors. In its response, Boustead
Securities included a list of funds that they had supposedly contacted on Legacy Cardio's behalf. While Boustead Securities'
contention appears to contradict earlier communications from Boustead Securities in which they indicated that they had not made any such
contacts or introductions, Boustead Securities is currently contending that they are due success fees for two years following the termination
of the Placement Agent Agreement on any transaction with any person on the list of supposed contacts or introductions. Legacy Cardio strongly
disputes this position. Notwithstanding the foregoing, the Company has not consummated any transaction, as defined, with any potential
party that purportedly was a contact of Boustead Securities in connection with the Placement Agent Agreement and has no plans to do so
at any time during the tail period. No legal proceedings have been instigated by either party, and Cardio believes that the final outcome
will not have a material adverse impact on its financial condition.

 The Benchmark Company, LLC Right of First Refusal

 As noted in Note
1, the Company completed a business combination with Mana on October 25, 2022. In connection with the proposed business combination, by
agreement dated May 13, 2022, Mana engaged The Benchmark Company, LLC ("Benchmark") as its M&A advisor. Upon closing of
the business combination, Legacy Cardio assumed the contractual engagement entered into by Mana. On November 14, 2022, Cardio and Benchmark
entered into Amendment No. 1 Engagement Letter (the "Amendment Engagement"). Pursuant to the Amendment Engagement, Benchmark
has been granted a right of first refusal to act as lead or joint-lead investment banker, lead or joint-lead book-runner and/or lead or
joint-lead placement agent for all future public and private equity and debt offerings through October 25, 2023. Based on the right of
first refusal, Benchmark alleges that it is owed damages because the Company entered into the Yorkville Convertible Debenture Transaction
(see Note 11 to Notes to Consolidated Financial Statements) without first offering Benchmark the right to serve as the lead or joint-lead
placement agent for the transaction. The Company is evaluating the claim. No legal proceedings have been instigated.

 Demand Letter and Potential Mootness Fee Claim

 On June 25, 2022, a plaintiffs'
securities law firm sent a demand letter to the Company alleging that the Company's Registration Statement on Form S-4 filed (the
"S-4 Registration Statement") with the Securities and Exchange Commission ("SEC") on May 31, 2022 omitted material
information with respect to the Business Combination and demanding that the Company and its Board of Directors immediately provide corrective
disclosures in an amendment or supplement to the Registration Statement. Subsequent thereto, the Company filed amendments to the S- 4
Registration Statement on July 27, 2022, August 23, 2022, September 15, 2022, October 4, 2022 and October 5, 2022 in which it responded
to various comments of the SEC staff and otherwise updated its disclosure. In October 2022, the SEC completed its review and declared
the S-4 registration statement effective on October 6, 2022. On February 23, 2023 and February 27, 2023, plaintiffs' securities
law firm contacted the Company's counsel asking who will be negotiating a mootness fee relating to the purported claims set forth
in the June 25, 2022 demand letter. The Company vigorously denies that the S-4 Registration Statement, as amended and declared effective,
is deficient in any respect and believes that no additional supplemental disclosures are material or required. The Company believes that
the claims asserted in the Demand Letter are without merit and that no further disclosure is required to supplement the S-4 Registration
Statement under applicable laws. As of the date of filing of this Annual Report on Form 10-K, no lawsuit has been filed against the Company
by that firm. The firm has indicated its willingness to litigate the matter if a mutually satisfactory resolution cannot be agreed upon;
however, Cardio believes that the final outcome will not have a material adverse impact on its financial condition.

 Northland
Securities, Inc.

 In January 2024, following the
Company's termination of its agreement with Yorkville and in connection with the Company's recent at the market offering and/or
its February 2024 private placement, a managing director of Northland Securities, Inc. ("Northland") contacted the Company
claiming the right to be paid a fee of approximately $150,000 pursuant to the agreement of March 1, 2023 between the Company and Northland
regarding the Yorkville financing. Subsequently, the Company has been advised by another representative of Northland that Northland would
not proceed with any such claim. The Company does not believe that it owes Northland any sum based on the termination of the Yorkville
Securities Purchase Agreement and the subsequent financing transactions.

 The Company cannot preclude the possibility
that claims or lawsuits brought relating to any alleged securities law violations or breaches of fiduciary duty could potentially require
significant time and resources to defend and/or settle and distract its management and board of directors from focusing on its business.

 Directors and
Officers Insurance

 In connection with
the Company's various contractual obligations arising in the ordinary course of business, the Company is required to maintain insurance
coverage for claims against its directors and officers.

 Notice
of Non-Compliance with Nasdaq Listing Requirements

 On June 3, 2024,
Cardio Diagnostics Holdings, Inc. (the "Company") received a letter (the "First Nasdaq Bid Price Letter") from The
Nasdaq Stock Market LLC ("Nasdaq") indicating that the Company is no longer in compliance with Nasdaq Listing Rule 5550(a)(2),
because the minimum bid price of the Company's common stock (the "Common Stock") had closed below the minimum $1.00 per
share requirement for continued listing on The Nasdaq Capital Market under Nasdaq Listing Rule 5550(a)(2) (the "Minimum Bid Price
Requirement"). In accordance with Nasdaq Listing Rule 5810(c)(3)(A), the Company was provided an initial period of 180 calendar
days, or until December 2, 2024, to regain compliance. On December 4, 2024 (the "Second Nasdaq Bid Price Letter"), Nasdaq
notified the Company that Nasdaq's Staff has determined that the Company is eligible for an additional 180 calendar day period,
or until June 2, 2025, to regain compliance (the "Second Compliance Period"). The determination is based on the Company's
meeting the continued listing requirement for market value of publicly held shares and all other applicable requirements for initial listing
on The Nasdaq Capital Market with the exception of the Minimum Bid Price Requirement, and the Company's written notice of its intention
to cure the deficiency during the Second Compliance Period by effecting a reverse stock split, if necessary. If the Company chooses to
implement a reverse stock split, it must complete the split no later than ten business days prior to the end of the Second Compliance
Period in order to timely regain compliance. As of the date of this report the Common Stock has not regained compliance with the Minimum
Bid Price Requirement.

 If we fail to regain
compliance with the minimum bid requirement within the cure period (or extended cure period) or if we fail to continue to meet all applicable
continued listing requirements for Nasdaq in the future, Nasdaq could delist our securities.

 Critical Accounting Policies and Estimates

 Cardio's
consolidated financial statements are prepared in accordance with GAAP in the United States. The preparation of its consolidated financial
statements and related disclosures requires it to make estimates and judgments that affect the reported amounts of assets, liabilities,
revenue, costs and expenses, and the disclosure of contingent assets and liabilities in Cardio's financial statements. Cardio bases
its estimates on historical experience, known trends and events and various other factors that it believes are reasonable under the circumstances,
the results of which form the basis for making judgments about the carrying values of assets and liabilities that are not readily apparent
from other sources. Cardio evaluates its estimates and assumptions on an ongoing basis. Cardio's actual results may differ from
these estimates under different assumptions or conditions.

 The SEC requested
that all registrants list their most "critical accounting polices" in the Management Discussion and Analysis. The SEC indicated
that a "critical accounting policy" is one which is both important to the portrayal of a company's financial condition
and results, and requires management's most difficult, subjective or complex judgments, often as a result of the need to make estimates
about the effect of matters that are inherently uncertain. While Cardio's significant accounting policies are described in more
detail in Note 3 to its consolidated financial statements, Cardio believes that the following accounting policies are those most critical
to the judgments and estimates used in the preparation of its consolidated financial statements.

 Stock-Based

 Cardio accounts
for its stock-based awards granted under its employee compensation plan in accordance with ASC Topic No. 718-20, Awards Classified
as Equity, which requires the measurement of compensation expense for all share-based compensation granted to employees and non-employee
directors at fair value on the date of grant and recognition of compensation expense over the related service period for awards expected
to vest. The Company uses the Black-Scholes option pricing model to estimate the fair value of its stock options and warrants. The Black-Scholes
option pricing model requires the input of highly subjective assumptions including the expected stock price volatility of the Company's
common stock, the risk-free interest rate at the date of grant, the expected vesting term of the grant, expected dividends, and an assumption
related to forfeitures of such grants. Changes in these subjective input assumptions can materially affect the fair value estimate of
the Company's stock options and warrants.

 Item 7A.
 Quantitative and Qualitative Disclosures About Market Risk

 As of December 31, 2024, we were not subject to any market or
interest rate risk.

 Item 8.
 Financial Statements and Supplemental Data

 INDEX TO FINANCIAL STATEMENTS

 Page

 Report of Independent Registered Public Accounting Firm (PCAOB ID 273)

 Consolidated Balance Sheets as of December 31, 2024 and 2023

 Consolidated Statements of Operations for the Years Ended December 31, 2024 and 2023

 Consolidated Statements of Changes in Stockholders' Equity for the Years Ended December 31, 2024 and 2023

 Consolidated Statements of Cash Flows for the Years Ended December 31, 2024 and 2023

 REPORT OF INDEPENDENT REGISTERED PUBLIC ACCOUNTING FIRM

 To the Stockholders and the Board of Directors of

 Cardio Diagnostics Holdings, Inc.

 Opinion on the Consolidated Financial Statements

 We have audited the accompanying consolidated
balance sheets of Cardio Diagnostics Holdings, Inc. (the "Company") as of December 31, 2024 and 2023, and the related consolidated
statements of operations, changes in stockholders' equity, and cash flows for the years ended December 31, 2024 and 2023, and the
related notes (collectively referred to as the consolidated financial statements). In our opinion, the consolidated financial statements
present fairly, in all material respects, the consolidated financial position of the Company as of December 31, 2024 and 2023, and the
results of its operations and its cash flows for the years ended December 31, 2024 and 2023, in conformity with accounting principles
generally accepted in the United States of America.

 Basis for Opinion

 These consolidated financial statements are the
responsibility of the Company's management. Our responsibility is to express an opinion on the Company's consolidated financial
statements based on our audits. We are a public accounting firm registered with the Public Company Accounting Oversight Board (United
States) (PCAOB) and are required to be independent with respect to the Company in accordance with the U.S. federal securities laws and
the applicable rules and regulations of the Securities and Exchange Commission and the PCAOB.

 We conducted our audits in accordance with the
standards of the PCAOB. Those standards require that we plan and perform the audit to obtain reasonable assurance about whether the consolidated
financial statements are free of material misstatement, whether due to error or fraud. The Company is not required to have, nor were we
engaged to perform, an audit of its internal control over financial reporting. As part of our audits, we are required to obtain an understanding
of internal control over financial reporting, but not for the purpose of expressing an opinion on the effectiveness of the Company's
internal control over financial reporting. Accordingly, we express no such opinion.

 Our audits included performing procedures to
assess the risks of material misstatement of the consolidated financial statements, whether due to error or fraud, and performing procedures
that respond to those risks. Such procedures included examining, on a test basis, evidence regarding the amounts and disclosures in the
consolidated financial statements. Our audits also included evaluating the accounting principles used and significant estimates made
by management, as well as evaluating the overall presentation of the consolidated financial statements. We believe that our audits provide
a reasonable basis for our opinion.

 /s/ Prager Metis CPAs
LLC

 We have served
as the Company's auditor since 2021

 Hackensack,
New Jersey

 F- 1

 CONSOLIDATED BALANCE SHEETS

 DECEMBER 31,

 2024

 2023

 ASSETS

 Current assets

 Cash

 $
 7,827,487

 $
 1,283,523

 Accounts receivable

 18,612

 4,960

 Prepaid expenses and other current assets

 944,683

 1,477,197

 Total current assets

 8,790,782

 2,765,680

 Long-term assets

 Property and equipment, net

 672,861

 571,873

 Right of use assets, net

 432,397

 575,227

 Intangible assets, net

 5,333

 21,333

 Deposits

 12,850

 12,850

 Patent costs, net

 701,089

 515,402

 Total assets

 $
 10,615,312

 $
 4,462,365

 LIABILITIES AND STOCKHOLDERS' EQUITY

 Current liabilities

 Accounts payable and accrued expenses

 $
 87,661

 $
 243,213

 Lease liability – current

 237,270

 223,929

 Finance agreement payable

 306,764

 374,000

 Total current liabilities

 631,695

 841,142

 Long-term liabilities

 Lease liability – long term

 425,829

 663,099

 Total liabilities

 1,057,524

 1,504,241

 Stockholders'
 equity

 Preferred
 stock, $.00001 par value; authorized – 100,000,000 shares; 0 shares issued and outstanding as of December 31, 2024 and 2023,
 respectively

 —

 —

 Common
 stock, $.00001 par value; authorized – 300,000,000 shares; 45,944,039 and 20,540,409 shares issued and outstanding as of December
 31, 2024 and 2023, respectively

 Additional
 paid-in capital

 32,309,162

 17,326,299

 Accumulated
 deficit

 ( 22,751,833
)

 ( 14,368,380
)

 Total
 stockholders' equity

 9,557,788

 2,958,124

 Total
 liabilities and stockholders' equity

 $
 10,615,312

 $
 4,462,365

 See accompanying notes to
the consolidated financial statements.

 F- 2

 CONSOLIDATED STATEMENTS OF OPERATIONS

 YEARS ENDED DECEMBER 31,

 2024

 2023

 Revenue

 $
 34,890

 $
 17,065

 Operating expenses

 Sales and marketing

 182,446

 158,514

 Research and development

 29,125

 145,182

 General and administrative expenses

 8,169,458

 6,936,646

 Amortization

 19,738

 19,182

 Total operating expenses

 8,400,767

 7,259,524

 Loss from operations

 ( 8,365,877
)

 ( 7,242,459
)

 Other income (expenses)

 Change in fair value of derivative liability

 —

 5,406,220

 Interest income

 1,064

 1,068

 Interest expense

 ( 18,640
)

 ( 6,735,013
)

 Gain on extinguishment of debt

 —

 193,350

 Total other income (expenses)

 ( 17,576
)

 ( 1,134,375
)

 Loss before provision for income taxes

)

)

 Provision for income taxes

 —

 —

 Net loss

 $
)

 $
)

 Basic and fully diluted income (loss) per common share:

 Net loss per common share

 $
 (.31
)

 $
 (.66
)

 Weighted average common shares outstanding – basic and fully diluted

 26,892,705

 12,685,133

 See accompanying notes to
the consolidated financial statements.

 F- 3

 CARDIO DIAGNOSTICS HOLDINGS,
 INC.

 CONSOLIDATED
STATEMENTS OF CHANGES IN STOCKHOLDERS' EQUITY

 YEARS ENDED DECEMBER 31, 2024 AND 2023

 Common Stock

 Additional Paid-in

 Accumulated

 Shares

 Amount

 Capital

 Deficit

 Totals

 Balances, December 31, 2022

 9,514,743

 $

 $
 10,293,159

 $
 ( 5,991,546
)

 $
 4,301,708

 Warrants converted to common stock

 100,000

 389,999

 —

 390,000

 Placement agent fee

 —

 —

 ( 315,000
)

 —

 ( 315,000
)

 Restricted stock awards vested

 303,547

 243,997

 —

 244,000

 Notes payable converted to common stock

 10,622,119

 5,604,846

 —

 5,604,952

 Compensation for vested stock options

 —

 —

 1,035,273

 —

 1,035,273

 Adjustment to liabilities assumed in merger with Mana

 —

 —

 74,025

 —

 74,025

 Net loss

 —

 —

 —

)

)

 Balances, December 31, 2023

 20,540,409

 17,326,299

 ( 14,368,380
)

 2,958,124

 Common stock and warrants issued for cash

 25,319,850

 12,546,696

 —

 12,546,949

 Placement agent fee

 —

 —

 ( 155,000
)

 —

 ( 155,000
)

 Restricted stock awards vested

 83,780

 75,999

 —

 76,000

 Compensation for vested stock options

 —

 —

 2,515,168

 —

 2,515,168

 Net loss

 —

 —

 —

)

)

 Balances, December 31, 2024

 45,944,039

 $

 $
 32,309,162

 $
 ( 22,751,833
)

 $
 9,557,788

 See accompanying notes to the consolidated
financial statements.

 F- 4

 CARDIO
DIAGNOSTICS HOLDINGS, INC.

 CONSOLIDATED
STATEMENTS OF CASH FLOWS

 YEARS
ENDED DECEMBER 31,

 2024

 2023

 CASH FLOWS FROM OPERATING ACTIVITIES:

 Net loss

 $
)

 $
)

 Adjustments to reconcile net loss to net cash used in operating activities

 Depreciation

 113,777

 3,790

 Amortization

 162,568

 107,830

 Stock-based compensation expense

 2,591,168

 1,279,273

 Non-cash interest expense

 —

 6,704,522

 Change in fair value of derivative liability

 —

 ( 5,406,220
)

 Gain on extinguishment of debt

 —

 ( 193,350
)

 Changes in operating assets and liabilities:

 Accounts receivable

 ( 13,652
)

 ( 4,960
)

 Prepaid expenses and other current assets

 915,969

 758,669

 Deposits

 —

 ( 7,900
)

 Accounts payable and accrued expenses

 ( 155,552
)

 ( 781,500
)

 Lease liability

 ( 223,929
)

 244,505

 NET CASH USED IN OPERATING ACTIVITIES

 ( 4,993,104
)

 ( 5,672,175
)

 CASH FLOWS FROM INVESTING ACTIVITIES:

 Purchases of property and equipment

 ( 214,765
)

 ( 575,663
)

 Payments for right of use asset

 —

 ( 21,352
)

 Patent
 and trademark costs incurred

 ( 189,425
)

 ( 197,276
)

 NET CASH
 USED IN INVESTING ACTIVITIES

 ( 404,190
)

 ( 794,291
)

 CASH FLOWS
 FROM FINANCING ACTIVITIES:

 Proceeds
 from sale of common stock and warrants

 12,546,949

 —

 Proceeds
 from convertible notes payable, net of original issue discount of $ 500,000

 —

 4,500,000

 Proceeds from exercise
 of warrants

 —

 390,000

 Payments
 of finance agreement

 ( 450,691
)

 ( 942,532
)

 Payments
 of placement agent fee

 ( 155,000
)

 ( 315,000
)

 NET
 CASH PROVIDED BY FINANCING ACTIVITIES

 11,941,258

 3,632,468

 NET INCREASE (DECREASE) IN
 CASH

 6,543,964

 ( 2,833,998
)

 CASH
 – BEGINNING OF YEAR

 1,283,523

 4,117,521

 CASH
 – END OF YEAR

 $
 7,827,487

 $
 1,283,523

 SUPPLEMENTAL DISCLOSURES OF CASH FLOW INFORMATION:

 Cash paid during the year for:

 Interest

 $
 18,640

 $
 30,491

 Income taxes

 $
 —

 $
 —

 Non-cash investing and financing activities:

 Debt discount related to derivative liability

 $
 —

 $
 5,000,000

 Notes payable converted to common stock

 $
 —

 $
 5,000,000

 Adjustment to liabilities assumed in acquisition

 $
 —

 $
 74,025

 Financing agreement entered into for prepaid insurance

 $
 383,455

 $
 467,500

 Right of use asset added for operating lease

 $
 —

 $
 642,523

 See accompanying notes to the consolidated
financial statements.

 F- 5

 CARDIO
DIAGNOSTICS HOLDINGS, INC.

 Notes
to Consolidated Financial Statements

 Note
1 – Organization and Basis of Presentation

 The
consolidated financial statements presented are those of Cardio Diagnostics Holdings, Inc., (the "Company") and its wholly-owned
subsidiary, Cardio Diagnostics, Inc. ("Legacy Cardio"). The Company was incorporated as Mana Capital Acquisition Corp. ("Mana")
under the laws of the state of Delaware on May 19, 2021, and Legacy Cardio was formed on January 16, 2017 as an Iowa limited liability
company (Cardio Diagnostics, LLC) and was subsequently incorporated as a Delaware C-Corp on September 6, 2019. The Company was formed
to develop and commercialize a patent-pending Artificial Intelligence ("AI")-driven DNA biomarker testing technology ("Core
Technology") for cardiovascular disease invented at the University of Iowa by the Founders, with the goal of becoming one of the
leading medical technology companies for enabling precision prevention, early detection and treatment of cardiovascular disease. The
Company is transforming the approach to cardiovascular disease from reactive to proactive. The Core Technology is being incorporated
into a series of products for major types of cardiovascular disease and associated co-morbidities including coronary heart disease (CHD),
stroke, heart failure and diabetes.

 Business
 Combination

 On May 27, 2022, Mana, Mana Merger Sub, Inc.
("Merger Sub"), a wholly-owned direct subsidiary of Mana, Meeshanthini Dogan, the Shareholders' Representative, and
Legacy Cardio entered into the Business Combination Agreement (the "Merger Agreement"). On October 25, 2022, pursuant to
the Merger Agreement, Legacy Cardio merged with and into Merger Sub, with Legacy Cardio surviving as the wholly-owned subsidiary of Mana.
Subsequent to the merger, Mana changed its name to Cardio Diagnostics Holdings, Inc.

 Note
2 – Merger Agreement and Reverse Recapitalization

 As
discussed in Note 1, on October 25, 2022, the Company (formerly known as Mana) and Legacy Cardio entered into the Merger Agreement, which
has been accounted for as a reverse recapitalization in accordance with GAAP. Pursuant to the Merger Agreement, the Company acquired
cash of $ 4,021 and assumed liabilities of $ 928,500 from Mana. The liabilities assumed of $ 928,500
were payable to two investment bankers and due on October 25, 2023. The assumed liabilities decreased to $ 854,475, net of an early payment
discount of $ 74,025 issued by one of the two investment bankers on March 22, 2023. On March 27, 2023, the Company accepted the early
payment discount and paid Ladenburg the net balance due and payable of $ 419,475. On October 24, 2023, the Company paid the remaining
post-merger liabilities balance of $ 435,000 to Benchmark.

 Mana's
common stock had a redemption right in connection with the business combination. Mana's stockholders exercised their right to redeem
 6,465,452 shares of common stock, which constituted approximately 99.5 % of the shares with redemption rights, for cash at a redemption
price of approximately $ 10.10 per share, for an aggregate redemption amount of $ 65,310,892. In accounting for the reverse recapitalization,
the Company's legacy issued and outstanding 1,976,749 shares of common stock were reversed and the Mana shares of common stock
totaling 9,514,743 were recorded, as described in Note 10. Transactions costs incurred in connection with the recapitalization totaled
$ 1,535,035 and were recorded as a reduction to additional paid in capital.

 F- 6

 As
additional consideration for the transaction, Cardio will issue to each holder who was entitled to merger consideration at the Closing,
its pro rata proportion of up to 1,000,000 shares of our authorized but unissued common stock (the "Earnout Shares"
or "Contingently Issuable Common Stock"), if on or prior to the fourth anniversary of the Closing Date (the "Earnout
Period"), the VWAP of the Company's Common Stock equals or exceeds four different price triggers for 30 of any 40 consecutive
trading days, as follows: (i) one-quarter of the Earnout Shares will be issued if the VWAP equals or exceeds $12.50 per share for the
stated period; (ii) one-quarter of the Earnout Shares will be issued if the VWAP equals or exceeds $15.00 per share for the stated period;
(iii) one-quarter of the Earnout Shares will be issued if the VWAP equals or exceeds $17.50 for the stated period; and (iv) one-quarter
of the Earnout Shares will be issued if the VWAP equals or exceeds $20.00 for the stated period.

 In
evaluating the accounting treatment for the earnout, we have concluded that the earnout is not a liability under Accounting Standards
Codification ("ASC") 480, Distinguishing Liabilities from Equity, is not subject to the accounting guidance under ASC 718,
Compensation—Stock Compensation, and is not subject to derivative accounting under ASC 815, Derivative and Hedging. As such, the
earnout is recognized in equity at fair value upon the closing of the Business Combination. As of the date of filing of this Annual Report
on Form 10-K, the Company's common stock did not trade at equal to or greater than $12.50 for a period of at least 30 trading days
out of 40 consecutive trading days and the Company has not issued any Earnout Shares.

 Note
3 – Summary of Significant Accounting Policies

 Principles
of Consolidation

 The
consolidated financial statements include the accounts of the Company and its wholly-owned subsidiary, Legacy Cardio. All intercompany
accounts and transactions have been eliminated.

 Use
of Estimates in the Preparation of Financial Statements

 The
preparation of financial statements in conformity with generally accepted accounting principles requires management to make estimates
and assumptions that affect the reported amounts of assets and liabilities and disclosure of contingent assets and liabilities at the
date of the consolidated financial statements and the reported amounts of revenues and expenses during the period. Actual results could
differ from those estimates.

 Fair
Value Measurements

 The
Company adopted the provisions of ASC Topic 820, Fair Value Measurements and Disclosures, which defines fair value as used in
numerous accounting pronouncements, establishes a framework for measuring fair value and expands disclosure of fair value measurements.

 The
estimated fair value of certain financial instruments, including cash and cash equivalents, accounts receivable, accounts payable and
accrued expenses are carried at historical cost basis, which approximates their fair values because of the short-term nature of these
instruments. The carrying amounts of our short- and long-term credit obligations approximate fair value because the effective yields
on these obligations, which include contractual interest rates taken together with other features such as concurrent issuances of warrants
and/or embedded conversion options, are comparable to rates of returns for instruments of similar credit risk.

 ASC
820 defines fair value as the exchange price that would be received for an asset or paid to transfer a liability (an exit price) in the
principal or most advantageous market for the asset or liability in an orderly transaction between market participants on the measurement
date. ASC 820 also establishes a fair value hierarchy, which requires an entity to maximize the use of observable inputs and minimize
the use of unobservable inputs when measuring fair value. ASC 820 describes three levels of inputs that may be used to measure fair value:

 Level
1 – quoted prices in active markets for identical assets or liabilities

 Level
2 – quoted prices for similar assets and liabilities in active markets or inputs that are observable

 Level 3 – inputs that
are unobservable (for example cash flow modeling inputs based on assumptions)

 The
estimated fair value of the derivative liability was calculated using the Black-Scholes option pricing model. The Company uses Level
3 inputs to value its derivative liabilities. The following table provides a reconciliation of the beginning and ending balances for
the major classes of assets and liabilities measured at fair value using significant unobservable inputs (Level 3) and reflects gains
and losses for the years ended December 31, 2024 and 2023.

 F- 7

 Schedule of fair value measurements

 2024

 2023

 Liabilities:

 Balance of derivative liabilities – beginning of year

 $
 —

 $
 —

 Issued

 —

 9,192,672

 Converted

 —

 ( 3,786,452
)

 Change in fair value recognized in operations

 —

 ( 5,406,220
)

 Balance of derivative liabilities – end of year

 $
 —

 $
 —

 The following table represents the Company's
derivative instruments that are measured at fair value on a recurring basis as of December 31, 2024 and 2023, for each fair value hierarchy
level:

 Schedule of fair value hierarchy level

 December 31, 2024

 Derivative Liabilities

 Total

 Level I

 $
 —

 $
 —

 Level II

 $
 —

 $
 —

 Level III

 $
 —

 $
 —

 December 31, 2023

 Derivative Liabilities

 Total

 Level I

 $
 —

 $
 —

 Level II

 $
 —

 $
 —

 Level III

 $
 —

 $
 —

 Convertible Instruments

 The Company evaluates and accounts for conversion options
embedded in convertible instruments in accordance with ASC 815, Derivatives and Hedging Activities.

 Applicable GAAP requires companies
to bifurcate conversion options from their host instruments and account for them as free standing derivative financial instruments according
to certain criteria. The criteria include circumstances in which (a) the economic characteristics and risks of the embedded derivative
instrument are not clearly and closely related to the economic characteristics and risks of the host contract, (b) the hybrid instrument
that embodies both the embedded derivative instrument and the host contract is not re-measured at fair value under other GAAP with changes
in fair value reported in earnings as they occur and (c) a separate instrument with the same terms as the embedded derivative instrument
would be considered a derivative instrument.

 The Company accounts for
convertible instruments (when it has been determined that the embedded conversion options should not be bifurcated from their host instruments)
as follows: The Company records, when necessary, discounts to convertible notes for the intrinsic value of conversion options embedded
in debt instruments based upon the differences between the fair value of the underlying common stock at the commitment date of the note
transaction and the effective conversion price embedded in the note. Debt discounts under these arrangements are amortized over the term
of the related debt to their stated date of redemption.

 The
Company accounts for the conversion of convertible debt when a conversion option has been bifurcated using the general extinguishment
standards. The debt and equity linked derivatives are removed at their carrying amounts and the shares issued are measured at their then-current
fair value, with any difference recorded as a gain or loss on extinguishment of the two separate accounting liabilities.

 Revenue Recognition

 The Company offers its products, Epi+Gen CHD and PrecisionCHD, via telemedicine providers, provider organizations such as concierge practices,
longevity clinics, and risk-bearing provider organizations, and employer organizations. The Company is continuing to expand its markets
and payment optionality, and therefore, other organization types not listed below may be added, and from time-to-time, there may be additional
payment options.

 •
 Telemedicine

 For telemedicine, the telemedicine
provider collects payments from patients upon completion of eligibility screening and test order. Patients then send their samples to
the lab for biomarker assessments. The Company performs all quality control, analytical assessments and report generation and shares test
reports with the ordering healthcare provider. Revenue is recognized upon invoicing the telemedicine providers. Telemedicine providers
are invoiced at the end of each month for all tests completed since prior invoicing.

 •
 Provider organizations

 For provider organizations,
the cost of each test is negotiated prior to testing commencing. Pricing is determined based largely on the provider organization type
and testing volume commitment. Upon ordering a test, a patient's sample is sent to the lab for biomarker assessments. The Company
performs all quality control, analytical assessments and report generation and shares test reports with the ordering healthcare provider.
Revenue is recognized upon invoicing the provider organization. The provider organization is invoiced the agreed upon pricing at the end
of each month for all samples accepted or tests completed since prior invoicing.

 F- 8

 •
 Employer organizations

 For employer organizations,
the cost of each test is negotiated prior to testing commencing. Pricing is determined based largely on testing volume commitment. Patient
samples are sent to the lab for biomarker assessments. The Company performs all quality control, analytical assessments and report generation
and shares test reports with the ordering healthcare provider. Revenue is recognized upon invoicing the employer organization. The employer
organization is invoiced the agreed upon pricing once a heart disease fair is completed or all testing is completed.

 The Company accounts for revenue
under Accounting Standards Update ("ASU") 2014-09, "Revenue from Contracts with Customers (Topic 606)", using
the modified retrospective method. The modified retrospective adoption used by the Company did not result in a material cumulative effect
adjustment to the opening balance of accumulated deficit.

 The Company determines the measurement of revenue and the timing
of revenue recognition utilizing the following core principles:

 1.
 Identifying
 the contract with a customer;

 2.
 Identifying
 the performance obligations in the contract;

 3.
 Determining
 the transaction price;

 4.
 Allocating
 the transaction price to the performance obligations in the contract; and

 5.
 Recognizing
 revenue when (or as) the Company satisfies its performance obligations.

 Research and Development

 Research and development
costs are expensed as incurred. Research and development costs charged to operations for the years ended December 31, 2024 and 2023 were
$ 29,125 and $ 145,182, respectively.

 Advertising Costs

 The Company expenses advertising costs as incurred. Advertising
costs of $ 182,446 and $ 158,514 were charged to operations for the years ended December 31, 2024 and 2023, respectively.

 Cash
and Cash Equivalents

 Cash and cash equivalents are comprised of
cash and highly liquid investments with original maturities of 90 days or less at the date of purchase. The Company does no t have any
cash equivalents as of December 31, 2024 and 2023. Cash is maintained at a major financial institution. Accounts held at U.S. financial
institutions are insured by the FDIC up to $ 250,000. The Company is exposed to credit risk in the event of default by the financial institutions
or the issuers of these investments to the extent the amounts on deposit or invested are in excess of amounts that are insured. The Company's
accounts at this major financial institution may, at times, exceed the federally insured limits. The amount in excess of the FDIC insurance
as of December 31, 2024 and 2023, was approximately $ 7.5 million and $ 933,523, respectively. The Company has not experienced any losses
on these accounts and management believes, based upon the quality of this major financial institution, that the credit risk with regard
to these deposits is not significant.

 Accounts Receivable

 Accounts receivable is stated
at invoiced amount, net of an allowance for doubtful accounts and bear no interest. An allowance for losses is established through a provision
for losses charged to expenses. Receivables are charged against the allowance for losses when management believes collectability is unlikely.
The allowance (if any) is an amount that management believes will be adequate to absorb estimated losses on existing receivables, based
on evaluation of the collectability of the accounts and prior loss experience.

 Property and Equipment

 Property
and equipment are stated at cost. Maintenance and repairs are charged to expense when incurred. When property and equipment are retired
or otherwise disposed of, the related cost and accumulated depreciation are removed from the respective accounts and any gain or loss
is credited or charged to income. Depreciation for both financial reporting and income tax purposes is computed using combinations of
the straight line and accelerated methods over the estimated lives of the respective assets as follows:

 Schedule of estimated lives

 Office and computer equipment

 5 years

 Furniture and fixtures

 7 years

 Lab equipment

 7 years

 Leasehold improvements

 7 years

 F- 9

 Intangible Assets

 Intangible
assets are acquired individually or as part of a group of assets, and are initially recorded at cost. The cost of a group of assets acquired
in a transaction is allocated to the individual assets based on their relative fair values. Intangible assets are carried at cost less
accumulated amortization and any recorded impairment. Intangible assets with finite useful lives are amortized using a straight-line
method over the period of estimated useful life. The estimated useful life of the Company's intangible assets (Know-how license)
is 5 years. The Company evaluates intangible assets for impairment whenever events or changes in circumstances indicate that the assets
might be impaired.

 Patent Costs

 The Company accounts for patents in accordance
with ASC 350-30, General Intangibles Other than Goodwill. The Company capitalizes patent costs representing legal fees associated
with filing patent applications and amortize them on a straight-line basis. The Company evaluates its patents' estimated useful
life and begins amortizing the patents when they are brought to the market or otherwise commercialized.

 Impairment
of Long-Lived Assets

 In accordance with ASC 360-10-35,
the Company assesses the valuation of components of its long-lived assets whenever events or circumstances dictate that the carrying value
might not be recoverable. The Company bases its evaluation on indicators such as the nature of the assets, the future economic benefit
of the assets, any historical or future profitability measurements and other external market conditions or factors that may be present.
If such factors indicate that the carrying amount of an asset or asset group may not be recoverable, the Company determines whether an
impairment has occurred by analyzing an estimate of undiscounted future cash flows at the lowest level for which identifiable cash flows
exist. If the estimate of undiscounted cash flows during the estimated useful life of the asset is less than the carrying value of the
asset, the Company recognizes a loss for the difference between the carrying value of the asset and its estimated fair value, generally
measured by the present value of the estimated cash flows.

 Leases

 The Company accounts for leases
under ASC 842, "Leases". The Company determines if an arrangement is a lease or contains a lease at inception of the
arrangement. Operating lease liabilities are recognized based on the present value of the remaining lease payments, discounted using the
discount rate for the lease at the commencement date. As the rate implicit in the lease is not readily determinable for the operating
lease, the Company generally uses an incremental borrowing rate based on information available at the commencement date to determine the
present value of future lease payments. Operating lease right-of-use assets ("ROU assets") represent the Company's right
to control the use of an identified asset for the lease term and lease liabilities represent the Company's obligation to make lease
payments arising from the lease. ROU assets are generally recognized based on the amount of the initial measurement of the lease liability.
Lease expense is recognized on a straight-line basis over the lease term. The Company elected to keep leases with an initial term of 12
months or less off the balance sheet.

 ROU assets are reviewed for
impairment when indicators of impairment are present. ROU assets from operating and finance leases are subject to the impairment guidance
in ASC 360, Property, Plant, and Equipment, as ROU assets are long-lived nonfinancial assets. ROU assets are tested for impairment individually
or as part of an asset group if the cash flows related to the ROU assets are not independent from the cash flows of other assets and liabilities.
An asset group is the unit of accounting for long-lived assets to be held and used, which represents the lowest level for which identifiable
cash flows are largely independent of the cash flows of other groups of assets and liabilities.

 Stock-Based Compensation

 The Company accounts for its stock-based
awards granted under its employee compensation plan in accordance with ASC Topic No. 718-20, Awards Classified as Equity, which requires
the measurement of compensation expense for all share-based compensation granted to employees and non-employee directors at fair value
on the date of grant and recognition of compensation expense over the related service period for awards expected to vest. The Company
uses the Black-Scholes option pricing model to estimate the fair value of its stock options and warrants. The Black-Scholes option pricing
model requires the input of highly subjective assumptions including the expected stock price volatility of the Company's common
stock, the risk free interest rate at the date of grant, the expected vesting term of the grant, expected dividends, and an assumption
related to forfeitures of such grants. Changes in these subjective input assumptions can materially affect the fair value estimate of
the Company's stock options and warrants.

 Income
 Taxes

 The Company accounts for income
taxes using the asset and liability method in accordance with ASC Topic No. 740, Income Taxes. Under this method, deferred tax assets
and liabilities are determined based on differences between financial reporting and tax bases of assets and liabilities, and are measured
using the enacted tax rates and laws that are expected to be in effect when the differences are expected to reverse.

 The Company applies the provisions
of ASC Topic No. 740 for the financial statement recognition, measurement and disclosure of uncertain tax positions recognized in the
Company's financial statements. In accordance with this provision, tax positions must meet a more-likely-than-not recognition threshold
and measurement attribute for the financial statement recognition and measurement of a tax position.

 F- 10

 Recent Accounting Pronouncements

 We have reviewed other recent
accounting pronouncements and concluded they are either not applicable to the business, or no material effect is expected on the consolidated
financial statements as a result of future adoption.

 Note
4 – Property and Equipment

 Property and equipment are carried at cost and consist of the following at December 31, 2024 and 2023:

 Schedule of property and equipment

 2024

 2023

 Office and computer equipment

 $
 21,032

 $
 17,394

 Furniture and fixtures

 96,818

 76,099

 Lab equipment

 170,423

 —

 Leasehold improvements

 502,155

 482,170

 Less: Accumulated depreciation

 ( 117,567
)

 ( 3,790
)

 Total

 $
 672,861

 $
 571,873

 Leasehold improvements of $ 502,155 represent costs
of the buildout of the leased laboratory in Iowa City, Iowa that was completed in January 2024. Depreciation expense of $ 113,777 and $ 3,790
was charged to operations for the years ended December 31, 2024 and 2023, respectively.

 Note
5 – Intangible Assets

 The
following table provides details associated with the Company's acquired identifiable intangible assets at December 31, 2024 and
2023:

 Schedule of intangible assets

 2024

 2023

 Know-how license

 $
 80,000

 $
 80,000

 Less: Accumulated amortization

 ( 74,667
)

 ( 58,667
)

 Total

 $
 5,333

 $
 21,333

 Amortization expense charged to operations was $ 16,000 for the
years ended December 31, 2024 and 2023, respectively.

 Note
6 – Patent Costs

 As of December 31, 2024, in the first family
of patents and patent applications owned solely by UIRF and is exclusively licensed by Cardio, there are seven granted patents (US (2),
EU, China, Australia, India and Hong Kong) and other pending patent applications. The Company has pending patent applications in patent
families two, three, four, five and six. Legal fees associated with the patents totaled $ 701,089 and $ 515,402, net of accumulated amortization
of $ 6,920 and $ 3,182 as of December 31, 2024 and 2023, respectively and are presented in the consolidated balance sheets as patent costs.
Patents are amortized over their estimated useful lives of approximately 14 and 15 years, respectively. Amortization expense charged to
operations was $ 3,738 and $ 3,182 for the years ended December 31, 2024 and 2023, respectively.

 Note
7 – Operating Leases

 The Company determines if
a contract is, or contains, a lease at contract inception. Operating leases are included in operating lease right-of-use ("ROU")
assets, current portion of operating lease liabilities and operating lease liabilities, net of current portion in the Company's
consolidated balance sheets. Finance leases are included in property and equipment, current portion of finance lease obligations and finance
lease obligations, net of current portion in the Company's consolidated balance sheets.

 ROU assets represent the right
to use an underlying asset for the lease term and lease liabilities represent the obligation to make lease payments arising from the lease.
ROU assets and lease liabilities are recognized at the commencement date based on the present value of lease payments over the lease term.
In addition, ROU assets include initial direct costs incurred by the lessee as well as any lease payments made at or before the commencement
date and exclude lease incentives. The Company used the implicit rate in the lease in determining the present value of lease payments.
Lease terms include options to extend or terminate the lease when it is reasonably certain that the Company will exercise that option.
Leases with a term of one year or less are generally not included in ROU assets and corresponding operating lease liabilities.

 F- 11

 In 2023, the Company entered
into a lease agreement for office space in Chicago, Illinois, commencing on August 1, 2023 for a term of three years and four months and
expiring on November 30, 2026. The monthly rent for August to November 2023 was abated and the Company started to make monthly rental
installments from December 2023 of $12,847. The monthly rental payment increases by approximately 2% every August starting from 2024.

 On July 20, 2023, the Company entered into
another lease agreement for laboratory facilities in Iowa City, Iowa, commencing on August 1, 2023 for a term of five years and four months
and expiring on November 30, 2028. The monthly rent for August to November 2023 was abated and the Company agreed to pay a monthly rent
of $ 8,505 ($ 102,060 annually) commencing December 1, 2023. In addition, the landlord agreed to provide the Company with a one-time Tenant
Improvement Allowance ("TIA") in the amount of up to, but not exceeding $50 per rentable square foot of the premises for a
maximum allowance of $ 253,000.

 Pursuant to ASC Topic 842
Leases, the Company accounted for both leases as operating leases and accounted for the TIA as a lease incentive, which was estimated
to be payable on December 1, 2023. The Company received the TIA from landlord in maximum amount of $ 253,000 on January 16, 2024 and recorded
a reimbursement receivable from landlord of $ 253,000 as of December 31, 2023, which was included in Prepaid expenses and other current
assets on the consolidated balance sheets.

 During the year ended December 31, 2023, the
Company recorded ROU assets of $ 663,875 and operating lease liabilities of $ 642,523 at the lease commencement date. The discount rate
used to determine the present value is the incremental borrowing rate, estimated to be 4.57 % for the Chicago lease and 4.24 % for the Iowa
City lease, respectively, as the interest rate implicit in our lease is not readily determinable.

 As
of December 31, 2024 and 2023, operating lease ROU assets and operating lease liabilities are recorded on the consolidated balance sheets
as follows:

 Schedule of operating lease ROU assets and operating lease liabilities

 December 31,

 December 31,

 2024

 2023

 Operating Leases:

 Operating lease right-of-use assets, net

 $
 432,397

 $
 575,227

 Current portion of operating lease liabilities

 $
 237,270

 $
 223,929

 Operating lease liabilities, net of current portion

 $
 425,829

 $
 663,099

 As of December 31, 2024, the weighted-average
remaining lease terms of the two operating leases were 1.9 years and 3.9 years, respectively.

 The following table summarizes maturities
of operating lease liabilities based on lease terms as of December 31:

 Schedule of future minimum payments due

 2025

 $
 260,611

 2026

 250,152

 2027

 102,060

 2028

 93,555

 Total lease payments

 706,378

 Less: Imputed interest

 43,279

 Present value of lease liabilities

 $
 663,099

 At December 31, 2024, the Company had the
following future minimum payments due under the non-cancelable lease:

 2025

 $
 260,611

 2026

 250,152

 2027

 102,060

 2028

 93,555

 Total minimum lease payments

 $
 706,378

 F- 12

 Consolidated rental expense for all operating
leases was $ 204,717 and $ 138,266 for the years ended December 31, 2024 and 2023, respectively.

 The following table summarizes the cash paid
and related right-of-use operating lease recognized for the years ended December 31, 2024 and 2023.

 Schedule of cash paid and related right-of-use operating lease

 Years Ended December 31,

 2024

 2023

 Cash paid for amounts included in the measurement of
 lease liabilities:

 Operating cash flows from operating leases

 $
 257,508

 $
 21,352

 Right-of-use lease assets obtained in the exchange for
 lease liabilities:

 Operating leases

 $
 223,929

 $
 4,950

 Note
8 – Finance Agreement Payable

 On October 25, 2023, the Company entered into
an agreement with a premium financing company to finance its Directors and Officers insurance premiums for 12-month policies effective
October 25, 2023. The amount financed of $ 467,500 is payable in 10 monthly installments plus interest at a rate of 8.95 % through August
25, 2024. Accordingly, Directors and Officers insurance premiums of $ 550,000 was recorded in prepaid expenses and was amortized over
the life of the policy until October 25, 2024.

 On October 25, 2024, the Company entered into
an agreement with a premium financing company to finance its Directors and Officers insurance premiums for 12-month policies effective
October 25, 2024. The amount financed of $ 383,455 is payable in 10 monthly installments plus interest at a rate of 8.80 % through August
25, 2025. Accordingly, Directors and Officers insurance premiums of $ 451,124 has been recorded in prepaid expenses and is being amortized
over the life of the policy until October 25, 2025.

 Finance agreement payable for above two agreements
was $ 306,764 and $ 374,000 at December 31, 2024 and 2023, respectively. Unamortized balance of Directors and Officers insurance premiums
was $ 368,315 and $ 449,041 as of December 31, 2024 and 2023, respectively.

 Note
9 – Earnings (Loss) Per Common Share

 The Company calculates net income (loss) per common
share in accordance with ASC 260 " Earnings Per Share " ("ASC 260"). Basic and diluted net earnings (loss)
per common share was determined by dividing net earnings (loss) applicable to common stockholders by the weighted average number of common
shares outstanding during the period. The Company's potentially dilutive shares, which include outstanding common stock options,
and common stock warrants have not been included in the computation of diluted net loss per share for the years ended December 31, 2024
and 2023 as the result would be anti-dilutive.

 Schedule of anti dilutive earning per share

 Years
 Ended December 31,

 2024

 2023

 Stock warrants

 8,528,766

 7,854,620

 Stock options

 3,594,202

 2,584,599

 Total shares excluded from calculation

 12,122,968

 10,439,219

 Note
10 – Stockholders' Equity

 Stock Transactions

 Pursuant to the Business Combination Agreement on October
25, 2022, the Company issued the following securities:

 Holders of conversion rights issued as a component of units
in Mana's initial public offering (the "Public Rights") were issued an aggregate of 928,571 shares of the Company's
common stock.

 Holders of existing shares
of common stock of Legacy Cardio and the holder of equity rights of Legacy Cardio (together, the "Legacy Cardio Stockholders")
received an aggregate of 6,883,306 shares of the Company's Common Stock, calculated based on the exchange
ratio of 3.427259 pursuant to the Merger Agreement (the "Exchange Ratio") for each share of Legacy Cardio Common Stock
held or, in the case of the equity rights holder, that number of shares of the Company's Common Stock equal to 1% of the Aggregate
Closing Merger Consideration, as defined in the Merger Agreement.

 The Legacy Cardio Stockholders
received, in addition, an aggregate of 43,334 shares of the Company's Common Stock ("Conversion Shares") upon conversion
of an aggregate of $ 433,334 in principal amount of promissory notes issued by Mana to Legacy Cardio in connection with its loan of such
amount in order to extend Mana's duration through October 26, 2022 (the "Extension Notes"), which Conversion Shares
were distributed to the Legacy Cardio Stockholders in proportion to their respective interest in Legacy Cardio.

 Mana public stockholders
(excluding Mana Capital, LLC, the SPAC sponsor (the "Sponsor"), and Mana's former officers and directors) own 34,548
shares of the Company's Common Stock and the Sponsor, Mana's former officers and directors and certain permitted transferees
own 1,625,000 shares of the Company's Common Stock.

 Immediately after giving effect to the Business Combination,
there were 9,514,743 issued and outstanding shares of the Company's Common Stock.

 F- 13

 On October 25, 2022, in connection
with the approval of the Business Combination, the Company's stockholders approved the Cardio Diagnostics Holdings, Inc. 2022 Equity
Incentive Plan (the "2022 Plan"). The purpose of the 2022 Plan is to promote the interests of the Company and its stockholders
by providing eligible employees, officers, directors and consultants with additional incentives to remain with the Company and its subsidiaries,
to increase their efforts to make the Company more successful, to reward such persons by providing an opportunity to acquire shares of
Common Stock on favorable terms and to attract and retain the best available personnel to participate in the ongoing business operations
of the Company. The 2022 Plan permits the grant of Incentive Stock Options, Nonstatutory Stock Options, Restricted Stock, Restricted Stock
Units, Stock Appreciation Rights, Performance Units and Performance Shares.

 The
2022 Plan, as approved, permits the issuance of up to 3,265,516 shares of Common Stock (the "Share Reserve") upon exercise
or conversion of grants and awards made from time to time to officers, directors, employees and consultants, however that the Share Reserve
will increase on January 1st of each calendar year and ending on and including January 1, 2027 (each, an "Evergreen Date"),
in an amount equal to the lesser of (i) 7% of the total number of shares of Common Stock outstanding on the December 31st immediately
preceding the applicable Evergreen Date and (ii) such lesser number of shares of Common Stock as determined to be appropriate by the
Compensation Committee, which administers the 2022 Plan, in its sole discretion. There was no increase in the Share Reserve on January
1, 2023. In January 2024, the Compensation Committee approved an annual increase in the Share Reserve of 1,060,458 shares.

 Common Stock Issued

 Private
Placement

 In connection with a private offering memorandum that the
Company issued through a placement agent on January 23, 2024, the Company completed entering into subscription agreements with 7 accredited
investors (the "Subscription Agreements"), whereby the Company issued a total of 561,793 units ("Units"), with
each Unit consisting of (i) one share of the Company's common stock, $ 0.00001 par value (the "Common Stock"), and (ii)
one six year Common Stock purchase warrant (the "Warrants"), having an exercise price of $ 1.78 per share (the "Private
Placement"). The Private Placement resulted in the issuance to investors of 561,793 shares of Common Stock and 561,793 Warrants.
The purchase price of the securities was $1.78 per Unit, resulting in gross proceeds to the Company of $ 1,000,000, before deducting placement
agent fees (10% or $ 100,000) and other offering expenses. The Company intends to use the net proceeds from the Private Placement for working
capital and general corporate purposes. The Private Placement closed on February 2, 2024.

 In connection with the Private Placement, the
Company entered into a Placement Agent Agreement with Altitude Capital Group, LLC, as placement agent ("Altitude Capital"
or the "Placement Agent"). The Company's Non-Executive Chairman of the Board owns 10% of Altitude Capital. Pursuant
to the Placement Agent Agreement, at closing, Altitude Capital was paid a cash commission equal to 10% of the gross proceeds received
by the Company, plus 20% warrant coverage, providing Altitude Capital with the right to purchase 112,353 shares of Common Stock at $1.78
per share through February 2, 2030 (the "Placement Agent Warrants").

 At-the-Market Issuance

 In connection with an At-the-Market Issuance Sales Agreement
(the "Sales Agreement") that the Company entered into with a placement agent on January 26, 2024, the Company sold 24,758,057
shares of Common Stock at various amounts per share to investors for gross proceeds totaling $ 11,546,949 before deducting sales commissions
of $ 288,674 to placement agent, during the year ended December 31, 2024. The Company also paid the placement agent a fee of $ 55,000.

 Other Common Stock Issuance

 During the year ended December 31, 2024, the Company issued
 48,568 shares of Common Stock to two consultants for services pursuant to vesting of Restricted Stock Units granted, valued at $ 26,000.

 On March 31, 2024, the Company issued 35,212 shares of Common
Stock to the board of directors for services pursuant to vesting of Restricted Stock Units granted, valued at $ 50,000.

 On March 2, 2023, a shareholder exercised warrants
in exchange for 100,000 shares of Common Stock for proceeds of $ 390,000.

 During the year ended December 31, 2023, the
Company issued 52,375 shares of Common Stock to two consultants for services pursuant to vesting of Restricted Stock Units granted, valued
at $ 44,000.

 During the year ended December 31, 2023, the
Company issued 251,172 shares of Common Stock to the board of directors for services pursuant to vesting of Restricted Stock Units granted,
valued at $ 200,000.

 F- 14

 In connection with the convertible notes payable
(see Note 11 below) the noteholders converted $ 5,000,000 of principal balance to 10,622,119 shares of Common Stock during the year ended
December 31, 2023. The number of shares of Common Stock issued was determined based on the terms of the convertible notes.

 Warrants

 On October 1, 2019, the Company issued warrants
to a seed funding firm equivalent to 2% of the fully-diluted equity of the Company, or 22,500 shares of Common Stock at the time of issuance.
The warrant is exercisable on the earlier of the closing date of the next Qualified Equity Financing occurring after the issuance of the
warrant, and immediately before a Change of Control. The exercise price is the price per share of the shares sold to investors in the
next Qualified Equity Financing, or if the warrant became exercisable in connection with a Change in Control before the next Qualified
Equity Financing, the greater of the quotient obtained by dividing $150,000 by the Pre-financing Capitalization, and the price per share
paid by investors in the then-most recent Qualified Equity Financing, if any. The warrant will expire upon the earlier of the consummation
of any Change of Control, or 15 years after the issuance of the warrant.

 In April 2022, the Company issued fully vested
warrants to investors as part of private placement subscription agreements pursuant to which the Company issued Common Stock. Each shareholder
received warrants to purchase 50% of the Common Stock issued at an exercise price of $ 3.90 per share with an expiration date of June 30,
2027.

 As of May 23, 2022, the Company issued fully
vested warrants to investors as part of an additional private placement subscription agreements pursuant to which the Company issued Common
Stock. Each shareholder received warrants to purchase 50% of the Common Stock issued at an exercise price of $ 6.21 per share with an expiration
date of five years from the date of issue.

 All of the warrants issued by Legacy Cardio
were exchanged in the Business Combination for warrants of the Company based on the merger exchange ratio.

 During the year ended December 31, 2024, in
connection with the Private Placement as described above, the Company issued an aggregate of 674,146 warrants.

 Warrant
activity during the years ended December 31, 2024 and 2023 was as follows:

 Schedule of warrant activity

 Warrants
 Outstanding

 Weighted
 Average Exercise
 Price

 Weighted Average Remaining Contractual
 Life

 (Years)

 Warrants outstanding at December 31, 2022

 7,954,620

 $
 9.63

 4.46

 Warrants exercised

 ( 100,000
)

 3.90

 Warrants outstanding at December 31, 2023

 7,854,620

 9.70

 3.72

 Warrants granted

 674,146

 1.78

 Warrants outstanding at December 31, 2024

 8,528,766

 $
 9.08

 2.91

 F- 15

 Options

 On June 23, 2023, the Company granted 825,000
stock options to management, which vested immediately on grant date. Each option has an exercise price of $ 1.26 per share with an expiration
date of June 23, 2033. These immediately vested stock options were valued at $ 1,035,273 at grant date based on the Black-Scholes Option
Pricing model. The following assumptions were utilized in the Black-Scholes valuation of these immediately vested stock options during
the year ended December 31, 2023, risk free interest rate of 5.41 %, volatility of 176 % and an exercise price of $ 1.26.

 On January 23, 2024, the Company authorized
an additional 1,060,458 shares to the Equity Incentive Plan Reserve (the "2022 Plan") and granted 1,187,826 options to management
and employees, 1,166,826 of which vested immediately with the remaining 21,000 options subject to 50% vesting on June 30, 2024 and 100%
vesting on December 31, 2024. Each option has an exercise price of $ 2.11 per share with an expiration date of January 23, 2034. The immediately
vested 1,166,826 stock options were valued at $ 2,461,404 at grant date based on the Black-Scholes Option Pricing model. The following
assumptions were utilized in the Black-Scholes valuation of these immediately vested stock options during the year ended December 31,
2024, risk free interest rate of 5.22 %, volatility of 228 % and an exercise price of $2.11. For the remaining 21,000 options, 7,500 options
were vested on June 30, 2024, 5,000 options were vested on December 31, 2024 and 8,500 options were forfeited before vesting with the
leaving of the employees before December 31, 2024. The vested stock options were valued at $4,106 at vesting date based on the Black-Scholes
Option Pricing model. The following assumptions were utilized in the Black-Scholes valuation of these vested stock options during the
year ended December 31, 2024, risk free interest rate of 4.40 %, volatility of 188 % and an exercise price of $ 2.11.

 On June 30, 2024, the Company granted 30,300
stock options to the board of directors, which vested immediately on grant date. Each option has an exercise price of $0.55 per share
with an expiration date of June 30, 2034. These immediately vested stock options were valued at $ 16,625 at grant date based on the Black-Scholes
Option Pricing model. The following assumptions were utilized in the Black-Scholes valuation of these immediately vested stock options
during the year ended December 31, 2024, risk free interest rate of 4.40 %, volatility of 188 % and an exercise price of $ 0.55.

 On September 30, 2024, the Company granted
 74,744 stock options to the board of directors, which vested immediately on grant date. Each option has an exercise price of $0.22 per
share with an expiration date of September 30, 2034. These immediately vested stock options were valued at $ 16,618 at grant date based
on the Black-Scholes Option Pricing model. The following assumptions were utilized in the Black-Scholes valuation of these immediately
vested stock options during the year ended December 31, 2024, risk free interest rate of 3.79 %, volatility of 184 % and an exercise price
of $ 0.22.

 On November 14, 2024, the Company granted 15,728
stock options to two independent directors of the board, which vested immediately on grant date. Each option has an exercise price of
$0.27 per share with an expiration date of November 14, 2034. These immediately vested stock options were valued at $ 4,125 at grant date
based on the Black-Scholes Option Pricing model. The following assumptions were utilized in the Black-Scholes valuation of these immediately
vested stock options during the year ended December 31, 2024, risk free interest rate of 4.44 %, volatility of 156 % and an exercise price
of $ 0.27. The two independent directors did not stand for re-election at the 2024 Annual Meeting but did receive the options upon vesting.

 On December 31, 2024, the Company granted 13,632
stock options to the board of directors, which vested immediately on grant date. Each option has an exercise price of $0.92 per share
with an expiration date of December 31, 2034. These immediately vested stock options were valued at $ 12,289 at grant date based on the
Black-Scholes Option Pricing model. The following assumptions were utilized in the Black-Scholes valuation of these immediately vested
stock options during the year ended December 31, 2024, risk free interest rate of 4.58 %, volatility of 146 % and an exercise price of $ 0.92.

 F- 16

 Option
activity during the years ended December 31, 2024 and 2023 was as follows:

 Schedule of option activity

 Options
 Outstanding

 Weighted
 Average Exercise Price

 Weighted
 Average Remaining Contractual Life (Years)

 Options outstanding at December 31, 2022

 1,759,599

 $
 3.90

 9.35

 Options granted

 825,000

 1.26

 Options outstanding at December 31, 2023

 2,584,599

 3.06

 8.71

 Options granted

 1,322,231

 1.93

 Options expired or cancelled or forfeited

 ( 312,628
)

 1.93

 Options outstanding at December 31, 2024

 3,594,202

 $
 2.74

 8.12

 Options vested and exercisable at December 31, 2024

 3,594,202

 $
 2.74

 Note 11 – Convertible Notes Payable

 On March 8, 2023, the Company
entered into a securities purchase agreement ("Securities Purchase Agreement") with YA II PN, Ltd., an investment fund managed
by Yorkville Advisors Global, LP ("Yorkville") under which the Company agreed to sell and issue to Yorkville convertible debentures
("Convertible Debentures") in a gross aggregate principal amount of up to $ 11.2 million ("Subscription Amount").
The Convertible Debentures were convertible into shares of common stock of the Company and were subject to various contingencies being
satisfied as set forth in the Securities Purchase Agreement. The notes were convertible at any time through the maturity date, which,
in each case, was one year from the date of issuance. The conversion price was determined on the basis of 92 % of the two lowest VWAP (Volume
Weighted Average Prices) of the Common Stock during the prior seven trading day period, initially with a floor conversion price of $ 0.55,
but subsequently lowered by mutual agreement of the parties to $ 0.20.

 On March 8, 2023, the Company
issued and sold to Yorkville a Convertible Debenture in the principal amount of $ 5.0 million, for which it received $ 4.5 million, with
a $ 500,000 original issue discount ("OID"). Interest on the outstanding principal balance accrued at a rate of 0 % and would
increase to 15 % upon an Event of Default for so long as it remained uncured.

 The Company recorded a debt
discount related to identified embedded derivatives relating to the conversion features (see Note 12) based on fair values as of the inception
date of the Note. The calculated debt discount, including the OID, equaled the face of the Note and was amortized over the term of the
note.

 Yorkville fully converted the initial $ 5,000,000
Convertible Debenture into an aggregate of 10,622,119 shares of Common Stock during the year ended December 31, 2023.

 On January 4, 2024, the Company
and Yorkville terminated the Securities Purchase Agreement dated as of March 8, 2023, as amended, by the mutual consent of the parties,
effective as of January 4, 2024. The First Convertible Debenture was fully converted, and as of January 4, 2024, the obligation of the
Company to issue and sell, and Yorkville's obligation to purchase, the Second Convertible Debenture was terminated. At the time
of termination, there were no outstanding borrowings, advance notices or shares of Common Stock to be issued under the Securities Purchase
Agreement. In addition, there were no fees due by the Company or Yorkville in connection with the termination of the Securities Purchase
Agreement.

 F- 17

 Note
12 – Derivative Liability

 The Company has determined
that the conversion feature embedded in the convertible notes described in Note 11 contain a potential variable conversion amount which
constitutes a derivative which has been bifurcated from the note and recorded as a derivative liability at fair value, with a corresponding
discount recorded to the associated debt. The excess of the derivative value over the face amount of the note is recorded immediately
to interest expense at inception, which aggregated $4,692,672. The Company used the Binomial Black-Scholes Option Pricing model to value
the conversion features.

 The
Company used Level 3 inputs for its valuation methodology for the conversion option liability in determining the fair value using a Black-Scholes
option-pricing model with the following assumption inputs:

 Schedule of option liability

 Year Ended

 December 31,

 2023

 Annual dividend yield

 —

 Expected life (years)

 1.0

 Risk-free interest rate

 4.89 % - 5.59 %

 Expected volatility

 164 % - 187 %

 Exercise price

 $ 0.19 - $ 3.53

 Stock price

 $ 0.22 - $ 5.32

 Based
upon ASC 840-15-25 (EITF Issue 00-19, paragraph 11) the Company has adopted a sequencing approach regarding the application of ASC 815-40
to its outstanding convertible notes. Pursuant to the sequencing approach, the Company evaluates its contracts based upon earliest issuance
date.

 Note
13 – Income Taxes

 The
reconciliation between income tax expense computed by applying the federal statutory corporate tax rate and actual income tax expense
(benefit) for the years ended December 31, 2024 and 2023 is as follows:

 Schedule of effective income tax rate reconciliation

 Years Ended

 December 31,

 2024

 2023

 Statutory U.S. federal income tax rate

 ( 21.0
)%

 ( 21.0
)%

 State income taxes, net of federal income tax benefit

 ( 0.0
)%

 ( 0.0
)%

 Tax effect of expenses that are not deductible for income tax purposes:

 Amortization of debt discount

 0.0
 %

 16.8
 %

 Change in fair value of derivative liability

 0.0
 %

 ( 13.5
)%

 Stock based compensation

 6.3
 %

 2.7
 %

 Other

 ( 0.0
)%

 ( 0.6
)%

 Change in Valuation Allowance

 14.7
 %

 15.6
 %

 Effective tax rate

 0.0
 %

 0.0
 %

 At
December 31, the significant components of the deferred tax assets (liabilities) are summarized below:

 Schedule of deferred income tax assets

 2024

 2023

 Deferred Tax Assets:

 Net operating losses

 $
 5,580,034

 $
 4,222,999

 Other

 2,328

 1,743

 Property and equipment

 25,169

 —

 Total deferred tax assets

 5,607,531

 4,224,742

 Deferred Tax Liabilities

 —

 —

 Valuation Allowance

 ( 5,607,531
)

 ( 4,224,742
)

 Net deferred tax assets

 $
 —

 $
 —

 F- 18

 As
of December 31, 2024, the Company had federal net operating loss carryforwards of approximately $ 17.2 million which may be carried forward
indefinitely, and state net operating loss carryforwards of approximately $ 12.6 million (Iowa) and $ 16.6 million (Illinois), respectively
which expire at various dates from 2040 through 2044. These net operating loss carryforwards may be used to offset future taxable income
and thereby reduce the Company's U.S. federal income taxes. The net operating losses may be subject to limitation under Internal
Revenue Code Section 382 should there be a greater than 50 % change in ownership as determined under the regulations.

 In assessing the realization of deferred tax
assets, management considers whether it is more likely than not that some portion or all of the deferred tax assets will be realized.
The ultimate realization of deferred tax assets is dependent upon the generation of future taxable income during the periods in which
those temporary differences become deductible. Management considers the scheduled reversal of deferred tax liabilities, projected future
taxable income and tax planning strategies in making this assessment. Based on the assessment, management has established a full valuation
allowance against all of the deferred tax assets for every period because it is more likely than not that all of the deferred tax assets
will not be realized.

 In accordance with ASC 740, a valuation allowance
must be established if it is more likely than not that the deferred tax assets will not be realized. This assessment is based upon consideration
of available positive and negative evidence, which includes, among other things, the Company's most recent results of operations
and expected future profitability. Based on the Company's cumulative losses in recent years, a full valuation allowance against
the Company's deferred tax assets as of December 31, 2024 and 2023 respectively has been established as Management believes that
the Company will not more likely than not realize the benefit of those deferred tax assets. Therefore, no tax provision has been recorded
for the years ended December 31, 2024 and 2023, respectively.

 The Company complies with
the provisions of ASC 740-10 in accounting for its uncertain tax positions. ASC 740-10 addresses the determination of whether tax benefits
claimed or expected to be claimed on a tax return should be recorded in the financial statements. Under ASC 740-10, the Company may recognize
the tax benefit from an uncertain tax position only if it is more likely that not that the tax position will be sustained on examination
by the taxing authorities, based on the technical merits of the position. Management has determined that the Company has no significant
uncertain tax positions requiring recognition under ASC 740-10.

 The Company is subject
to income tax in the U.S., and certain state jurisdictions. The Company has not been audited by the U.S. Internal Revenue Service, or
any states in connection with income taxes. The Company's tax years generally remain open to examination for all federal and state
income tax matters until its net operating loss carryforwards are utilized and the applicable statutes of limitation have expired. The
federal and state tax authorities can generally reduce a net operating loss (but not create taxable income) for a period outside the statute
of limitations in order to determine the correct amount of net operating loss which may be allowed as a deduction against income for a
period within the statute of limitations.

 The Company recognizes
interest and penalties related to unrecognized tax benefits, if incurred, as a component of income tax expense. No interest or penalties
have been recorded for the years ended December 31, 2024 and 2023, respectively.

 On
March 27, 2020, the Coronavirus Aid, Relief, and Economic Security Act (CARES Act) was enacted in response to the COVID-19 pandemic.
The CARES Act, among other things, permits NOL carryovers and carrybacks to offset 100% of taxable income for taxable years beginning
before 2021. In addition, the CARES Act allows NOLs incurred in 2018, 2019, and 2020 to be carried back to each of the five preceding
taxable years to generate a refund of previously paid income taxes. At present the Company does not expect that the NOL carryback provision
of the CARES Act will result in a material cash benefit to us.

 F- 19

 Note
14 – Commitments and Contingencies

 Prior
Relationship of Cardio with Boustead Securities, LLC

 At the commencement of efforts
to pursue what ultimately ended in a terminated business acquisition, Legacy Cardio entered into a Placement Agent and Advisory Services
Agreement (the "Placement Agent Agreement"), dated April 12, 2021, with Boustead Securities, LLC ("Boustead Securities").
This agreement was terminated in April 2022, when Legacy Cardio terminated the underlying agreement and plan of merger and the accompanying
escrow agreement relating to that proposed business acquisition after efforts to complete the transaction failed, despite several extensions
of the closing deadline.

 Under the terminated Placement
Agent Agreement, Legacy Cardio agreed to certain future rights in favor of Boustead Securities, including (i) a two-year tail period during
which Boustead Securities would be entitled to compensation if Cardio were to close on a transaction (as defined in the Placement Agent
Agreement) with any party that was introduced to Legacy Cardio by Boustead Securities; and (ii) a right of first refusal to act as the
Company's exclusive placement agent for 24-months from the end of the term of the Placement Agent Agreement (the "right of
first refusal"). Cardio has taken the position that due to Boustead Securities' failure to perform as contemplated by the
Placement Agent Agreement, these provisions purporting to provide future rights are null and void.

 Boustead Securities responded
to the termination of the Placement Agent Agreement by disputing Legacy Cardio's contention that it had not performed under the
Placement Agent Agreement because, among other things, Boustead Securities had never sought out prospective investors. In its response,
Boustead Securities included a list of funds that they had supposedly contacted on Legacy Cardio's behalf. While Boustead Securities'
contention appears to contradict earlier communications from Boustead Securities in which they indicated that they had not made any such
contacts or introductions, Boustead Securities is currently contending that they are due success fees for two years following the termination
of the Placement Agent Agreement on any transaction with any person on the list of supposed contacts or introductions. Legacy Cardio strongly
disputes this position. Notwithstanding the foregoing, the Company has not consummated any transaction, as defined, with any potential
party that purportedly was a contact of Boustead Securities in connection with the Placement Agent Agreement and has no plans to do so
at any time during the tail period. No legal proceedings have been instigated by either party, and Cardio believes that the final outcome
will not have a material adverse impact on its financial condition.

 The Benchmark Company, LLC Right of First Refusal

 As noted in Note 1, the Company
completed the business combination on October 25, 2022. In connection with the proposed business combination, by agreement dated May 13,
2022, Mana engaged The Benchmark Company, LLC ("Benchmark") as its M&A advisor. Upon closing of the business combination,
Legacy Cardio assumed the contractual engagement entered into by Mana. On November 14, 2022, the Company and Benchmark entered into Amendment
No. 1 Engagement Letter (the "Amendment Engagement"). Pursuant to the Amendment Engagement, the parties agreed that the Company
would pay Benchmark $230,000 at the closing of the business combination and an additional $435,000 on October 25, 2023. Both of those
payments have been made in full. In addition, the Amendment Engagement provided that Benchmark has been granted a right of first refusal
to act as lead or joint-lead investment banker, lead or joint-lead book- runner and/or lead or joint-lead placement agent for all future
public and private equity and debt offerings through October 25, 2023. Based on the right of first refusal, Benchmark alleges that it
is owed damages because the Company entered into the Yorkville Convertible Debenture Transaction (see Note 11) without first offering
Benchmark the right to serve as the lead or joint-lead placement agent for the transaction. The Company is evaluating the claim. No legal
proceedings have been instigated.

 F- 20

 Demand Letter and Potential Mootness Fee Claim

 On
June 25, 2022, a plaintiffs' securities law firm sent a demand letter to the Company alleging that the Company's Registration
Statement on Form S-4 filed (the "S-4 Registration Statement") with the Securities and Exchange Commission ("SEC")
on May 31, 2022 omitted material information with respect to the Business Combination and demanding that the Company and its Board of
Directors immediately provide corrective disclosures in an amendment or supplement to the Registration Statement. Subsequent thereto,
the Company filed amendments to the S-4 Registration Statement on July 27, 2022, August 23, 2022, September 15, 2022, October 4, 2022
and October 5, 2022 in which it responded to various comments of the SEC staff and otherwise updated its disclosure. In October 2022,
the SEC completed its review and declared the S-4 registration statement on October 6, 2022. On February 23, 2023 and February 27, 2023,
plaintiffs' securities law firm contacted the Company's counsel asking who will be negotiating a mootness fee relating to
the purported claims set forth in the June 25, 2022 demand letter. The Company vigorously denies that the S-4 Registration Statement,
as amended and declared effective, is deficient in any respect and that no additional supplemental disclosures are material or required.
The Company believes that the claims asserted in the Demand Letter are without merit and that no further disclosure is required to supplement
the S-4 Registration Statement under applicable laws. As of the date of filing of this Annual Report on Form 10-K, no lawsuit has been
filed against the Company by that firm. The firm has indicated its willingness to litigate the matter if a mutually satisfactory resolution
cannot be agreed upon; however, Cardio believes that the final outcome will not have a material adverse impact on its financial condition.

 Northland Securities, Inc.

 In January 2024, following
the Company's termination of its agreement with Yorkville and in connection with the Company's recent at the market offering
and/or its February 2024 private placement, a managing director of Northland Securities, Inc. ("Northland") contacted the
Company claiming the right to be paid a fee of approximately $ 150,000 pursuant to the agreement of March 1, 2023 between the Company and
Northland regarding the Yorkville financing. Subsequently, the Company has been advised by another representative of Northland that Northland
would not proceed with any such claim. The Company does not believe that it owes Northland any sum based on the termination of the Yorkville
Securities Purchase Agreement and the subsequent financing transactions.

 The Company cannot preclude
the possibility that claims or lawsuits brought relating to any alleged securities law violations or breaches of fiduciary duty could
potentially require significant time and resources to defend and/or settle and distract its management and board of directors from focusing
on its business.

 Directors and Officers Insurance

 In connection with the Company's various
contractual obligations arising in the ordinary course of business, the Company is required to maintain insurance coverage for claims
against its directors and officers.

 Notice of Non-Compliance with Nasdaq
Listing Requirements

 On June 3, 2024,
Cardio Diagnostics Holdings, Inc. (the "Company") received a letter (the "First Nasdaq Bid Price Letter") from The
Nasdaq Stock Market LLC ("Nasdaq") indicating that the Company is no longer in compliance with Nasdaq Listing Rule 5550(a)(2),
because the minimum bid price of the Company's common stock (the "Common Stock") had closed below the minimum $ 1.00 per
share requirement for continued listing on The Nasdaq Capital Market under Nasdaq Listing Rule 5550(a)(2) (the "Minimum Bid Price
Requirement"). In accordance with Nasdaq Listing Rule 5810(c)(3)(A), the Company was provided an initial period of 180 calendar
days, or until December 2, 2024, to regain compliance. On December 4, 2024 (the "Second Nasdaq Bid Price Letter"), Nasdaq
notified the Company that Nasdaq's Staff has determined that the Company is eligible for an additional 180 calendar day period,
or until June 2, 2025, to regain compliance (the "Second Compliance Period"). The determination is based on the Company's
meeting the continued listing requirement for market value of publicly held shares and all other applicable requirements for initial listing
on The Nasdaq Capital Market with the exception of the Minimum Bid Price Requirement, and the Company's written notice of its intention
to cure the deficiency during the Second Compliance Period by effecting a reverse stock split, if necessary. If the Company chooses to
implement a reverse stock split, it must complete the split no later than ten business days prior to the end of the Second Compliance
Period in order to timely regain compliance. As of the date of this report the Common Stock has not regained compliance with the Minimum
Bid Price Requirement.

 If we fail to
regain compliance with the minimum bid requirement within the cure period (or extended cure period) or if we fail to continue to meet
all applicable continued listing requirements for Nasdaq in the future, Nasdaq could delist our securities.

 F- 21

 Note 15 – Subsequent Events

 The Company evaluated its December 31, 2024 consolidated financial statements
for subsequent events through the date the consolidated financial statements were issued.

 Sales of the Company's Common Stock may
be made pursuant to the Sales Agreement up to an aggregate of $ 9,476,508 under the Company's Registration Statement on Form
S-3 filed on February 7, 2025 (File No. 333-284775), declared effective by the SEC on February 14, 2025.

 Common
Stock Issued

 Subsequent to December 31, 2024, the Company sold 6,201,377 shares of Common
Stock for gross proceeds totaling $ 3,511,042 under the At-the-Market Issuance Sales Agreement as of the date of this report.

 Item 9.
 Changes in and Disagreements with Accountants on Accounting and Financial Disclosure

 None.

 Item 9A.
 Controls and Procedures

 Evaluation
of Disclosure Controls and Procedures

 Under the supervision
and with the participation of our management, including our principal executive officer and principal financial and accounting officer,
we conducted an evaluation of the effectiveness of the design and operation of our disclosure controls and procedures as of December
31, 2024, as such term is defined in Rules 13a-15(e) and 15d-15(e) under the Exchange Act. Based on this evaluation, our principal executive
officer and principal financial and accounting officer have concluded that during the period covered by this report, our disclosure controls
and procedures were not effective. As a result, we performed additional analysis as deemed necessary to ensure that our financial statements
were prepared in accordance with U.S. generally accepted accounting principles. Accordingly, management believes that the financial statements
included in this Form 10-K present fairly in all material respects our financial position, results of operations and cash flows for the
period presented.

 Disclosure controls and procedures
are designed to ensure that information required to be disclosed by us in our Exchange Act reports is recorded, processed, summarized,
and reported within the time periods specified in the SEC's rules and forms, and that such information is accumulated and communicated
to our management, including our principal executive officer and principal financial officer or persons performing similar functions,
as appropriate to allow timely decisions regarding required disclosure.

 We do not expect that our
disclosure controls and procedures will prevent all errors and all instances of fraud. Disclosure controls and procedures, no matter how
well conceived and operated, can provide only reasonable, not absolute, assurance that the objectives of the disclosure controls and procedures
are met. Further, the design of disclosure controls and procedures must reflect the fact that there are resource constraints, and the
benefits must be considered relative to their costs. Because of the inherent limitations in all disclosure controls and procedures, no
evaluation of disclosure controls and procedures can provide absolute assurance that we have detected all our control deficiencies and
instances of fraud, if any. The design of disclosure controls and procedures also is based partly on certain assumptions about the likelihood
of future events, and there can be no assurance that any design will succeed in achieving its stated goals under all potential future
conditions.

 Management's
Report on Internal Controls Over Financial Reporting

 This Annual Report on Form 10-K does
not include a report of management's assessment regarding internal control over financial reporting or an attestation report of
our independent registered public accounting firm due to a transition period established by rules of the SEC for newly public companies.

 Changes
in Internal Control over Financial Reporting

 There have been no changes in
our internal control over financial reporting during the period ended December 31, 2024 that have materially affected, or are reasonably
likely to materially affect, our internal control over financial reporting.

 Item 9B.
 Other Information

 During the Company's fourth quarter, no director
or officer adopted or terminated a Rule 10b5-1 trading arrangement or a non-Rule 10b5-1 trading arrangement.

 Item 9C.
 Disclosure Regarding Foreign Jurisdictions that Prevent Inspections

 Not applicable.

 Item 10.
 Directors, Executive Officers and Corporate Governance.

table sets forth certain information, including ages as of March 20, 2025, of our executive officers and members of the Board of Directors.

 Name

 Age

 Position

 Executive Officers

 Meeshanthini (Meesha) V. Dogan, PhD

 Chief Executive Officer and Director

 Robert (Rob) Philibert, MD PhD

 Chief Medical Officer and Director

 Elisa Luqman, JD MBA

 Chief Financial Officer

 Timur Dogan, PhD

 Chief Technology Officer

 Non-Employee Directors

 Warren Hosseinion, MD

 Non-Executive Chairman

 James Intrater

 Peter K. Fung, MD

 Wendy J. Betts

 Paul Burton

 Biographical Information

 Executive Officers

 The following is a brief biography of each of our executive
 officers:

 Meeshanthini V. Dogan has
served as our Chief Executive Officer and a director since inception. Together with Dr. Philibert, she is the Co-Founder of Legacy Cardio,
with over 15 years' experience in bridging medicine, engineering and artificial intelligence towards building solutions to fulfill
unmet clinical needs such as in cardiovascular disease prevention and management. Coming from a family with a two-generation history of
heart disease and having worked for an extensive time interacting with those affected by heart disease, she understands the pain points
and founded Legacy Cardio to help prevent others from experiencing its devastating impacts. Dr. Dogan is a pioneer in artificial intelligence/machine
learning-driven integrated genetic-epigenetic approaches, which includes highly cited publications, and platform presentations at the
American Heart Association and American Society of Human Genetics. She co-invented the patent-pending Integrated Genetic-Epigenetic Engine
of Cardio Diagnostics (six granted patents and numerous pending patents). In 2017, Dr. Dogan founded Legacy Cardio to commercialize this
technology through a series of patent-pending clinical tests towards making heart disease prevention and early detection more accessible,
personalized and precise. Under her leadership, Legacy Cardio was awarded the prestigious One To Watch award in 2020 by Nature and Merck,
the 2021 Clinical Diagnostics Solution of the Year from Biotech Breakthrough and Fast Company's Next Big Things in Tech 2022, has worked
its way to become a technology leader in cardiovascular diagnostics, launched four products, secured both dilutive and non-dilutive funding
and key relationships with world renowned healthcare organizations and key opinion leaders. Dr. Dogan holds a PhD degree in Biomedical
Engineering and BSE/MS degrees in Chemical Engineering from University of Iowa. She was named FLIK Woman Entrepreneur to Watch in 2021.
We believe that, as a co-founder of our Company and co-inventor of our Company's key technologies and products, as well as her leadership
skills, Dr. Dogan is uniquely positioned to bring unmatched experience and insights into the boardroom and to the daily operations of
our Company.

 Robert Philibert has served
as our Chief Medical Officer and as a director since inception. Together with Dr. Dogan, he is a co-founder of Legacy Cardio. Dr. Philibert
graduated from the University of Iowa Medical Scientist Training Program and completed a residency in Psychiatry at the University of
Iowa. Between 1993 and 1998, he completed a Pharmacology Research Training Program ("PRAT") Fellowship and a Staff Fellowship
at the National Institutes of Health while also serving in the United States Uniformed Public Health Service. In late 1998, he returned
to the University of Iowa where he now is a Professor of Psychiatry, with joint appointments in Neuroscience, Molecular Medicine and Biomedical
Engineering. He has published over 170 peer reviewed manuscripts and is the recipient of numerous NIH grant awards and both national and
international patents for his pioneering work in epigenetics. In particular, he is credited with discovering the epigenetic signatures
for cigarette and alcohol consumption. In 2009, he founded Behavioral Diagnostics, LLC, a leading provider of epigenetic testing services
which has introduced two epigenetic tests, Smoke Signature and Alcohol Signature to the commercial market. Simultaneously,
he has licensed related non-core technologies to manufacturing partners while developing an ecosystem of key complementary service providers
in the clinical diagnostics space.

 Elisa Luqman has served
as our Chief Financial Officer on a part time basis since March 2021. In March 2021, Legacy Cardio and Ms. Luqman entered into a consulting
agreement under which she was retained to provide services in connection with a potential merger transaction. Since April 2022, Ms. Luqman
has also been serving as Chief Legal Officer (SEC) for Nutex Health, Inc. ("Nutex"), a physician-led, technology-enabled healthcare
services company. She attained that position upon the closing of a merger transaction in which her employer, Clinigence Holdings, Inc.
("Clinigence"), was the surviving entity. She served as the Chief Financial Officer, Executive Vice President Finance and General
Counsel of Clinigence from October 2019 until the merger. She also served as a director of Clinigence from October 2019 to February 2021.
At Clinigence, Ms. Luqman was responsible for maintaining the corporation's accounting records and statements, preparing its SEC
filings and overseeing compliance requirements. She was an integral member of the Clinigence team responsible for obtaining the company's
NASDAQ listing and completing the reverse merger with Nutex. At Nutex Ms. Luqman continues to be responsible for preparing its SEC filings
and overseeing compliance requirements. Ms. Luqman co-founded bigVault Storage Technologies, a cloud- based file hosting company acquired
by Digi-Data Corporation in February 2006. From March 2006 through February 2009, Ms. Luqman was employed as Chief Operating Officer of
the Vault Services Division of Digi-Data Corporation, and subsequently during her tenure with Digi-Data Corporation she became General
Counsel for the entire corporation. In that capacity she was responsible for acquisitions, mergers, patents, customer, supplier, and employee
contracts, and worked very closely with Digi-Data's outside counsel firms. In March 2009, Ms. Luqman rejoined iGambit Inc. ("IGMB")
as Chief Financial Officer and General Counsel. Ms. Luqman has overseen and been responsible for IGMB's SEC filings, FINRA filings
and public company compliance requirements from its initial Form 10 filing with the SEC in 2010 through its reverse merger with Clinigence
Holdings, Inc. in October 2019. Ms. Luqman received a BA degree, a JD in Law, and an MBA Degree in Finance from Hofstra University. Ms.
Luqman is a member of the bar in New York and New Jersey.

 Timur
Dogan has served as our Chief Technology Officer since May 2022. He has been employed by Legacy Cardio since August 2019, after obtaining
his Ph. D., and was serving as its Senior Data Scientist until he was promoted to CTO. Dr. Dogan was instrumental in developing and advancing
the Integrated Genetic-Epigenetic Engine that is at the core of Cardio's cardiovascular solutions. Along with the founding
team, he is the co-inventor of several patent-pending technologies in cardiovascular disease and diabetes. He holds a joint B.S.E./M.S.
and Ph. D. degrees in Mechanical Engineering from the University of Iowa where he researched complex fluid flows. He developed machine
learning models on high-performance computing systems using a mixture of low and high-fidelity numerical simulations and experiments
to draw insights from non-linear physics.

 Non-Employee
Members of the Board of Directors

 The following is a brief biography of each of our non-employee
directors:

 Warren
Hosseinion, MD has served as the Company's Non-Executive Chairman of the Board since the consummation of the Business Combination
in October 2022. He was Legacy Cardio's Non-Executive Chairman of the Board from May 2022 and was on Legacy Cardio's Board
of Directors beginning in November 2020. In March 2021, Legacy Cardio and Dr. Hosseinion entered into a consulting agreement under which
he was retained to provide services in connection with a potential merger transaction. He continues to provide consulting services to
the Company under that contract. He is also currently the President and a director of Nutex Health, Inc. (Nasdaq: NUTX), positions he
has held since April 2022. In 2001, Dr. Hosseinion co-founded Astrana Health, Inc. (Nasdaq: ASTH) (formerly, Apollo Medical Holdings,
Inc. (Nasdaq: AMEH)) and served as a member of Astrana's Board of Directors from July 2008 to March 2019. He served as Astrana's
Chief Executive Officer from July 2008 to December 2017 and its Co-Chief Executive Officer from December 2017 to March 2019. Dr. Hosseinion
received his B.S. in Biology from the University of San Francisco, his M.S. in Physiology and Biophysics from the Georgetown University
Graduate School of Arts and Sciences, his Medical Degree from the Georgetown University School of Medicine and completed his residency
in internal medicine from the Los Angeles County-University of Southern California Medical Center. Dr. Hosseinion's experience
as a physician, along with his background at Astrana and Nutex, brings to our Board and our Company a depth of understanding of physician
culture and the healthcare market, as well as a strong knowledge of the public markets.

 James Intrater
 is the director who was designated by Mana, and he began his term upon Closing of the Business Combination in October 2022. Mr.
Intrater is a senior materials and process engineer with over 35 years of professional experience. He has worked in both commercial product
development and on Federal R&D projects, including work for NASA, the U.S. Department of Defense, and the U.S. Department of Energy.
Since June 2014, Mr. Intrater has served as the president of IntraMont Technologies, a consumer health products development company. In
addition, since May 2020, he has also provided engineering consultancy services for Falcon AI, a private investment firm to evaluate potential
portfolio investments. Mr. Intrater has published numerous technical works and reports for various agencies of the federal government
and in technical journals and is listed as holder or co-holder of five patents, with another patent pending. Mr. Intrater received his
Master of Science in Metallurgical Engineering from the University of Tennessee and a Bachelor of Sciences in Ceramic Engineering from
Rutgers University - College of Engineering. Mr. Intrater was selected to serve as a member of our board of directors due to his significant
experience developing healthcare-related products as well as products in other industries.

 Wendy J. Betts has
served as a member of the Company's Board of Directors since November 15, 2024. Since June 2024, Ms. Betts has been serving
as the Information Security Officer at Rotary International, where she is managing the cybersecurity department, which includes cyber
defense, cyber operations and deployment of strategic technology. Prior to that, she was the Director of Cybersecurity Strategy at United
Airlines from October 2022 to September 2023, where she managed the strategic initiatives for the cybersecurity program. From July
2019 to October 2022, Ms. Betts served as Senior Risk Manager at Bank of America, where she oversaw the second line work for
cybersecurity defense including SOC, Malware, DDoS and Cloud. From March 2010 to July 2019, Ms. Betts was employed by Northern Trust,
most recently serving as Vulnerability Manager, where she developed the Secure SDLC program and rolled out DevSecOps methodology
throughout the application development environment. Ms. Betts is continually active in the technology industry, where she is currently
a member of Information Systems Security Association ("ISSA"), Women in Cybersecurity ("WiCyS"), and Chief, the
private network for senior women executives. Ms. Betts earned her BA in Operations Management Information Systems from Northern Illinois
University and an MBA with an emphasis in finance from the Keller Graduate School of Management. She is a Certified Information Systems
Security Professional ("CISSP") and Certified Cloud Security Professional ("CCSP"). She also serves as a Director
for the Luminarts Culture Foundation, an organization dedicated to supporting young artists through its competitive programs that
offer financial awards, artistic opportunities and mentoring that bridge the gap between education and career. Ms. Betts was nominated
due to her background and experience in cybersecurity, finance, and corporate leadership, all of which are areas of expertise
we believe bring valuable insights to our boardroom including with respect to cybersecurity oversight requirements.

 Peter
K. Fung, M.D. has served as a member of the Company's Board of Directors since November
15, 2024. Since 2004, Dr. Fung has served as the Director of Cardiovascular Division of Beverly Hospital in Montebello, California.
He is also the Director of Research and Education at Central California Heart Institute in Fresno, California since 1992 and
Director of Nuclear Cardiology at Central Cardiology Medical Clinic in Bakersfield, California since 1991. Earlier in his professional
career from 1990 to 1997, Dr. Fung served as Clinical Faculty at University of California Los Angeles (UCLA). He received his B.Sc.
in Psychobiology in 1979 from University of Southern California, his MD in 1983 from Stanford University School of Medicine, and
was an Internal Medicine resident between 1983 and 1986 and Cardiology Fellow between 1986 and 1989 at Cedars-Sinai Medical Center/UCLA.
His board certifications include Diplomat of the American Board of Internal Medicine, Diplomat Subspecialty Board of Cardiovascular Disease,
Fellow of American College of Cardiology, Fellow of American College of Angiology and Diplomat of Subspecialty Board of Interventional
Cardiology. His extensive clinical expertise includes more than 5,000 cases of coronary angiography, more than 2,000 cases of percutaneous
transluminal coronary angioplasty, more than 400 cases of Peripheral Angiography, more than 200 cases of Peripheral Angioplasty including
balloon and TEC devices, more than 100 cases of Carotid Angiography, more than 100 cases of Peripheral Stent placement, more than 100
cases of Renal Artery Stent Placement, Rotational Artherectomy, Coronary TEC, Pacemaker Implantation, Laser Artherectomy, Stent Placement,
Brachytherapy, and Abdominal Aortic Aneurysm Percutaneous Repair/& Grafting. Dr. Fung was selected to serve on our board of directors
due to his extensive clinical experience in cardiology.

 Paul
F. Burton has served as a member of the Company's Board of Directors since December 2023. Since May 2021, Mr. Burton has
served as the Managing Partner, of 2Flo Ventures, a start-up studio and early-stage healthcare investor. Through 2Flo Ventures, he
provides strategic and financial advice to healthcare companies. In 2010, he founded and continues to serve as Managing Principal of
Burton Advisory, Inc., which provides strategic and financial advice to healthcare companies, drawing from over 20 years of
experience in corporate finance and strategic advisory services. In connection therewith, since December 2018, Mr. Burton has been
the Chief Executive Officer of Akan Biosciences, a biotech start-up company developing regenerative medicinal therapeutics. From
2019 he also has been serving as the Chief Financial Officer of Temprian Therapeutics. From 2019 through 2022 he served as the
fractional CFO for both Cancer IQ and 4D Healthware. From 2019 through 2022, Mr. Burton was also an Entrepreneur in Residence at
Northwestern University, supporting students and faculty with healthcare-oriented commercialization projects. Previously, he was the
Chief Executive Officer of ResQ Pharma, Inc. In 2013 he co-founded Vivacelle Bio, Inc., where he served as Chief Financial Officer
and a member of its board of directors. Mr. Burton currently serves as a member of the Chicago Biomedical Consortium's VC
Advisory Committee, as a member of MATTER, a Chicago-based healthcare incubator, and the Bunker Labs, an incubator started in
Chicago for U.S. military veterans. He also is a member of the Board of Directors of Millennium Beacon, a healthcare incubator based
on the southside of Chicago, seeking to serve overlooked populations. Prior thereto, Mr. Burton worked as an investment banking
associate at Salomon Brothers (now Citigroup Corporate & Investment Bank). He also served as a United States Regular Army
Commissioned Officer (Infantry). Mr. Burton earned his JD and MBA from the University of Illinois at Urbana-Champaign and earned two
Bachelor's Degrees from the University of Illinois at Chicago. He currently serves on the Board of Trustees of the Ravinia
Festival, an internationally-renowned, not-for-profit music festival. Mr. Burton was nominated due to his extensive experience in
the working of numerous capacities with early-stage healthcare companies as well as his corporate finance background, both of which
are areas of expertise we believe bring invaluable insights to our Board.

 Family
 Relationships

 Other than
Meeshanthini Dogan and Timur Dogan, who are wife and husband, there are no family relationships among our executive officers and directors.

 Corporate
 Governance

 Cardio has structured its corporate governance in a manner that
we believe closely aligns its interests with those of its stockholders. Notable features of this corporate governance include:

 Cardio has independent director representation on its audit, compensation
and nominating and corporate governance committees, and its independent directors will meet regularly in executive sessions without the
presence of its corporate officers or non-independent directors;

 at least one of its directors has qualified as an "audit committee financial expert" as defined
by the SEC; and

 it has and will implement a range of other corporate governance best practices,
including a robust director education program.

 Leadership
Structure of the Board

 The
roles of our Non-Executive Chairman and our Chief Executive Officer have been separated. We believe that this is appropriate under current
circumstances because it allows management to make the operating decisions necessary to manage the business, while separating out oversight
function of the Board and operating decisions. We feel that this has provided an appropriate balance of operational focus, flexibility
and oversight. We do not separately have a lead independent director. Currently, Dr. Hosseinion serves as Non-executive Chairman of the
Board, participates in setting the agenda of Board and committee meetings, facilitating communications among members of the Board and
management, and maintaining the focus and punctuality of Board and committee meetings. Dr Hosseinion also currently leads the efforts
in evaluating our Chief Executive Officer and in succession planning, considering Board committee membership and leadership. He will
be presiding at this Annual Meeting.

 Background
and Experience of Directors

 Our nominating and corporate
governance committee is responsible for, among other things, identifying individuals qualified to become members of our board of directors,
consistent with criteria approved by our board of directors, overseeing succession planning for our Chief Executive Officer and other
executive officers, periodically reviewing our board of directors' leadership structure and recommending any proposed changes to
our board of directors, overseeing an annual evaluation of the effectiveness of our board of directors and its committees, and developing
and recommending to our Board of Directors a set of corporate governance guidelines.

 Composition
of the Board of Directors and Company Officers

 Cardio's business and affairs are managed under the direction
of our board of directors.

 The Company's board consists of seven directors. The board
of directors are elected each year at the annual meeting of stockholders.

 The Company officers are appointed
by the board of directors and serve at the discretion of the board of directors, rather than for specific terms of office, subject to
the terms of employment agreements, where applicable. The board of directors is authorized to appoint persons to the offices set forth
in our bylaws as it deems appropriate. The Company's bylaws provide that our officers may consist of a Chairman of the Board, Chief
Executive Officer, Chief Financial Officer, President, one or more Vice Presidents, Secretary, Treasurer, one or more Assistant Secretaries
and such other offices as may be determined by the board of directors.

 Independence

 The Nasdaq listing standards
require that a majority of our Board of Directors be independent. An "independent director" is defined generally as a person
who has no material relationship with the listed company (either directly or as a partner, stockholder or officer of an organization that
has a relationship with the company). The Company's independent directors expect to have regularly scheduled meetings at which only
independent directors are present. Any affiliated transactions will be on terms no less favorable to the Company than could be obtained
from independent parties. The Company's Board of Directors will review and approve all affiliated transactions with any interested
director abstaining from such review and approval.

 Based on information provided by
each director concerning his or her background, employment and affiliations, the Board has determined that Paul Burton, James Intrater,
Wendy Betts, and Peter Fung, MD, representing four of the Company's seven directors, do not have a relationship that would interfere
with the exercise of independent judgment in carrying out the responsibilities of a director and that each of these directors is an "independent
director" as defined under the listing standards of Nasdaq and applicable SEC rules. In making these determinations, the Company
Board considered the current and prior relationships that each non-employee director has with the Company and all other facts and circumstances
that the Company Board deemed relevant in determining their independence, including the beneficial ownership of the Company capital stock
by each non- employee director, and the transactions involving them. See "Certain Cardio Relationships and Related Persons Transactions."

 Board
 Committees

 The standing committees of the Cardio
Board consist of an audit committee, a compensation committee and a nominating and corporate governance committee. The board of directors
may from time to time establish other committees.

 Cardio's chief executive officer
and other executive officers regularly report to the non-executive directors and the audit, the compensation and the nominating and corporate
governance committees to ensure effective and efficient oversight of our activities and to assist in proper risk management and the ongoing
evaluation of management controls.

 Audit Committee

 Cardio has an audit committee consisting
of Paul Burton, James Intrater and Wendy Betts, with
Mr. Burton serving as the chair of the committee. The Cardio Board has determined that each
member of the audit committee qualifies as an independent director under the independence requirements of the Sarbanes-Oxley Act, Rule
10A-3 under the Exchange Act and Nasdaq listing requirements. The Cardio Board has determined that Mr. Burton
 qualifies as an "audit committee financial expert," as defined in Item 407(d)(5) of Regulation S-K, and that he possesses
financial sophistication, as defined under the rules of Nasdaq. Mr. Burton was selected to serve on our Board and as the chair of our
audit committee due to his extensive experience working in numerous capacities with early-stage healthcare companies as well as his corporate
finance background, both of which are areas of expertise that bring invaluable insights to the Cardio boardroom.

 The audit committee's responsibilities include, among
other things:

 reviewing and discussing with management and the independent auditor the
annual audited financial statements, and recommending to the Board whether the audited financial statements should be included in our
Form 10-K;

 discussing with management and the independent auditor significant financial reporting issues and judgments
made in connection with the preparation of our financial statements;

 discussing with management major risk assessment and risk Management policies;

 monitoring the independence of the independent auditor;

 verifying the rotation of the lead (or coordinating) audit partner having primary responsibility for
the audit and the audit partner responsible for reviewing the audit as required by law;

 reviewing and approving all related-party transactions;

 inquiring and discussing with management our compliance with applicable laws and regulations;

 pre-approving all audit services and permitted non-audit services to be performed by our independent
auditor, including the fees and terms of the services to be performed;

 appointing or replacing the independent auditor;

 determining the compensation and oversight of the work of the independent
auditor (including resolution of disagreements between Management and the independent auditor regarding financial reporting) for the purpose
of preparing or issuing an audit report or related work;

 reviewing and approving any annual or long-term incentive cash bonus or equity or other incentive plans
in which our executive officers may participate;

 establishing procedures for the receipt, retention and treatment of complaints
received by us regarding accounting, internal accounting controls or reports which raise material issues regarding our financial statements
or accounting policies; and

 approving reimbursement of expenses incurred by our management team in identifying potential target
 businesses.

 The board
of directors has adopted a written charter for the audit committee that is available on our website.

 Compensation Committee

 Cardio has a compensation committee
consisting of Wendy Betts, James Intrater and Peter Fung, MD with Ms. Betts serving as chair
of the committee. The Cardio Board has determined that each member of the compensation committee qualifies as an independent director
under the independence requirements of the Sarbanes-Oxley Act, Rule 10A-3 under the Exchange Act and Nasdaq listing requirements.

 The compensation committee's responsibilities include,
among other things:

 establishing, reviewing, and approving our overall executive compensation philosophy and policies;

 reviewing and approving on an annual basis the corporate goals and objectives
relevant to our Chief Executive Officer's compensation, evaluating our Chief Executive Officer's performance in light of such
goals and objectives and determining and approving the remuneration (if any) of our Chief Executive Officer based on such evaluation;

 reviewing and approving the compensation of all of our other executive officers;

 approving reimbursement of expenses incurred by our management team in identifying potential target
 businesses.

 reviewing our executive compensation policies and plans;

 receiving and evaluating performance target goals for the senior officers
and employees (other than executive officers) and reviewing periodic reports from the CEO as to the performance and compensation of such
senior officers and employees;

 implementing and administering our incentive compensation equity-based remuneration plans;

 reviewing and approving any annual or long-term incentive cash bonus or equity or other incentive plans
in which our executive officers may participate;

 reviewing and approving for our chief executive officer and other executive
officers any employment agreements, severance arrangements, and change in control agreements or provisions;

 reviewing and discussing with Management the Compensation Discussion and
Analysis set forth in Securities and Exchange Commission Regulation S-K, Item 402, if required, and, based on such review and discussion,
determine whether to recommend to the Board that the Compensation Discussion and Analysis be included in our annual report or proxy statement
the annual meeting of stockholders;

 assisting management in complying with our proxy statement and annual report disclosure requirements;

 approving all special perquisites, special cash payments and other special compensation and benefit
arrangements for our executive officers and employees;

 if required, producing a report on executive compensation to be included in our annual proxy statement;

 reviewing and recommending to the Board for approval the frequency with
which we will conduct Say-on-Pay Votes, taking into account the results of the most recent stockholder advisory vote on frequency of Say-on-Pay
Votes required by Section 14A of the Exchange Act, and review and recommend to the Board for approval the proposals regarding the Say-
on-Pay Vote and the frequency of the Say-on-Pay Vote to be included in our proxy statements filed with the SEC;

 conducting an annual performance evaluation of the committee; and

 reviewing, evaluating and recommending changes, if appropriate, to the remuneration for directors.

 The board of directors has adopted a written charter for
the compensation committee that is available on our website.

 Compensation Committee Interlocks and Insider Participation

 None of our executive officers serves
as a member of the compensation committee of the board of directors (or other committee performing equivalent functions) of any entity
that has one or more executive officers serving on our board of directors.

 Nominating and Corporate Governance Committee

 Cardio has a nominating and corporate
governance committee consisting of James Intrater, Paul Burton and Peter Fung, MD with Mr. Intrater serving as chair of the committee.
The Cardio Board has determined that each member of the nominating and corporate governance committee qualifies as an independent director
under the independence requirements of the Sarbanes-Oxley Act, Rule 10A-3 under the Exchange Act and Nasdaq listing requirements.

 The nominating and corporate governance committee's responsibilities
include, among other things:

 review and assess and make recommendations to the board of directors regarding desired qualifications,
expertise and characteristics sought of board members;

 identify, evaluate, select or make recommendations to the board of directors regarding nominees for
election to the board of directors;

 develop policies and procedures for considering stockholder nominees for election to the board of directors;

 review the Company's succession planning process for Company's chief executive officer,
and assist in evaluating potential successors to the chief executive officer;

 review and make recommendations to the board of directors regarding the composition, organization and
governance of the board and its committees;

 review and make recommendations to the board of directors regarding corporate governance guidelines
and corporate governance framework;

 oversee director orientation for new directors and continuing education for directors;

 oversee the evaluation of the performance of the board of directors and its committees;

 review and monitor compliance with the Company's code of business conduct and ethics; and

 administer policies and procedures for communications with the non-management members of the Company's
Board of Directors.

 The board of directors has adopted a written charter for the
nominating and corporate governance committee that is available on our website.

 Guidelines for Selecting Director Nominees

 The guidelines for selecting nominees generally provide that
persons to be nominated:

 should have demonstrated notable or significant achievements in business, education or public service;

 should possess the requisite intelligence, education and experience to
make a significant contribution to the Board of Directors and bring a range of skills, diverse perspectives and backgrounds to its deliberations;
and

 should have the highest ethical standards, a strong sense of professionalism and intense dedication
to serving the interests of the stockholders.

 The nominating and governance committee
will consider a number of qualifications relating to management and leadership experience, background and integrity and professionalism
in evaluating a person's candidacy for membership on the Board of Directors. The nominating and governance committee may require
certain skills or attributes, such as financial or accounting experience, to meet specific board needs that arise from time to time and
will also consider the overall experience and makeup of its members to obtain a broad and diverse mix of board members. The nominating
and governance committee does not distinguish among nominees recommended by stockholders and other persons.

 Code
of Ethics

 The Company has adopted a
written code of business conduct and ethics that applies to its principal executive officer, principal financial or accounting officer
or person serving similar functions and all of our other employees and members of our board of directors. The code of ethics codifies
the business and ethical principles that govern all aspects of our business. Cardio intends to make any legally required disclosures regarding
amendments to, or waivers of, provisions of our code of ethics on our website.

Recovery ("Clawback") Policy

 Effective October 2, 2023,
we adopted a compensation recovery policy (the "Clawback Policy"), which provides that if we are required to prepare an accounting
restatement due to any material non-compliance with financial reporting requirements under the federal securities laws, then the Board
or a duly established committee thereof may require certain officers, including our executive officers named in the Summary Compensation
Table presented later in this proxy statement (our "NEOs"), to repay or forfeit any "excess compensation" in the
event it finds, in its sole discretion, that the executive officer contributed to the circumstances requiring the restatement and that
it involved either (a) intentional misconduct or an intentional violation of any of the Company's rules or applicable legal or regulatory
requirements or (b) fraud. "Excess compensation" refers to the pre-tax amount in excess of what would have been paid to the
executive officer under the accounting restatement of any incentive-based compensation that is granted, earned or vested based on the
attainment of a performance measure during the three-year period preceding the date on which we are required to prepare such accounting
restatement. The Clawback Policy applies to incentive-based compensation granted after the adoption of this policy.

 Conflicts
of Interest

 Potential investors should be aware of the following potential
conflicts of interests:

 None of our officers and directors is required to
commit their full time to our affairs and, accordingly, they may have conflicts of interest in allocating their time among various business
 activities.

 In the course of their other business activities,
our officers and directors may become aware of investment and business opportunities which may be appropriate for presentation to our
company as well as the other entities with which they are affiliated. Our Management has pre-existing fiduciary duties and contractual
obligations to such entities (as well as to us) and may have conflicts of interest in determining to which entity a particular business
opportunity should be presented.

 Our officers and directors may in the future become affiliated with entities engaged in business activities
similar to those intended to be conducted by our company.

 The conflicts described above may not be resolved in our favor.

 All ongoing and future transactions
between us and any of our management team or their respective affiliates, will be on terms believed by us to be no less favorable to us
than are available from unaffiliated third parties. Such transactions will require prior approval by a majority of our uninterested "independent"
directors or the members of our board of directors who do not have an interest in the transaction, in either case who had access, at our
expense, to our attorneys or independent legal counsel. We will not enter into any such transaction unless our disinterested "independent"
directors determine that the terms of such transaction are no less favorable to us than those that would be available to us with respect
to such a transaction from unaffiliated third parties.

 Limitation
on Liability and Indemnification of Officers and Directors

 The Company intends to enter into
indemnification agreements with each of its directors and executive officers that may be broader than the specific indemnification provisions
contained in the DGCL. These indemnification agreements, which have been authorized for execution by the Cardio board of directors, requires
the Company, among other things, to indemnify its directors and executive officers against liabilities that may arise by reason of their
status or service. These indemnification agreements also require the Company to advance all expenses reasonably and actually incurred
by its directors and executive officers in investigating or defending any such action, suit or proceeding. Our By-laws provide that Cardio
must indemnify and advance expenses to Cardio's directors and officers to the fullest extent authorized by the DGCL. We believe
that these agreements and By-laws provisions are necessary to attract and retain qualified individuals to serve as directors and executive
officers.

 Cardio
maintains insurance policies under which its directors and officers are insured, within the limits and subject to the limitations of
those policies, against certain expenses in connection with the defense of, and certain liabilities which might be imposed as a
result of, actions, suits, or proceedings to which they are parties by reason of being or having been its directors or officers. The
coverage provided by these policies may apply whether or not the Company would have the power to indemnify such person against such
liability under the provisions of the DGCL. At present, we are not aware of any pending litigation or proceeding involving any
person who will be one of the Company's directors or officers or is or was one of its directors or officers, or is or was one
of its directors or officers serving at its request as a director, officer, employee or agent of another corporation, partnership,
joint venture, trust or other enterprise, for which indemnification is sought, and we are not aware of any threatened litigation
that may result in claims for indemnification.

 The DGCL authorizes corporations
to limit or eliminate the personal liability of directors of corporations and their stockholders for monetary damages for breaches of
directors' fiduciary duties, subject to certain exceptions. Our Second Amended and Restated Certificate of Incorporation includes
a provision that eliminates the personal liability of directors for damages for any breach of fiduciary duty as a director where, in civil
proceedings, the person acted in good faith and in a manner that person reasonably believed to be in or not opposed to the best interests
of our Company or, in criminal proceedings, where the person had no reasonable cause to believe that his or her conduct was unlawful.

 The limitation of liability, advancement
and indemnification provisions in our Second Amended and Restated Certificate of Incorporation and our By-laws may discourage stockholders
from bringing lawsuit against directors for breach of their fiduciary duty. These provisions also may have the effect of reducing the
likelihood of derivative litigation against directors and officers, even though such an action, if successful, might otherwise benefit
Cardio and our stockholders. In addition, your investment may be adversely affected to the extent Cardio pays the costs of settlement
and damage awards against directors and officer pursuant to these indemnification provisions.

 There is currently no pending material litigation or proceeding
involving any of Cardio's directors, officers, or employees for which indemnification is sought.

 Section
16(a) Beneficial Ownership Reporting Compliance

 Section 16(a) of the Securities Exchange
Act of 1934, as amended, or the Exchange Act, requires our executive officers, directors, and persons who beneficially own more than 10%
of a registered class of our equity securities to file with the Securities and Exchange Commission initial reports of ownership and reports
of changes in ownership of our shares of common stock and other equity securities. These executive officers, directors, and greater than
10% beneficial owners are required by SEC regulation to furnish us with copies of all Section 16(a) forms filed by such reporting persons.

 Based solely on
our review of such forms furnished to us and written representations from certain reporting persons, we believe that, during the fiscal
year ended December 31, 2024, our directors, executive officers, and ten percent stockholders complied with all Section 16(a) filing requirements,
other than three Form 3s filed one each by Wendy J. Betts, Peter Fung and Paul Burton, three Form 4s filed by Oded Levy, four Form 4s
filed each by Paul Burton, James Intrater, Stanley Lau and Oded Levy, and one Form 4 filed each by Warren Hosseinion, Elisa Luqman, Meeshanthini
Dogan Timur Dogan and Robert Philibert, which were filed late.

 Securities
Trading

 The Company
has adopted a Securities Trading Policy that governs the purchase, sale, and/or other dispositions of the Company's securities by our
directors, officers and employees that are reasonably designed to promote compliance with insider trading laws, rules and regulations,
and any listing standards applicable to the Company. A copy of our policy against insider trading is filed as Exhibit 19.1 to this Annual
Report on Form 10-K for the fiscal year ended December 31, 2024. Our policy against insider trading prohibits directors, officers, employees
and other covered persons from engaging in transactions while aware of material nonpublic information about the Company. Directors, officers
and certain other employees are subject to pre-clearance requirements for all transactions in the Company's securities and are
generally prohibited from transacting in the Company's securities during designated blackout periods. Our policy against insider
trading prohibits employees, officers and directors from engaging in any speculative or hedging transactions in our securities. We prohibit
transactions such as puts, calls, swaps, forward sale contracts, and other derivatives or similar arrangements or instruments designed
to hedge or offset decreases in the market value of our securities. No employee, officer or director may engage in short sales of our
securities, hold our securities in a margin account, purchase shares of our stock on margin or pledge our securities as collateral for
a loan.

 Item 11.
 Executive Compensation

 Overview

 This
section discusses the material components of the executive compensation program for our executive officers who are named in the
"2024 Summary Compensation Table" below. For the year ended December 31,
2024, our "named executive officers" ("NEOs") and their positions were as follows:

 Meeshanthini V. Dogan, Chief Executive Officer;

 Warren Hosseinion, Non-executive Chairman of the Board*; and

 Elisa Luqman, Chief Financial Officer

 Timur Dogan, Chief Technology Officer

 *Dr. Hosseinion provides ongoing
services to our company as Chairman of the Board and as a consultant. As such, he is not an executive officer and would not be included
in the executive compensation tables or accompanying narrative as an NEO under SEC disclosure rules. However, because his contractual
compensation is significant and would be payable to him, even if he were no longer our Chairman, we are treating him as an NEO in this
Item 11 in the interest of full disclosure of the compensation payable to the highest paid persons who work for our company. Dr. Hosseinion
is not considered a Named Executive Officer for any purpose other than the following disclosures.

 2024
Summary Compensation Table

 The following table sets forth information concerning the compensation
of our named executive officers for fiscal years ended December 31, 2024 and 2023.

 Current Officers Name & Principal
 Position

 Year

 Salary
 ($)

 Bonus

 Stock

 Option
 Awards (2)

 All Other
 Compensation ($)

 Total

 ($)

 ($)

 ($)

 ($)

 ($)

 ($)

 Meeshanthini V. Dogan,

 2024

 300,000

 1,004,656

 11,000
 (1)

 1,315,656

 CEO

 2023

 300,000

 341,640

 7,253
 (1)

 648,893

 Warren Hosseinion,

 2024

 300,000

 75,349

 375,349

 Chairman

 2023

 300,000

 155,291

 455,291

 Elisa Luqman,

 2024

 275,000

 75,349

 350,349

 CFO

 2023

 275,000

 72,469

 347,469

 Timur Dogan,

 2024

 250,000

 502,328

 9,167
 (1)

 761,495

 CTO

 2023

 250,000

 196,702

 446,702

 (1)
 All Other Compensation includes Cardio's contribution to the Company's 401(k) account on
behalf of the executive and health and dental insurance coverage.

 (2)
 Discretionary stock option grants made in 2024 and 2023 by
the Compensation Committee. The 2024 amounts reflect the grant date fair values of performance awards based upon the Nasdaq closing stock
price of $2.11 on the date of grant. The 2023 amounts reflect the grant date fair values of performance awards based upon the Nasdaq
closing stock price of $1.26 on the date of grant.

 Narrative to the Summary Compensation Table

 2024 Base Salary

 The
named executive officers receive a base salary to compensate them for services rendered to our company. The base salary payable to
each named executive officer is intended to provide a fixed component of compensation reflecting the executive's skill set,
experience, role and responsibilities. In 2024, the base salaries paid to each of Dr. Dogan, Dr. Hosseinion, Ms. Luqman and
Mr. Dogan are set forth in the "Summary Compensation Table" above in the column titled "Salary." Each of the
NEOs has entered into an employment agreement (or, in the case of Dr. Hosseinion, a Non- Executive Chairman and Consulting
Agreement), which became effective as of the Closing of the Business Combination. A brief summary of those agreements is set forth
below under the caption, "Agreements with Our Executive Officers and Non-Executive Chairman of the Board."

 Annual
 Bonuses

 We do not
currently maintain an annual bonus program for our employees, including our named executive officers. However, the employment agreements
and, in the case of Dr. Hosseinion, his Non-Executive Chairman and Consulting Agreement, provide that our named executive officers are
eligible to receive an annual cash bonus based on the extent to which, in the discretion of the Board, each such person achieves or exceeds
specific and measurable individual and Company performance objectives. The Board did not award any annual bonuses in 2023 and 2024.

 Equity

 T he
Cardio Diagnostics Holdings, Inc. 2022 Equity Incentive Plan (the "2022 Equity Plan"), was adopted by the Mana Board of Directors
and approved by the Mana stockholders in connection with the Business Combination.

 The 2022 Equity
Plan, as adopted, provides for the grant of up to 3,265,516 shares of Common Stock upon exercise of granted options, awards of restricted
stock units, rewards of restricted stock and other equity awards as may be determined by the Board of Directors. In the discretion of
the Board, the number of shares of Common Stock available under the 2022 Plan may be increased as of January 1 of each year, without additional
stockholder approval. The Board did not increase the aggregate number of shares available under the 2022 Equity Plan on January 1, 2023
but the 2022 Equity Plan was increased by 1,060,458 shares as of January 1, 2024 and granted 1,187,826 options to management
and employees, 1,166,826 of which vested immediately with the remaining 21,000 options subject to 50% vesting on June 30, 2024
and 100% vesting on December 31, 2024. Each option has an exercise price of $2.11 per share with an expiration date of January 23, 2034.
Among the 21,000 options, 7,500 options were vested on June 30, 2024, 5,000 options were vested on December 31, 2024 and 8,500 options
were forfeited before vesting with the leaving of the employees before December 31, 2024.

 On June 30, 2024,
we granted 30,300 stock options to the board of directors, which vested immediately on grant date.
 Each option has an exercise price of $0.55 per share with an expiration date of June 30, 2034. On September 30,
2024, we granted 74,744 stock options to the board of directors, which vested immediately on grant
date. Each option has an exercise price of $0.22 per share with an expiration date of September 30, 2034. On November
14, 2024, we granted 15,728 stock options to the board of directors, which vested immediately on
grant date. Each option has an exercise price of $0.27 per share with an expiration date of November 14, 2034. On
December 31, 2024, we granted 13,632 stock options to the board of directors, which vested immediately
on grant date. Each option has an exercise price of $0.92 per share with an expiration date of December 31, 2034.
In the future, we may grant cash and equity incentive awards to directors, employees (including our named executive officers) and consultants
in order to continue to attract, motivate and retain the talent for which we compete.

 A total of 344,445 shares were available
for issuance under the 2022 Equity Plan at December 31, 2024. At December 31, 2024, there were 3,594,202 options outstanding for the purchase
of Common Stock, all of which were vested and exercisable.

 The following table sets
forth information as of December 31, 2024 regarding Common Stock that may be issued under the 2022 Equity Plan, which, as of the date
of this report, is the only equity compensation plan that has been adopted by our Board of Directors.

 Plan Category

 (A)

 Number of Securities to be issued upon exercise of outstanding options, warrants and rights

 (B)

 Weighted average per share exercise price of outstanding options, warrants and rights

 (C)

 Number of Securities remaining available for future issuance under equity compensation plans (excluding securities reflected in column (A))

 Equity compensation plans approved by security holders

 3,594,202
 (1)

 2.74
 (2)

 344,445
 (3)

 Equity compensation plans not approved by security holders

 —

 —

 —

 (1)
 Includes 3,594,202 outstanding options to purchase shares of Common Stock under the 2022 Equity Plan.

 (2)
 1,759,599 outstanding options are exercisable at $3.90, 759,000 outstanding
options are exercisable at $1.26, 941,198 outstanding options are exercisable at $2.11, 30,300 outstanding options are exercisable at
$0.55, 74,744 outstanding options are exercisable at $0.22, 15,728 outstanding options are exercisable at $0.27 and 13,632 outstanding
options are exercisable at $0.92 subject to adjustment for stock splits, reverse stock splits and other similar events of recapitalization.

 (3)
 This amount includes the deduction of 83,780 shares in settlement of RSUs
issued in 2024 and 303,547 shares in settlement of RSUs issued in 2023 to our independent directors and advisors. This amount does not
include any additional shares that may become available for future issuance under the 2022 Equity Plan pursuant to the automatic increase
to the share reserve on January 1 of each of our calendar years through 2027 (each, an "Evergreen Date") by the number of
shares equal to the lesser of (i) 7% of the total number of shares of Common Stock outstanding on the December 31st immediately preceding
the applicable Evergreen Date and (ii) such lesser number of shares of Common Stock as determined to be appropriate by the committee in
its sole discretion. Effective January 1, 2024, the 2022 Equity Plan increased by 1,060,458 shares pursuant to the evergreen provision
of the plan.

 Refer to
Note 10 to the consolidated financial statements included in this annual report for additional information relating to outstanding options.

 Equity
Award Grant Practices

 Our equity-based incentive awards are designed to align
our interests and the interests of our stockholders with those of our employees and consultants, including our Named Executive Officers.
The Board or Compensation Committee is responsible for approving equity grants. We typically grant equity awards to new hires or employees
receiving bonuses annually for the previous fiscal year's performance. Annual awards are typically granted in the first quarter of
each year. Generally, our equity awards granted to our Named Executive Officers vest over four years, subject to the employee's
continued employment with us on each vesting date. The board of directors annual compensation is paid 50% in the form of stock options,
payable quarterly. The regularly-scheduled grant dates for the board of directors stock options are the last calendar day of the each
fiscal quarter.

 The Board and Compensation Committee does not take material
nonpublic information into account when determining the timing and terms of equity-based awards, and the Company does not time the disclosure
of material nonpublic information for the purpose of affecting the value of executive compensation. For all stock option awards, the exercise
price is the closing price of our Common Stock on the Nasdaq Capital Market on the date of the grant. If the grant date falls on a non-trading
day, the exercise price is the closing price of our Common Stock on the Nasdaq Capital Market on the last trading day preceding the date
of grant. We have not timed the disclosure of material nonpublic information for the purpose of affecting the value of executive compensation
for any Named Executive Officer grants in fiscal year 2024.

 Other
Elements of Compensation

 Retirement
 Plan

 We maintain a 401(k) retirement
savings plan for our employees, including our named executive officers, who satisfy certain eligibility requirements. The Internal Revenue
Code allows eligible employees to defer a portion of their compensation, within prescribed limits, on a pre-tax basis through contributions
to the 401(k) plan. We believe that providing a vehicle for tax- deferred retirement savings though our 401(k) plan adds to the overall
desirability of our executive compensation package and further incentivizes our employees, including our named executive officers, in
accordance with our compensation policies.

 Employee Benefits and Perquisites

 Health/Welfare Plans. All of our full-time employees, including
our named executive officers, are eligible to participate in our health and welfare plans, including:

 •
 medical, dental and vision benefits;

 •
 medical and dependent care flexible spending accounts;

 •
 life insurance and accidental death and dismemberment;

 We believe the benefits described above
are necessary and appropriate to provide a competitive compensation package to our employees, including our named executive officers.
We do not provide any perquisites to our named executive officers.

 No Tax Gross- Ups

 We do not make gross-up payments to cover our named executive
officers' personal income taxes that may pertain to any of the compensation or benefits paid or provided by our Company.

 Outstanding
Equity Awards at Fiscal Year-End Table

table summarizes the number of shares of common stock underlying outstanding equity incentive plan awards for each named executive officer
as of December 31, 2024. We have made no stock awards under the 2022 Plan and accordingly, that portion of the table has been omitted.

 Option Awards

 Name

 Number of Securities Underlying Unexercised Options (#)(1)

 Equity Incentive Plan Awards: Number of Securities Underlying Unexercised Unearned Options (#)

 Option Exercise Price ($)

 Option Expiration Date

 Exercisable

 Unexercisable

 Meeshanthini V. Dogan

 272,250

 —

 —

 $

 1.26

 6/23/2033

 685,452

 —

 —

 $

 3.90

 5/6/2032

 476,256

 —

 —

 $

 2.11

 1/23/2034

 Warren Hosseinion

 123,750

 —

 —

 $

 1.26

 6/23/2033

 342,726

 —

 —

 $

 3.90

 5/6/2032

 35,719

 —

 —

 $

 2.11

 1/23/2034

 Elisa Luqman

 57,750

 —

 —

 $

 1.26

 6/23/2033

 171,363

 —

 —

 $

 3.90

 5/6/2032

 35,719

 —

 —

 $

 2.11

 1/23/2034

 Timur Dogan

 40,589

 —

 —

 $

 3.90

 5/6/2032

 156,750

 —

 —

 $

 1.26

 6/23/2033

 238,128

 —

 —

 $

 2.11

 1/23/2034

 Agreements
with Our Executive Officers and Non-Executive Chairman of the Board

 In connection with preparations
for the Business Combination, Cardio executed employment agreements as of May 27, 2022 with each person expected to be named an executive
officer of the combined entity. The agreements became effective upon Closing of the Business Combination. The principal terms of each
of agreements is as follows:

 Employment Agreement between Cardio and Meeshanthini V. Dogan
(Chief Executive Officer)

 Dr. Dogan's five-year employment
agreement provides for (i) an annual base salary of $300,000, (ii) eligibility to receive an annual cash bonus based on the extent to
which, in the discretion of the Board, Dr. Dogan achieves or exceeds specific and measurable individual and Company performance objectives,
and (iii) eligibility to participate in any long-term incentive plan that is made available to similarly positioned executives, employee
benefit or group insurance plans maintained from time to time by Cardio. Long-term incentive plan awards may include cash, or equity awards
settled in shares of Company stock, including but not limited to stock options, restricted stock and performance shares. If Dr. Dogan
were to leave the Company as a "Good Leaver," as defined in the employment agreement, terms of any long-term incentive award
will be deemed satisfied immediately prior to such termination and as such, all awards and grants will be deemed fully vested. In addition,
Dr. Dogan will be reimbursed for her reasonable and usual business expenses incurred on behalf of the Company. Severance benefits will
be payable in the event Dr. Dogan's termination is either by the Company without cause or by her with "good reason,"
as defined in the agreement. In such event and in addition to accrued salary benefits as of the date of termination, the Company will
pay Dr. Dogan an amount equal to a (x) two times the sum of her most recent base salary and target annual bonus and (y) an amount in cash
equal to the Company's premium amounts paid for her coverage under group medical, dental and vision programs for a period of 24
months. The agreement also contains customary confidentiality, non- solicitation, non-competition and cooperation provisions. The employment
agreement will automatically renew for an additional year following the initial term and any renewal term, unless either party provides
60-days' written notice before the end of the then-current term. The Company may terminate Dr. Dogan's employment without
cause (as defined in the agreement) by providing 60 days' advance written notice. Dr. Dogan may terminate her employment for any
reason.

 Non-Executive Chairman and Consulting Agreement between Cardio
and Warren Hosseinion

 Cardio has retained Dr. Hosseinion
under a five-year consulting agreement to serve as Non-Executive Chairman of the Board following the Merger and to provide other services
as requested. Upon expiration of such provision, the agreement may be renewed for an additional one-year term. In addition to his duties
as Chairman, the agreement provides that Dr. Hosseinion will provide consulting services assisting management in developing business strategy
and business plans, identifying business opportunities and identifying strategic relationships and strategies to further develop the Company's
brand. In the event he is not reelected as Chairman of the Board, the terms of this agreement will continue strictly as a consulting services
agreement.

 Conversely, if his consulting services are terminated,
such termination will not affect his Chairman Services, provided that he remains eligible to serve as Chairman. For his Chairman services
and consulting services, the agreement provides for a fee of $300,000 per year payable in monthly installments of $25,000. In addition,
Dr. Hosseinion is entitled to be awarded any equity compensation otherwise payable to Board members in connection with their service on
the Board and to be reimbursed for all reasonable and necessary business expenses incurred in the performance of his consulting services
and Chairman services. If Dr. Hosseinion's services are terminated by the Company other than for Cause (as defined in the agreement),
including any discharge without Cause, liquidation or dissolution of the Company, or a termination caused by death or Disability (as defined
in the agreement), the Company will pay Dr. Hosseinion (or his estate) the consulting fees equal to two times his annual consulting compensation,
payable within 60 days, in one lump sum, plus any expenses owing for periods prior to and including the date of termination of the consulting
services. The agreement also contains customary confidentiality, non-solicitation, non-disparagement and cooperation provisions. Either
party may terminate the agreement without cause after giving prior written notice to the other party. The agreement may be terminated
by the Company at any time for cause, as defined in the agreement.

 Employment
Agreement between Cardio and Elisa Luqman (Chief Financial Officer)

 Ms. Luqman's
five-year employment agreement provides for (i) an annual base salary of $275,000, (ii) eligibility to receive an annual cash bonus based
on the extent to which, in the discretion of the Board, Ms. Luqman achieves or exceeds specific and measurable individual and Company
performance objectives, and (iii) eligibility to participate in any long-term incentive plan that is made available to similarly positioned
executives, employee benefit or group insurance plans maintained from time to time by Cardio. Long-term incentive plan awards may include
cash, or equity awards settled in shares of Company stock, including but not limited to stock options, restricted stock and performance
shares. If Ms. Luqman were to leave the Company as a "Good Leaver," as defined in the employment agreement, terms of any long-term
incentive award will be deemed satisfied immediately prior to such termination and as such, all awards and grants will be deemed fully
vested. In addition, Ms. Luqman will be reimbursed for her reasonable and usual business expenses incurred on behalf of the Company.
Severance benefits will be payable in the event Ms. Luqman's termination is either by the Company without cause or by her with
"good reason," as defined in the agreement. In such event and in addition to accrued salary benefits as of the date of termination,
the Company will pay Ms. Luqman an amount equal to a (x) the sum of her most recent base salary and target annual bonus and (y) an amount
in cash equal to the Company's premium amounts paid for her coverage under group medical, dental and vision programs for a period
of 12 months, provided that she has elected continued coverage under COBRA. The agreement also contains customary confidentiality, non-solicitation,
non-competition and cooperation provisions. The employment agreement will automatically renew for an additional year following the initial
term and any renewal term, unless either party provides 60-days' written notice before the end of the then-current term. The Company
may terminate Ms. Luqman's employment without cause (as defined in the agreement) by providing 60 days' advance written notice.
Ms. Luqman may terminate her employment for any reason.

 Employment Agreement between Cardio and Tim Dogan (Chief
Technical Officer)

 Dr. Dogan's five-year employment
agreement provides for (i) an annual base salary of $250,000, (ii) eligibility to receive an annual cash bonus based on the extent to
which, in the discretion of the Board, Dr. Dogan achieves or exceeds specific and measurable individual and Company performance objectives,
and (iii) eligibility to participate in any long-term incentive plan that is made available to similarly positioned executives, employee
benefit or group insurance plans maintained from time to time by Cardio. Long-term incentive plan awards may include cash, or equity awards
settled in shares of Company stock, including but not limited to stock options, restricted stock and performance shares. If Dr. Dogan
were to leave the Company as a "Good Leaver," as defined in the employment agreement, terms of any long-term incentive award
will be deemed satisfied immediately prior to such termination and as such, all awards and grants will be deemed fully vested. In addition,
Dr. Dogan will be reimbursed for his reasonable and usual business expenses incurred on behalf of the Company. Severance benefits will
be payable in the event Dr. Dogan's termination is either by the Company without cause or by him with "good reason,"
as defined in the agreement. In such event and in addition to accrued salary benefits as of the date of termination, the Company will
pay Dr. Dogan an amount equal to a (x) the sum of his most recent base salary and target annual bonus and (y) an amount in cash equal
to the Company's premium amounts paid for his coverage under group medical, dental and vision programs for a period of 12 months,
provided that he has elected continued coverage under COBRA. The agreement also contains customary confidentiality, non-solicitation,
non-competition and cooperation provisions. The employment agreement will automatically renew for an additional year following the initial
term and any renewal term, unless either party provides 60-days' written notice before the end of the then-current term. The Company
may terminate Dr. Dogan's employment without cause (as defined in the agreement) by providing 60 days' advance written notice.
Dr. Dogan may terminate his employment for any reason.

individuals served as non-employee directors of the Company for all or part of 2024 (other than Dr. Hosseinion, who, as discussed above,
is being treated as an NEO for purposes of the compensation disclosure in this Annual Report): Paul Burton, James Intrater, Stanley K.
Lau, Oded Levy, Wendy J. Betts and Peter K. Fung, MD. The following table sets forth information concerning the compensation for our
non-employee directors for services rendered during the year ended December 31, 2024. Additionally, we reimburse our non-employee directors
for reasonable travel and other out-of-pocket expenses incurred in connection with attending board of director and committee meetings
or undertaking other business on behalf of Cardio.

 Name

 Fees Earned or Paid in Cash
 ($)

 Stock Awards ($)

 All Other Compensation ($)

 Total ($)

 Paul Burton

 25,000

 25,000

 —

 50,000

 James Intrater

 25,000

 25,000

 —

 50,000

 Wendy J. Betts (1)

 4,167

 2,083

 —

 6,250

 Peter K. Fung, MD (1)

 4,167

 2,083

 —

 6,250

 Stanley K. Lau (2)

 20,833

 22,917

 —

 43,750

 Oded Levy (2)

 20,833

 22,917

 —

 43,750

 (1)
 Wendy J. Betts and Peter K. Fung, MD were elected to the Board
at the November 15, 2024 Annual Meeting of Stockholders.

 (2)
 Stanley K. Lau and Oded Levy did not stand for re-election at the
2024 Annual Meeting but did receive shares of Common Stock upon vesting and settlement of previously awarded RSUs on December 31, 2023
and January 22, 2024, and Stock Options awarded through November 14, 2024.

 Narrative Disclosure to Non-Employee Director Compensation
Table

 During 2024,
Cardio compensated its non-employee, independent directors for service as a director with a combination of Restricted Stock Units ("RSUs")
in the amount of $12,500, Option Agreements in the amount of $12,500 and Cash payments in the amount of $25,000.

 The
RSUs were awarded on January 23, 2024 for $12,500 to compensate for one quarter of service. The RSUs were vested and settled on March
31, 2024 based on the closing price of our Common Stock on March 31, 2024. Thereafter, on June 30, 2024, September 30, 2024, and December
31, 2024, each independent director received $8,333 in cash payments and $4,167 in Stock Options awards. The number of shares of Common Stock into which the Options
may be exercised were based on the closing price of our Common Stock on June 30, 2024, September 30, 2024 and December 31, 2024, respectively.
Directors who transitioned on or off the Board were compensated on a pro-rata basis for days of service.

 Non-employee
directors are also eligible to be granted options under the Company's 2022 Equity.

 The Company
reimburses its non-employee directors for reasonable travel and out-of-pocket expenses incurred in connection with attending board of
director and committee meetings or undertaking other business on behalf of our Company.

 As discussed
below under "Certain Relationships and Related Party Transactions," we have entered into indemnification agreements with,
and obtained directors liability protection for, covering our directors.

of Other Members of the Board of Directors

 In fiscal 2024, Dr. Dogan, our co-founder and Chief
Executive Officer, and Dr. Hosseinion, our Non-Executive Chairman of the Board, were compensated as an employee and a consultant, respectively,
and did not receive any additional compensation for service on our Board. Their total 2024 compensation in all capacities is reflected
in the Summary Compensation Table. As noted in connection with the Summary Compensation Table above, Dr. Hosseinion's compensation
is disclosed as though he is a Named Executive Officer in order to provide complete transparency as to the compensation he is paid by
us as Non-Executive Chairman and a consultant to our company. Robert Philibert, our co-founder, Chief Medical Officer and a director,
is not compensated for his service as a member of the Board of Directors.

 Item 12.
 Security Ownership of Certain Beneficial Owners and Management and Related Stockholder Matters

table sets forth information regarding the beneficial ownership of the Company's Common Stock as of March 20, 2025 by:

 each person known to the Company to be the beneficial owner of more than 5% of the Company's Common
 Stock;

 each person who is a "named executive officer" or a director of the Company and

 all of the Company's executive officers and directors as a group.

 Beneficial ownership is determined
in accordance with SEC rules and includes voting or investment power with respect to securities. Except as indicated by the footnotes
below, the Company believes, based on the information furnished to it as of the Closing of the Business Combination, that the persons
named in the table below have, sole voting and investment power with respect to all stock that they beneficially own, subject to applicable
community property laws. All Company stock subject to options or warrants exercisable within 60 days of the date of the table are deemed
to be outstanding and beneficially owned by the persons holding those options or warrants for the purpose of computing the number of shares
beneficially owned and the percentage ownership of that person. They are not, however, deemed to be outstanding and beneficially owned
for the purpose of computing the percentage ownership of any other person.

 Subject to the
paragraph above, percentage ownership of outstanding shares is based on 52,145,416 shares
of the Company's Common Stock outstanding as of March 20, 2025.

 Name and Address of Beneficial Owner (1)

 Amount and Nature of Beneficial Ownership

 Approximate Percentage of Outstanding Shares

 Directors, Executive Officers and Greater than 5% Holders

 Meeshanthini V. Dogan (2)

 3,089,387

 5.92
 %

 Robert Philibert (3)

 2,489,332

 4.77
 %

 Warren Hosseinion (4)

 618,248

 1.19
 %

 Elisa Luqman (5)

 322,772

 0.62
 %

 James Intrater (7)

 102,401

 0.20
 %

 Peter K. Fung (8)

 2,272

 —

 Wendy Betts (8)

 2,272

 —

 Paul Burton (7)

 39,608

 0.08
 %

 Timur Dogan (6)

 563,812

 1.08
 %

 All Executive Officers and Directors as a Group (9 individuals)
 * Less than 1%.

 7,230,104

 13.87
 %

 (1)
 Unless otherwise noted, the address for the persons in the table is 311 West Superior Street,
Suite 444, Chicago IL 60654.

 (2)
 Meeshanthini Dogan and Timur Dogan are married. The beneficial
ownership of Meeshanthini Dogan reflected in the table includes the shares and options of Timur Dogan. Meeshanthini Dogan's direct
ownership is 1,586,464 shares of common stock, 1,433,958 shares issuable upon exercise of options
and 68,965 shares of common stock held jointly with her spouse. Dr. Dogan may be deemed to be the indirect beneficial owner of the securities
owned by her husband; however, she disclaims beneficial ownership of the shares held indirectly, except to the extent of her pecuniary
interest.

 (3)
 Robert Philibert a Director and Chief Medical Officer (CMO) of the
 registrant, is the direct owner of 75,676 of the securities of the registrant reported herein, owns and controls BD Holding Inc.,
 the direct owner of 1,586,464 of the securities of the registrant reported herein, owns and controls Behavioral Diagnostics LLC, the
 direct owner of 14,126 of the securities of the registrant reported herein, and his spouse is the direct owner of 7,601 of the
 securities of the registrant reported herein. Also includes 805,465 shares of Common Stock issuable upon exercise
of options that are currently exercisable.

 (4)
 Includes 502,195 shares of common stock issuable upon exercise
of options.

 (5)
 Includes 264,832 shares of common stock issuable upon exercise
of options.

 (6)
 Timur Dogan and Meeshanthini Dogan are married. The beneficial
ownership of Timur Dogan reflected in the table includes the shares and options of Meeshanthini Dogan. Timur Dogan's direct ownership
is 128,345 shares of common stock, 435,467 shares issuable upon exercise of options and 68,965 shares of common stock held jointly with
his spouse. Dr. Dogan may be deemed to be the indirect beneficial owner of the securities owned by his wife; however, he disclaims beneficial
ownership of the shares held indirectly, except to the extent of his pecuniary interest.

 (7)
 Includes 30,805 shares of common stock issuable upon exercise
of options.

 (8)
 Includes 2,272 shares of common stock issuable upon exercise
of options.

 Item 13.
 Certain Relationships, and Related Transactions and Director Independence

 There have
been no transactions since January 1, 2024 to which we have been a party in which the amount involved exceeded or will exceed the lesser
of $120,000 or 1% of the average of our total assets at year end for the last two completed fiscal years, and in which any of our directors,
executive officers or, to our knowledge, beneficial owners of more than 5% of our capital stock or any member of the immediate family
of any of the foregoing persons had or will have a direct or indirect material interest, other than transactions that are described under
the section "Executive and Director Compensation."

 Cardio has an exclusive, worldwide
patent license of the Core Technology from the University of Iowa Research Foundation (UIRF). Under UIRF's Inventions Policy inventors
are generally entitled to 25% of income from earnings from their inventions. Consequently, Meeshanthini Dogan and Robert Philibert will
benefit from this policy.

 Timur Dogan, the
Company's Chief Technology Officer is the spouse of Meeshanthini (Meesha) Dogan, the Company's Co-Founder, Chief Executive
Officer and Director.

 At the Closing
of the Business Combination, Dr. M. Dogan, Dr. Philibert, Ms. Luqman, and Dr. T.
 Dogan each entered into an Invention and Non-Disclosure Agreement. An integral part of the Invention and Non-Disclosure Agreement
is the disclosure by the employee of any discoveries, ideas, inventions, improvements, enhancements, processes, methods, techniques,
developments, software and works of authorship ("developments") that were created, made, conceived or reduced to practice
by the employee prior to his or her employment by Cardio and that are not assigned to the Company. Dr. Philibert's agreement lists
certain developments that are epigenetic methods unrelated to the current mission of Cardio and that were developed separate and apart
from Cardio. There is no assurance that as the Company broadens the scope of its products and services that one or more of Dr. Philibert's
developments could be relevant. Under the agreement, all rights to the developments listed by Dr. Philibert are his sole property and
their use, if desired by the Company, would be in the sole discretion of Dr. Philibert, who is under no obligation to license or otherwise
grant permission to the Company to use them.

 Our Certificate
of Incorporation, as amended, restated and currently in effect, and our Bylaws provide for indemnification and advancement of expenses
for our directors and officers to the fullest extent permitted by Delaware law, subject to certain limited exceptions. We have entered
into indemnification agreements with each member of our Board and several of our officers.

 Warren Hosseinion
M.D., who serves as the Non-Executive Chairman of the Board of the Company, is also a minority ten percent (10%) owner of Altitude Capital
Group LLC ("Altitude"), a separate entity engaged as the Placement Agent for our Private Placement. This ownership interest
creates a potential conflict of interest because Dr. Hosseinion may have a financial interest in the success of Altitude, which could
affect his decision-making with respect to the Offering and other matters related to the Company. However, the Company has established
policies and procedures designed to address and mitigate any potential conflicts of interest that may arise in connection with Mr. Hosseinion's
dual roles. All material agreements and arrangements between the Company and Altitude, as well as this Private Placement Memorandum and
the Offering, have be reviewed and approved by the Company's independent Board of Directors. Dr. Hosseinion did not receive any compensation
in relation to the Private Placement.

 Related
Party Policy

 The audit committee of the board
of directors had adopted a policy setting forth the policies and procedures for its review and approval or ratification of "related
party transactions." The policy provides that a "related party transaction" is defined in the policy as any consummated
or proposed transaction or series of transactions: (i) in which the Company was or is to be a participant; (ii) the amount of which exceeds
(or is reasonably expected to exceed) the lesser of $120,000 or 1% of the average of the Company's total assets at year-end for
the prior two completed fiscal years in the aggregate over the duration of the transaction (without regard to profit or loss); and (iii)
in which a "related party" had, has or will have a direct or indirect material interest. "Related parties" under
this policy included: (i) Cardio's directors, nominees for director or executive officers; (ii) any record or beneficial owner of
more than 5% of any class of Cardio's voting securities; (iii) any immediate family member of any of the foregoing if the foregoing
person is a natural person; and (iv) any other person who maybe a "related person" pursuant to Item 404 of Regulation S-K
under the Exchange Act. Pursuant to the policy, the audit committee would consider (i) the relevant facts and circumstances of each related
party transaction, including if the transaction is on terms comparable to those that could be obtained in arm's-length dealings
with an unrelated third party, (ii) the extent of the related party's interest in the transaction, (iii) whether the transaction
contravenes our code of ethics or other policies, (iv) whether the audit committee believes the relationship underlying the transaction
to be in the best interests of Cardio and its stockholders and (v) the effect that the transaction may have on a director's status
as an independent member of Cardio's board and on his or her eligibility to serve on Cardio's board's committees. The
policy requires that the Company's management present to the audit committee each proposed related party transaction, including
all relevant facts and circumstances relating thereto. Under the policy, the Company is permitted to consummate related party transactions
only if the audit committee approves or ratifies the transaction in accordance with the guidelines set forth in the policy. The policy
does not permit any director or executive officer to participate in the discussion of, or decision concerning, a related person transaction
in which he or she is the related party.

 Item 14.
 Principal Accounting Fees and Services

 Fees
Paid to the Independent Registered Public Accounting Firm

table presents fees for professional audit services and other services rendered by Prager Metis CPAs LLC for the fiscal years ended December
31, 2024 and 2023:

 For the
 Year Ended
 December 31, 2024

 For the
 Year Ended
 December 31, 2023

 Audit Fees (1)

 $
 107,500

 $
 85,5000

 Audit-Related Fees (2)

 42,500

 —

 Tax Fees (3)

 —

 —

 All Other Fees (4)

 —

 —

 Total Fees

 $
 150,000

 $
 85,5000

 (1)
 Audit
 Fees. Audit fees consist of fees billed for professional services rendered for the audit
 of our year-end financial statements, reviews of our quarterly interim financial statements,
 and services that are normally provided by our independent registered public accounting firm
 in connection with statutory and regulatory filings. As noted above, we engaged Prager Metis
 CPAs LLC to conduct the audit of our financial statements for the years ended December 31,
 2024 and 2023.

 (2)
 Audit-Related Fees. Audit-related fees consist of fees
billed for assurance and related services that are reasonably related to performance of the audit or review of our year-end consolidated
financial statements and are not reported under "Audit Fees." These services include attest services that are not required
by statute or regulation and consultation concerning financial accounting and reporting standards.

 (3)
 Tax Fees. Tax fees consist of fees billed for professional
services relating to tax compliance, tax planning and tax advice. We did not pay our independent registered public accountants for tax services
for the periods shown in the table above.

 (4)
 All Other Fees. All other fees consist of fees billed for all
 other services including permitted due diligence services related to potential business combinations. We did not pay our independent
 registered public accountants for other services for the periods shown in the table above.

 Auditor
 Independence

 In 2024, there were no other professional
services provided by Prager Metis CPAs LLC, other than those listed above, that would have
required our Audit Committee to consider their compatibility with maintaining the independence of Prager Metis CPAs LLC.

 Pre-Approval Policies and Procedures

 Our Audit Committee is required to pre-approve the audit and non-audit
services performed by our independent registered public accounting firm in order to assure that the provision of such services does not
impair the auditor's independence. Any proposed services exceeding pre-approved cost levels require specific pre-approval by our
Audit Committee.

 Our Audit Committee at least annually reviews and provides general
pre-approval for the services that may be provided by the independent registered public accounting firm. The term of the general pre-approval
is 12 months from the date of approval, unless our Audit Committee specifically provides for a different period. If our Audit Committee
has not provided general pre-approval, then the type of service requires specific pre-approval by our Audit Committee.

 All services performed and related fees billed by Prager Metis
CPAs LLC during fiscal years 2023 and 2024 were pre-approved by our Audit Committee pursuant to regulations of the SEC.

 PART
 IV

 Item
15. Exhibits and Financial Statement Schedules

 1. Financial Statements

 As part of this Annual Report on Form 10-K,
the consolidated financial statements are listed in the accompanying Index to Financial Statements on page F-1.

 2. Financial Statement Schedules

 All schedules are omitted because they are not
applicable, or the required information is shown in the Financial Statements or notes thereto.

 3. Exhibit Index

 Incorporation
 by Reference

 Exhibit
 Number

 Description

 Form

 Exhibit

 Filing

 Dat e

 2.1

 Agreement and Plan of Merger dated as of May 27, 2022 by and among Mana Capital Acquisition Corp., Mana Merger Sub, Inc., Cardio Diagnostics, Inc., and Meeshanthini (Meesha) Dogan, as representatives of the shareholders (included as Annex A to the Proxy Statement/Prospectus)

 2.1

 5/31/22

 2.2

 Amendment dated September 15, 2022 to Agreement and Plan of Merger dated as of May 27, 2022 by and among Mana Capital Acquisition Corp., Mana Merger Sub, Inc., Cardio Diagnostics, Inc., and Meeshanthini (Meesha) Dogan, as representatives of the shareholders

 2.1

 9/15/22

 2.3

 Waiver Agreement dated as of October 25, 2022 with respect to Agreement and Plan of Merger dated as of May 27, 2022, as amended on September 15, 2022

 2.3

 10/31/22

 3.1

 Third Amended and Restated Certificate of Incorporation of Cardio Diagnostics Holdings, Inc., dated May 30, 2023

 3.1

 5/30/23

 3.2

 By-laws

 S-1

 3.3

 10/19/21

 4.1

 Specimen Stock Certificate

 S-1/A

 4.2

 11/10/21

 4.2

 Specimen Warrant Certificate (contained in Exhibit 4.3)

 4.1

 11/26/21

 4.3

 Warrant Agreement, dated November 22, 2021, by and between the Company and Continental Stock Transfer & Trust Company, as warrant agent

 4.1

 11/26/21

 4.4

 Form of Private Placement Warrant

 4.1

 2/2/24

 4.5

 Description
 of Securities

 4.5

 4/1/2024

 10.1

 Form of Non-Competition and Non-Solicitation Agreement

 S-4

 10.8

 5/31/22

 10.2#

 Form of Board of Directors Agreement, dated June 19, 2023

 10.1

 6/22/23

 10.3

 Registration Rights Agreement, dated November 22, 2021, by and among the Company, the Sponsor and other holders party thereto

 10.4

 11/26/21

 10.4#

 Cardio
 Diagnostics Holdings, Inc. 2022 Equity Incentive Plan and related forms of agreements

 10.4

 4/1/2024

 10.5#

 Form of Indemnification Agreement

 S-1

 10.5

 12/12/22

 10.6#

 Employment Agreement, executed as of May 27, 2022, between Cardio Diagnostics, Inc. and Meeshanthini Dogan

 S-4/A

 10.13

 10.7#

 Employment Agreement, executed as of May 27, 2022, between Cardio Diagnostics, Inc. and Robert Philibert

 S-4/A

 10.14

 10.8#

 Employment Agreement, executed as of May 27, 2022, between Cardio Diagnostics, Inc. and Elisa Luqman

 S-4/A

 10.15

 10.9#

 Employment Agreement, executed as of May 27, 2022, between Cardio Diagnostics, Inc. and Timur Dogan

 S-4/A

 10.16

 10.11#

 Non-Executive Chairman and Consulting Agreement between Cardio Diagnostics, Inc. and Warren Hosseinion

 S-4/A

 10.18

 10.12

 Exclusive License Agreement between Cardio Diagnostics, LLC and the University of Iowa Research Foundation dated May 2, 2017

 S-4/A

 10.11

 10.13

 First Amendment to Exclusive License Agreement between Cardio Diagnostics, Inc. and the University of Iowa Research Foundation dated September 2, 2022

 S-4/A

 10.19

 9/15/22

 10.14§

 Lease Agreement, dated July 20, 2023, between the Registrant and 246 Group LC dba North Point Crossing

 10.1

 8/14/23

 10.15

 Office Building Lease Agreement, dated June 15, 2023, between the Registrant and 311 W. Superior, L.L.C.

 10.2

 8/14/23

 10.16

 Engagement Letter, dated as of May 13, 2022, between Mana Capital Acquisition Corp. and The Benchmark Company, LLC

 10.18

 3/31/23

 10.17

 Amendment No. 1 to Engagement Letter, dated November 14, 2022, between the Registrant and The Benchmark Company, LLC

 10.19

 3/31/23

 10.18

 At the Market Offering
 Agreement, dated January 26, 2024, between Cardio Diagnostics Holdings, Inc. and Craig-Hallum Capital Group, LLC

 S-3

 1.2

 1/26/24

 19.1*

 Securities Insider Trading Policy

 21.1*

 List of Subsidiaries

 23.1*

 Consent of Prager Metis CPAs LLC, independent registered public accounting firm

 24.1*

 Power of Attorney (included on signature page of this Form 10-K)

 31.1*

 Certification of Principal Executive Officer Pursuant to Exchange Act Rules 13a-14(a) and 15d-14(a), as adopted pursuant to Section 302 of the Sarbanes-Oxley Act of 2002

 31.2*

 Certification of Principal Financial Officer Pursuant to Exchange Act Rules 13a-14(a) and 15d-14(a), as adopted pursuant to Section 302 of the Sarbanes-Oxley Act of 2002

 32.1*+

 Certification of Principal Executive Officer and Principal Financial Officer pursuant to 18 U.S. C. Section 1350, as adopted pursuant to Section 906 of the Sarbanes-Oxley Act of 2002

 97#

 Cardio Diagnostics Holdings,
 Inc. "Clawback" Policy

 97.1

 4/1/2024

 101.INS*++

 101.SCH*++

 101.CAL*++

 101.DEF*++

 101.LAB*++

 101.PRE*++

 104*

 *
 Filed herewith.

 #
 Indicates a management contract or compensatory plan, contract or arrangement.

 §
 Certain of the exhibits or schedules to this Exhibit have been omitted in accordance with
Regulation S-K Item 601(a)(5). The Registrant agrees to furnish a copy of all omitted exhibits and schedules to the SEC upon its request;
provided, however, that the Registrant may request confidential treatment pursuant to Rule 24b-2 of the Exchange Act, as amended, for
any schedule or exhibit so furnished.

 +
 Furnished herewith. The certifications attached as Exhibit 32.1 that accompanies this Annual
Report on Form 10-K is deemed furnished and not filed with the Securities and Exchange Commission and is not to be incorporated by reference
into any filing of Cardio Diagnostics Holdings,, Inc. under the Securities Act of 1933, as amended, or the Securities Exchange Act of
1934, as amended, whether made before or after the date of this Annual Report on Form 10-K, irrespective of any general incorporation
language contained in such filing.

 ++
 Furnished herewith. Pursuant to Rule 406T of Regulation S-T, the Interactive Data Files on
Exhibit 101 hereto are deemed not filed or part of a registration statement or prospectus for purposes of Sections 11 or 12 of the Securities
Act of 1933, as amended, are deemed not filed for purposes of Section 18 of the Securities Exchange Act of 1934, as amended, and otherwise
are not subject to liability under those sections.

 Item
16. Form 10-K Summary

 None.

 SIGNATURES

 Pursuant
to the requirements of Section 13 or 15(d) of the Securities Exchange Act of 1934, the Registrant has duly caused this Report to be signed
on its behalf by the undersigned, thereunto duly authorized.

 Cardio Diagnostics Holdings, Inc.

 Dated:

 By:

 /s/ Meeshanthini V. Dogan

 Meeshanthini V. Dogan

 Chief Executive Officer

 (Principal Executive Officer)

 POWER OF ATTORNEY

 Each person whose signature
appears below constitutes and appoints Meeshanthini V. Dogan and Elisa Luqman, and each one of them, as her true and lawful attorneys-in-fact
and agents, with full power of substitution and resubstitution, for her and in their name, place, and stead, in any and all capacities,
to sign any and all amendments to this Annual Report on Form 10-K, and to file the same, with all exhibits thereto and other documents
in connection therewith, with the Securities and Exchange Commission, granting unto said attorneys-in-fact and agents, and each of them,
full power and authority to do and perform each and every act and thing requisite and necessary to be done in connection therewith, as
fully to all intents and purposes as he or she might or could do in person, hereby ratifying and confirming all that said attorneys-in-fact
and agents or any of them, or his or her substitute or substitutes, may lawfully do or cause to be done by virtue hereof.

 Pursuant to the requirements
of the Securities Exchange Act of 1934, this Annual Report on Form 10-K has been signed by the following persons on behalf of the registrant
and in the capacities and on the dates indicated.

 Signature

 Title and Capacity

 Date

 /s/ Meeshanthini V. Dogan

 Chief Executive Officer and Director

 Meeshanthini V. Dogan, PhD

 /s/ Elisa Luqman

 Chief Financial Officer and Principal

 Elisa Luqman

 Accounting Officer

 /s/ Warren Hosseinion

 Director (Chairman of the Board)

 Warren Hosseinion, MD

 /s/ James Intrater

 James Intrater

 /s/ Peter K.
 Fung

 Peter K. Fung

 /s/ Wendy J. Betts

 Wendy J. Betts

 /s/ Robert Philibert

 Robert Philibert, MD

 /s/ Paul Burton

 Paul Burton