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 UNITED
STATES

 SECURITIES
AND EXCHANGE COMMISSION

 WASHINGTON
D.C. 20549

 FORM

 (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, 2023

 OR

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

 COMMISSION
FILE NUMBER: 001-35731

 InspireMD,
Inc.

 (Exact
name of registrant as specified in its charter)

 Delaware

 26-2123838

 (State
 or other jurisdiction of

 incorporation
 or organization)

 (I.R.S.
 Employer

 Identification
 Number)

 Menorat Hamaor St.

 Tel
 Aviv, Israel

 6744832

 (Address
 of principal executive offices)

 (Zip
 Code)

 Registrant's
telephone number, including area code: (888) 776-6804

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

 Title
 of each class

 Trading
 Symbol(s)

 Name
 of each exchange on which registered

 Common Stock, par value
 $0.0001 per share

 NSPR

 Nasdaq Capital Market

 Securities
registered pursuant to Section 12(g) of the 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 Section 15(d) of the 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 of 1934 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

by check mark whether the registrant is a large accelerated filer, an accelerated filer, a non-accelerated filer, a 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

 The
aggregate market value of the voting and non-voting stock held by non-affiliates of the registrant as of June 30, 2023, based on the
price at which the common equity was last sold on such date, was $ 46,130,594. For purposes of this computation only, all officers, directors
and 10% or greater stockholders of the registrant are deemed to be affiliates.

the number of shares outstanding of each of the registrant's classes of common stock as of the latest practicable date.

 Class

 Outstanding
 at March 5, 2024

 Common Stock, $0.0001 par
 value

 23,456,590

 Documents
incorporated by reference:

 Portions
of the Registrant's definitive proxy statement for its 2024 Annual Meeting of Stockholders, which the Registrant intends to file
pursuant to Regulation 14A with the Securities and Exchange Commission not later than 120 days after December 31, 2023, are incorporated
by reference into Part III of this Annual Report on Form 10-K.

 TABLE
OF CONTENTS

 Page

 Cautionary
 Note Regarding Forward-Looking Statements

 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 Supplementary 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 and Financial Statement Schedules.

 - 2 -

 SPECIAL
NOTE REGARDING FORWARD-LOOKING STATEMENTS

 This
Annual Report on Form 10-K contains "forward-looking statements," which include information relating to future events, future
financial performance, strategies, expectations, competitive environment and regulation, including, revenue growth. Words such as "may,"
"will," "should," "could," "would," "predicts," "potential,"
"continue," "expects," "anticipates," "future," "intends," "plans,"
"believes," "estimates," and similar expressions, as well as statements in future tense, identify forward-looking
statements. Forward-looking statements should not be read as a guarantee of future performance or results and will probably not be accurate
indications of when such performance or results will be achieved. Forward-looking statements are based on information we have when those
statements are made or our management's good faith belief as of that time with respect to future events, and are subject to risks
and uncertainties that could cause actual performance or results to differ materially from those expressed in or suggested by the forward-looking
statements. Important factors that could cause such differences include, but are not limited to:

 our
 history of recurring losses and negative cash flows from operating activities, significant future commitments and the uncertainty
 regarding the adequacy of our liquidity to pursue our complete business objectives;

 our
 need to raise additional capital to meet our business requirements in the future and such capital raising may be costly or difficult
 to obtain and could dilute out stockholders' ownership interests;

 market
 acceptance of our products;

 an
 inability to secure and maintain regulatory approvals for the sale of our products;

 negative
 clinical trial results or lengthy product delays in key markets;

 our
 ability to maintain compliance with the Nasdaq listing standards;

 our
 ability to generate revenues from our products and obtain and maintain regulatory approvals for our products;

 our
 ability to adequately protect our intellectual property;

 our
 dependence on a single manufacturing facility and our ability to comply with stringent manufacturing quality standards and to increase
 production as necessary;

 the
 risk that the data collected from our current and planned clinical trials may not be sufficient to demonstrate that our technology
 is an attractive alternative to other procedures and products;

 intense
 competition in our industry, with competitors having substantially greater financial, technological, research and development, regulatory
 and clinical, manufacturing, marketing and sales, distribution and personnel resources than we do;

 entry
 of new competitors and products and potential technological obsolescence of our products;

 inability
 to carry out research, development and commercialization plans;

 loss
 of a key customer or supplier;

 technical
 problems with our research and products and potential product liability claims;

 product
 malfunctions;

 price
 increases for supplies and components;

 - 3 -

 insufficient
 or inadequate reimbursement by governmental and other third-party payers for our products;

 our
 efforts to successfully obtain and maintain intellectual property protection covering our products, which may not be successful;

 adverse
 federal, state and local government regulation, in the United States, Europe or Israel and other foreign jurisdictions;

 the
 fact that we conduct business in multiple foreign jurisdictions, exposing us to foreign currency exchange rate fluctuations, logistical
 and communications challenges, burdens and costs of compliance with foreign laws and political and economic instability in each jurisdiction;

 security,
 political and economic instability in the Middle East that could harm our business, including due to the current war between Israel
 and Hamas; and

 current
 or future unfavorable economic and market conditions and adverse developments with respect to financial institutions and associated
 liquidity risk

 The
foregoing does not represent an exhaustive list of matters that may be covered by the forward-looking statements contained herein or
risk factors that we are faced with that may cause our actual results to differ from those anticipated in our forward-looking statements.
You should review carefully the risks and uncertainties described under the heading "Item 1A. Risk Factors" in this Annual
Report on Form 10-K for a discussion of these and other risks that relate to our business and investing in shares of our common stock.
Moreover, new risks regularly emerge, and it is not possible for our management to predict or articulate all the risks we face, nor can
we assess the impact of all risks on our business or the extent to which any risk, or combination of risks, may cause actual results
to differ from those contained in any forward-looking statements. All forward-looking statements included in this Annual Report are based
on information available to us on the date of this Annual Report. Except to the extent required by applicable laws or rules, we undertake
no obligation to publicly update or revise any forward-looking statement, whether as a result of new information, future events or otherwise.
All subsequent written and oral forward-looking statements attributable to us or persons acting on our behalf are expressly qualified
in their entirety by the cautionary statements contained above and throughout this Annual Report.

 The
forward-looking statements contained in this Annual Report on Form 10-K are expressly qualified in their entirety by this cautionary
statement. We do not undertake any obligation to publicly update any forward-looking statement to reflect events or circumstances after
the date on which any such statement is made or to reflect the occurrence of unanticipated events.

 All
information in this Annual Report on Form 10-K relating to shares or price per share reflects the 1-for-15 reverse stock split effected
by us on April 26, 2021.

 - 4 -

 PART
I

 In
this Annual Report on Form 10-K, unless the context requires otherwise, the terms "we," "our," "us,"
or "the Company" refer to InspireMD, Inc., a Delaware corporation, and its subsidiaries, including InspireMD Ltd., taken
as a whole.

 Item
1. Business.

 Overview

 We
are a medical device company focusing on the development and commercialization of our proprietary MicroNet stent platform for
the treatment of carotid artery disease and other vascular disease. A stent is an expandable "scaffold-like" device, usually
constructed of a metallic material, that is inserted into the lumen of the artery to create patency and revascularization of blood flow.
MicroNet, a micron mesh sleeve, is attached over a stent to provide embolic protection both during and after stenting procedures.

 Our
CGuard carotid embolic prevention system ("CGuard EPS") combines MicroNet and a unique self-expandable nitinol stent
in a single device for use in carotid artery revascularization. Our CGuard EPS originally received CE mark approval under Medical Device
Directive 93/42/EEC ("MDD") in the European Union ("EU") in March 2013 and was fully launched in Europe in September
2015. Subsequently, we launched CGuard EPS in over 30 countries and on February 3, 2021, we executed a distribution agreement with Chinese
partners for the purpose of expanding our presence in the Asian markets. In January 2024, we received CE mark recertification under the
EU's Medical Device Regulation regulatory framework. Currently, we are seeking strategic partners for a potential launch of CGuard
EPS in Japan and other Asian countries.

 On
September 8, 2020, we received approval from the U.S. Food and Drug Administration ("FDA") of our Investigation Device Exemption
("IDE"), thereby allowing us to proceed with a pivotal study of our CGuard Carotid Stent System, C-GUARDIANS, for
prevention of stroke in patients in the United States. C-GUARDIANS is a prospective, multicenter, single-arm, pivotal study to evaluate
the safety and efficacy of the CGuard Carotid Stent System when used to treat symptomatic and asymptomatic carotid artery stenosis
in patients undergoing carotid artery stenting ("CAS"). The study, which completed enrollment in June 2023, enrolled 316
patients across 24 trial sites in the U.S. and Europe and from April 2023 included deployment of the CGuard stent using CGuard Prime,
our next generation CAS stent platform.

 The
primary endpoint is a composite of: (1) incidence of major adverse events including Death (all-cause mortality), any Stroke, and
Myocardial Infarction (DSMI) through 30-days post index procedure, or (2) ipsilateral stroke from day 31 to day 365 post-procedure.
All events are adjudicated by an independent clinical events committee. The composite index will be compared to a performance goal
based on the observed rate of the two components of the primary endpoint from previous pivotal stent trials which are considered
industry standard. The performance goal will be considered met if the upper bound of the two-sided 95% confidence interval
calculated from the observed primary endpoint rate is < 11.6% and the p-value is less than 0.025.

 In
November 2023, we announced positive 30-day follow up results from the C-GUARDIANS trial in which stenting with the CGuard Carotid
Stent System in patients with carotid artery stenosis and at high risk for carotid endarterectomy had a DSMI rate of 0.95%, measured
from the date of the procedure through 30 days follow-up post-procedure. We anticipate reporting primary endpoint results from the
C-GUARDIANS trial mid 2024 that may support the submission of a premarket approval, or PMA, application in the third quarter of 2024
with a view to potential FDA approval of the CGuard Prime stent system in the first half of 2025.

 We
continue to invest in current and future potential new indications, products and manufacturing enhancements for CGuard that are
expected to reduce cost of goods and/or provide the best-in-class performing delivery systems, such as CGuard Prime. In furtherance
of our strategy that focuses on establishing the CGuard Carotid Stent System as a viable alternative to vascular surgery, we are
developing a new transcarotid artery revascularization (TCAR) system, SwitchGuard neuroprotection system ("SwitchGuard
NPS"), for transcarotid access and neuro protection. In addition, we intend to explore new indications for CGuard to
leverage the advantages of stent design and mesh protection, well suited in labels such as acute stroke with tandem
lesions.

 - 5 -

 We
consider our current addressable market for our CGuard Carotid Stent System and SwitchGuard NPS to be both symptomatic and asymptomatic
individuals with diagnosed high-grade carotid artery stenosis for whom intervention is preferable to medical (drug) therapy. This group
includes not only carotid artery stenting patients but also individuals undergoing carotid endarterectomy, as the two approaches compete
for the same patient population. Assuming full penetration of the intervention caseload by CGuard, we estimate that the addressable market
for CGuard Carotid Stent System and SwitchGuard NPS is approximately $1.3 billion (source: Health Research International Personal
Medical Systems, Inc. September 13, 2021 Results of Update Report on Global Carotid Stenting Procedures and Markets by Major Geography
and Addressable Markets and internal estimates). According to this same report and internal estimates, assuming full penetration of treatment
for all individuals diagnosed with high-grade carotid artery stenosis, we estimate the total available market for CGuard Carotid Stent System and SwitchGuard
NPS to be approximately $9.3 billion, which may grow over time if expanded treatment options such as CGuard Carotid Stent System and SwitchGuard NPS lead
to increased patient screening for carotid artery disease.

 In
October 2023, the Centers for Medicare and Medicaid Service ("CMS") issued its final National Coverage Determination ("NCD"),
expanding coverage of CAS to include both asymptomatic and standard risk patients, significantly expanding the U.S. CAS addressable market.

 Our
mission is to offer a comprehensive set of delivery solutions (TCAR and Transfemoral) in order to deliver best in class results through
patient outcomes by way of stent performance with CGuard Carotid Stent System and SwitchGuard NPS.

 We
were organized in the State of Delaware on February 29, 2008.

 Private
Placement

 On
May 12, 2023, we entered into a securities purchase agreement (the "Purchase Agreement") pursuant to which we agreed to sell
and issue in a private placement (the "Private Placement Offering") an aggregate of 10,266,270 shares (the "Private
Placement Shares") of our common stock, pre-funded warrants (the "Pre-Funded Warrants") to purchase up to 15,561,894
shares of common stock and warrants to purchase up to an aggregate of 51,656,328 shares of common stock, consisting of Series H warrants
to purchase up to 12,914,086 shares of common stock (the "Series H Warrants"), Series I warrants to purchase up to 12,914,078
shares of common stock (the "Series I Warrants"), Series J warrants to purchase up to 12,914,086 shares of Common Stock (the
"Series J Warrants") and Series K warrants to purchase up to 12,914,086 shares of common stock (the "Series K Warrants"
and together with the Series H Warrants, Series I Warrants and Series J Warrants, the "Warrants"), at an offering price of
$1.6327 per Private Placement Share and associated Warrants and an offering price of $1.6326 per Pre-Funded Warrant and associated Warrants.

 The
Pre-Funded Warrants will be immediately exercisable at an exercise price of $0.0001 per share and will not expire until exercised in
full. The Warrants will be immediately exercisable upon issuance at an exercise price of $1.3827 per share, subject to adjustment as
set forth therein. The Warrants have a term of the earlier of (i) five years from the date of issuance and (ii) (A) in the case of the
Series H Warrants, 20 trading days following the Company's public release of primary and secondary end points related to one year
follow up study results from the Company's C-GUARDIANS pivotal trial, (B) in the case of the Series I Warrants, 20 trading days
following the Company's announcement of receipt of Premarket Approval from the Food and Drug Administration ("FDA")
for the CGuard Prime Carotid Stent System (135 cm), (C) in the case of the Series J Warrants, 20 trading days following the Company's
announcement of receipt of FDA approval for the SwitchGuard and CGuard Prime 80 and (D) in the case on the Series K Warrants, 20 trading
days following the end of the fourth fiscal quarter after the fiscal quarter in which the first commercial sales of the CGuard Carotid
Stent System in the United States begins.

 The
Warrants may be exercised on a cashless basis if there is no effective registration statement registering the shares underlying the Warrants.
Under the terms of the Pre-Funded Warrants and Warrants, certain of the selling stockholders may not exercise the Pre-Funded Warrants
or Warrants to the extent such exercise would cause such selling stockholder, together with its affiliates and attribution parties, to
beneficially own a number of shares of common stock which would exceed 4.99% or 9.99% of our then outstanding common stock following
such exercise, excluding for purposes of such determination common stock issuable upon exercise of the Pre-Funded Warrants or Warrants
which have not been exercised. The Warrants may be exercised into pre-funded warrants if the selling stockholder is unable to exercise
the Warrant due to the foregoing beneficial ownership limitation or at the selling shareholder's election.

 In
connection with the Purchase Agreement, we entered into a registration rights agreement (the "Registration Rights Agreement").
Pursuant to the Registration Rights Agreement, we were required to file a resale registration statement (the "Registration Statement")
with the SEC to register for resale the Private Placement Shares and the shares of common stock issuable upon exercise of the Pre-Funded
Warrants and Warrants, within 20 days of the signing date of the Purchase Agreement (the "Signing Date"), and to have such
Registration Statement declared effective within 45 days after the Signing Date in the event the Registration Statement is not reviewed
by the SEC, or 90 days of the Signing Date in the event the Registration Statement is reviewed by the SEC. We were obligated to pay certain
liquidated damages if we fail to file the Registration Statement when required, fails to cause the Registration Statement to be declared
effective by the SEC when required, of if we fail to maintain the effectiveness of the Registration Statement. The Registration Statement
was subsequently filed on May 23, 2023 and declared effective on June 1, 2023. We paid LifeSci Capital LLC, a placement fee equal to
5.6% of the aggregate gross proceeds from the closing of the Private Placement Offering, or approximately $2.4 million, and legal expenses
of $41,600. In addition, we paid Piper Sandler & Co. a financial advisory fee of $1.5 million, AGP/Alliance Global Partners a financial
advisory fee of $250,000 and lead investor counsel expenses of $125,000.

 - 6 -

 Our
Industry

 Carotid

 Carotid
arteries are located on each side of the neck and provide the primary blood supply to the brain. Carotid artery disease, also called
carotid artery stenosis, is a type of atherosclerosis (hardening of the arteries) that is one of the major risk factors for ischemic
stroke. In carotid artery disease, plaque accumulates in the artery walls, narrowing the artery and disrupting the blood supply to the
brain. This disruption in blood supply, together with plaque debris breaking off the artery walls and traveling to the brain, are the
primary causes of stroke. According to the World Health Organization (
every year, 15 million people worldwide suffer a stroke, and nearly six million die and another five million are left permanently disabled.
According to the same source, stroke is the second leading cause of disability, after dementia.

 In
2022, 3.0 million people between the age of 50 and 89 years old were estimated to be diagnosed with high grade carotid artery disease,
of which, approximately 394,000 of those diagnosed required intervention for carotid artery disease (according to the Health Research
International Personal Medical Systems, Inc. September 13, 2021 Results of Update Report on Global Carotid Stenting Procedures and Markets
by Major Geography and Addressable Markets). There are three current intervention treatments used for carotid artery disease. The first
is a carotid endarterectomy where a surgeon accesses the blocked carotid artery though an incision in the neck, and then surgically removes
the plaque. The second is transcarotid artery revascularization where a surgeon accesses the blocked carotid artery though an incision
in the neck, and then places a stent to open the artery and prevent embolization while combining high-rate blood flow reversal to protect
the brain. The third is carotid artery stenting, which is a minimally invasive endovascular treatment for carotid artery disease and
an alternative to carotid endarterectomy. Endovascular techniques using stents and carotid embolic prevention system protect against
plaque and debris traveling downstream, blocking off the vessel and disrupting blood flow. We believe that the use of a stent with an
embolic protection system should increase the number of patients being treated since it would avoid the need for complex surgery.

 Our
Products

 MicroNet
Mesh Platform Technology

 MicroNet
is our proprietary circular knitted mesh which wraps around a stent to protect patients from plaque debris flowing downstream upon deployment.
MicroNet is made of a single fiber from a biocompatible polymer widely used in medical implantations. The size, or aperture, of the current
MicroNet 'pore' is only 150-180 microns in order to maximize protection against the potentially dangerous plaque and thrombus.
The MicroNet mesh is the core technology around which we have developed products for specific applications.

 CGuard – Carotid Artery Applications

 Our
CGuard EPS combines our MicroNet mesh and a self-expandable nitinol stent (a stent that expands without balloon dilation pressure or
need of an inflation balloon) in a single device for use in carotid artery applications. MicroNet is placed over and attached to an open
cell nitinol metal stent platform which is designed to trap debris and emboli that can dislodge from the diseased carotid artery and
potentially travel to the brain and cause a stroke. This danger is one of the greatest limitations of carotid artery stenting with conventional
carotid stents and stenting methods. The CGuard EPS technology is a highly flexible stent system that conforms to the carotid anatomy.

 We
believe that our CGuard EPS design provides advantages over existing therapies in treating carotid artery stenosis, such as conventional
carotid stenting and surgical endarterectomy, given the superior embolic protection characteristics provided by the MicroNet. We believe
the MicroNet will provide acute embolic protection at the time of the procedure, but more importantly, we believe that CGuard EPS will
provide post-procedure protection against embolic dislodgement, which can occur up to 48 hours post-procedure. It is in this post-procedure
time frame that embolization is the source of post-procedural strokes in the brain. Schofer, et al. ("Late cerebral embolization
after emboli-protected carotid artery stenting assessed by sequential diffusion-weighted magnetic resonance imaging," Journal
of American College of Cardiology Cardiovascular Interventions, Volume 1, 2008) have shown that the majority of the incidents of
embolic showers associated with carotid stenting occur post-procedure.

 - 7 -

 Our
CGuard EPS originally received CE mark approval in the EU in March 2013 and was fully launched in Europe in September 2015. Subsequently,
we launched CGuard EPS in 30 plus countries and on February 3, 2021, we executed a distribution agreement with Chinese partners for the
purpose of expanding our presence in China.

 On
September 8, 2020, we received approval from the FDA of our IDE, thereby allowing us to proceed with a pivotal study of our CGuard
Carotid Stent System, C-GUARDIANS, for prevention of stroke in patients in the United States. C-GUARDIANS is a prospective, multicenter,
single-arm, pivotal study to evaluate the safety and efficacy of the CGuard Carotid Stent System when used to treat symptomatic
and asymptomatic carotid artery stenosis in patients undergoing carotid artery stenting. The study, which completed enrollment in June
2023, enrolled 316 patients across 24 trial sites in the U.S. and Europe and from April 2023 included deployment of the CGuard stent using CGuard Prime, our next generation CAS stent platform.

 The
primary endpoint is a composite of: (1) incidence of major adverse events including Death (all-cause mortality), any Stroke, and Myocardial
Infarction (DSMI) through 30-days post index procedure, or (2) ipsilateral stroke from day 31 to day 365 post-procedure. All events are
adjudicated by an independent clinical events committee. The composite index will be compared to a performance goal based on the observed
rate of the two components of the primary endpoint from previous pivotal stent trials which are considered industry standard. The performance
goal will be considered met if the upper bound of the two-sided 95% confidence interval calculated from the observed primary endpoint
rate is < 11.6% and the p-value is less than 0.025.

 In
November 2023, we announced positive 30-day follow up results from the C-GUARDIANS trial in which stenting with the CGuard Carotid
Stent System in patients with carotid artery stenosis and at high risk for carotid endarterectomy had a DSMI rate of 0.95%, measured
from the date of the procedure through 30 days follow-up post-procedure. We anticipate reporting primary endpoint results from the
C-GUARDIANS trial in mid 2024 that may support the submission of a PMA application in the third quarter of 2024 with a view to
potential FDA approval of the CGuard Prime stent system in the first half of 2025.

Prime Stent System

 The
CGuard Prime stent system is a mesh-covered self-expanding carotid stent that is loaded into a transfemoral rapid exchange (Rx)
delivery system that we are developing and that is subject to regulatory approval.

 The
CGuard Prime Carotid Stent is a self-expanding nitinol stent covered with a MicroNet bio-stable sleeve woven from a single strand of
23 m Polyethylene Terephthalate (PET). The MicroNet sleeve is designed to trap and seal thrombus and plaque against the vessel
wall, providing continuous embolic prevention. The CGuard Prime Carotid Stent is available in diameters ranging from 6.0mm to 10mm
and in lengths of 20, 30, 40 and 60mm. The CGuard Prime delivery system is a rapid exchange (Rx), delivery system with a 6Fr profile
that can accommodate all stent sizes from 6mm to 10mm. The CGuard Prime is available in two lengths: 80 cm and
135 cm.

Prime advances the first generation CGuard transfemoral delivery system with new handle design for deployment accuracy, new catheter
design for more flexible navigation of tortuous anatomy especially in acute revascularize settings as well as two lengths, 135cm and
80cm for booth transfemoral and transcarotid access. From April 2023, the C-GUARDIANS trial included deployment of the CGuard
stent using CGuard Prime.

 Switchguard
NPS

 SwitchGuard
NPS is a Class IIa, non-invasive transcarotid artery revascularization (TCAR) device that we are developing and that is subject to regulatory
approval that is composed of medical grade tubing with male Luer lock connectors at each end and an in-line 200-micron blood filter.
The device is intended as an external arterial-venous (A-V) shunt, allowing arterial blood to flow into the venous system, while filtering
particulate before returning blood to the patient on the venous side.

 The
SwitchGuard arterio-venous extension line with filter is intended for flow circuit and particle removal when connecting arterial and/or
venous introducers during interventional procedures.

 SwitchGuard
is being developed to answer a need of flow reversal for cerebral protection in coronary artery stenting ("CAS") since symptomatic
distal embolization, caused by the release of material (thrombotic, necrotic, or atherosclerotic) from the site of the lesion during
the intervention, is the most frequent and important complication of CAS. Reversing blood flow has been shown to reduce stroke risk during
carotid artery procedures.

 - 8 -

 Physicians
frequently use extension lines constructed from blood filter transfusion sets during interventional procedures for the purpose of A-V
shunting.

 We
expect to submit an IDE to the FDA for the C-GUARDIANS II clinical trial during the second half of 2024, which, if approved, would
allow us to initiate a clinical trial to support the clearance of the SwitchGuard NPS coupled with CGuard Prime. In February 2024,
we appointed the principal investigators for the C-GUARDIANS II clinical trial of SwitchGuard NPS.

 Acute
Stroke with Tandem Lesions

 It
is estimated that 20-30% of acute ischemic strokes are caused by large vessel occlusion involve tandem lesions- high grade
stenosis/occlusion of the internal carotid artery plus thrombotic occlusion of an intracranial vessel. Currently there is no
indicated use of CAS for these lesions during stroke treatment when the placement of an embolic protection device is not possible.
We believe CGuard Prime is optimally suited for intervention in this acute setting by way for design (flexible / low metal
structure) as well as MicroNet mesh offering embolic protection both during and post procedural implantation. Our goal is to develop
CGuard Prime to mitigate strokes in this acute setting.

 In
November 2023, we announced a strategic agreement with Jacobs Institute to execute an early feasibility study of CGuard Prime for
the treatment of acute stroke patients with tandem lesions. The study is expected to enroll 15 acute stroke patients across three
U.S. sites to explore the safety and feasibility. of using CGuard Prime to treat acute ischemic stroke patients with tandem
lesions.

 MGuard
Prime

 We
historically developed and sold the MGuard Prime embolic protection system ("MGuard Prime EPS") which was marketed for use
in patients with acute coronary syndromes, notably acute myocardial infarction (heart attack) and saphenous vein graft coronary interventions.
Over the past years there has been a shift in industry preferences towards drug eluting stents. As a result of declining sales and utilization
of the MGuard Prime EPS, which was largely driven by the predominant industry preferences favoring drug-eluting stents, during the second
quarter of 2022 we ceased sales of MGuard Prime EPS following a phase out period.

 Completed
Clinical Trials for CGuard EPS

 CARENET

 The
CARENET trial was the first multi-center study of CGuard EPS following the receipt of CE mark of this device in March 2013. The CARENET
trial was designed to evaluate feasibility and safety of CGuard EPS in treatment of carotid lesions in consecutive patients suitable
for CASin a multi-operator, real-life setting. The acute, 30-day, magnetic resonance imaging ("MRI"), ultrasound and six-month
clinical event results were presented at the LINC conference in Leipzig, Germany in February, 2015. In the third quarter of 2015, the
results of the CGuard CARENET trial were published in the Journal of the American College of Cardiology. In November 2015, positive twelve-month
follow-up data from the CGuard CARENET trial was presented at the 42nd Annual Symposium on Vascular and Endovascular Issues, documenting
the benefits of the CGuard MicroNet technology as well as the patency benefits (maintaining the artery open) of the internal and external
carotid arteries at twelve months. In September 2022, the results of the CGuard CARENET trial five year follow up were published in the
Journal of the American College of Cardiology: Cardiovascular Interventions Vol. 15, No 18, 2022 September 26, 2022:1883-1891. There
was no ipsilateral stroke or ipsilateral stroke-related death which occurred throughout the five years. In addition, no stent restenosis
or external carotid artery occlusion occurred in CARENET by 5 years, indicating normal healing and uncompromised side-branch patency.

 MACCE
(myocardial infarction ("MI"), stroke or death) rate was 0.0% at 30 days. At six months, there was one death, which was not
device or procedure-related but did result in a MACCE rate of 3.6% at six months. At twelve months there were two additional deaths,
which were not device or procedure-related resulting in a MACCE rate of 10.7% at one year.

 - 9 -

 days

 (n=30)

 months

 (n=28)

 months

 (n=28)

 MACCE (MI, stroke, death)

 (0)
 0.0
 %

 (1)
 3.6
 %

 (3)
 10.7
 %

 MI

 (0)
 0.0
 %

 (0)
 0.0
 %

 (0)
 0.0
 %

 stroke

 (0)
 0.0
 %

 (0)
 0.0
 %

 (0)
 0.0
 %

 death

 (0)
 0.0
 %

 (1)
 3.6
 %

 (3)
 10.7
 %

 CAS
carries the risk of cerebral embolization during and following the procedure, leading to life-threatening complications, mainly cerebral
ischemic events. Diffusion-weighted magnetic resonance imaging (DW-MRI) is a sensitive tool used to identify cerebral emboli during CAS
by measuring "lesions" within the brain which are areas that are ischemic and do not receive oxygenated blood due to cerebral
emboli. In the CARENET trial, 37.0% of patients treated with CGuard EPS had new ischemic lesions at 48 hours after the procedure, with
an average volume of 0.039 cm3. Of these lesions, there was only one that remained at 30 days following the procedure and all others
had resolved. Complete details appear in the following table. Where there is a second number shown below after a symbol, it
indicates the potential error in the measurement.

 hours
 n=27

 days
 n=26

 Subjects with new Acute Ischemic
 Lesions ("AIL")

 Incidence of new lesions

 37.0
 %

 4.0
 %

 Total number new AIL

 Avg. number new AIL per patient

 3.19
 10.33

 0.04
 0.20

 Average lesion volume (cm 3)

 0.039
 0.08

 0.08
 0.00

 Maximum lesion volume (cm 3)

 0.445

 0.116

 Permanent AIL at 30 days

 —

 The
healing process of the tissue and in-stent restenosis can be measured by a non-invasive form of ultrasound called duplex ultrasound.
This type of ultrasound measures the velocity of the blood that flows within the carotid arteries, which increases exponentially as the
lumen of the internal carotid artery narrows and the percent stenosis increases. One of the measurements is called PSV (peak systolic
volume) and is known to be highly correlated to the degree of in-stent restenosis; PSV values higher than 300 cm/sec are indicative of
>70% stenosis, while PSV values lower than 104 cm/sec are indicative of <30% restenosis and healthy healing. In the CARENET trial,
duplex ultrasound measurements done at 30 days, 6 months and 12 months following the stenting procedure all attest to healthy normal
healing without restenosis concerns, as the PSV values were 60.96 cm/sec 22.31, 85.24 cm/sec 39.56, and 90.22 cm/sec
 37.72 respectively. The internal carotid artery was patent in all patients (100%).

 The
conclusions of the CARENET trial were:

 The
 CARENET trial demonstrated safety of the CGuard EPS stent, with a 30 day MACCE rate of 0%.

 Incidence
 of new ipsilateral lesions (percent of patients with new lesions on the ipsilateral side (same side where the stent was employed))
 at 48 hours was reduced by almost half compared to published data, and volume was reduced almost tenfold.

 All
 but one lesion had resolved completely by 30 days.

 Twelve-month
 data showed no stroke or stroke-related deaths, and no cardiac adverse events.

 Five-year
 data showed no ipsilateral stroke or ipsilateral stroke-related deaths, and no stent restenosis or external carotid artery occlusion
 occurred in CARENET by 5 years, indicating normal healing and uncompromised side-branch patency.

 EPS offers enhanced benefits for patients undergoing CAS with unprecedented safety.

 - 10 -

 Physician-Sponsored
Clinical Trials for CGuard—PARADIGM-101 and PARADIGM -500 Studies

 PARADIGM-101
( P rospective evaluation of A ll-comer pe R cutaneous c A roti D revascularization
 I n symptomatic and increased-risk asymptomatic carotid artery stenosis, using C G uard M esh-covered
embolic prevention stent system-101) was an investigator-led, single center study with the objective of evaluating feasibility and outcome
of routine use of CGuard EPS in 101 consecutive unselected all-comer patients referred for carotid revascularization, initiated in 2015.
In May 2016, the 30-day results were presented at the EuroPCR 2016 Late-Breaking Clinical Trial Session in Paris, and in the Journal
of EuroIntervention. In Dec 2020, the 12 month results were presented in the Official Journal of the EuroPCR and the European Association
of Percutaneous Coronary Interventions, EuroIntervention 2020;16:e950-e952. DOI: 10.4244/EIJ-D-19-01014) Key findings from the PARADIGM-101
study and the follow-up data are as follows.

 EPS delivery success was 99.1%. The clinical evaluation also found no device foreshortening or elongation;

 Angiographic
 diameter stenosis or vessel narrowing was reduced from 83 9% to only 6.7 5% (p<0.001);

 Periprocedural
 death/major stroke/ myocardial infarction ("MI") rates were 0%;

 Between
 30 days and 12 months, there were no strokes or stroke-related deaths. There were four non -device related deaths (heart failure
 exacerbation, urosepsis, pulmonary embolism and microcellular pulmonary cancer).

 The
results of the PARADIGM-101 study demonstrated that CGuard EPS can safely be used in a high risk, all-comer population of patients with
carotid artery stenosis and indicated that routine use of CGuard EPS may prevent cerebral events, such as strokes, by holding plaque
against the vessel wall, preventing emboli from being released into the blood stream. The PARADIGM-101 study found that CGuard EPS is
applicable in up to 90% of all-comer patients with carotid stenosis.

 PARADIGM-101
was subsequently increased to include 500 consecutive patients with symptomatic or increased stroke risk asymptomatic atherosclerotic
carotid stenosis patients. The new study is known as PARADIGM -500. In June 2022, the 1-year results were presented at the EuroPCR in
Leipzig, Germany.

 Key
findings from the PARADIGM-500 study are as follows.

 Day Death/Stroke rate of 0.75%; 30-day death/stroke/myocardial infarction rate of 0.94%;

 12-month
 freedom from ipsilateral stroke, in stent restenosis and target lesion revascularization rate of 99.6%.

Results and Mechanical Properties of the Carotid CGUARD Double-Layered Embolic Prevention Stent Study

 "Clinical
Results and Mechanical Properties of the Carotid CGUARD Double-Layered Embolic Prevention Stent Study" was an investigator-led,
prospective single-center study which evaluated CGuard EPS in 30 consecutive patients with internal carotid artery stenosis disease with
the objective of reporting early clinical outcomes with a novel MicroNet covered stent for the internal carotid artery and the in vitro
investigation of the device's mechanical properties. In October 2016, the 30-day positive results were published online-ahead-of-print
in the Journal of Endovascular Therapy.

 Key

 100%
 success in implanting CGuard EPS without residual stenosis;

 - 11 -

 No
 peri- or post-procedural complications;

 No
 deaths, major adverse events, minor or major strokes, or new neurologic symptoms during the six months following the procedure;

 Modified
 Rankin Scale improved for the symptomatic patients from 1.56 prior to the procedure to 0 afterwards;

 All
 vessels treated with CGuard EPS remained patent (open) at six months; and

 DW-MRI
 performed in 19 of 30 patients found no new ipsilateral lesions after 30 days and after six months compared with the baseline DW-MRI
 studies.

based on engineering evaluations, the study concluded that CGuard EPS provides a high radial force and strong support in stenotic lesions.
The stent is easy to use and safe to implant because it does not foreshorten and its structure adapts well to changes in diameter and
direction of tortuous vascular anatomies. The MicroNet mesh of CGuard did not cause any changes to specific mechanical parameters of
the underlying stent.

 Safety
and Efficacy of the New Micromesh-Covered Stent CGuard in Patients Undergoing Carotid Artery Stenting: Early Experience From a Single
Center

 "Safety
and Efficacy of the New Micromesh-Covered Stent CGuard in Patients Undergoing Carotid Artery Stenting: Early Experience From a Single
Center" was an investigator-led, single-center study which evaluated CGuard EPS in 82 consecutive patients. The aim of the study
was to evaluate the safety (technical success) and efficacy (clinical success) of the CGuard stent system – a new nitinol stent
covered by a closed-cell polyethylene and terephthalate mesh designed to prevent embolic events. In 2017, the 30-day positive results
were published online-ahead-of-print in the European Journal of Vascular and Endovascular Surgery (2017),

 Key

 100%
 success in implanting CGuard EPS;

 One
 case of acute stent thrombosis occurred within 4 hours of the procedure:

 One
 minor stroke was recorded within the peri-operative period following the acute stent thrombosis, mentioned above;

 No
 new adverse neurological events were recorded at the post-operative period.

 DW-MRI
 was performed to assess the occurrence of new ischaemic brain lesions from the target vessel following placement of the CGuard stent
 peri- (48-72 hours) and post-operatively (30 days) in 21 and 11 patients, respectively. Five of 21 patients (23.8%) had new ischaemic
 brain lesions peri-operatively (48-72 hours) on the ipsilateral side, for a total number of 30 lesions, with an average lesion volume
 of 0.039 +/- 0.025 cm3. Four patients (19.1%) had new ischaemic brain lesions on the contralateral side, for a total number of nine
 lesions, with an average lesion volume of 0.019 +/- 0.011 cm3 (range 0.016-0.034 cm3). At the postoperative period, spontaneous resolution
 was noted in all the lesions recorded in the peri-operative period in the 11 patients participating. Only one symptomatic patient
 had two new ischaemic brain lesions (1 ipsilateral and 1 contralateral).

 - 12 -

 CGUARD
Mesh-Covered Stent in Real World: The IRON-Guard Registry

 "CGUARD
Mesh-Covered Stent in Real World: The IRON-Guard Registry using CGuard EPS" was a physician initiated prospective multi-center
registry that included 200 patients from 12 medical centers in Italy. The objective of the study was to report 30-day outcomes (including
MACCE) in a prospective series of patients who were treated with CGuard EPS between April 2015 and June 2016. In January 2017, 30-day
results were presented at the Leipzig Interventional Course (LINC) 2017 and published in the Journal of EuroIntervention in May 2017.
The 12-month follow-up was published in the Journal of EuroIntevention in October 2018.

 Key
30-day results presented were:

 100%
 success in implanting CGuard EPS;

 No
 MI, major stroke or death at 30 days;

 There
 were two transient ischemic attacks and five periprocedural minor strokes, including one thrombosis solved by surgery.

 Total
 elimination of post-procedural neurologic complications by 30 days;

 DW-MRI
 performed pre-procedure and between 24- and 72-hours post-procedure in 61 patients, indicated that 12 patients had new micro emboli
 (19%).

 At
 12-month, there were no new major neurological adverse events, thrombosis or external carotid occlusion recorded;

 One
 myocardial infarction occurred at 12 months.

 Initial
Clinical Study of the New CGuard EPS MicroNet Covered Carotid Stent: "One Size Fits All"

 "Initial
Clinical Study of the New CGuard EPS MicroNet Covered Carotid Stent: 'One Size Fits All'" was an investigator-led,
single-center study, which evaluated CGuard EPS in 30 consecutive patients with symptomatic stenosis of the internal carotid artery with
the objective of evaluating the CGuard EPS MicroNet covered stent for its ability to adjust to different vessel diameters. The results
of the study were published in the Journal of Endovascular Therapy in May 2019. The conclusion of the study as reported was that CGuard
EPS has high conformability combined with an almost equivalent outward radial force at expansion diameters ranging from 5.5 to 9.0 mm.
The first clinical results demonstrate the "One Size Fits All" stent can be implanted in internal carotid arteries with reference
diameters within this range.

 - 13 -

 Key
findings from the study were as follows:

 100%
 technical success in implanting CGuard EPS;

 No
 neurological events within 30 days;

 The
 chronic outward force normalized by stent length demonstrated a near-equivalent radial force outcome; and

 The
 stent displayed only a minor difference between the minimal radial force at 9.0 mm (0.195 N/mm) and the maximal radial force at 5.5
 mm (0.330 N/mm).

 Preliminary
Results from a Prospective Real-World Multicenter Clinical Practice of Carotid Artery Stenting Using the CGuard Embolic Prevention System:
The IRONGUARD 2 Study

 "Preliminary
Results From a Prospective Real-World Multicenter Clinical Practice of Carotid Artery Stenting Using the CGuard Embolic Prevention System:
The IRONGUARD 2 Study" is a physician initiated prospective multi-center registry enrolling 733 patients from 20 medical centers
in Italy, from January 2017 to June 2019. The objective of the study is to evaluate periprocedural (24 hours), post-procedural (up to
30 days), and 12-month outcomes in a largest, prospective, multicenter series of patients submitted for protected carotid artery stenting
with the CGuard Embolic Prevention System. The 24-hour, 30-day and 12-month preliminary results (data available on 726 patients out of
the 733 treated) were presented at the Leipzig Interventional Course (LINC) in January 2021. The study's preliminary results from
the IRONGUAURD 2 study suggested in a real-world evaluation of carotid artery stenting, CGuard EPS can be safely used for treatment of
extracranial carotid artery stenosis, allowing a low rate of post procedural adverse events by 12 months.

 Key

 100%
 procedural success in implanting CGuard EPS;

 death from hemorrhagic stroke (patient was admitted for immediate treatment of CAS due to stroke), 2 minor strokes, 6 TIAs and one
 nonfatal AMI at 24 hours;

 minor stroke, 2 TIAs, three AMIs, no deaths and no stent thrombosis/occlusions between 24 hours and 30 days; and

 minor stroke, 4 TIAs, 2 AMIs and 8 deaths (the 2 mentioned AMIs, 4 malignancies, 1 suicide and 1 undefined complication in Guillain-Barr
 Syndrome) between 30 days and 1 year.

 Thirty-Day
Results of the Novel CGuard-Covered Stent in Patients Undergoing Carotid Artery Stenting

 "Thirty-Day
Results of the Novel CGuard-Covered Stent in Patients Undergoing Carotid Artery Stenting" was an investigator-led, prospective
single-center study which evaluated CGuard EPS in 103 patients that underwent carotid artery stenting procedures. The aim of the study
was to provide early-term evaluation, safety, and efficacy of the novel CGuard micromesh self-expanding stent with embolic protection
system (EPS). In April 2021, the 30-day positive results were published in the Journal of Endovascular Therapy, DOI: 10.1177/15266028211007466.

 Key

 100%
 technical success was achieved in all patients:

 No
 major adverse events (death, stroke, or myocardial infarction) at 30 days.

 - 14 -

 The
SIBERIA Trial for Carotid Artery Stenosis: A Randomized Controlled Trial of Conventional Versus Micronet -Covered Stent Use in
Percutaneous Neuroprotected Carotid Artery Revascularization: Peri-procedural and 30-day Diffusion-Weighted Magnetic Resonance Imaging
and Clinical Outcomes (RCT trial)

 "The
SIBERIA Trial for Carotid Artery Stenosis: A Randomized Controlled Trial of Conventional Versus Micronet -Covered Stent Use in
Percutaneous Neuroprotected Carotid Artery Revascularization: Peri-procedural and 30-day Diffusion-Weighted Magnetic Resonance Imaging
and Clinical Outcomes" was an investigator-initiated randomized clinical trial, single-center study, which evaluated one hundred
patients who qualified for carotid revascularization with high risk for surgery and were randomized 1:1 to either CGuard EPS or Acculink TM.
The primary endpoints were incidence and volume of new cerebral embolic post-procedural lesions (24-48 hours) as determined by diffusion
weighted magnetic resonance imaging (DW-MRI). The principal secondary endpoints included incidence of periprocedural or postprocedural
stroke, myocardial infarction and death at 30 days. The 30-day results of the study were presented in a late-breaking session at the
EuroPCR in June 2020 and published (Randomized Controlled Trial of Conventional Versus MicroNet-Covered Stent in Carotid Artery Revascularization,
JACC Cardiovascular Interventions, Vol. 14, November 21, 2021). The conclusion of the study was that the CGuard Micronet -covered
stent use in consecutive unselected patients subjected to neuroprotected carotid artery stenting was associated with a greater than three-fold
reduction in the procedure-generated mean cerebral lesion volume, and with zero post-procedural cerebral embolisms observed. The MicroNet
covered stent significantly reduced periprocedural and abolished post procedural cerebral embolism in relation to a conventional carotid
stent. This is consistent with the MicroNet covered stent's sustained embolism prevention, translating into cerebral protection
not only during but after carotid artery stenting. The incidence of restenosis and vessel occlusion according to the ICA (internal carotid
artery) ultrasound and the incidence of strokes, myocardial infarctions or deaths between the study arms at 365 days were presented at
the LINC conference in Leipzig, Germany in June, 2022. The 12-month outcomes demonstrated a significantly higher prevalence of the combined
endpoint of death, stroke or myocardial infarctions and in-stent restenosis and vessel occlusion rate in the first generation (single
layer) carotid stent, Acculink TM, versus the MicroNet-Covered Stent, CGuard.

 Key

 Peri
 Procedure, the CGuard arm was observed to have a 57% reduction in new cerebral lesion average volume per patient (171 mm 3
 vs. 73 mm 3), a statistically significant improvement (p=0.017) and 222 mm 3 vs. 84 mm 3 (p=0.038);

 Post
 Procedure (24-48 hours), the CGuard arm was observed to have a 78% reduction in the average volume of new cerebral lesions
 (157 mm 3 vs. 700 mm 3), a statistically significant improvement (p=0.007);

 At
 30 days, DW-MRI showed zero new cerebral lessons in the CGuard arm versus six in the Acculink arm (p=0.03);

 At
 30 days, there were zero strokes, myocardial infarctions or deaths in the CGuard arm and two events the Acculink arm (two
 strokes);

 At
 365 there were zero cases of restenosis and vessel occlusion in the CGuard arm versus 3 cases of restenosis and 1 case of
 vessel occlusion in the Acculink arm;

 At
 365 days, there were one event in the CGuard arm (one death) and five events the Acculink arm (two strokes, two deaths and
 one myocardial infarction).

 On-going
and Planned Clinical Trials

 C-GUARDIANS

 C-GUARDIANS
is a prospective, multicenter, single-arm, pivotal study to evaluate the safety and efficacy of the CGuard Carotid Stent System when
used to treat symptomatic and asymptomatic carotid artery stenosis in patients undergoing carotid artery stenting.

 The
study completed enrollment in June 2023. The primary endpoint is a composite of: (1) incidence of major adverse events including Death
(all-cause mortality), any Stroke, and Myocardial Infarction (DSMI) through 30-days post index procedure, or (2) ipsilateral stroke from
day 31 to day 365 post-procedure. All events are adjudicated by an independent clinical events committee. The composite index will be
compared to a performance goal based on the observed rate of the two components of the primary endpoint from previous pivotal stent trials
which are considered industry standard. The performance goal will be considered met if the upper bound of the two-sided 95% confidence
interval calculated from the observed primary endpoint rate is < 11.6% and the p-value is less than 0.025.

 - 15 -

 From
July 2021 to June 2023, 316 patients were prospectively enrolled at 24 sites in the US and the EU and from April 2023 included deployment of the CGuard stent using CGuard
Prime, our next generation CAS stent platform. All CAS procedures were
performed utilizing the CGuard MicroNet TM mesh covered stent and cleared intra-procedural cerebral protection distal
embolic filters or proximal embolic protection with flow cessation, or both. At 30 days, the hierarchical DSMI rate was 0.95% in the
intent to treat (ITT) analysis and 0.63% in the per- protocol (PP) analysis. Three patients experienced major adverse cardiovascular
events by 30-days: one patient who did not take dual antiplatelet therapy (protocol violation) had a major stroke and died and two
other patients had a stroke. There was no myocardial infarction (MI). These results support a potential
"neuroprotective" effect of the CGuard stent from the procedure to 30 days follow-up.

 We
expect the primary endpoint at 1-year will be analyzed during the third quarter of 2024 when the last patient enrolled reaches
1-year of follow-up. We anticipate reporting primary endpoint results from the C-GUARDIANS trial in mid 2024 that may support the
submission of a PMA application in the third quarter of 2024 with a view to potential FDA approval of
the CGuard Prime stent system in the first half of 2025.

 Early
Feasibility Study of CGuard EPS for Acute Stroke Patients with Tandem Lesions

 In
November 2023, we announced the entry into a strategic agreement with the Jacobs Institute at the State University of New York at Buffalo
to execute an early feasibility study of CGuard EPS for the treatment of acute stroke patients with tandem lesions. The study, a prospective,
single center, single-arm, open label, non-blinded study is expected to enroll 15 acute stroke patients across three U.S. sites to assess
the safety and feasibility.of using CGuard EPS to treat acute ischemic stroke patients with tandem lesions. of Dr. Adnan Siddiqui, Vice-Chairman
and Professor of Neurosurgery at the State University of New York at Buffalo, CEO of the Jacobs Institute, is the Principal Investigator
for the study. First patient enrollment is expected in the second quarter of 2024.

 C-GUARDIANS
II for SwitchGuard NPS

 The
SwitchGuard NPS is designed to allow the treating physician to reverse cerebral blood flow during a TCAR procedure. SwitchGuard
is intended to prevent embolic debris generated during the procedure from traveling to the brain, passing the blood through the filter
housed within the SwitchGuard before returning it to the patient to minimize blood loss.

 We
plan to submit an IDE to the FDA in the second half of 2024 for C-GUARDIANS II, a multicenter, single-arm, pivotal study to evaluate
the safety and efficacy of the SwitchGuard NPS for providing cerebral embolic protection during carotid artery stenting via the Transcarotid
Artery Revascularization (TCAR) approach. We appointed Patrick Geraghty, M.D., professor of surgery and radiology, section of vascular
surgery at Washington University School of Medicine in St. Louis, MO, and Patrick Muck, M.D., program director and chief of vascular
surgery at Good Samaritan Hospital in Cincinnati, OH, to act as lead principal investigators for the trial.

William Gray, M.D., system chief of the cardiovascular division at Main Line Health in Wynnewood, PA and professor of medicine at Thomas
Jefferson University in Philadelphia, PA, will act as a strategic advisor to the Company.

 Future
Clinical Trials

 Pre
and post-marketing clinical trials (outside the United States) could be conducted to further evaluate the safety and efficacy of CGuard
EPS in specific indications.

 Growth
Strategy

 Our
primary business objective is to utilize our proprietary MicroNet technology and products to become the industry standard for the treatment
of carotid disease and prevention of stroke and to provide a superior solution to the common acute problems caused by current stenting
procedures, such as restenosis, embolic showers and late thrombosis. We are pursuing the following business strategies to achieve this
objective.

 Widen
 the adoption of CGuard. We are seeking to expand the population of CGuard patients in those countries in which CGuard is commercially available. In particular, our focus is on establishing CGuard as a viable alternative (in appropriate cases)
 to carotid endarterectomy and the use of conventional carotid stents within the applicable medical communities. We intend to accomplish
 this goal by continuing to publish and present our clinical data, supporting investigator-initiated clinical registries and exploring
 the addition of additional devices to our portfolio, including the SwithchGuard NPS for use in TCAR cases. We have partnered and
 will continue to seek out partnerships with organizations focused on the treatment of stroke. We will also continue to engage advisory
 boards and to develop a network of key opinion leaders to assist us in our efforts to widen the adoption of CGuard. We aim to
 be the only company focusing on both the surgeons and interventionalists who perform both CAS and TCAR procedures.

 - 16 -

 Portfolio
 expansion and pipeline development We plan to continue to invest in advancing our portfolio with new delivery system alternatives
 to facilitate the use of CGuard and SwitchGuard by all physicians. We believe our delivery systems, if approved, will enable all
 endovascular access points including accessory devices for trans carotid artery revascularization.

 Grow
 our presence in existing and new markets for CGuard EPS. We have launched CGuard EPS in most European and Latin American countries
 through a comprehensive distributor sales organizations network. We are continuing to focus on larger growing markets through this
 network by supporting our distributors with robust marketing and clinical education programs. We plan to continue to evaluate the
 transition to a direct selling model in certain currently served distributor markets, increasing our control on the market and gross
 profit margins. We are pursuing additional product registrations and distribution contracts with local distributors in other countries
 in Europe, Asia and Latin America. In February 2021, we executed a distribution agreement with Chinese partners for the purpose of
 expanding our presence in China. Currently, we are seeking strategic partners for a potential launch of CGuard EPS in Japan and other
 Asian countries. In addition, we plan to commercialize in the United States through a direct sales organization upon potential PMA
 approval of CGuard Prime.

 CMS
 approval of National Coverage Determination (NCD) – On October 11 2023, CMS issued an NCD covering the use of carotid stents
 (both CAS and TCAR) for the treatment of both symptomatic and asymptomatic patients either at high- or standard-surgical risk. This
 decision significantly increases the available market to endovascular procedures. Previously, only symptomatic patients at high-risk
 to surgery were covered through the CMS coverage, NCA - Percutaneous Transluminal Angioplasty (PTA) of the Carotid Artery Concurrent
 with Stenting (CAG-00085R8) - Tracking Sheet (cms.gov)

 Continue
 to leverage our MicroNet technology to develop additional applications for interventional cardiologists and vascular surgeons. In
 addition to the applications described above, we believe that we will eventually be able to utilize our proprietary MicroNet technology
 to address imminent market needs for new product innovations to significantly improve patient care. We continue to broadly develop
 and protect intellectual property using our mesh technology. Examples of some areas include peripheral vascular disease and neurovascular
 disease.

 Establish
 relationships with collaborative and development partners to fully develop and market our existing and future products. We are
 seeking strategic partners for collaborative research, development, marketing, distribution, or other agreements, which could assist
 with our development and commercialization efforts for CGuard and other potential products that are based on our MicroNet technology.

 Competition

 The
markets in which we compete are highly competitive, subject to change and impacted by new product introductions and other activities
of industry participants.

 - 17 -

 Carotid

 With
respect to competition for our carotid embolic prevention system, CGuard EPS, the manufacturers of products used in connection
with CAS procedures in the United States, including a number of large companies, including Abbott Laboratories, Boston Scientific Corporation,
Medtronic and Cordis Corporation. In Europe, in addition to the above-mentioned manufacturers, Terumo Medical Corporation also participates
in the market for products used in connection with CAS procedures. As we develop and seek regulatory approval in the United States and
Europe for our new TCAR neuroprotection system SwitchGuard, and continue to seek greater market share for CGuard, we
expect to compete with Silk Road Medical in the total carotid artery revascularization market that comprises CAS, TCAR and carotid endarterectomy
("CEA").

 Many
of these companies are larger companies or divisions of publicly-traded companies that have certain competitive advantages, including
greater capital resources, larger customer bases, broader product lines, larger sales forces, greater marketing and management resources,
larger research and development staffs and larger facilities than ours and have established reputations, relationships with our target
customers and worldwide distribution methods that are more effective than ours. However, while there are currently many market participants
in the U.S. carotid stent market, we believe that the European market is somewhat more fragmented for CAS products, and, in our opinion,
smaller competitors may be able to gain market share with greater flexibility and more efficiently than in the United States.

 We
believe the principal competitive factors in our market include the following:

 Strength
 of clinical evidence- patient outcomes and adverse event rates;

 Scale
 and effectiveness of commercialization efforts/organizations

 Acceptance
 by treating physicians and referral sources;

 Physician
 learning curve;

 Ease-of-use
 and reliability;

 Economic
 benefits and cost savings;

 Availability
 of reimbursement; and

 Patient
 experience

 Sales
and Marketing

 Sales
and Marketing

 Based
on the positive CGuard EPS clinical data, we initiated the commercial launch of CGuard EPS in CE marked countries in early 2015. In September
2015, we announced full market launch of CGuard EPS in Europe. Since 2017 we have focused on sales of our products through local distribution
partners and our own internal sales initiatives to gain greater reach into all the relevant clinical specialties and to expand our geographic
coverage. Our current strategy seeks to broaden our sales efforts to increase CGuard EPS penetration within the community of interventionalists.
In parallel, we aim at transitioning vascular surgeons from carotid endarterectomy procedures to carotid stenting with CGuard and
accessory devices, which we believe can greatly expand our customer base. We have focused and we plan to continue to focus our marketing
efforts primarily on key growth markets and to evaluate opportunities in new territories as they become available. In addition, we are
using international trade shows and industry conferences to gain market exposure and brand recognition. We continue to work with leading
physicians to enhance our marketing efforts and are developing relationships with new key opinion leaders to champion our technology
and work with us in clinical studies.

 Product
Positioning

 We
believe that CGuard has potential to become the standard of care in treading carotid artery disease. It is a second-generation stent
with positive patient outcomes demonstrating significant reduction in post-procedural neurological events.

we intend to continue to evaluate potential product and manufacturing enhancements for CGuard expected to reduce cost of goods or
provide the best-in-class performing delivery system and accessory solutions. We believe these improvements may allow us to reduce cost
of goods and increase penetration in our existing geographies and better position us for entry into new markets.

 - 18 -

 Insurance
Reimbursement

 While
most countries have established reimbursement codes for stenting procedures, certain countries may require additional clinical data before
recognizing coverage and/or to obtain a certain level of reimbursement for one or more of our products. In these situations, we intend
to complete the required clinical studies to obtain reimbursement approval in countries where it makes economic sense to do so.

 In
October 2023, CMS issued its final National Coverage Determination ("NCD"), expanding coverage of CAS to include both asymptomatic
and standard risk patients, significantly expanding the U.S. CAS addressable market.

 Intellectual
Property

 Patents

 We
have 59 issued patents, including 19 patents issued in the U.S., and 26 pending patent applications, 7 of which are pending in the United
States. Many of these patents and applications cover aspects of our CGuard and MGuard technology. Patents outside the U.S. have been
filed in Canada, China, Europe, Israel, India, Japan, Australia, and South Africa. The patents and applications fall into a number of
patent families, as listed below:

 Base
 Title of Patent Family

 Pending
 patent

 applications

 (Countries)

 Issued
 patents

 (Country
 and Patent No.)

 Issue
 Date

 Bifurcated
 Stent Assemblies

 US
 8,961,586

 China
 ZL200780046676.2

 02/24/2015

 9/26/2012

 Deformable
 Tip for Stent Delivery and Methods of Use

 US
 10,258,491

 260,945

 4/16/2019

 07/01/2020

 Handle
 for Two-Stage Deployment of a Stent

 US
 (cont)

 EP

 CN

 JP

 IN

 US
 11,844,893

 12/12/2023

 Shunts
 with Blood-Flow Indicators

 US
 (cont)

 EP

 CN

 JP
 (allowed)

 JP
 (divisional)

 US
 11,844,893

 12/19/2023

 IN

 HK

 Device
 for Shunting Blood Between the Arterial and Venous Systems

 US

 EP

 CN

 JP

 IN

 HK

 Devices
 for shunting blood

 US

 PCT

 In
 Vivo Filter Assembly

 US
 9,132,261

 09/15/2015

 Knitted
 Stent Jackets

 2,666,728

 2,887,189

 China
 ZL200780046697.4

 China
 ZL201210320950.3

 EP
 2076212

 Germany,
 France, & UK

 US
 10,137,015

 India
 323792

 6/23/2015

 5/1/2018

 10/10/2012

 12/2/2015

 3/29/2017

 11/27/2018

 10/28/2019

 - 19 -

 Optimized
 Stent Jacket

 US
 (cont)

 2,670,724

 3,013,758

 China
 ZL201210454357.8

 China
 ZL200780043259.2

 India
 297,257

 230,922

 US
 9,132,003

 US
 9,526,644

 US
 9,782,281

 US
 10,070,976

 US
 10,406,006

 US
 10,406,008

 US
 11,051,959

 EP
 2088962

 (BE,
 CH, DE, FR, UK, IT, IE, LX, NL)

 EP3292837

 (UK,
 DE, FR, IE)

 12/11/2018

 09/14/2021

 12/09/2015

 01/02/2013

 05/30/2018

 10/01/2020

 09/15/2015

 10/10/2017

 12/27/2016

 09/11/2018

 09/10/2019

 09/10/2019

 07/06/2021

 10/11/2017

 11/09/2022

 Stent
 Apparatuses for Treatment Via Body Lumens and Methods of Use

 EPO

 South
 Africa 2007/10751

 2,609,687

 2,843,097

 EP
 1885281

 (CH,
 DE, FR, GB, IE, IT)

 US
 10,932,926

 US
 10,058,440

 US
 10,070,977

 10/27/2010

 4/22/2014

 10/27/2015

 2/13/2019

 03/02/2021

 8/28/2018

 9/11/2018

 Stent
 Thermoforming Apparatus and Methods

 JP
 6553178

 US
 9,527,234

 US
 10,376,393

 7/12/2019

 12/27/2016

 8/13/2019

 Methods
 or using a self-adjusting stent assembly and kits including the same

 US
 (cont)

 EP

 IN

 CN
 (div)

 US
 11,684,498

 China
 ZL 2019800679437

 06/27/2023

 05/03/2022

 Intravascular
 sheath

 US
 (provisional)

 The
patents and patent applications listed above cover various aspects of our products, specifically focusing on the mesh sleeve covering
our stents, as well as methods for production and delivery mechanisms of the stents. We believe that our patents, in particular those
covering the use of a knitted micron-level mesh sleeve over a stent for various indications, as well as our pending patent applications
(if issued as patents with claims substantially in their present form), create a significant barrier against other companies seeking
to use similar technology. We believe these patents and patent applications collectively cover all our existing products and may be useful
in protecting our future technological developments. We intend to aggressively continue patenting new technologies and to actively pursue
any infringement of our key patents.

 - 20 -

 Trade
Secrets

 We
also rely on trade secret protection to protect our interests in proprietary know-how and/or for processes for which patents are difficult
to obtain or enforce. As part of our trade secret policy, we rely on non-disclosure and confidentiality agreements with employees, consultants
and other parties to protect trade secrets and other proprietary technology.

 Trademarks

 We
have registered or applied to register the following trademarks, which we use in connection with our products:

 InspireMD
 (US, European Union, and UK)

 MGuard
 (European Union, and UK)

 (US, European Union, and UK)

 MGuard
 Prime (European Union, and UK)

 NGuard
 (European Union and UK)

 PVGuard
 (European Union, and UK)

 Micronet
 (US)

 (MNP
 Micronet Protection logo) (European Union and UK)

 Carenet)European
 Union and UK)

 SmartFit
 (US, UK, EP and CN)

 SmartFit
 Logo (EP, UK, CN)

 Prime (EP, UK, US, CN, JP)

 SwitchGuard
 (EP, UK, US, JP)

 True
 North Medical (EP, UK)

 MicroMesh
 logo (EP, UK)

 Micronet
 logo (updated version) (US, EP, UK, JP)

 The
trademarks are renewable indefinitely, so long as we continue using the marks and make the appropriate filings when required. We also
use and may have common-law rights to various trademarks, trade names, and service marks.

 Government
Regulation

 The
manufacture and sale of our products are subject to regulation by numerous governmental authorities, principally the European Union CE
mark and other corresponding foreign agencies.

 Sales
of medical devices outside the United States are subject to foreign regulatory requirements that vary widely from country to country.
These laws and regulations range from simple product registration requirements in some countries to complex approval process, clinical
trials and production controls in others. As a result, the processes and time periods required to obtain foreign marketing approval may
be longer or shorter than those necessary to obtain FDA market authorization. These differences may affect the timeliness of international
market introduction of our products. For the European Union nations, medical devices must obtain a CE mark before they may be placed
on the market. In order to obtain and maintain the CE mark, we must comply with EU law on medical devices, which, until May 26, 2021
was governed by the MDD, by presenting comprehensive technical files for our products demonstrating safety and efficacy of the product
to be placed on the market and passing initial and annual quality management system audit as per ISO 13485 standard by a European Notified
Body. We have obtained ISO 13485 quality system certification and CGuard EPS that we currently distribute into the European Union, displays
the required CE mark. In order to maintain certification, we are required to pass an annual surveillance audit conducted by Notified
Body auditors. The European Union replaced the MDD with the new MDR regulation. The MDR entered into force after a transitional period
of three years and a one year extension of that transition period due to the COVID-19 pandemic on May 26, 2021 and which changes several
aspects of the regulatory framework in the European Union. Manufacturers had the duration of the transition period to update their technical
documentation and processes to meet the new requirements in order to obtain a CE Mark. In January 2024, we received CE mark recertification
of CGuard EPS under the MDR.

 - 21 -

 We
have or had regulatory approval and made sales of CGuard EPS either through distributors pursuant to distribution agreements or directly,
in the countries listed in the table below. While each of the European Union member countries accepts the CE mark as its sole requirement
for marketing approval, some of these countries still require us to take additional steps in order to gain reimbursement rights for our
products. Furthermore, while we believe that certain of the below-listed countries that are not members of the European Union and accept
the CE mark as a primary requirement for marketing approval, each such country requires additional regulatory requirements for final
marketing approval of our products. Furthermore, we are currently targeting additional countries in Europe, Asia, and Latin America;
however, even if all governmental regulatory requirements are satisfied in each such country, we anticipate that obtaining marketing
approval in each country could take as few as three months or as many as twelve months or more, due to the nature of the approval process
in each individual country, including typical wait times for application processing and review, as discussed in greater detail below.

 Please
refer to the table below setting forth the approvals and sales made for CGuard EPS on a country-by-country basis

 Approvals
and Sales of CGuard EPS on a Country-by-Country Basis*

 Countries

 EPS

 Approval

 EPS

 Sales

 Argentina

 Y

 Y

 Australia

 Y

 Y

 Austria

 Y

 Y

 Belarus

 Y

 Y

 Belgium

 Y

 Y

 Brazil

 Y

 Y

 Bulgaria

 N

 N

 Chile

 Y

 Y

 Colombia

 Y

 Y

 Croatia

 Y

 N

 Cyprus

 Y

 Y

 Czech Republic

 Y

 Y

 Denmark

 Y

 N

 Dominican Republic

 N

 N

 Ecuador

 Y

 N

 Estonia

 Y

 Y

 Finland

 Y

 Y

 France

 Y

 Y

 Germany

 Y

 Y

 Greece

 Y

 Y

 Netherlands

 Y

 Y

 Hong Kong

 N

 N

 Hungary

 Y

 N

 Iceland

 Y

 N

 India

 Y

 Y

 Ireland

 Y

 N

 Y

 Y

 Italy

 Y

 Y

 Kazakhstan

 Y

 Y

 Latvia

 Y

 Y

 Lithuania

 Y

 Y

 Liechtenstein

 Y

 N

 Luxembourg

 Y

 N

 Malaysia

 N

 N

 Malta

 Y

 N

 Mexico

 Y

 Y

 Moldova

 Y

 Y

 Montenegro

 N

 N

 New Zealand

 Y

 N

 Norway

 Y

 N

 - 22 -

 Peru

 Y

 Y

 Poland

 Y

 Y

 Portugal

 Y

 Y

 Romania

 Y

 Y

 Russia

 Y

 Y

 Saudi
 Arabia

 N

 N

 Serbia

 Y

 Y

 Slovakia

 N

 N

 Slovenia

 Y

 Y

 South
 Africa

 Y

 Y

 Spain

 Y

 Y

 Sweden

 Y

 Y

 Switzerland

 Y

 Y

 Turkey

 N

 N

 Taiwan

 Y

 Y

 Venezuela

 N

 N

 Vietnam

 Y

 Y

 Ukraine

 Y

 Y

 United
 Kingdom

 Y

 Y

 United
 States

 N

 Y

 (1)

 (1)

 Refers
 to CGuard units used in our ongoing FDA trial.

 FDA
Government Regulation of Medical Devices for Human Subjects

 Many
of our activities are subject to regulatory oversight by the FDA under provisions of the Federal Food, Drug, and Cosmetic Act and regulations
thereunder, including regulations governing the development, marketing, labeling, promotion, manufacturing, and export of medical devices.

 FDA
Approval/Clearance Requirements

 In
the United States, most Class II or III medical devices must be cleared or approved by the FDA prior to commercialization. Unless an
exemption applies, each medical device that is marketed in the United States must receive either 510(k) clearance or PMA. Medical devices
that are class II devices receive 510(k) clearance are "cleared" by the FDA to market, distribute, and sell in the United
States. Medical devices that are class III devices obtain a premarket approval by the FDA are "approved" to market, distribute,
and sell in the United States, after FDA performs an on-site audit at the company premises.

 Class
I devices are those for which safety and effectiveness can be assured by adherence to the FDA's general regulatory controls
for medical devices, or the General Controls, which include compliance with the applicable portions of the FDA's quality system
regulations, facility registration and product listing, reporting of adverse medical events, and appropriate, truthful and non-misleading
labeling, advertising, and promotional materials. Some Class I devices also require premarket clearance by the FDA through the 510(k)
process described below.

 Class
II devices are required to file a Premarket review of 510(k) application that may also require General Controls, and any other special controls as deemed necessary by the FDA to ensure the safety and effectiveness of the
device. Pursuant to the
Medical Device User Fee and Modernization Act of 2002 (MDUFMA), as of October 2002, unless a specific exemption applies, 510(k)
submissions are subject to user fees. Certain Class II devices are exempt from this premarket review process.

 - 23 -

 Class
III includes devices with the greatest risk. Devices in this class must demonstrate safety and efficacy requirements. In addition, Class III devices cannot generally be marketed until they receive a premarket
approval. The safety and effectiveness of Class III devices cannot be assured solely by the General Controls and the other
requirements described above. These devices require formal clinical studies to demonstrate safety and effectiveness. Under MDUFMA,
PMAs (and supplemental PMAs) are subject to significantly higher user fees than 510(k) applications, and they also require
considerably more time and resources.

 The
FDA decides whether a device line must undergo either the 510(k) clearance or premarket approval based on statutory criteria that
utilize a risk-based classification system. Premarket approval is the FDA process of scientific and regulatory review to evaluate
the safety and effectiveness of Class III medical devices and, in many cases, Class II medical devices. Class III devices are those
that support or sustain human life, are of substantial importance in preventing impairment of human health, or which present a
potential, unreasonable risk of illness or injury. The FDA uses these criteria to decide whether a premarket approval or a 510(k) is
appropriate, including the level of risk that the agency perceives is associated with the device and a determination by the agency
of whether the product is a type of device that is similar to devices that are already legally marketed. Devices deemed to pose
relatively less risk are placed in either Class I or II. In many cases, the FDA requires the manufacturer to submit a 510(k)
requesting clearance (also referred to as a premarket notification), unless an exemption applies. The 510(k) must demonstrate that
the manufacturer's proposed device is "substantially equivalent" in intended use and in safety and effectiveness
to a legally marketed predicate device. A "predicate device" is a pre-existing medical device to which equivalence can
be drawn, generally by a Class II device that was in commercial distribution before May 28, 1976, for which the FDA has not yet
called for submission of a PMA. A product that lacks a predicate device will default to a Class III device, although a company may
seek to submit a De Novo classification request, rather than a PMA. The De Novo request allows a regulatory pathway to classify
novel medical devices and FDA will determine which category is appropriate for that device and for which general controls alone, or
general and special controls, provide reasonable occurrence of safety and effectiveness for the intended use, but for which there is
no legally marketed predicate device.

 Premarket
Approval Pathway

 Our
CGuard Carotid Stent System is classified as a Class III medical device (considered a PMA) by the FDA. Class III medical devices are generally the
highest risk devices and are therefore subject to more rigorous regulatory requirements by the FDA, since the FDA process of
premarket approval involves scientific and regulatory review to evaluate the safety and effectiveness of Class III medical devices
for the purpose(s) intended. The FDA will either approve or deny a premarket approval application and we cannot market a device
until the FDA approves a premarket approval application.

 A
PMA must be supported by extensive data including, but not limited to, analytical, preclinical, clinical trials, manufacturing,
statutory preapproval inspections, and labeling to demonstrate to the FDA's satisfaction the safety and effectiveness of the
device is safe and effective for its intended use. Before a premarket approval application is submitted, a manufacturer must
generally apply for an Investigational Device Exemption (IDE) to conduct clinical trials. If the device presents a
"significant risk," as defined by the FDA, to human health, the FDA requires the device sponsor to file an IDE
application with the FDA and obtain IDE approval prior to initiation of broader human clinical trials.

 The
IDE application must be supported by appropriate data, such as analytical, animal and laboratory testing results, manufacturing information,
and an Investigational Review Board (IRB) approved protocol showing that it is safe to test the device in humans and that the testing
protocol is scientifically sound, as well as ensuring patient informed consent is obtained.

 A
clinical trial may be suspended by either the FDA or the IRB at any time for various reasons, including a belief that the risks to the
study participants outweigh the benefits of participation in the study. Even if a study is completed, clinical testing results may not
demonstrate the safety and efficacy of the device, or they may be equivocal or otherwise insufficient to obtain approval of the product
being tested. After the clinical trials have been completed, if at all, and the clinical trial data and results are collected and organized,
a manufacturer may complete a premarket approval application.

 - 24 -

 Following
the IDE, a PMA application must be prepared and after a PMA is sufficiently complete, then the FDA will accept the application and
begin an in-depth review of the submitted information. By statute, the FDA has 180 days to review the "accepted
application," although, generally, review of the application can take between one and three years, but it may take
significantly longer. During this review period, the FDA may request additional information or clarification of information already
provided. Also, during the review period, an advisory panel of experts from outside the FDA may be convened to review and evaluate
the application and provide recommendations to the FDA as to the approvability of the device. The preapproval inspections conducted
by the FDA include an evaluation of the manufacturing facility to ensure compliance with the Quality Systems Regulations, as well as
inspections of the clinical trial sites by the Bioresearch Monitoring group to evaluate compliance with good clinical practice and
human subject protections. New premarket approval applications or premarket approval supplements are required for modifications that
affect the safety or effectiveness of the device, including, for example, certain types of modifications to the device's
indication for use, manufacturing process, labeling and design. Significant changes to an approved premarket approval require a
180-day supplement, whereas less substantive changes may utilize a 30-day notice, or a 135-day supplement. Premarket approval
supplements often require submission of the same type of information as a premarket approval application, except that the supplement
is limited to information needed to support any changes from the device covered by the original premarket approval application, and
it may not require as extensive clinical data or the convening of an advisory panel.

 510(k)
Clearance Pathway

 We
do not currently market, distribute, or sell any products that have market clearance by the FDA under its 510(k) process. If, in the
future, we develop products where 510(k) clearance is required, we would be required to submit a 510(k) demonstrating that such proposed
devices are substantially equivalent to a respective previously cleared 510(k) device or a device that was in commercial distribution
before May 28, 1976, for which the FDA has not yet called for the submission of 510(k). The FDA's 510(k) clearance pathway usually
takes from three to twelve months but could take longer. In some cases, the FDA may require additional information, including clinical
data, to make a determination regarding substantial equivalence.

 If
a device receives 510(k) clearance, any modification that could significantly affect its safety or effectiveness, or that would constitute
a new or major change in its intended use, will require a new 510(k) clearance or, depending on the modification, a premarket approval.
The FDA requires each device manufacturer to determine whether the proposed change requires submission of a new 510(k) or a premarket
approval, but the FDA can review any such decision and can disagree with a manufacturer's determination. If the FDA disagrees with
a manufacturer's determination, the FDA can require the manufacturer to cease marketing and/or recall the modified device until
510(k) clearance or premarket approval of the modified device is obtained.

 Pervasive
and Continuing FDA Regulation

 A
host of regulatory requirements apply to our approved devices, including the quality system regulation (which requires manufacturers
to follow elaborate design, testing, control, documentation and other quality assurance procedures), the Medical Device Reporting regulations
(which require that manufacturers report to the FDA specified types of adverse events involving their products), labeling regulations,
and the FDA's general prohibition against promoting products for unapproved or "off-label" uses. Class II devices also
can have special controls such as performance standards, post-market surveillance, patient registries, and certain FDA guidelines do
apply to Class I devices.

 A
noncomprehensive list of the regulatory requirements that apply to our approved products classified as medical devices include:

 product
 listing and establishment registration, which helps facilitate FDA inspections and other regulatory action;

 Quality
 Systems Regulations, which requires manufacturers, including third-party manufacturers, to follow stringent design, testing, control,
 documentation and other quality assurance procedures during all aspects of the development and manufacturing process;

 - 25 -

 labeling
 regulations and FDA prohibitions against the promotion of products for uncleared, unapproved or off-label use or indication;

 clearance
 of product modifications that could significantly affect safety or efficacy or that would constitute a major change in intended use
 of one of our cleared devices (if obtained);

 approval
 of product modifications that affect the safety or effectiveness of one of our cleared devices (if obtained);

 medical
 device reporting regulations, which require that manufacturers comply with FDA requirements to report if their device may have caused
 or contributed to a death or serious injury, or has malfunctioned in a way that would likely cause or contribute to a death or serious
 injury if the malfunction of the device or a similar device were to recur;

 post-approval
 restrictions or conditions, including post-approval study commitments;

 post-market
 surveillance regulations, which apply when necessary to protect the public health or to provide additional safety and effectiveness
 data for the device;

 the
 FDA's recall authority, whereby it can ask, or under certain conditions order, device manufacturers to recall from the market
 a product that is in violation of governing laws and regulations;

 regulations
 pertaining to voluntary recalls; and,

 notices
 of corrections or removals.

 At
this time, we have not registered as an establishment with the FDA. If we are approved or cleared to manufacture, prepare, or
process a device in the United States, we and any third-party manufacturers that we may use will be required to register our
establishments with the FDA. In addition, we and our manufacturing facilities will be subject to FDA inspections for compliance with
the FDA's Quality System Regulation. Additionally, some of our subcontractors may also be subject to FDA announced and
unannounced inspections for compliance with the FDA's Quality System Regulation and assurances that the Company is marketing
appropriately the indications for use of the product. These regulations will require that we manufacture our products and maintain
our documents in a prescribed manner with respect to design, manufacturing, testing and quality control activities and ensure that marketing materials and promotion are in compliance. As a medical
device manufacturer, we will further be required to comply with FDA requirements regarding the reporting of adverse events
associated with the use of our medical devices, as well as product malfunctions that would likely cause or contribute to death or
serious injury if the malfunction were to recur. FDA regulations also govern product labeling and prohibit a manufacturer from
marketing a medical device for unapproved applications.

 U.S.
Healthcare Laws and Regulations

 In
addition to the FDA regulations, there are a variety of other healthcare laws and regulations to which we may be subject if any of
our products are marketed, sold, distributed, and/or utilized in the United States. In the United States, we may be subject to the
oversight of FDA, Office of the Inspector General within the Department of Health and Human Services (OIG), the Center for Medicare
and Medicaid Services (CMS), the Department of Justice (DOJ), in addition to others. We supply products that may be reimbursed by
federally funded programs such as Medicare. As a result, our activities may be subject to regulation by CMS and potential
enforcement by CMS, OIG and DOJ. Of specific note are federal and state fraud and abuse laws, which prohibit the payment or receipt
of kickbacks, bribes or other remuneration, including the offer or solicitation of such payment, intended to induce or reward the
purchase, recommendation or generation of business involving healthcare products any item or service payable by a health-care
program. Other provisions of federal and state laws prohibit presenting, or causing to be presented, to third party payors
(including, government programs, such as Medicare and Medicaid) for reimbursement, claims that are false or fraudulent, or which are
for items or services that were not provided as claimed. In addition, other healthcare laws and regulations may apply, such as
transparency and reporting requirements and privacy and security requirements. Violations of these laws can lead to civil and
criminal penalties, including exclusion from participation in federal and state healthcare programs, any of which could have a
material adverse effect on our business. These laws are potentially applicable to manufacturers of products regulated by the FDA as
medical devices, such as us, and hospitals, physicians and other institutional or individual providers that may refer or purchase
such products. The healthcare laws that may be applicable to our business or operations include, but are not limited to:

 The
 federal Anti-Kickback Statute, which prohibits a person from knowingly and willfully offering, soliciting or receiving any remuneration,
 directly or indirectly, overtly or covertly, in cash or in kind, in return for or to induce referring or recommending an individual
 to another person to receive items or services or to purchase, lease, order, or arrange for any good, facility, item or service payable
 in whole or in part under a Federal health care program;

 - 26 -

 Federal
 false claims laws and civil monetary penalty laws, including the False Claims Act, prohibit, among other things, individuals or entities
 from knowingly presenting, or causing to be presented, claims for payment from Medicare, Medicaid or other government healthcare
 programs that are false or fraudulent, or making a false statement to avoid, decrease or conceal an obligation to pay money to the
 federal government. The False Claims Act imposes liability on any person or entity that, among other things, knowingly presents,
 or causes to be presented, a false or fraudulent claim for payment by a federal health care program, knowingly makes, uses or causes
 to be made or used, a false record or statement material to a false or fraudulent claim, or knowingly makes a false statement to
 avoid, decrease or conceal an obligation to pay money to the U.S. federal government. The federal Civil Monetary Penalties Law prohibits,
 among other things, the offering or transferring of remuneration to a Medicare or Medicaid beneficiary that the person knows or should
 know is likely to influence the beneficiary's selection of a particular supplier of Medicare or Medicaid payable items or services;

 The
 federal Health Insurance Portability and Accountability Act of 1996 ("HIPAA"), which includes provisions that prohibit
 knowingly and willfully executing, or attempting to execute, a scheme to defraud any healthcare benefit program or obtain, by means
 of false or fraudulent pretenses, representations, or promises, any of the money or property owned by, or under the custody or control
 of, any healthcare benefit program, and for knowingly and willfully falsifying, concealing or covering up a material fact or making
 any materially false statements in connection with the delivery of or payment for healthcare benefits, items or services;

 HIPAA,
 as amended by the Health Information Technology for Economic and Clinical Health Act of 2009, and its implementing regulations, including privacy protection that
 impose obligations and requirements on healthcare providers, health plans, and healthcare clearinghouses as well as their respective
 business associates that perform certain services for them that involve the use or disclosure of individually identifiable health
 information, with respect to safeguarding the privacy and security of certain individually identifiable health information;

 The
 federal transparency requirements under the Affordable Care Act, including the provision commonly referred to as the Open Payments
 Act or Physician Payments Sunshine Act, which requires certain manufacturers of drugs, devices, biologics and medical supplies that
 are reimbursable under Medicare, Medicaid or Children's Health Insurance Program to report annually to Centers for Medicare
 and Medicaid Services, or CMS, information related to payments and other transfers of value to physicians and teaching hospitals,
 and ownership and investment interests held by physicians and their immediate family members; and

 Analogous
 state and foreign laws and regulations, such as state anti-kickback and false claims laws, which may be broader in scope and apply
 to referrals and items or services reimbursed by both governmental and non-governmental third-party payors, including private insurers,
 many of which differ from each other in significant ways and often are not preempted by federal law, thus complicating compliance
 efforts.

 Customers

 Our
customer base is varied. We currently have distribution agreements for our CE mark-approved CGuard EPS with medical product distributors
based in Europe, the Middle East, Asia Pacific and Latin America. We are currently in discussions with additional distribution companies
in Europe, Asia, and Latin America.

 - 27 -

 Our
distribution agreements stipulate that, while we shall assist in training by providing training materials, marketing guidance, marketing
materials, and technical guidance, each distributor will be responsible for carrying out local registration, sales and marketing activities.
In addition, in most cases, all sales costs, including sales representatives, incentive programs, and other marketing activities, will
be borne by the distributor. Under current agreements, distributors purchase stents from us at a fixed price. Our current agreements
with distributors are generally for a term of two to three years.

 On
February 3, 2021, we entered into a Distribution Agreement with three China-based partners, pursuant to which the Chinese partners will
be responsible for conducting the necessary registration trials for commercial approval of our products in China, followed by an exclusive
distribution right to sell our products in China. Under the Distribution Agreement, the China-based partners will be subject to minimum
purchase obligations.

 Manufacturing
and Suppliers

 The
polymer fiber for MicroNet is supplied by Biogeneral, Inc., a San Diego, California-based specialty polymer manufacturer for medical
and engineering applications.

 Our
catheter supplier for CGuard EPS supplies us with catheters that help create the base for our CGuard EPS stents. Our agreement with the
supplier may be terminated by us upon eight months' notice. On September 17, 2019, we amended the agreement with the supplier so
that we are responsible for purchasing and handling inventory of components used in the manufacturing of CGuard EPS catheters, and they
are responsible for the manufacturing process.

 Our
catheter supplier for CGuard Prime supplies us with catheters that help create the base for our CGuard Prime stent system. Our agreement
with the supplier which may be terminated by us upon 9 months' notice, calls for non-binding minimum orders.

 We
manufacture our CGuard EPS and our CGuard Prime at our own facility. The self-expanding bare-metal stents for our CGuard EPS and our
CGuard Prime are being manufactured and supplied by a third-party. Our agreement with the supplier for the production of electro polished
L605 bare-metal stents for CGuard EPS and CGuard Prime is priced on a per-stent basis, subject to the quantity of stents ordered. The
complete assembly process for CGuard EPS and CGuard Prime, including knitting and securing the sleeved to the stent and the crimping
of the sleeved stent in to a delivery catheter, is done at our Israel manufacturing site. Once CGuard EPS and CGuard Prime have been
assembled, they are sent for sterilization in a third-party facility in Israel, and then back to our facility for final packaging and
distribution.

 A
CGuard EPS and CGuard Prime consists of a CGuard stent and the delivery system. Each CGuard stent is manufactured from two main components,
a self-expending nickel-titanium stent and the mesh polymer. This material is readily available and we acquire it in the open market.
The mesh is made from polyethylene terephthalate (polyester). We have patent rights that cover the proposed CGuard stent with mesh. During
2022 our mesh supplier informed us that it will not be able to supply the polymer fiber in the future due to issues with raw materials,
therefore we purchased inventory which should be sufficient to support our production needs until the end of 2026. We are currently testing
a different source of PET showing equivalent mechanical properties of the original raw material. BioGeneral will produce the fiber from
the new PET: samples were already produced for preliminary R&D testing. Complete validation process will take up to 18 months. The
delivery system for CGuard is made out of polymer tubes we acquire from an original equipment manufacturer. In the event that our supplier
can no longer supply this material, we would need to qualify another supplier, which could take up to a year. In addition, in order to
retain the approval of the CE mark, we are required to perform periodic audits of the quality control systems of our key suppliers in
order to ensure that their products meet our predetermined specifications.

 - 28 -

 Human
Capital Management

 As
of December 31, 2023, we had 66 employees, 65 full-time and 1 part-time, consisting of 5 in executive management, 6 in research and development,
10 in quality assurance and compliance, 5 in finance and accounting, 26 in operations/production, 11 in sales, marketing and clinical,
and 3 in all other miscellaneous roles, Human resources, and administration. Except for 5 of our employees in Europe, our employees are
not party to any collective bargaining agreements. We do not expect the collective bargaining agreements to which our employees are party
to have a material effect on our business or results of operations. We also employ 2 independent contractors in Poland and 1 in Brazil.

 We
believe that our future success will depend, in part, on our continued ability to attract, hire and retain qualified personnel. In particular,
we depend on the skills, experience and performance of our senior management and research personnel. We compete for qualified personnel
with other medical device, biotechnology, pharmaceutical and healthcare companies, as well as universities and non-profit research institutions.

 We
provide competitive compensation and benefits programs to help meet the needs of our employees. In addition to salaries, these programs
(which vary by country/region and employment classification) include incentive compensation plan, pension, healthcare and insurance benefits,
paid time off, family leave, and on-site services, among others. We also use targeted equity-based grants with vesting conditions to
facilitate retention of personnel, particularly for our key employees.

 We
consider our relations with our employees to be good.

 Item
1A. Risk Factors.

 There
are numerous and varied risks, known and unknown, that may prevent us from achieving our goals. You should carefully consider the risks
described below and the other information included in this Annual Report on Form 10-K, including the consolidated financial statements
and related notes. If any of the following risks, or any other risks not described below, actually occur, it is likely that our business,
financial condition, and/or operating results could be materially adversely affected. The risks and uncertainties described below include
forward-looking statements and our actual results may differ from those discussed in these forward-looking statements.

 Summary
Risk Factors

 Our
business is subject to numerous risks and uncertainties, including those highlighted in the section titled "Risk Factors"
immediately following this prospectus summary. These risks include, among others, the following:

 we
 have a history of net losses and may experience future losses;

 our
 history of recurring losses and negative cash flows from operating activities, significant future commitments and the uncertainty
 regarding the adequacy of our liquidity to pursue our complete business objectives,

 we
 will need to raise additional capital to meet our business requirements in the future, and such capital raising may be costly or
 difficult to obtain and could dilute our stockholders' ownership interests;

 we
 may become subject to claims by much larger and better capitalized competitors enforcing their intellectual property rights against
 us or seeking to invalidate our intellectual property or our rights thereto;

 completing
 clinical trials for CGuard Carotid Stent System and SwitchGuard NPS in the United States require meeting a number of regulatory
 requirements and must be conducted in compliance with the FDA's IDE regulations. Failure to maintain compliance with IDE
 regulations could have a material adverse effect on our business;

 clinical
 trials necessary to support a pre-market approval application will be lengthy and expensive and will require the enrollment of a
 large number of patients, and suitable patients may be difficult to identify and recruit. Any such delay or failure of clinical trials
 could prevent us from commercializing our stent products, which would materially and adversely affect our results of operations and
 the value of our business;

 - 29 -

 the
 results of our clinical trials may be insufficient to obtain regulatory approval for our products;

 our
 products may in the future be subject to product notifications, recalls, or voluntary market withdrawals that could harm our reputation,
 business and financial results;

 we
 may be subject, directly or indirectly, to applicable U.S. federal and state anti-kickback, false claims laws, physician payment
 transparency laws, fraud and abuse laws or similar healthcare and security laws and regulations, which could expose us to criminal
 sanctions, civil penalties, contractual damages, reputational harm and diminished profits and future earnings;

 we
 may be exposed to product liability claims and insurance may not be sufficient to cover these claims;

 even
 if one or more of our products are approved by the FDA, we may fail to obtain an adequate level of reimbursement for our products
 by third party payors, such that there may be no commercially viable markets for our products or the markets may be much smaller
 than expected;

 in
 the United States and European Union, our business could be significantly and adversely affected by healthcare reform initiatives
 and/or other legislation or judicial interpretations of existing or future healthcare laws and/or regulations;

 if
 we are unable to obtain and maintain intellectual property protection covering our products, others may be able to make, use or sell
 our products, which would adversely affect our revenue;

 we
 are an international business, and we are exposed to various global and local risks that could have a material adverse effect on
 our financial condition and results of operations venue;

 our
 business, operating results and growth rates may be adversely affected by current or future unfavorable economic and market conditions
 and adverse developments with respect to financial institutions and associated liquidity risk;

 there
 are inherent limitations in all control systems, and misstatements due to error or fraud may occur and not be detected;

 we
 anticipate being subject to fluctuations in currency exchange rates because we expect a substantial portion of our revenues will
 be generated in Euros and U.S. dollars, while a significant portion of our expenses will be incurred in New Israeli Shekels;

 if
 there are significant shifts in the political, economic and military conditions in Israel and its neighbours, it could have a material
 adverse effect on our business relationships and profitability;

 it
 may be difficult for investors in the United States to enforce any judgments obtained against us or some of our directors or officers;

 the
 market prices of our common stock and our publicly traded warrants are subject to fluctuation and have been and may continue to be
 volatile, which could result in substantial losses for investors; and

 our
 common stock could be delisted from the Nasdaq Stock Market if we fail to meet its continued
 listing requirements, including requirements with respect to the market value of publicly-held-shares,
 market value of listed shares, minimum bid price per share, and minimum stockholder's
 equity, among others, and requirements relating to board and committee independence.

 - 30 -

 Risks
Related to Our Financial Condition

 We
have a history of net losses and may experience future losses.

 We
have yet to establish any history of profitable operations. We reported a net loss of $19.9 million for the fiscal year ended December
31, 2023, and had a net loss of approximately $18.5 million during the fiscal year ended December 31, 2022. As of December 31, 2023,
we had an accumulated deficit of $222 million. We expect to incur additional operating losses for the foreseeable future. There can be
no assurance that we will be able to achieve sufficient revenues throughout the year or be profitable in the future.

 We
will need to raise additional capital to meet our business requirements in the future, and such capital raising may be costly or difficult
to obtain and could dilute our stockholders' ownership interests.

 In
order for us to pursue our business objectives without materially curtailing our operations, we will need to raise additional capital,
which additional capital may not be available on reasonable terms or at all. For instance, we will need to raise additional funds to
accomplish the following:

 furthering
 our efforts to ultimately seek the FDA approval for commercial sales of CGuard EPS and Switchguard NPS in the United States;

 development
 of our current and future products, including CGuard EPS and SwitchGuard NPS enhancements;

 pursuing
 growth opportunities, including more rapid expansion and funding regional distribution systems;

 making
 capital improvements to improve our infrastructure;

 hiring
 and retaining qualified management and key employees;

 responding
 to competitive pressures;

 complying
 with regulatory requirements such as licensing and registration; and

 maintaining
 compliance with applicable laws.

 In
May 2023, we issued four series of Warrants that expire upon the earlier of five years and 20 trading days following the occurrence of
certain milestones specific to each series. If the Warrants are exercised in cash in full, this would result in $71.4 million of gross
proceeds. There can be no assurance that we will achieve any of the milestones set forth in the Warrants or that the Warrants will be
exercised in cash in full.

 Any
additional capital raised through the sale of equity or equity-backed securities may dilute our stockholders' ownership percentages
and could also result in a decrease in the market value of our equity securities.

 The
terms of any securities issued by us in future capital transactions may be more favorable to new investors, and may include preferences,
superior voting rights and the issuance of warrants or other derivative securities, which may have a further dilutive effect on the holders
of any of our securities then outstanding.

 In
addition, we may incur substantial costs in pursuing future capital financing, including investment banking fees, legal fees, accounting
fees, securities law compliance fees, printing and distribution expenses and other costs. We may also be required to recognize non-cash
expenses in connection with certain securities we issue, such as convertible notes and warrants, which may adversely impact our financial
condition.

 - 31 -

 Risk
Related to Commercialization of Our Products

 While
we derive most of our revenue from the sale of CGuard EPS in CE marked countries, our ability to generate significant revenues and achieve
profitability depends, among other things, on our ability to receive FDA approval of CGuard Prime and SwitchGuard and other products
we may develop. If we fail to obtain FDA approval for CGuard Prime, SwitchGuard or any other products we may develop, our results of
operations and the value of our business would be materially and adversely affected.

 We
derive most of our revenue from sales of our CGuard EPS in CE marked countries and certain other select jurisdictions. We have not received
approvals in the United States and certain other jurisdictions for CGuard Prime and have not received any approvals for SwitchGuard and
there can be no assurance that we will be able to receive regulatory approvals to commence marketing and sales for our products in any
jusrisdiction where we are seeking approvals. Our ability to generate significant revenues and achieve profitability depends on our ability
to successfully obtain required regulatory approvals in the U.S. as well as to demonstrate sufficient clinical evidence and manufacture
commercial quantities of our CGuard Prime, SwitchGuard and any other products we may develop at an acceptable cost. In addition, there
may be insufficient demand for CGuard Prime, SwitchGuard and any other products we develop. If we fail to generate sufficient revenues
from these products, our results of operations and the value of our business and securities would be materially and adversely affected.

 The
future success of our business cannot be determined at this time, and we do not anticipate generating significant revenues from
product sales for the foreseeable future. In addition, we have no experience in commercializing our CGuard Prime or any other
product we develop on a mass scale and face a number of challenges with respect to our commercialization efforts, including, among
others, that:

 we
 may not have adequate financial or other resources to demonstrate adequate clinical results, attain required regulatory approvals
 and licensures, and begin the commercialization efforts for our CGuard Prime, SwitchGuard or any other product we develop in our
 target markets;

 we
 may fail to obtain or maintain required regulatory approvals and licensures for our CGuard Prime, SwitchGuard or any other product
 we develop in our target markets or may face adverse regulatory or legal actions relating to our products even if regulatory approval
 is obtained;

 we
 may not demonstrate adequate clinical safety and clinical effectiveness results from our CGuard Prime, SwitchGuard or any other
 product we develop to support regulatory body approval or market acceptance and adoption;

 We
 may not be able to scale up the manufacture of our CGuard Prime, SwitchGuard or any other product we develop to commercial quantities
 at an adequate quality or at an acceptable cost;

 we
 may not be able to establish adequate sales, marketing and distribution channels;

 healthcare
 professionals and patients may not accept our CGuard Prime, SwitchGuard or any other product we develop;

 other
 technological challenges may reduce the demand for our CGuard Prime, SwitchGuard or any other product we develop;

 new
 alliances between existing market participants and the entrance of new market participants may interfere with our market penetration
 efforts;

 government
 and private third-party payors may not agree to provide coding, coverage and payment adequate to reimburse healthcare providers and
 patients for any or all of the purchase price of CGuard Prime, SwitchGuard or any other product we develop which may adversely affect
 healthcare providers' and patients' willingness to purchase our C-Scan system;

 - 32 -

 uncertainty
 as to market demand may result in inefficient pricing of our CGuard Prime, SwitchGuard or any other product we develop;

 we
 may not be able to adequately protect our intellectual property or may face third-party claims of intellectual property infringement;
 and

 we
 are dependent upon the results of ongoing clinical studies relating to our CGuard Prime and the products of our competitors.

 If
we are unable to meet any one or more of these challenges successfully, our ability to effectively commercialize CGuard Prime, SwitchGuard or any other product we develop could be limited, which in turn could have a material adverse effect on our business, financial
condition and results of operations.

 Although
we completed the enrollment in our C-GUARDIANS trial of the CGuard Carotid Stent System, the outcome of the study is inherently uncertain.

 In
June 2023, we completed enrollment in the C-GUARDIANS trial. We anticipate reporting primary endpoint results from the C-GUARDIANS
trial in mid 2024 that may support the submission of a PMA application in the third quarter of 2024 with a view to potential FDA
approval of the CGuard Prime stent system in the first half of 2025. Although we reported positive 30-day follow-up data in November
2023, there can be no assurance that the primary endpoint results will be sufficient to support a PMA application or FDA approval,
Clinical failure can occur at any stage of clinical development. Our clinical trials have been conducted under differing protocols,
while using specific inclusion criteria and we cannot assure you that its actual clinical performances will be satisfactory to
support proposed indications and regulatory approvals and clinical acceptance and adoption, or that its use will not result in
unanticipated complications. Furthermore, the results of our clinical trials are subject to human analyses and interpretation of the
data accumulated, which could be affected by various errors due to, among others, lack of sufficient clinical experience with CGuard
EPS, SwitchGuard or any other product we develop, assumptions used in the statistical analysis of results, and interpretation errors
in the analysis of the clinical trials results. Failure can occur at any time during the clinical trial process. If CGuard EPS,
SwitchGuard or any other product we develop does not function as expected over time, we may not achieve regulatory clearances, and
may not be widely adopted by healthcare providers and patients.

 We
plan on self-commercializing CGuard Prime in the U.S. if we receive FDA approval and historically have no experience selling, marketing
or distributing products in the U.S.

 We
plan on self-commercializing CGuard Prime in the U.S., subject to receipt of FDA approval. As part of our plan, we intend to build out
manufacturing, sales, marketing and distribution capabilities. Historically we have not had experience in manufacturing, selling, marketing
or distributing products in the U.S. To be able to commercialize CGuard Prime upon approval, if at all, we must either develop internal
manufacturing, sales, marketing and distribution capabilities, which is expensive and time-consuming, or enter into arrangements with
third parties to perform these services.

 There
are risks involved with establishing our own manufacturing, sales, marketing and distribution capabilities. We must commit significant
financial and managerial resources to develop a manufacturing facility and marketing and sales force with technical expertise and with
supporting distribution capabilities. Factors that may inhibit our efforts to commercialize our products directly and without strategic
partners include:

 our
 inability to recruit and retain adequate numbers of effective manufacturing, sales and marketing personnel;

 the
 inability of sales personnel to obtain access to or persuade physicians to use our stents;

 - 33 -

 the
 inability to price our products at a sufficient price point to ensure an adequate and attractive level of profitability;

 the
 difficulty of obtaining reimbursement from governmental and commercial payers;

 the
 lack of complementary products to be offered by sales personnel, which may put us at a competitive disadvantage relative to companies
 with more extensive product lines; and

 unforeseen
 costs and expenses associated with creating and sustaining an independent manufacturing, sales and marketing organization.

 We
may not be successful in recruiting the manufacturing, sales and marketing personnel necessary to sell CGuard Prime upon approval, if
at all, and, even if we do build a sales force, we may not be successful in marketing CGuard Prime, which would have a material adverse
effect on our business, financial condition and results of operations.

 If
we are unable to establish our own manufacturing, sales, marketing and distribution capabilities or enter into successful arrangements
with third parties to perform these services, any future product revenues and our profitability, may be materially adversely affected.

 Physicians
may not widely adopt our products unless they determine, based on experience, long-term clinical data and published peer reviewed journal
articles, among other standard-of-care considerations, that the use of our stents provides a safe and effective alternative to other
existing treatments for coronary artery disease and carotid artery disease.

 We
believe that physicians will not widely adopt our products unless they determine, based on experience, long-term clinical data, published
peer reviewed journal articles and payor coverage policies, among other factors, that the use of our products provide a safe and effective
alternative to other existing treatments for the conditions we are seeking to address.

 If
we fail to demonstrate safety and efficacy that is at least comparable to existing and future therapies available on the market, our
ability to successfully market our products will be significantly limited. Even if the data collected from clinical studies or clinical
experience indicate positive results, each physician's actual experience with our products will vary. Clinical trials conducted
with our products may involve procedures performed by physicians who are technically proficient and are high-volume stent users of such
products. Consequently, both short-term and long-term results reported in these clinical trials may be significantly more favorable than
typical results of practicing physicians, which could negatively affect rates of adoptions of our products. We also believe that published
peer-reviewed journal articles and recommendations and support by influential physicians regarding our products will be important for
market acceptance and adoption, and we cannot assure you that we will receive these recommendations and support, or that supportive articles
will be published.

 If
our manufacturing facilities are unable to provide an adequate supply of products, our growth could be limited and our business could
be harmed.

 We
currently manufacture CGuard at our facility in Tel Aviv, Israel. If there were a disruption to our existing manufacturing facility,
we would have no other means of manufacturing CGuard until we were able to restore the manufacturing capability at our
facility or develop alternative manufacturing facilities. If we were unable to produce sufficient quantities of CGuard,
SwitchGuard or any other product we develop to meet market demand or for use in our current and planned clinical trials, or if our manufacturing
process yields substandard stents, our development and commercialization efforts would be delayed.

 - 34 -

 To
manufacture CGuard, SwitchGuard and any other product we develop in quantities to meet anticipated market demand if we were to
receive FDA approval, we will need to increase manufacturing capacity, which will involve significant challenges. In addition, the development
of U.S. commercial-scale, regulation-compliant manufacturing capabilities will require us to invest substantial additional funds and
hire and retain the technical personnel who have the necessary manufacturing experience. We may not successfully complete any required
increase to existing manufacturing processes in a timely manner, or at all.

any damage to or destruction of our Tel Aviv facility or its equipment, prolonged power outage or contamination at our facility would
significantly impair our ability to produce CGuard.

 Finally,
the production of our stents must occur in a highly controlled, clean environment to minimize particles and other yield and quality-limiting
contaminants. In spite of stringent quality controls, weaknesses in process control or minute impurities in materials may cause a substantial
percentage of defective products in a lot. If we are unable to maintain stringent quality controls, or if contamination problems arise,
our clinical development and commercialization efforts could be delayed, which would harm our business and results of operations.

 CGuard is a complex medical deice that requires training for qualified personal.

 CGuard and SwitchGuard are complex medical devices that requires training for qualified personal, including physicians. Although our distributors
will be required to ensure that CGuard and SwitchGuard is prescribed only by trained clinicians, the potential for misuse of CGuard and SwitchGuard still exists due to its complexity. Such misuse could result in adverse medical consequences for patients that could
damage our reputation, subject us to costly product liability litigation and otherwise have a material adverse effect on our business,
financial condition and results of operations.

 We
operate in an intensely competitive and rapidly changing business environment, and there is a substantial risk our products could become
obsolete or uncompetitive.

 The
medical device market is highly competitive. We compete with many medical device companies globally in connection with our current products
and products under development. We face intense competition from numerous pharmaceutical and biotechnology companies in the therapeutics
area, as well as competition from academic institutions, government agencies and research institutions. Abbott Laboratories, Boston Scientific
Corporation, Medtronic, Cordis Corporation and Terumo Medical Corporation produce a polytetrafluoroethylene mesh-covered stent and a
double layer metal stent, respectively As we develop and seek regulatory approval in the United States and Europe for our new TCAR neuroprotection
system SwitchGuard and continue to seek greater market share for CGuard, we expect to compete with Silk Road Medical in the total
carotid artery revascularization market that comprises CAS, TCAR and CEA. Most of our current and potential competitors, including but
not limited to those listed above, have, and will continue to have, substantially greater financial, technological, research and development,
regulatory and clinical, manufacturing, marketing and sales, distribution and personnel resources than we do. There can be no assurance
that we will have sufficient resources to successfully commercialize our products, if and when they are approved for sale. The worldwide
market for stent products is characterized by intensive development efforts and rapidly advancing technology. For example, during the
second quarter of 2022 we ceased sales of our MGuard Prime EPS following a phase out period due to a shift in industry preferences. Our
future success will depend largely upon our ability to anticipate and keep pace with those developments and advances. Current or future
competitors could develop alternative technologies, products or materials that are more effective, easier to use or more economical than
what we or any potential licensee develop. If our technologies or products become obsolete or uncompetitive, our related product sales
and licensing revenue would decrease. This would have a material adverse effect on our business, financial condition and results of operations.

 - 35 -

 We
may become subject to claims by much larger and better capitalized competitors enforcing their intellectual property rights against us
or seeking to invalidate our intellectual property or our rights thereto.

 Based
on the prolific litigation that has occurred in the stent industry and the fact that we may pose a competitive threat to some large and
well-capitalized companies that own or control patents relating to stents and their use, manufacture and delivery, we believe that it
is possible that one or more third parties will assert a patent infringement claim against the manufacture, use or sale of our stents
based on one or more of these patents. These companies also own patents relating to the use of drugs to treat restenosis, stent architecture,
catheters to deliver stents, and stent manufacturing and coating processes and compositions, as well as general delivery mechanism patents
like rapid exchange, which might be alleged to cover one or more of our products. In addition, it is possible that a lawsuit of which
we are not aware asserting patent infringement, misappropriation of intellectual property, or related claims may have already been filed
against us. As the number of competitors in the stent market grows and as the geographies in which we commercially market grow in number
and scope, the possibility of patent infringement by us, and/or a patent infringement or misappropriation claim against us, increases.

 Our
competitors have maintained their positions in the market by, among other things, establishing intellectual property rights relating
to their products and enforcing these rights aggressively against their competitors and new entrants into the market. All the major companies
in the field of stents and related markets, including Boston Scientific, C.R. Bard, Inc., W.L. Gore & Associates and Medtronic, have
been repeatedly involved in patent litigation relating to stents since at least 1997. The field of stents and related markets have experienced
rapid technological change and obsolescence in the past, and our competitors have strong incentives to stop or delay the introduction
of new products and technologies. We may pose a competitive threat to many of the companies in these markets. Accordingly, these companies
will have a strong incentive to take steps, through patent litigation or otherwise, to prevent us from distributing our products. Such
litigation or claims would divert attention and resources away from the development and/or commercialization of our products and could
result in an adverse court judgment that would make it impossible or impractical to sell our products in one or more territories.

 If
we fail to maintain or establish satisfactory agreements or arrangements with suppliers or if we experience an interruption of the supply
of materials from suppliers, we may not be able to obtain materials that are necessary to develop our products.

 We
depend on outside suppliers for certain raw materials. These raw materials or components may not always be available at our standards
or on acceptable terms, if at all, and we may be unable to locate alternative suppliers or produce necessary materials or components
on our own.

 Some
of the components of our products are currently provided by only one vendor, or a single-source supplier. We may have difficulty obtaining
similar components from other suppliers that are acceptable to the FDA or foreign regulatory authorities if it becomes necessary. During
2022, our mesh supplier informed us that it will not be able to supply the polymer fiber in the future due to issues with raw materials,
therefore we purchased inventory which should be sufficient to support our production needs until the middle of 2028. We are currently
testing a different source of PET showing equivalent mechanical properties of the original raw material however there can be no assurance
that the alternative source will result in successful validation and if we are unable to timely source an alternative supplier this could
result regulatory delays and the interruption of our manufacturing and delivery of stents for an extended period of time which would
delay completion of our clinical trials or commercialization of our products.

 In
addition, we will be required to obtain prior regulatory approval from the FDA or foreign regulatory authorities to use different suppliers
or components that may not be as safe or as effective. As a result, regulatory approval of our products may not be received on a timely
basis or at all.

 Finally,
we rely on a third-party vendor to perform the sterilization process. A third-party vendor's failure to properly sterilize a component
may cause delays or disruptions in our manufacturing process.

 If
there is a renewed outbreak of the COVID-19 pandemic, it may have a significant adverse effect on our business.

 In
the past, we were impacted by the COVID-19 pandemic, which has caused interruptions or delays of our business plan. If there is a renewed
outbreak of COVID-19 it may result in restrictions and safety measures that could cause fluctuations in sales of our products, ability
to manufacture, as well as potential disruptions to our supply chain.

 - 36 -

 In
addition, if there is a renewed outbreak of COVID-19, this may cause disruptions that could have a material adverse impact on our FDA
clinical trial plans and timelines, including:

 in receiving authorizations from local regulatory authorities, ethics committees and institutional review boards to initiate planned
 clinical trials;

 or difficulties in enrolling patients in our clinical trials;

 or difficulties in clinical site initiation, including difficulties in recruiting clinical site investigators and clinical site staff;

 in clinical sites receiving the supplies and materials needed to conduct our clinical trials, including interruptions in global shipping
 that may affect the transport of clinical trial materials;

 Changes
 in local regulations as part of a response to the COVID-19 pandemic which may require us to change the ways in which our clinical
 trials are conducted, which may result in unexpected costs, or to discontinue the clinical trials altogether;

 Diversion
 of healthcare resources away from the conduct of clinical trials, including the diversion of hospitals serving as our clinical trial
 sites and hospital staff supporting the conduct of our clinical trials;

 Diversion
 of healthcare resources away from the conduct of clinical trials, including the diversion of hospitals serving as our clinical trial
 sites and hospital staff supporting the conduct of our clinical trials;

 Interruption
 of key clinical trial activities, such as clinical trial site monitoring, due to limitations on travel imposed or recommended by
 federal or state governments, employers and others, or interruption of clinical trial subject visits and study procedures, the occurrence
 of which could affect the integrity of clinical trial data;

 Risk
 that participants enrolled in our clinical trials will acquire COVID-19 while the clinical trial is ongoing, which could impact the
 results of the clinical trial, including by increasing the number of observed adverse events;

 in necessary interactions with local regulators, ethics committees and other third parties and contractors due to limitations in
 employee resources or forced furlough of government employees;

 Limitations
 in employee resources that would otherwise be focused on the conduct of our clinical trials, including because of sickness of employees
 or their families or the desire of employees to avoid contact with large groups of people; and

 Refusal
 of the FDA to accept data from clinical trials in affected geographies.

 Any
of these occurrences may significantly harm our business, financial condition and prospects. In addition, many of the factors that cause,
or lead to, a delay in the commencement or completion of clinical trials may also ultimately lead to the delay or denial of regulatory
approvals or clearances of our product.

 The
extent to which any future outbreak of COVID-19 will impact our results will depend on future developments, which are highly uncertain
and cannot be predicted, including new information which may emerge concerning the severity of the virus.

 Increasing
inflation could adversely affect our business, financial condition, results of operations or cash flows.

 Inflation
and some of the measures taken by or that may be taken by the governments in countries where we operate in an attempt to curb inflation
may have negative effects on the economies of those countries generally. If the United States or other countries where we operate experience
substantial inflation in the future, our business may be adversely affected. This could have a material adverse impact on our business,
financial condition, results of operations or cash flows.

 - 37 -

 Risks
Related to our Clinical Trials and Regulatory Matters

 Completing
clinical trials for CGuard, SwitchGuard or any other product we develop in the United States require meeting a number of regulatory
requirements and must be conducted in compliance with the FDA's IDE regulations. Failure to maintain compliance with IDE regulations
could have a material adverse effect on our business.

trials involve use of a medical device on human subjects under the supervision of qualified investigators in accordance with current
Good Clinical Practices, including the requirement that all research subjects provide informed consent for their participation in the
clinical study. The FDA classifies medical device candidates into "significant risk" and "non-significant risk"
devices. Significant risk devices present a potential for serious risk to the health, safety, or welfare of a subject. Examples may include
implants, devices that support or sustain human life, and devices that are substantially important in diagnosing, curing, mitigating,
or treating disease or in preventing impairment to human health. If a medical device candidate presents a significant risk, an IDE application
must be submitted and approved prior to commencing any human clinical trials in the United States in connection with such device.

 In
addition to our IDE approval, we must apply for and obtain IRB approval in connection with each clinical site before commencing any study
activities. A written protocol with predefined end points, an appropriate sample size, and pre-determined patient inclusion and exclusion
criteria, is also required before we may initiate or conduct the trial.

 Importantly,
the C-GUARDIANS trial and any others that we are conducting or may conduct in the future, must be conducted in accordance with the FDA's
IDE regulations, which, among other things, establish requirements for investigational device labeling, prohibit pre-approval promotion
of a device candidate, and specify recordkeeping, reporting, and monitoring responsibilities of study sponsors and study investigators.

 We
may not be able to obtain IRB approval to undertake clinical trials in the United States for any products we intend to market in the
United States in the future. If we do obtain such approvals, we may not be able to conduct studies which comply with the IDE and other
regulations governing clinical investigations or the data from any such trials may not support clearance or approval of the investigational
device. Failure to obtain such approvals or to comply with such regulations could have a material adverse effect on our business, financial
condition and results of operations.

 Relatedly,
certainty that clinical trials must meet FDA requirements, including desired endpoints, produce meaningful or useful data, and be
free of unexpected adverse effects, or that the FDA will accept the validity of foreign clinical study data, as applicable, cannot
be guaranteed, and such uncertainty could preclude or delay regulatory approvals and commercialization, resulting in significant
financial costs and reduced revenue. Moreover, the timing of the commencement, continuation, and completion of any future clinical
trial may be subject to significant delays attributable to various causes, including, but not limited to, scheduling conflicts with
participating clinicians and clinical institutions, difficulties in identifying and enrolling patients who meet trial eligibility
criteria, failure of patients to complete the clinical trial, delay in or failure to meet regulatory and/or IRB requirements to
conduct a clinical trial at a one or more prospective sites, and shortages of supply in the investigational device.

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trials necessary to support a PMA application are lengthy and expensive and require the enrollment of a large number of patients, and
suitable patients may be difficult to identify and recruit. Any such delay or failure of clinical trials could prevent us from commercializing
our stent products, which would materially and adversely affect our results of operations and the value of our business.

trials necessary to support a pre-market approval application to the FDA for our products, including CGuard, SwitchGuard and any
other product we develop stent are expensive and require the enrollment of a large number of patients, and suitable patients may be difficult
to identify and recruit, which may cause a delay in the development and commercialization of our products. Patient enrollment in clinical
trials and the ability to successfully complete patient follow-up depends on many factors, including the size of the patient population,
the nature of the trial protocol, the proximity of patients to clinical sites, the eligibility criteria for the clinical trial and patient
compliance. For example, patients may be discouraged from enrolling in our clinical trials if the trial protocol requires them to undergo
extensive post-treatment procedures or follow-up to assess the safety and efficacy of our products, or they may be persuaded to participate
in contemporaneous clinical trials of competitive products. In addition, patients participating in our clinical trials may die before
completion of the trial or suffer adverse medical events unrelated to or related to our products. Delays in patient enrollment or failure
of patients to continue to participate in a clinical trial, including during a follow-up period, may cause an increase in costs and delays
or result in the failure of the clinical trial.

 In
addition, the length of time required to complete clinical trials for pharmaceutical and medical device products varies substantially
according to the degree of regulation and the type, complexity, novelty and intended use of a product, and can continue for several years
and cost millions of dollars. The commencement and completion of clinical trials for our products under development may be delayed by
many factors, including governmental or regulatory delays and changes in regulatory requirements, policy and guidelines or our inability
or the inability of any potential licensee to manufacture or obtain from third parties materials sufficient for use in preclinical studies
and clinical trials.

 The
results of our C-GUARDIANS trial as well as any other clinical trials may be insufficient to obtain regulatory approval for our products.

 We
will only receive regulatory approval to commercialize CGuard Prime, SwitchGuard or any other product we develop if we can demonstrate
to the satisfaction of the FDA or the applicable foreign regulatory agency, in well designed and conducted clinical trials, that the
product is safe and effective. If we are unable to demonstrate that a product is safe and effective in advanced clinical trials involving
large numbers of patients, we will be unable to submit the necessary application to receive regulatory approval to commercialize the
product. We face risks that:

 the
 product may not prove to be safe or effective;

 the
 product's benefits may not outweigh its risks;

 the
 results from advanced clinical trials may not confirm the positive results from pre-clinical studies and early clinical trials;

 the
 FDA or comparable foreign regulatory authorities may interpret data from pre-clinical and clinical testing in different ways than
 us; and

 the
 FDA or other regulatory agencies may require additional or expanded trials and data.

 Patients
may discontinue their participation in our clinical studies, which may negatively impact the results of these studies and extend the
timeline for completion of our development programs.

trials for our products require sufficient patient enrollment. We may not be able to enroll a sufficient number of patients in a timely
or cost-effective manner. Patients enrolled in our clinical studies may discontinue their participation at any time during the study
as a result of a number of factors, including withdrawing their consent or experiencing adverse clinical events, which may or may not
be judged to be related to our products under evaluation. If a large number of patients in a study discontinue their participation in
the study, the results from that study may not be positive or may not support a filing for regulatory approval of the product.

 In
addition, the time required to complete clinical trials is dependent upon, among other factors, the rate of patient enrollment. Patient
enrollment is a function of many factors, including the following:

 the
 size of the patient population;

 the
 nature of the clinical protocol requirements;

 the
 availability of other treatments or marketed therapies (whether approved or experimental);

 - 39 -

 our
 ability to recruit and manage clinical centers and associated trials;

 the
 proximity of patients to clinical sites; and

 the
 patient eligibility criteria for the study.

 Even
if CGuard Prime, SwitchGuard or any other product we develop receives marketing approval, we or others may later discover that the product
is less effective than previously believed or causes undesirable side effects that were not previously identified, which could compromise
our ability or that of any collaborators to market the product, and could cause regulatory authorities to take certain regulatory actions.

 It
is possible that our clinical trials may indicate an apparent positive effect of a product that is greater than the actual positive effect,
if any, or alternatively fail to identify undesirable side effects. For example, we, or others, may discover that our products are less
safe and effective than previously believed. If, we, or others, discover that a product is less effective than previously believed or
causes undesirable side effects that were not previously identified, any of the following adverse events could occur:

 regulatory
 authorities may withdraw their approval of the product or seize the product;

 we,
 or any of our collaborators, may be required to recall the product, change the way the product is administered or conduct additional
 clinical trials;

 additional
 restrictions may be imposed on the marketing of, or the manufacturing processes for, the particular product;

 we,
 or any of our collaborators, may be subject to fines, injunctions or the imposition of civil or criminal penalties;

 regulatory
 authorities may require the addition of labeling statements, such as a "black box" warning or a contraindication
 including with the product;

 we,
 or any of our collaborators, may be required to create a Medication Guide outlining the risks of the previously unidentified side
 effects for distribution to patients;

 we
 could be sued and held liable for harm caused to patients;

 physicians
 and patients may stop using our product; and

 our
 reputation may suffer.

 Any
of these events could harm our business and operations and could negatively impact our stock price.

 Our
products may in the future be subject to product notifications, recalls, or voluntary market withdrawals that could harm our reputation,
business and financial results.

 After
regulatory approval has been obtained for medical device products, the product and the manufacturer are subject to continual review,
including the review of adverse events and clinical results that are reported after our products are made available to patients, and
there can be no assurance that such approval will not be withdrawn or restricted. Regulators may also subject approvals to restrictions
or conditions or impose post-approval obligations on the holders of these approvals, and the regulatory status of such products may be
jeopardized if such obligations are not fulfilled. If post-approval studies are required, such studies may involve significant time and
expense.

 The
manufacturing and marketing of medical devices involves an inherent risk that our products may prove to be defective and cause a health
risk even after regulatory clearances have been obtained. Medical devices may also be modified after regulatory clearance is obtained
to such an extent that additional regulatory clearance is necessary before the device can be further marketed. In these events, we may
voluntarily implement a recall or market withdrawal or may be required to do so by a regulatory authority.

 - 40 -

 In
the European Economic Area, we must comply with the EU Medical Device Vigilance System. Under this system, manufacturers are required
to take Field Safety Corrective Actions ("FSCAs") to reduce a risk of death or serious deterioration in the state of health
associated with the use of a medical device that is already placed on the market. A FSCA may include the recall, modification, exchange,
destruction or retrofitting of the device. FSCAs must be communicated by the manufacturer or its legal representative to its customers
and/or to the end users of the device through Field Safety Notices.

 Any
adverse event involving our products could result in other future voluntary corrective actions, such as recalls or customer notifications,
or agency action, such as inspection or enforcement action. Adverse events have been reported to us in the past, and we cannot guarantee
that they will not occur in the future. Any corrective action, whether voluntary or involuntary, as well as defending ourselves in a
lawsuit, would require the dedication of our time and capital, distract management from operating our business and could harm our reputation
and financial results.

 We
have only limited experience in regulatory affairs, which may affect our ability, or the time required, to navigate complex regulatory
requirements and obtain necessary regulatory approvals, if such approvals are received at all. Regulatory delays or denials may increase
our costs, cause us to lose revenue and materially and adversely affect our results of operations and the value of our business.

 Because
long-term success measures have not been completely validated for our products, especially CGuard, SwitchGuard and any other product
we may develop, regulatory agencies may take a significant amount of time in evaluating product approval applications. Treatments may
exhibit a favorable measure using one metric and an unfavorable measure using another metric. Any change in accepted metrics may result
in reconfiguration of, and delays in, our clinical trials. Additionally, we have only limited experience in filing and prosecuting the
applications necessary to gain regulatory approvals, and our clinical, regulatory and quality assurance personnel are currently composed
of only ten employees. As a result, we may experience delays in connection with obtaining regulatory approvals for our products.

 In
addition, the products we and any potential licensees license, develop, manufacture and market are subject to complex regulatory requirements,
particularly in the United States, Europe and Asia, which can be costly and time-consuming. There can be no assurance that such approvals
will be granted on a timely basis, if at all. Furthermore, there can be no assurance of continued compliance with all regulatory requirements
necessary for the manufacture, marketing and sale of the products we will offer in each market where such products are expected to be
sold, or that products we have commercialized will continue to comply with applicable regulatory requirements. If a government regulatory
agency were to conclude that we were not in compliance with applicable laws or regulations, the agency could institute proceedings to
detain or seize our products, issue a recall, impose operating restrictions, enjoin future violations and assess civil and criminal penalties
against us, our officers or employees and could recommend criminal prosecution. Furthermore, regulators may proceed to ban, or request
the recall, repair, replacement or refund of the cost of, any device manufactured or sold by us. Furthermore, there can be no assurance
that all necessary regulatory approvals will be obtained for the manufacture, marketing and sale in any market of any new product developed
or that any potential licensee will develop using our licensed technology.

 Even
if our products are approved by regulatory authorities, if we or our suppliers fail to comply with ongoing regulatory requirements, or
if we experience unanticipated problems with our products, these products could be subject to restrictions or withdrawal from the market.

 Any
regulatory approvals that we receive for our products will require surveillance to monitor the safety and efficacy of the product and
may require us to conduct post-approval clinical studies. In addition, if a regulatory authority approves our products, the manufacturing
processes, labeling, packaging, distribution, adverse event reporting, storage, advertising, promotion, import, export and recordkeeping
for our products will be subject to extensive and ongoing regulatory requirements.

 - 41 -

 Moreover,
if we obtain regulatory approval for any of our products, we will only be permitted to market our products for the indication approved
by the regulatory authority, and such approval may involve limitations on the indicated uses or promotional claims we may make for our
products. In addition, later discovery of previously unknown problems with our products, including adverse events of unanticipated severity
or frequency, or with our suppliers or manufacturing processes, or failure to comply with regulatory requirements, may result in, among
other things:

 restrictions
 on the marketing or manufacturing of our products, withdrawal of the product from the market, or voluntary or mandatory product recalls;

 fines,
 warning letters, or untitled letters;

 holds
 on clinical trials;

 refusal
 by the regulatory authority to approve pending applications or supplements to approved applications filed by us or suspension or
 revocation of license approvals;

 product
 seizure or detention, or refusal to permit the import or export of our products; and

 injunctions,
 the imposition of civil penalties or criminal prosecution.

 The
FDA also requires that our sales and marketing efforts, as well as promotions, be consistent with various laws and regulations. Approved
medical device promotions must be consistent with and not contrary to labeling, balanced, truthful and not false or misleading, adequately
substantiated (when required), and include adequate directions for use. In addition to the requirements applicable to approved products,
we may also be subject to enforcement action in connection with any promotion of an investigational new device. A sponsor or investigator,
or any person acting on behalf of a sponsor or investigator, may not represent in a promotional context that an investigational new device
is safe or effective for the purposes for which it is under investigation or otherwise promote the device.

 If
the FDA investigates our marketing and promotional materials or other communications and finds that any of our investigational devices,
or future commercial products, if any, are being marketed or promoted in violation of the applicable regulatory restrictions, we could
be subject to the enforcement actions listed above, among others. Any enforcement action (or related lawsuit, which could follow such
action) brought against us in connection with alleged violations of applicable device promotion requirements, or prohibitions, could
harm our business and our reputation, as well as the reputation of any devices that may be approved for marketing in the U.S. in the
future.

 The
applicable regulatory authorities' policies may change, and additional government regulations may be enacted that could prevent,
limit or delay regulatory approval of our products. We cannot predict the likelihood, nature or extent of government regulation that
may arise from future legislation or administrative action, either in the United States or abroad. If we are slow or unable to adapt
to changes in existing requirements or the adoption of new requirements or policies, or if we are not able to maintain regulatory compliance,
we may lose any marketing approval that we may have obtained and we may not achieve or sustain profitability.

 Failure
to obtain regulatory approval in foreign jurisdictions will prevent us from marketing our products in such jurisdictions.

 We
market CGuard EPS in certain international markets. In order to market any our products in other foreign jurisdictions, we must obtain
separate regulatory approvals from the appropriate governing body in each applicable country. The approval processes vary among countries
and can involve additional testing, and the time required to obtain approval may differ from that required to obtain CE mark or FDA approval.
Foreign regulatory approval processes may include all of the risks associated with obtaining CE mark or FDA approval in addition to other
risks. We may not obtain foreign regulatory approvals on a timely basis, if at all. CE mark approval or any future FDA approval does
not ensure approval by regulatory authorities in other countries. We may not be able to file for regulatory approvals and may not receive
necessary approvals to commercialize our products in certain markets.

 - 42 -

 We
are, or may be, subject to federal, state and foreign healthcare laws and regulations and implementation of or changes to such healthcare
laws and regulations could adversely affect our business and results of operations.

 In
both the United States and certain foreign jurisdictions, there are laws and regulations specific to the healthcare industry which may
affect all aspects of our business, including development, testing, marketing, sales, pricing, and reimbursement. Additionally, there
have been a number of legislative and regulatory proposals in recent years to change the healthcare system in ways that could impact
our ability to sell our products. If we are found to be in violation of any of these laws or any other federal or state regulations,
we may be subject to administrative, civil and/or criminal penalties, damages, fines, individual imprisonment, exclusion from federal
healthcare programs and the restructuring of our operations. Any of these could have a material adverse effect on our business and financial
results. Since many of these laws have not been fully interpreted by the courts, there is an increased risk that we may be found in violation
of one or more of their provisions. Any action against us for violation of these laws, even if we ultimately are successful in our defense,
will cause us to incur significant legal expenses and divert our management's attention away from the operation of our business.

 We
may be subject, directly or indirectly, to applicable U.S. federal and state anti-kickback, false claims laws, physician payment transparency
laws, fraud and abuse laws or similar healthcare and security laws and regulations, which could expose us to criminal sanctions, civil
penalties, contractual damages, reputational harm and diminished profits and future earnings.

 Healthcare
providers, physicians and others will play a primary role in the recommendation, ordering and utilization of any products for which we
obtain regulatory approval. If we obtain U.S. Food & Drug Administration approval for any of our products and begin commercializing
those products in the United States, our operations may be subject to various federal and state fraud and abuse laws, including, without
limitation, the federal Anti-Kickback Statute, the federal False Claims Act, and physician payment sunshine laws and regulations. These
laws may impact, among other things, our potential sales, marketing and education programs. In addition, we may be subject to patient
privacy regulation by both the federal government and the states in which we conduct our business. The laws that may affect our ability
to operate include:

the federal Anti-Kickback Statute, which prohibits, among other things, knowingly and willfully soliciting, receiving, offering or paying
any remuneration (including any kickback, bribe, or rebate), directly or indirectly, overtly or covertly, in cash or in kind, to induce,
or in return for, either the referral of an individual, or the purchase, lease, order or recommendation of any good, facility, item or
service for which payment may be made, in whole or in part, under a federal healthcare program, such as the Medicare and Medicaid programs;

federal civil and criminal false claims laws and civil monetary penalty laws, including the False Claims Act, which may be pursued through
civil whistleblower or qui tam actions, impose criminal and civil penalties against individuals or entities for knowingly presenting,
or causing to be presented, to the federal government, claims for payment or approval from Medicare, Medicaid or other third-party payors
that are false or fraudulent or making a false statement to avoid, decrease or conceal an obligation to pay money to the federal government;

federal criminal statutes created through the Health Insurance Portability and Accountability Act of 1996 ("HIPAA"), which
prohibit knowingly and willfully executing, or attempting to execute, a scheme to defraud any healthcare benefit program or obtain, by
means of false or fraudulent pretenses, representations, or promises, any of the money or property owned by, or under the custody or
control of, any healthcare benefit program, regardless of the payor (e.g., public or private) and knowingly and willfully falsifying,
concealing or covering up by any trick or device a material fact or making any materially false statements in connection with the delivery
of, or payment for, healthcare benefits, items or services relating to healthcare matters;

HIPAA, as amended by the Health Information Technology for Economic and Clinical Health Act of 2009 and their respective implementing
regulations, which imposes requirements on certain covered healthcare providers, health plans, and healthcare clearinghouses as well
as their respective business associates that perform services for them that involve the use, or disclosure of, individually identifiable
health information, relating to the privacy, security and transmission of individually identifiable health information;

the federal transparency requirements under The Patient Protection and Affordable Care Act and the Health Care and Education Reconciliation
Act, enacted into law in the United States in March 2010 (known collectively as the "Affordable Care Act"), including the
provision commonly referred to as the Physician Payments Sunshine Act, which requires manufacturers of drugs, biologics, devices and
medical supplies for which payment is available under Medicare, Medicaid or the Children's Health Insurance Program to report annually
to the U.S. Department of Health and Human Services information related to payments or other transfers of value made to physicians and
teaching hospitals, as well as ownership and investment interests held by physicians and their immediate family members; and

 - 43 -

state and federal consumer protection and unfair competition laws, which broadly regulate marketplace activities and activities that
potentially harm consumers.

we may be subject to state and non-U.S. equivalents of each of the healthcare laws described above, among others, some of which may be
broader in scope and may apply regardless of the payor. Many U.S. states have adopted laws similar to the federal Anti-Kickback Statute,
some of which apply to the referral of patients for healthcare services reimbursed by any source, not just governmental payors, including
private insurers. Several states impose marketing restrictions or require medical device companies to make marketing or price disclosures
to the state. There are ambiguities as to what is required to comply with these state requirements, and if we fail to comply with an
applicable state law requirement, we could be subject to penalties.

 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
future business activities could be subject to challenge under one or more of such laws. In addition, healthcare reform legislation has
strengthened these laws. For example, the Affordable Care Act, among other things, amended the intent requirement of the federal Anti-Kickback
and criminal healthcare fraud statutes. As a result of such amendment, a person or entity no longer needs to have actual knowledge of
these statutes or specific intent to violate them in order to have committed a violation. Moreover, the Affordable Care Act provides
that the government may assert that a claim including items or services resulting from a violation of the federal Anti-Kickback Statute
constitutes a false or fraudulent claim for purposes of the False Claims Act.

 Violations
of fraud and abuse laws may be punishable by criminal and/or civil sanctions, including penalties, fines and/or exclusion or suspension
from federal and state healthcare programs such as Medicare and Medicaid and debarment from contracting with the U.S. government. In
addition, private individuals have the ability to bring actions on behalf of the U.S. government under the False Claims Act as well,
as under the false claim laws of several states.

 Efforts
to ensure that our business arrangements with third parties comply with applicable healthcare laws and regulations will involve substantial
costs. It is possible that governmental authorities will conclude that our existing or future business practices do not comply with current
or future statutes, regulations or case law involving applicable fraud and abuse or other healthcare laws and regulations. Any such actions
instituted against us could have a significant adverse impact on our business, including the imposition of civil, criminal and administrative
penalties, damages, disgorgement, monetary fines, possible exclusion from participation in Medicare, Medicaid and other federal healthcare
programs, contractual damages, reputational harm, diminished profits and future earnings, and curtailment of our operations, any of which
could adversely affect our ability to operate our business and our results of operations. Even if we are successful in defending against
such actions, we may nonetheless be subject to substantial costs, reputational harm and adverse effects on our ability to operate our
business. In addition, the approval and commercialization of any of our products outside the United States will also likely subject us
to non-U.S. equivalents of the healthcare laws mentioned above, among other non-U.S. laws.

 If
any of our employees, agents, or the physicians or other providers or entities with whom we expect to do business are found to have violated
applicable laws, we may be subject to criminal, civil or administrative sanctions, including exclusions from government funded healthcare
programs, or, if we are not subject to such actions, we may suffer reputational harm for conducting business with persons or entities
found, or accused of being, in violation of such laws. Any such events could adversely affect our ability to operate our business and
our results of operations.

 - 44 -

 We
may be exposed to product liability claims and insurance may not be sufficient to cover these claims.

 We
may be exposed to product liability claims based on the use of any of our products, or products incorporating our licensed technology,
in the market or clinical trials. We may also be exposed to product liability claims based on the sale of any products under development
following the receipt of regulatory approval. Product liability claims could be asserted directly by consumers, health-care providers
or others. We have obtained product liability insurance coverage; however, such insurance may not provide full coverage for our future
clinical trials, products to be sold, and other aspects of our business. Insurance coverage is becoming increasingly expensive, and we
may not be able to maintain current coverage or expand our insurance coverage to include future clinical trials or the sale of new products
or existing products in new territories, at a reasonable cost or in sufficient amounts to protect against losses due to product liability
or at all. A successful product liability claim, or series of claims brought against us could result in judgments, fines, damages and
liabilities that could have a material adverse effect on our business, financial condition and results of operations. We may incur significant
expense investigating and defending these claims, even if they do not result in liability. Moreover, even if no judgments, fines, damages
or liabilities are imposed on us, our reputation could suffer, which could have a material adverse effect on our business, financial
condition and results of operations.

 Even
if one or more of our products are approved by the FDA, we may fail to obtain an adequate level of reimbursement for our products by
third party payors, such that there may be no commercially viable markets for our products, or the markets, may be much smaller than
expected.

 The
availability and levels of reimbursement by governmental and other third-party payors affect the market for our products. The efficacy,
safety, performance and cost-effectiveness of our products and of any competing products are factors that may impact the availability
and level of reimbursement. Reimbursement and healthcare payment systems in international markets vary significantly by country and include
both government sponsored healthcare and private insurance. To obtain reimbursement or pricing approval in some countries, we may be
required to produce clinical data, which may involve one or more clinical trials that compares the cost-effectiveness of our products
to other available therapies. We may not obtain international reimbursement or pricing approvals in a timely manner, if at all. Our failure
to receive international reimbursement or pricing approvals would negatively impact market acceptance of our products in the international
markets in which those approvals are sought.

 We
believe that future reimbursement may be subject to increased restrictions both in the U.S. and in international markets. There is increasing
pressure by governments worldwide to contain healthcare costs by limiting both the coverage and the level of reimbursement for therapeutic
products and by refusing, in some cases, to provide any coverage for products that have not been approved by the relevant regulatory
agency. Future legislation, regulation or reimbursement policies of third party payors may adversely affect the demand for our products
and limit our ability to sell our products on a profitable basis. In addition, third party payors continually attempt to contain or reduce
the costs of healthcare by challenging the prices charged for healthcare products and services. If reimbursement for our products is
unavailable or limited in scope or amount, or if pricing is set at unsatisfactory levels, market acceptance of our products would be
impaired, and future revenues, if any, would be adversely affected.

 In
the United States and European Union, our business could be significantly and adversely affected by healthcare reform initiatives and/or
other legislation or judicial interpretations of existing or future healthcare laws and/or regulations.

 The
Affordable Care Act, signed into law in the United States in March 2010, contains certain provisions which can be modified through the
regulatory process and for which it is unclear what the full impact and changes will be under the law.

 The
law also focuses on a number of provisions aimed at improving quality, broadening access to health insurance, enhancing remedies for
fraud and abuse, adding transparency requirements, and decreasing healthcare costs, among others. Uncertainties remain regarding what
negative unintended consequences these provisions will have on patient access to new technologies, pricing and the market for our products,
and the healthcare industry in general. The Affordable Care Act includes provisions affecting the Medicare program, such as value-based
payment programs, increased funding of comparative effectiveness research, reduced hospital payments for avoidable readmissions and hospital
acquired conditions, and pilot programs to evaluate alternative payment methodologies that promote care coordination (such as bundled
physician and hospital payments). Additionally, the provisions include a reduction in the annual rate of inflation for hospitals which
started in 2011 and the establishment of an independent payment advisory board to recommend ways of reducing the rate of growth in Medicare
spending. Any reduction in reimbursement from Medicare or other government programs may result in a similar reduction in payments from
private payors.

 - 45 -

 Since
its enactment, there have been judicial and Congressional challenges to certain aspects of the Affordable Care Act, to modify, repeal
or otherwise invalidate all, or certain provisions of, the Affordable Care Act. Following the enactment of the Tax Act, on December 14,
2018 in a case in the United States District Court for the Northern District of Texas, a federal judge ruled that the individual mandate
imposed by the Affordable Care Act is unconstitutional and inseverable from the other provisions of the Affordable Care Act and, therefore,
the remaining provisions of the Affordable Care Act are invalid. On November 10, 2020, the United States Supreme Court heard arguments
on whether the Affordable Care Act is constitutional, in whole or in part, and determined that the case lacked standing. The regulatory
process of implementation of the Affordable Care Act will remain ongoing and may also increase our regulatory burdens and operating costs.
Litigation and legislation related to the Affordable Care Act are likely to continue, with unpredictable and uncertain results. We cannot
predict with certainty what affect further changes to the Affordable Care Act, and other similar health care laws that are enacted, would
have on our business.

 In
addition, other legislative changes have been proposed and adopted since the Affordable Care Act was enacted. These changes included
aggregate reductions to Medicare payments to providers of up to two percent per fiscal year, which will remain in effect through 2027
unless additional Congressional action is taken. It is unclear what impact new quality and payment programs may have on our business,
financial condition, results of operations or cash flows. Individual states in the United States have also become increasingly aggressive
in passing legislation and implementing regulations designed to control product pricing, including price or patient reimbursement constraints,
and discounts, and require marketing cost disclosure and transparency measures. We believe that additional state and federal health care
reform measures may be adopted in the future that could have a material adverse effect on our industry generally and on our customers.
Any changes in, or uncertainty with respect to, future reimbursement rates could impact our customers' demand for our products,
which in turn could have a material adverse effect on our business, financial condition, results of operations, or cash flows. Further,
the federal, state and local governments, Medicare, Medicaid, managed care organizations, and foreign governments have in the past considered,
are currently considering, and may in the future consider healthcare policies and proposals intended to curb rising healthcare costs,
including those that could significantly affect both private and public reimbursement for healthcare services. Future significant changes
in the healthcare systems in the United States or other countries, including changes intended to reduce expenditures along with uncertainty
about whether and how changes may be implemented, could have a negative impact on the demand for our products. We are unable to predict
with certainty whether other healthcare policies, including policies stemming from legislation or regulations affecting our business,
may be proposed or enacted in the future; what effect such policies would have on our business; or the effect ongoing uncertainty about
these matters will have on our customers' purchasing decisions.

 We
cannot predict the impact that such actions against the Affordable Care Act and other laws enacted after its enactment will have on our
business, and there is uncertainty as to what healthcare programs and regulations may be implemented or changed at the federal and/or
state level in the United States, or the effect of any future legislation or regulation. Furthermore, we cannot predict what actions
the Biden administration will implement in connection with laws impacting us. However, it is possible that such initiatives could have
an adverse effect on our ability to obtain approval and/or successfully commercialize products in the United States in the future. For
example, any changes that reduce, or impede the ability to obtain, reimbursement for the type of products we intend to commercialize
in the United States (or our products more specifically, if approved) or reduce medical procedure volumes could adversely affect our
business plan to introduce our products in the United States.

 In
May 2017, the European parliament and the council of the European Union approved the MDR which has replaced the existing medical device
directives (93/42/EEC). The regulations entered into full application in May 26, 2021. The MDR provided a transitional period for placing on the market or putting into service of medical devices, which
period was further extended on March 20. 2023, but such transitional provisions are not relevant to our products where already certified
under the The MDR imposes
stricter requirements on medical device manufacturers and strengthens the supervising competences of the competent authorities of European
Union member states, the notified bodies and the authorized representatives. If we fail to comply with the modified regulation and requirements,
it can adversely affect our business, operating results and prospects. Any new regulations or revisions or reinterpretations of existing
regulations may impose additional costs or lengthen review times of future products.

 - 46 -

 Risk
Factors Related to Our Intellectual Property

 If
we are unable to obtain and maintain intellectual property protection covering our products, others may be able to make, use or sell
our products, which would adversely affect our revenue.

 Our
ability to protect our products from unauthorized or infringing use by third parties depends substantially on our ability to obtain and
maintain valid and enforceable patents. Similarly, the ability to protect our trademark rights might be important to prevent third party
counterfeiters from selling poor quality goods using our designated trademarks, and trade names. Due to evolving legal standards relating
to the patentability, validity and enforceability of patents covering medical devices and pharmaceutical inventions and the scope of
claims made under these patents, our ability to enforce patents is uncertain and involves complex legal and factual questions. Accordingly,
rights under any of our pending patent applications and patents may not provide us with commercially meaningful protection for our products
or may not afford a commercial advantage against our competitors or their competitive products or processes. In addition, patents may
not be issued from any pending or future patent applications owned by or licensed to us, and moreover, patents that may be issued to
us now or in the future may later be found invalid or unenforceable. Further, even if valid and enforceable, our patents may not be sufficiently
broad to prevent others from marketing products like ours, despite our patent rights.

 The
validity of our patent claims depends, in part, on whether prior art references exist that describe or render obvious our inventions
as of the filing date of our patent applications. We may not have identified all prior art, such as U.S. and foreign patents or published
applications or published scientific literature, that could adversely affect the patentability of our issued patents and pending patent
applications. For example, some material references may be in a foreign language and may not be uncovered during examination of our patent
applications. Additionally, patent applications in the United States are maintained in confidence for up to 18 months after their filing.
In some cases, however, patent applications remain confidential in the U.S. Patent and Trademark Office for the entire time prior to
issuance as a U.S. patent. Patent applications filed in countries outside the U.S. are not typically published until at least 18 months
from their first filing date. Similarly, publication of discoveries in the scientific or patent literature often lags behind actual discoveries.
Therefore, we cannot be certain that we were the first to invent, or the first to file patent applications relating to, our stent technologies
and related surgical technologies that we are developing. Third parties may initiate adversarial proceedings, known as an inter-partes
review (IPR) in the U.S. Patent and Trademark Office to challenge the validity of our patent claims in the United States. It is possible
that we may be unsuccessful in the proceedings, resulting in a loss of some portion or all of our patent rights in the United States.

 In
addition, statutory differences in patentable subject matter among jurisdictions may limit the protection we can obtain on certain of
the technologies we develop. The laws of some foreign jurisdictions do not offer the same protection to, or may make it more difficult
to effect the enforcement of, proprietary rights as in the United States. This risk may be exacerbated if we move our manufacturing to
certain countries in Asia. If we encounter such difficulties or are otherwise precluded from effectively protecting our intellectual
property rights in any foreign jurisdictions, our business prospects could be substantially harmed.

 Our
initiation of litigation to enforce our patent rights may prompt adversaries in such litigation to challenge the validity, scope, ownership,
or enforceability of our patents. Third parties can sometimes bring challenges against a patent holder to resolve these issues, as well.
If a court decides that any such patents are not valid, not enforceable, not wholly owned by us, or are of a limited scope, we may not
have the right to stop others from using our inventions. Also, even if our patent rights are determined by a court to be valid and enforceable,
they may not be sufficiently broad to prevent others from marketing products similar to ours or designing around our patents, despite
our patent rights, nor do they provide us with freedom to operate unimpeded by the patent and other intellectual property rights of others
that may cover our products. We may be forced into litigation to uphold the validity of the claims in our patent portfolio, as well as
our ownership rights to such intellectual property, and litigation is often an uncertain and costly process.

 We
may not be able to protect our trade secrets adequately. Although we rely on non-disclosure and confidentiality agreements with employees,
consultants and other parties to protect, in part, trade secrets and other proprietary technology, these agreements may be breached and
we may not have adequate remedies for such breach. Moreover, others may independently develop equivalent proprietary information, and
third parties may otherwise gain access to our trade secrets and proprietary knowledge. Any disclosure of confidential data into the
public domain or to third parties could allow competitors to learn our trade secrets and use the information in competition against us.

 - 47 -

 Intellectual
property rights of third parties could adversely affect our ability to commercialize our products and services, and we might be required
to litigate or obtain licenses from third parties in order to develop or market our products. Such litigation or licenses could be costly
or not available on commercially reasonable terms.

 It
is inherently difficult to conclusively assess our freedom to operate without infringing on third-party rights. Our competitive
position may be adversely affected if existing patents or patents resulting from patent applications issued to third parties or
other third-party intellectual property rights are held to cover our products or services or elements thereof, or our manufacturing
or uses relevant to our development plans. In such cases, we may not be in a position to develop or commercialize products or
services unless we successfully pursue litigation to nullify or invalidate the third-party intellectual property right concerned or
enter into a license agreement with the intellectual property right holder, if available on commercially reasonable terms. There may
also be pending patent applications that if they result in issued patents, could be alleged to be infringed by our new products or
services. If such an infringement claim should be brought and be successful, we may be required to pay substantial damages, be
forced to abandon our new products or services or seek a license from any patent holders. No assurances can be given that a license
will be available on commercially reasonable terms, if at all.

 It
is also possible that we have failed to identify relevant third-party patents or applications. For example, certain U.S. patent applications
that will not be filed outside the United States remain confidential until patents issue. Patent applications in the United States and
elsewhere are published approximately 18 months after the earliest filing for which priority is claimed, with such earliest filing date
being commonly referred to as the priority date. Therefore, patent applications covering our new products or services could have been
filed by others without our knowledge. Additionally, pending patent applications can, subject to certain limitations, be later amended
in a manner that could cover our services, our new products or the use of our new products. Third-party intellectual property right holders
may also actively bring infringement claims against us. We cannot guarantee that we will be able to successfully settle or otherwise
resolve such infringement claims. If we are unable to successfully settle future claims on terms acceptable to us, we may be required
to engage in or continue costly, unpredictable and time-consuming litigation and may be prevented from or experience substantial delays
in pursuing the development of and/or marketing our new products or services. If we fail in any such dispute, in addition to being forced
to pay damages, we may be temporarily or permanently prohibited from commercializing our new products or services that are held to be
infringing. We might, if possible, also be forced to redesign our new products so that we no longer infringe the third-party intellectual
property rights. Any of these events, even if we were ultimately to prevail, could require us to divert substantial financial and management
resources that we would otherwise be able to devote to our business.

 Patent
policy and rule changes could increase the uncertainties and costs surrounding the prosecution of our patent applications and the enforcement
or defense of any issued patents.

 Changes
in either the patent laws or interpretation of the patent laws in the United States and other countries may diminish the value of any
patents that may issue from our patent applications or narrow the scope of our patent protection. The laws of foreign countries may not
protect our rights to the same extent as the laws of the United States. Publications of discoveries in the scientific literature often
lag behind the actual discoveries, and patent applications in the United States and other jurisdictions are typically not published until
18 months after filing, or in some cases not at all. We therefore cannot be certain that we were the first to file the invention claimed
in our owned and licensed patent or pending applications, or that we or our licensor were the first to file for patent protection of
such inventions. Assuming all other requirements for patentability are met, in the United States prior to March 15, 2013, the first to
make the claimed invention without undue delay in filing, is entitled to the patent, while generally outside the United States, the first
to file a patent application is entitled to the patent. After March 15, 2013, under the Leahy-Smith America Invents Act, or the Leahy-Smith
Act, enacted on September 16, 2011, the United States has moved to a first to file system. The Leahy-Smith Act also includes a number
of significant changes that affect the way patent applications are prosecuted and also affect patent litigation. In general, the Leahy-Smith
Act and its implementation could increase the uncertainties and costs surrounding the prosecution of our patent applications and the
enforcement or defense of any issued patents, all of which could have a material adverse effect on our business and financial condition.

 - 48 -

 We
may be involved in lawsuits to protect or enforce our intellectual property, which could be expensive, time consuming, and unsuccessful.

 Competitors
may infringe our intellectual property. If we were to initiate legal proceedings against a third-party to enforce a patent covering one
of our products or services, the defendant could counterclaim that the patent covering our product is invalid and/or unenforceable. In
patent litigation in the United States, defendant counterclaims alleging invalidity and/or unenforceability are commonplace. Grounds
for a validity challenge could be an alleged failure to meet any of several statutory requirements, including lack of novelty, obviousness,
or non-enablement. Grounds for an unenforceability assertion could be an allegation that someone connected with prosecution of the patent
withheld relevant information from the United States Patent and Trademark Office, or USPTO, or made a misleading statement, during prosecution.
Under the Leahy-Smith Act, the validity of U.S. patents may also be challenged in post-grant and inter partes review proceedings before
the USPTO. The outcome following legal assertions of invalidity and unenforceability is unpredictable.

 Derivation
and interference proceedings initiated by third parties or brought by us may be necessary to determine the priority and ownership of
inventions and/or their scope with respect to our patent or patent applications or those of our licensors. An unfavorable outcome could
require us to cease using the related technology or to attempt to license rights to it from the prevailing party. Our business could
be harmed if the prevailing party does not offer us a license on commercially reasonable terms. Our defense of litigation or interference
proceedings may fail and, even if successful, may result in substantial costs and distract our management and other employees. In addition,
the uncertainties associated with litigation could have a material adverse effect on our ability to raise the funds necessary to continue
our clinical trials, continue our research programs, license necessary technology from third parties, or enter into development partnerships
that would help us bring our new products or services to market.

 Furthermore,
because of the substantial amount of discovery required in connection with intellectual property litigation, there is a risk that some
of our confidential information could be compromised by disclosure during this type of litigation. There could also be public announcements
of the results of hearings, motions, or other interim proceedings or developments. If securities analysts or investors perceive these
results to be negative, it could have a material adverse effect on the price of our shares of common stock.

 Risks
Related to Our Business Operations

 We
face risks associated with litigation and claims.

 We
have in the past and may, in the future, be involved in one or more lawsuits, claims or other proceedings. These suits could concern
issues including contract disputes, employment actions, employee benefits, taxes, environmental, health and safety, fraud and abuse,
personal injury and product liability matters.

 Our
business and operations would suffer in the event of computer system failures, cyber-attacks or deficiencies in our cyber-security.

 In
the ordinary course of our business, we collect and store sensitive data, including intellectual property, research data, our proprietary
business information and that of our suppliers, technical information about our products, clinical trial plans and employee records.
Similarly, our third-party providers possess certain of our sensitive data and confidential information. The secure maintenance of this
information is critical to our operations and business strategy. Despite the implementation of security measures, our internal computer
systems, and those of third parties on which we rely, are vulnerable to damage from computer viruses, malware, ransomware, cyber fraud,
natural disasters, terrorism, war, telecommunication and electrical failures, cyber-attacks or cyber-intrusions over the Internet, attachments
to emails, persons inside our organization, or persons with access to systems inside our organization. The risk of a security breach
or disruption, particularly through cyber-attacks or cyber intrusion, including by computer hackers, foreign governments, and cyber terrorists,
has generally increased as the number, intensity and sophistication of attempted attacks and intrusions from around the world have increased.
Any such breach could compromise our networks and the information stored there could be accessed, publicly disclosed, encrypted, lost
or stolen. Any such access, inappropriate disclosure of confidential or proprietary information or other loss of information, including
our data being breached at third-party providers, could result in legal claims or proceedings, liability or financial loss under laws
that protect the privacy of personal information, disruption of our operations or our product development programs and damage to our
reputation, which could adversely affect our business. For example, the loss of clinical trial data from completed or ongoing or planned
clinical trials could result in delays in our regulatory approval efforts and significantly increase our costs to recover or reproduce
the data.

 - 49 -

 The
loss of key members of our senior management team or our inability to attract and retain highly skilled scientists and laboratory and
field personnel could adversely affect our business.

 We
depend on the skills, experience and performance of our senior management and research personnel. The efforts of each of these persons
will be critical to us as we continue to further develop our products, increase sales and broaden our product offerings. If we were to
lose one or more of these key employees, we may experience difficulties in competing effectively, developing our technologies and implementing
our business strategies. Our research and development programs and commercial laboratory operations depend on our ability to attract
and retain highly skilled scientists and technicians. We may not be able to attract or retain qualified scientists and technicians in
the future due to the intense competition for qualified personnel among life science businesses. There can be no assurance that we will
be able to attract and retain necessary personnel on acceptable terms given the intense competition among medical device, biotechnology,
pharmaceutical and healthcare companies, universities and non-profit research institutions for experienced management, scientists, researchers,
sales and marketing and manufacturing personnel. If we are unable to attract, retain and motivate our key personnel to accomplish our
business objectives, we may experience constraints that will adversely affect our ability to support our operations, and our results
of operations may be materially and adversely affected.

 We
are an international business, and we are exposed to various global and local risks that could have a material adverse effect on our
financial condition and results of operations.

 We
operate globally and develop and market products in multiple countries. Consequently, we face complex legal and regulatory requirements
in multiple jurisdictions, which may expose us to certain financial and other risks. In addition, we are subject to global events beyond
our control, including war, public health crises, such as pandemics and epidemics, trade disputes and other international events. Any
of these changes could have a material adverse effect on our reputation, business, financial condition or results of operations.

 For
example, in the past we have been impacted by the COVID-19 pandemic which has caused interruptions or delays of our business plan. If
there is a renewed outbreak of COVID-19 it may result in restrictions and safety measures that could cause fluctuations in sales of our
products, ability to manufacture, as well as potential disruptions to our supply chain.

 International
sales and operations are subject to a variety of risks, including:

 foreign
 currency exchange rate fluctuations;

 greater
 difficulty in staffing and managing foreign operations;

 greater
 risk of uncollectible accounts;

 longer
 collection cycles;

 logistical
 and communications challenges;

 potential
 adverse changes in laws and regulatory practices, including export license requirements, trade barriers, tariffs and tax laws;

 changes
 in labor conditions;

 burdens
 and costs of compliance with a variety of foreign laws;

 political
 and economic instability;

 the
 escalation of hostilities in Israel, which could impair our ability to manufacture our products;

 - 50 -

 increases
 in duties and taxation;

 foreign
 tax laws and potential increased costs associated with overlapping tax structures;

 greater
 difficulty in protecting intellectual property;

 the
 risk of third party disputes over ownership of intellectual property and infringement of third party intellectual property by our
 products; and

 general
 economic and political conditions in these foreign markets.

 International
markets are also affected by economic pressure to contain reimbursement levels and healthcare costs. Profitability from international
operations may be limited by risks and uncertainties related to regional economic conditions, regulatory and reimbursement approvals,
competing products, infrastructure development, intellectual property rights protection and our ability to implement our overall business
strategy. We expect these risks will increase as we pursue our strategy to expand operations into new geographic markets. We may not
succeed in developing and implementing effective policies and strategies in each location where we conduct business. Any failure to do
so may harm our business, results of operations and financial condition.

 Environmental,
social and corporate governance (ESG) issues, including those related to climate change and sustainability, may have an adverse effect
on our business, financial condition and results of operations and damage our reputation.

 There
is an increasing focus from certain investors, customers, consumers, employees and other stakeholders concerning ESG matters. Additionally,
public interest and legislative pressure related to public companies' ESG practices continue to grow. If our ESG practices fail
to meet regulatory requirements or investor, customer, consumer, employee or other shareholders' evolving expectations and standards
for responsible corporate citizenship in areas including environmental stewardship, support for local communities, board of director
and employee diversity, human capital management, employee health and safety practices, product quality, supply chain management, corporate
governance and transparency, our reputation, brand and employee retention may be negatively impacted, and our customers and suppliers
may be unwilling to continue to do business with us.

 Customers,
consumers, investors and other shareholders are increasingly focusing on environmental issues, including climate change, energy and water
use, plastic waste and other sustainability concerns. Concern over climate change may result in new or increased legal and regulatory
requirements to reduce or mitigate impacts to the environment. Changing customer and consumer preferences or increased regulatory requirements
may result in increased demands or requirements regarding plastics and packaging materials, including single-use and non-recyclable plastic
products and packaging, other components of our products and their environmental impact on sustainability, or increased customer and
consumer concerns or perceptions (whether accurate or inaccurate) regarding the effects of substances present in certain of our products.
Complying with these demands or requirements could cause us to incur additional manufacturing, operating or product development costs.

 If
we do not adapt to or comply with new regulations, including the SEC's published proposed rules that would require companies to
provide significantly expanded climate-related disclosures in their periodic reporting, which may require us to incur significant additional
costs to comply and impose increased oversight obligations on our management and board of directors, or fail to meet evolving investor,
industry or stakeholder expectations and concerns regarding ESG issues, investors may reconsider their capital investment in our Company,
we may become subject to penalties, and customers and consumers may choose to stop purchasing our products, if approved for commercialization,
which could have a material adverse effect on our reputation, business or financial condition.

 - 51 -

 Our
business, operating results and growth rates may be adversely affected by current or future unfavorable economic and market conditions
and adverse developments with respect to financial institutions and associated liquidity risk.

 Our
business depends on the economic health of the global economies. If the conditions in the global economies remain uncertain or continue
to be volatile, or if they deteriorate, including as a result of the impact of military conflict, such as the war between Israel and
Hamas and Russia and Ukraine, terrorism or other geopolitical events, our business, operating results and financial condition may be
materially adversely affected. Economic weakness, inflation and increases in interest rates, limited availability of credit, liquidity
shortages and constrained capital spending have at times in the past resulted, and may in the future result, in challenging and delayed
sales cycles, slower adoption of new technologies and increased price competition, and could negatively affect our ability to forecast
future periods, which could result in an inability to satisfy demand for our products and a loss of market share.

 In
addition, increases in inflation raise our costs for commodities, labor, materials and services and other costs required to grow and
operate our business, and failure to secure these on reasonable terms may adversely impact our financial condition. Additionally, increases
in inflation, along with the uncertainties surrounding any resurgence of COVID-19, geopolitical developments and global supply chain
disruptions, have caused, and may in the future cause, global economic uncertainty and uncertainty about the interest rate environment,
which may make it more difficult, costly or dilutive for us to secure additional financing. A failure to adequately respond to these
risks could have a material adverse impact on our financial condition, results of operations or cash flows.

 There
can be no assurance that future credit and financial market instability and a deterioration in confidence in economic conditions will
not occur. Our general business strategy may be adversely affected by any such economic downturn, liquidity shortages, volatile business
environment or continued unpredictable and unstable market conditions. If the current equity and credit markets deteriorate, or if adverse
developments are experienced by financial institutions, it may cause short-term liquidity risk and also make any necessary debt or equity
financing more difficult, more costly, more onerous with respect to financial and operating covenants and more dilutive. Failure to secure
any necessary financing in a timely manner and on favorable terms could have a material adverse effect on our growth strategy, financial
performance and stock price and could require us to alter our operating plans. In addition, there is a risk that one or more of our service
providers, financial institutions, manufacturers, suppliers and other partners may be adversely affected by the foregoing risks, which
could directly affect our ability to attain our operating goals on schedule and on budget.

 We
are subject to financial reporting and other requirements that place significant demands on our resources.

 We
are subject to reporting and other obligations under the Securities Exchange Act of 1934, as amended, including the requirements of Section
404 of the Sarbanes-Oxley Act of 2002. Section 404 requires us to conduct an annual management assessment of the effectiveness of our
internal controls over financial reporting. These reporting and other obligations place significant demands on our management, administrative,
operational, internal audit and accounting resources. Any failure to maintain effective internal controls could have a material adverse
effect on our business, operating results and stock price. Moreover, effective internal control is necessary for us to provide reliable
financial reports and prevent fraud. If we cannot provide reliable financial reports or prevent fraud, we may not be able to manage our
business as effectively as we would if an effective control environment existed, and our business and reputation with investors may be
harmed.

 There
are inherent limitations in all control systems, and misstatements due to error or fraud may occur and not be detected.

 The
ongoing internal control provisions of Section 404 of the Sarbanes-Oxley Act of 2002 require us to identify material weaknesses in internal
control over financial reporting, which is a process to provide reasonable assurance regarding the reliability of financial reporting
for external purposes in accordance with accounting principles generally accepted in the United States. Our management, including our
chief executive officer and chief financial officer, does not expect that our internal controls and disclosure controls will prevent
all errors and all fraud. A control system, no matter how well conceived and operated, can provide only reasonable, not absolute, assurance
that the objectives of the control system are met. In addition, the design of a control system must reflect the fact that there are resource
constraints, and the benefit of controls must be relative to their costs. Because of the inherent limitations in all control systems,
no evaluation of controls can provide absolute assurance that all control issues and instances of fraud, if any, in our company have
been detected. These inherent limitations include the realities that judgments in decision-making can be faulty and that breakdowns can
occur because of simple errors or mistakes. Further, controls can be circumvented by individual acts of some persons, by collusion of
two or more persons, or by management override of the controls. The design of any system of controls is also based in part upon 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. Over time, a control may be inadequate because of changes in conditions, such as growth
of the company or increased transaction volume, or the degree of compliance with the policies or procedures may deteriorate. Because
of inherent limitations in a cost-effective control system, misstatements due to error or fraud may occur and not be detected.

 - 52 -

 In
addition, discovery and disclosure of a material weakness, by definition, could have a material adverse impact on our financial statements.
Such an occurrence could discourage certain customers or suppliers from doing business with us and adversely affect how our stock trades.
This could in turn negatively affect our ability to access equity markets for capital.

 Risks
Related to Operating in Israel

 We
anticipate being subject to fluctuations in currency exchange rates because we expect a substantial portion of our revenues will be generated
in Euros and U.S. dollars, while a significant portion of our expenses will be incurred in New Israeli Shekels.

 We
expect a substantial portion of our revenues will be generated in U.S. dollars and Euros, while a significant portion of our expenses,
principally salaries and related personnel expenses, is paid in New Israeli Shekels, or NIS. As a result, we are exposed to the risk
that the rate of inflation in Israel will exceed the rate of devaluation of the NIS in relation to the Euro or the U.S. dollar, or that
the timing of this devaluation will lag behind inflation in Israel. Because inflation has the effect of increasing the dollar and Euro
costs of our operations, it would therefore have an adverse effect on our dollar-measured results of operations. The value of the NIS,
against the Euro, the U.S. dollar, and other currencies may fluctuate and is affected by, among other things, changes in Israel's
political and economic conditions. Any significant revaluation of the NIS may materially and adversely affect our cash flows, revenues
and financial condition. Fluctuations in the NIS exchange rate, or even the appearance of instability in such exchange rate, could adversely
affect our ability to operate our business.

 If
there are significant shifts in the political, economic and military conditions in Israel and its neighbors, it could have a material
adverse effect on our business relationships and profitability.

 Our
executive office, sole manufacturing facility and certain of our key personnel are located in Israel. Our business is directly affected
by the political, economic and military conditions in Israel and its neighbors. Since the establishment of the State of Israel in 1948,
a number of armed conflicts have occurred between Israel and its Arab neighbors.

 In
October 2023, Hamas terrorists infiltrated Israel's southern border from the Gaza Strip and conducted a series of attacks on civilian
and military targets. Hamas also launched extensive rocket attacks on Israeli population and industrial centers located along Israel's
border with the Gaza Strip and in other areas within the State of Israel. These attacks resulted in extensive deaths, injuries and kidnapping
of civilians and soldiers. Following the attack, Israel's security cabinet declared war against Hamas and a military campaign against
these terrorist organizations commenced in parallel to their continued rocket and terror attacks. In addition, since the commencement
of these events, there have been continued hostilities along Israel's northern border with Lebanon (with the Hezbollah terror organization)
and southern border (with the Houthi movement in Yemen, as described below). It is possible that hostilities with Hezbollah in Lebanon
will escalate, and that other terrorist organizations, including Palestinian military organizations in the West Bank as well as other
hostile countries, such as Iran, will join the hostilities. Such clashes may escalate in the future into a greater regional conflict.

 In
connection with the Israeli security cabinet's declaration of war against Hamas and possible hostilities with other
organizations, several hundred thousand Israeli military reservists were drafted to perform immediate military service, including
five full time employees in Israel of ours. Although many of such military reservists have since been released, including all our
employees, they may be called up for additional reserve duty, depending on developments in the war in Gaza and along Israel's
other borders. Military service call ups that result in absences of personnel from us for an extended period of time may materially
and adversely affect our business, prospects, financial condition and results of operations. As of the date hereof, we currently
have 56 full-time employees located in Israel.

 - 53 -

 Since
the war broke out on October 7, 2023, our operations have not been adversely affected by this situation, and we have not experienced
disruptions to our clinical studies. None of the clinical sites currently participating in our clinical studies are located in Israel
however we currently manufacture our CGuard at our facility in Tel Aviv, Israel. If there were a disruption to our existing manufacturing
facility or our ability to procure raw materials and ship our products, we would have no other means of manufacturing and distributing CGuard until we were able to restore the manufacturing and distribution capability at our facility or develop alternative
manufacturing facilities and distribution capabilities.

 The
intensity and duration of Israel's current war against Hamas is difficult to predict at this stage, as are such war's economic
implications on the Company's business and operations and on Israel's economy in general. If the war extends for a long period
of time or expands to other fronts, such as Lebanon, Syria and the West Bank, our operations may be adversely affected.

 Our
commercial insurance does not cover losses that may occur as a result of events associated with war and terrorism. Although the Israeli
government currently covers the reinstatement value of direct damages that are caused by terrorist attacks or acts of war, we cannot
assure you that this government coverage will be maintained or that it will sufficiently cover our potential damages. Any losses or damages
incurred by us could have a material adverse effect on our business. Any armed conflicts or political instability in the region would
likely negatively affect business conditions and could harm our results of operations.

 The
continued political instability and hostilities between Israel and its neighbors and any future armed conflict, terrorist activity or
political instability in the region could adversely affect our operations in Israel and adversely affect the market price of our shares
of common stock. In addition, several organizations and countries may restrict doing business with Israel and Israeli companies have
been and are today subjected to economic boycotts. The interruption or curtailment of trade between Israel and its present trading partners
could adversely affect our business, financial condition and results of operations.

 Finally,
political conditions within Israel may affect our operations. Israel has held five general elections between 2019 and 2022, and prior
to October 2023, the Israeli government pursued extensive changes to Israel's judicial system, which sparked extensive political
debate and unrest. To date, these initiatives have been substantially put on hold. Actual or perceived political instability in Israel
or any negative changes in the political environment, may individually or in the aggregate adversely affect the Israeli economy and,
in turn, our business, financial condition, results of operations and growth prospects.

 We
may not be able to enforce covenants not-to-compete under current Israeli law.

 We
have non-competition agreements with most of our employees, many of which are governed by Israeli law. These agreements generally prohibit
our employees from competing with us or working for our competitors for a specified period following termination of their employment.
However, Israeli courts are reluctant to enforce non-compete undertakings of former employees and tend, if at all, to enforce those provisions
for relatively brief periods of time in restricted geographical areas and only when the employee has unique value specific to that employer's
business and not just regarding the professional development of the employee. Any such inability to enforce non-compete covenants may
cause us to lose any competitive advantage resulting from advantages provided to us by such confidential information.

 - 54 -

 We
may become subject to claims for remuneration or royalties for assigned service invention rights by our employees, which could result
in litigation and adversely affect our business.

 A
significant portion of our intellectual property has been developed by our Israeli employees in the course of their employment for us.
Under the Israeli Patent Law, 5727-1967 (the "Israeli Patent Law"), inventions conceived by an employee during the term and
as part of the scope of his or her employment with a company are regarded as "service inventions," which belong to the employer,
absent a specific agreement between the employee and employer giving the employee service invention rights. The Israeli Patent Law also
provides that if there is no such agreement between an employer and an employee, the Israeli Compensation and Royalties Committee (the
"C&R Committee"), a body constituted under the Israeli Patent Law, shall determine whether the employee is entitled to
remuneration for his inventions. The C&R Committee (decisions of which have been upheld by the Israeli Supreme Court) has held that
employees may be entitled to remuneration for their service inventions despite having specifically waived any such rights. We generally
enter into intellectual property assignment agreements with our employees pursuant to which such employees assign to us all rights to
any inventions created in the scope of their employment or engagement with us. Although our employees have agreed to assign to us service
invention rights and have specifically waived their right to receive any special remuneration for such assignment beyond their regular
salary and benefits, we may face claims demanding remuneration in consideration for assigned inventions. As a consequence of such claims,
we could be required to pay additional remuneration or royalties to our current or former employees, or be forced to litigate such claims,
which could negatively affect our business.

 It
may be difficult for investors in the United States to enforce any judgments obtained against us or some of our directors or officers.

 The
majority of our assets other than cash are located outside the U.S. In addition, certain of our officers are nationals and/or residents
of countries other than the U.S., and all or a substantial portion of such persons' assets are located outside the U.S. As a result,
it may be difficult for investors to enforce within the United States any judgments obtained against us or any of our non-U.S. officers,
including judgments predicated upon the civil liability provisions of the securities laws of the U.S. or any state thereof. Additionally,
it may be difficult to assert U.S. securities law claims in actions originally instituted outside of the U.S. Israeli courts may refuse
to hear a U.S. securities law claim because Israeli courts may not be the most appropriate forums in which to bring such a claim. Even
if an Israeli court agrees to hear a claim, it may determine that the Israeli law, and not U.S. law, is applicable to the claim. Further,
if U.S. law is found to be applicable, certain content of applicable U.S. law must be proved as a fact, which can be a time-consuming
and costly process, and certain matters of procedure would still be governed by the Israeli law. Consequently, you may be effectively
prevented from pursuing remedies under U.S. federal and state securities laws against us or any of our non-U.S. directors or officers.

 Risks
Related to Our Common Stock, Preferred Stock and Warrants

 The
market prices of our common stock are subject to fluctuation and have been and may continue to be volatile, which could result in substantial
losses for investors.

 The
market prices of our common stock have been and are likely to continue to be highly volatile and could fluctuate widely in response to
various factors, many of which are beyond our control, including the following:

 technological
 innovations or new products and services by us or our competitors;

 additions
 or departures of key personnel;

 our
 ability to execute our business plan;

 operating
 results that fall below expectations;

 loss
 of any strategic relationship;

 industry
 developments;

 economic,
 political and other external factors; and

 period-to-period
 fluctuations in our financial results.

 - 55 -

 In
addition, the securities markets have from time to time experienced significant price and volume fluctuations that are unrelated to the
operating performance of particular companies. These market fluctuations may also significantly affect the market prices of our common
stock.

 Our
common stock could be delisted from the Nasdaq Capital Market if we fail to meet the Nasdaq Capital Market's stockholders'
equity continued listing standards. Our ability to publicly or privately sell equity securities and the liquidity of our common stock
could be adversely affected if we are delisted from the Nasdaq Capital Market.

 Our
common stock is listed on the Nasdaq Capital Market, and we are therefore subject to its continued listing requirements, including requirements
with respect to the market value of publicly-held shares, market value of listed shares, minimum bid price per share, and minimum stockholders'
equity, among others, and requirements relating to board and committee independence. If we fail to satisfy one or more of the requirements,
we may be delisted from the Nasdaq Capital Market.

 Delisting
from the Nasdaq Capital Market may adversely affect our ability to raise additional financing through the public or private sale of equity
securities, may significantly affect the ability of investors to trade our securities and may negatively affect the value and liquidity
of our common stock. Delisting also could have other negative results, including the potential loss of employee confidence, the loss
of institutional investors or interest in business development opportunities.

 Delaware
law and our corporate charter and bylaws contain anti-takeover provisions that could delay or discourage takeover attempts that stockholders
may consider favorable.

 Our
board of directors is authorized to issue shares of preferred stock in one or more series and to fix the voting powers, preferences and
other rights and limitations of the preferred stock. Accordingly, we may issue shares of preferred stock with a preference over our common
stock with respect to dividends or distributions on liquidation or dissolution, or that may otherwise adversely affect the voting or
other rights of the holders of common stock. Issuances of preferred stock, depending upon the rights, preferences and designations of
the preferred stock, may have the effect of delaying, deterring or preventing a change of control, even if that change of control might
benefit our stockholders. In addition, we are subject to Section 203 of the Delaware General Corporation Law. Section 203 generally prohibits
a public Delaware corporation from engaging in a "business combination" with an "interested stockholder" for
a period of three years after the date of the transaction in which the person became an interested stockholder, unless (i) prior to the
date of the transaction, the board of directors of the corporation approved either the business combination or the transaction which
resulted in the stockholder becoming an interested stockholder; (ii) the interested stockholder owned at least 85% of the voting stock
of the corporation outstanding at the time the transaction commenced, excluding for purposes of determining the number of shares outstanding
(a) shares owned by persons who are directors and also officers and (b) shares owned by employee stock plans in which employee participants
do not have the right to determine confidentially whether shares held subject to the plan will be tendered in a tender or exchange offer;
or (iii) on or subsequent to the date of the transaction, the business combination is approved by the board and authorized at an annual
or special meeting of stockholders, and not by written consent, by the affirmative vote of at least 66, 2/3%, of the outstanding voting
stock which is not owned by the interested stockholder.

 Section
203 could delay or prohibit mergers or other takeover or change in control attempts with respect to us and, accordingly, may discourage
attempts to acquire us even though such a transaction may offer our stockholders the opportunity to sell their stock at a price above
the prevailing market price.

 We
have a staggered board of directors, which could impede an attempt to acquire us or remove our management.

 Our
board of directors is divided into three classes, each of which serves for a staggered term of three years. This division of our board
of directors could have the effect of impeding an attempt to take over our company or change or remove management, since only one class
will be elected annually. Thus, only approximately one-third of the existing board of directors could be replaced at any election of
directors.

 - 56 -

 As
a former shell company, resales of shares of our restricted common stock in reliance on Rule 144 of the Securities Act are subject to
the requirements of Rule 144(i).

 We
previously were a "shell company" and, as such, sales of our securities pursuant to Rule 144 under the Securities Act of
1933, as amended, cannot be made unless, among other things, at the time of a proposed sale, we are subject to the reporting requirements
of Section 13 or 15(d) of the Securities Exchange Act of 1934, as amended, and have filed all reports and other materials required to
be filed by Section 13 or 15(d) of the Securities Exchange Act of 1934 as amended, as applicable, during the preceding 12 months, other
than Form 8-K reports. Because, as a former shell company, the reporting requirements of Rule 144(i) will apply regardless of holding
period, restrictive legends on certificates for shares of our common stock cannot be removed except in connection with an actual sale
that is subject to an effective registration statement under, or an applicable exemption from the registration requirements of, the Securities
Act of 1933, as amended. Because our unregistered securities cannot be sold pursuant to Rule 144 unless we continue to meet such requirements,
any unregistered securities we issue will have limited liquidity unless we continue to comply with such requirements.

 If
securities and/or industry analysts fail to continue publishing research about our business, if they change their recommendations adversely
or if our results of operations do not meet their expectations, our stock price and trading volume could decline.

 The
trading market for our common stock will be influenced by the research and reports that industry or securities analysts publish about
us or our business. If one or more of these analysts cease coverage of our company or fail to publish reports on us regularly, we could
lose visibility in the financial markets, which in turn could cause our stock price or trading volume to decline. In addition, it is
likely that in some future period our operating results will be below the expectations of securities analysts or investors. If one or
more of the analysts who cover us downgrade our stock, or if our results of operations do not meet their expectations, our stock price
could decline.

 Aspects
of the tax treatment of the securities may be uncertain.

 The
tax treatment of our preferred stock and our warrants is uncertain and may vary depending upon whether you are an individual or a legal
entity and whether or not you are domiciled in the United States. In the event you are a non-U.S. investor, you should consult your tax
advisors as to the consequences, under the tax laws of the country where you are resident for tax purposes, of acquiring, holding and
disposing of our preferred stock and our warrants.

 Item
1B. Unresolved Staff Comments.

 Not

 Item
1C. Cybersecurity

 Risk
management and strategy

 We
have developed and maintain a cybersecurity risk management program that focuses primarily on securing and safeguarding computer systems,
networks, cloud services, business applications, and data and that is integrated in our overall risk management strategy and framework.
We have implemented protocols to protect against cyber threats and ensure the containment and security of sensitive business data, including
ongoing security reviews of critical systems, continuous monitoring of event data, and employee training programs, which processes are
aligned with our overall business and operational goals and strategies. Our risk assessment occurs on an ongoing basis and covers identification
of risks that could act against the company's objectives as well as specific risks related to a compromise to the security of data.

 We
engage a third-party to provide operational support for cybersecurity risks. This forms a critical part of our risk management strategy,
facilitating effective management and mitigation of risks, and ensuring adherence to applicable regulatory and industry standards.

 - 57 -

 Overall,
we believe that we have established a robust framework for confidentiality, integrity, and availability of information, adhering to relevant
security standards, practices, and compliance requirements. In addition, we maintain insurance to help protect against risks associated
with cybersecurity threats. As of the date of this report, we do not believe that any risks from cybersecurity threats have materially
affected, or are reasonably likely to materially affect, us, including our business strategy, results of operations, or financial condition.
However, despite our efforts, we cannot eliminate all risks from cybersecurity threats, or provide assurances that we have not experienced
an undetected cybersecurity incident. For more information about these risks, please see "Item 1.A – Risk Factors –
Risks Related to Our Business Operations – Our business and operations would suffer in the event of computer system failures, cyber-attacks
or deficiencies in our cyber-security." in this Form 10-K.

 Governance

 Our
board of directors provides oversight of our cybersecurity program and helps guide our strategy for managing cybersecurity risks in the
context of our overall risk management system. Our cybersecurity program is managed by our Senior Vice President of Finance, our internal
IT team and our external Chief Information Security Officer ("CISO") whose is responsible for leading enterprise-wide cybersecurity
strategy, protocols, framework, standards and processes. The Senior Vice President of Finance reports to our board of directors, as well
as our Chief Executive Officer and Chief Financial Officer and other members of senior management as appropriate.

 Item
2. Properties.

 Our
headquarters are located in Tel Aviv, Israel, where we lease a 1,700 square meter office and manufacturing facility that has the capacity
to manufacture and assemble 2,000 stents per month, based upon the production schedule of one shift per day. We believe that our current
facility is sufficient to meet anticipated future demand by adding additional shifts to our current production schedule.

 Item
3. Legal Proceedings.

 From
time to time, we may become involved in various lawsuits and legal proceedings, which arise in the ordinary course of business. Litigation
is subject to inherent uncertainties, and an adverse result in these or other matters may arise from time to time that may harm our business.
There are currently no pending material legal proceedings, and we are currently not aware of any legal proceedings or claims against
us or our property that we believe will have any significant effect on our business, financial position or operating results.

 Item
4. Mine Safety Disclosures.

 Not

 PART
II

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

 Market
Information

 Our
common stock has been quoted on the Nasdaq Capital Market ("Nasdaq") since May 21, 2021, under the symbol "NSPR."
The last reported sales price of our common stock on the Nasdaq on March 4, 2024, was $2.57 per share.

 Record
Holders

 As
of March 3, 2023, we had 278 stockholders of record of our common stock. This figure includes an indeterminate number of stockholders
who hold their shares in "street name."

 Dividends

 In
the past, we have not declared or paid cash dividends on our common stock. We do not intend to pay cash dividends in the future; rather,
we intend to retain future earnings, if any, to fund the operation and expansion of our business and for general corporate purposes.

 - 58 -

 The
holders of Series C Preferred Stock are not entitled to receive any dividends, unless and until specifically declared by our board of
directors. However, holders of our Series C Preferred Stock are entitled to receive dividends on shares of Series C Preferred Stock equal
(on an as-if-converted-to-common-stock basis, and without giving effect for such purposes to the 4.99% or 9.99% beneficial ownership
limitation, as applicable) to and in the same form as dividends actually paid on shares of the common stock when such dividends are specifically
declared by our board of directors. We are not obligated to redeem or repurchase any shares of Series C Preferred Stock. Shares of Series
C Preferred Stock are not otherwise entitled to any redemption rights, or mandatory sinking fund or analogous fund provision.

 Item
6. [Reserved]

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

 The
following discussion and analysis of our financial condition and results of operations should be read in conjunction with the accompanying
consolidated financial statements and related notes included elsewhere in this Annual Report on Form 10-K.

 Overview

 We
are a medical device company focusing on the development and commercialization of our proprietary MicroNet stent platform for
the treatment of carotid artery disease and other vascular disease. A stent is an expandable "scaffold-like" device, usually
constructed of a metallic material, that is inserted into the lumen of the artery to create patency and revascularization of blood flow.
MicroNet, a micron mesh sleeve, is attached over a stent to provide embolic protection both during and after stenting procedures.

 Our
CGuard EPS combines MicroNet and a unique self-expandable nitinol stent in a single device for use in carotid artery revascularization.
Our CGuard EPS originally received CE mark approval under the MDD in the EU in March 2013 and was fully launched in Europe in September
2015. Subsequently, we launched CGuard EPS in over 30 countries and on February 3, 2021, we executed a distribution agreement with Chinese
partners for the purpose of expanding our presence in the Asian markets. In January 2024, we received CE mark recertification under the
EU's Medical Device Regulation regulatory framework. Currently, we are seeking strategic partners for a potential launch of CGuard
EPS in Japan and other Asian countries.

 On
September 8, 2020, we received approval from the FDA of our IDE, thereby allowing us to proceed with a pivotal study of our CGuard
Carotid Stent System, C-GUARDIANS, for prevention of stroke in patients in the United States. C-GUARDIANS is a prospective, multicenter,
single-arm, pivotal study to evaluate the safety and efficacy of the CGuard Carotid Stent System when used to treat symptomatic
and asymptomatic carotid artery stenosis in patients undergoing CAS. The study, which completed enrollment in June 2023, enrolled 316
patients across 24 trial sites in the U.S. and Europe and from April 2023 included deployment of the CGuard stent using CGuard
Prime, our next generation CAS stent platform.

 The
primary endpoint is a composite of: (1) incidence of major adverse events including Death (all-cause mortality), any Stroke, and Myocardial
Infarction (DSMI) through 30-days post index procedure, or (2) ipsilateral stroke from day 31 to day 365 post-procedure. All events are
adjudicated by an independent clinical events committee. The composite index will be compared to a performance goal based on the observed
rate of the two components of the primary endpoint from previous pivotal stent trials which are considered industry standard. The performance
goal will be considered met if the upper bound of the two-sided 95% confidence interval calculated from the observed primary endpoint
rate is < 11.6% and the p-value is less than 0.025.

 In
November 2023, we announced positive 30-day follow up results from the C-GUARDIANS trial in which stenting with the C-Guard Carotid
Stent System in patients with carotid artery stenosis and at high risk for carotid endarterectomy had a DSMI rate of 0.95%, measured
from the date of the procedure through 30 days follow-up post-procedure. We anticipate reporting primary endpoint results from the
C-GUARDIANS trial in mid 2024 that may support the submission of a PMA application in the third quarter of 2024 with a view to
potential FDA approval of the CGuard Prime stent system in the first half of 2025.

 - 59 -

 We
continue to invest in current and future potential new indications, products and manufacturing enhancements for CGuard that are
expected to reduce cost of goods and/or provide the best-in-class performing delivery systems, such as CGuard Prime. In furtherance
of our strategy that focuses on establishing the CGuard Carotid Stent System as a viable alternative to vascular surgery, we are
developing a new transcarotid artery revascularization (TCAR) delivery system, SwitchGuard NPS, for transcarotid access and neuro
protection. In addition, we intend to explore new indications for CGuard to leverage the advantages of stent design and mesh
protection, well suited in labels such as acute stroke with tandem lesions.

 We
consider our current addressable market for our CGuard Carotid Stent System and SwitchGuard NPS to be both symptomatic and
asymptomatic individuals with diagnosed high-grade carotid artery stenosis) for whom intervention is preferable to medical (drug)
therapy. This group includes not only carotid artery stenting patients but also individuals undergoing carotid endarterectomy, as
the two approaches compete for the same patient population. Assuming full penetration of the intervention caseload by CGuard Carotid Stent System, we
estimate that the addressable market for CGuard Carotid Stent System and SwitchGuard NPS is approximately $1.3 billion (source: Health Research
International Personal Medical Systems, Inc. September 13, 2021 Results of Update Report on Global Carotid Stenting Procedures and
Markets by Major Geography and Addressable Markets and internal estimates). According to this same report and internal estimates,
assuming full penetration of treatment for all individuals diagnosed with high-grade carotid artery stenosis, we estimate the total
available market for CGuard Carotid Stent System and SwitchGuard NPS to be approximately $9.3 billion, which may grow over time if expanded treatment
options such as CGuard Carotid Stent System and SwitchGuard NPS lead to increased patient screening for carotid artery disease.

 Recent
Developments

 Private
Placement

 On
May 12, 2023, we entered into a securities purchase agreement (the "Purchase Agreement pursuant to which we agreed to sell and
issue in a private placement (the "Private Placement Offering) an aggregate of 10,266,270 shares (the "Private Placement
Shares") of our common stock, pre-funded warrants (the "Pre-Funded Warrants") to purchase up to 15,561,894 shares
of common stock and warrants to purchase up to an aggregate of 51,656,328 shares of common stock, consisting of Series H warrants to
purchase up to 12,914,078 shares of common stock (the "Series H Warrants"), Series I warrants to purchase up to
12,914,078 shares of common stock (the "Series I Warrants"), Series J warrants to purchase up to 12,914,086 shares of
Common Stock (the "Series J Warrants") and Series K warrants to purchase up to 12,914,078 shares of common stock (the
"Series K Warrants" and together with the Series H Warrants, Series I Warrants and Series J Warrants, the
"Warrants"), at an offering price of $1.6327 per Private Placement Share and associated Warrants and an offering price
of $1.6326 per Pre-Funded Warrant and associated Warrants.

 The
Pre-Funded Warrants will be immediately exercisable at an exercise price of $0.0001 per share and will not expire until exercised in
full. The Warrants will be immediately exercisable upon issuance at an exercise price of $1.3827 per share, subject to adjustment as
set forth therein. The Warrants have a term of the earlier of (i) five years from the date of issuance and (ii) (A) in the case of the
Series H Warrants, 20 trading days following the Company's public release of primary and secondary end points related to one year
follow up study results from the Company's C-GUARDIANS pivotal trial, (B) in the case of the Series I Warrants, 20 trading days
following the Company's announcement of receipt of Premarket Approval from the Food and Drug Administration ("FDA")
for the CGuard Prime Carotid Stent System (135 cm), (C) in the case of the Series J Warrants, 20 trading days following the Company's
announcement of receipt of FDA approval for the SwitchGuard and CGuard Prime 80 and (D) in the case on the Series K Warrants, 20 trading
days following the end of the fourth fiscal quarter after the fiscal quarter in which the first commercial sales of the CGuard Carotid
Stent System in the United States begins.

 - 60 -

 The
Warrants may be exercised on a cashless basis if there is no effective registration statement registering the shares underlying the Warrants.
Under the terms of the Pre-Funded Warrants and Warrants, certain of the selling stockholders may not exercise the Pre-Funded Warrants
or Warrants to the extent such exercise would cause such selling stockholder, together with its affiliates and attribution parties, to
beneficially own a number of shares of common stock which would exceed 4.99% or 9.99% of our then outstanding common stock following
such exercise, excluding for purposes of such determination common stock issuable upon exercise of the Pre-Funded Warrants or Warrants
which have not been exercised. The Warrants may be exercised into pre-funded warrants if the selling stockholder is unable to exercise
the Warrant due to the foregoing beneficial ownership limitation or at the selling shareholder's election.

 In
connection with the Purchase Agreement, we entered into a registration rights agreement (the "Registration Rights Agreement").
Pursuant to the Registration Rights Agreement, we were required to file a resale registration statement (the "Registration Statement")
with the SEC to register for resale the Private Placement Shares and the shares of common stock issuable upon exercise of the Pre-Funded
Warrants and Warrants, within 20 days of the signing date of the Purchase Agreement (the "Signing Date"), and to have such
Registration Statement declared effective within 45 days after the Signing Date in the event the Registration Statement is not reviewed
by the SEC, or 90 days of the Signing Date in the event the Registration Statement is reviewed by the SEC. We were obligated to pay certain
liquidated damages if we fail to file the Registration Statement when required, fails to cause the Registration Statement to be declared
effective by the SEC when required, of if we fail to maintain the effectiveness of the Registration Statement. The Registration Statement
was subsequently filed on May 23, 2023 and declared effective on June 1, 2023. We paid LifeSci Capital LLC, a placement fee equal to
5.6% of the aggregate gross proceeds from the closing of the Private Placement Offering, or approximately $2.4 million, and legal expenses
of $41,600. In addition, we paid Piper Sandler & Co. a financial advisory fee of $1.5 million, AGP/Alliance Global Partners a financial
advisory fee of $250,000 and lead investor counsel expenses of $125,000.

 Critical
Accounting Policies

 We
prepared our consolidated financial statements in accordance with U.S. Generally Accepted Accounting Principles ("U.S. GAAP").
U.S. GAAP represents a comprehensive set of accounting and disclosure rules and requirements, and applying these rules and requirements
requires management judgments and estimates including, in certain circumstances, choices between acceptable U.S. GAAP alternatives. The
following is a discussion of our most critical accounting policies, judgments and uncertainties that are inherent in our application
of U.S. GAAP.

 Use
of estimates

 The
preparation of financial statements in conformity with U.S. GAAP requires management to make estimates using assumptions that affect
the reported amounts of assets and liabilities, the disclosure of contingent assets and liabilities at the date of the financial statements
and the reported amounts of sales and expenses during the reporting periods. Actual results could differ from those estimates.

 As
applicable to these consolidated financial statements, the most significant estimates and assumptions relate to inventory valuations
and assessing the likelihood of exercise of options to extend the lease term.

 Marketable
securities

 Marketable
securities consist of debt securities. We elected the fair value option to measure and recognize our investments in debt securities in
accordance with ASC 825, Financial Instruments as we manage our portfolio and evaluates the performance on a fair value basis. Changes
in fair value, realized gains and losses on sales of marketable securities, are reflected in the statements of operation as finance expense
(income), net.

 Concentration
of credit risk and allowance for doubtful accounts

 Financial
instruments that may potentially subject us to a concentration of credit risk consist of cash and cash equivalents and short-term bank
deposits, which are deposited in major financially sound institutions in the U.S, Israel and Germany, and trade accounts receivable and
other receivables. Our trade accounts receivable is derived from revenues earned from customers from various countries. We perform ongoing
credit evaluations of our customers' financial condition and, requires no collateral from our customers. We also have a credit
insurance policy for some of our customers. We maintain the allowance for estimated losses resulting from the inability of our customers
to make required payments. The allowance represents the current estimate of lifetime expected credit losses over the remaining duration
of existing accounts receivable considering current market conditions and supportable forecasts when appropriate. The estimate is a result
of our ongoing evaluation of collectability, customer creditworthiness, historical levels of credit losses, and future expectations.
The allowance for expected credit losses was immaterial during the periods presented.

 - 61 -

 Inventory

 Inventories
are stated at the lower of cost (cost is determined on a "first-in, first-out" basis) or net realizable value. Our inventories
generally have a limited shelf life and are subject to impairment as they approach their expiration dates. We regularly evaluate the
carrying value of our inventories and when, based on such evaluation, factors indicate that impairment has occurred, we impair the inventories'
carrying value. In addition, we write-off fails in production based on actual and estimated.

 Leases

 Operating
leases are included in operating lease right-of-use ("ROU") assets, Accounts payable and accruals - Other, and operating
lease liabilities. ROU assets represent Company's right to use an underlying asset for the lease term and lease liabilities represent
obligation to make lease payments arising from the lease. Operating lease ROU assets and liabilities are recognized at the lease commencement
date based on the present value of lease payments over the lease term. In determining the present value of lease payments, we use the
incremental borrowing rate based on the information available at the lease commencement date as the rate implicit in the lease is not
readily determinable. The determination of the incremental borrowing rate requires management judgment based on information available
at lease commencement. The lease terms may include periods covered by options to extend the lease when it is reasonably certain that
we will exercise such options, and periods covered by options to terminate the lease when it is reasonably certain that we will not exercise
such options. Operating lease cost is recognized on a straight-line basis over the lease term. Lease agreements that include lease and
non-lease components are accounted for as a single lease component. The Company elected the short-term lease recognition exemption for
leases with a lease term of 12 months or less.

 Revenue
recognition

 A
contract with a customer exists only when: 1) the parties to the contract have approved it and are committed to perform their respective
obligations, 2) we can identify each party's rights regarding the distinct goods or services to be transferred ("Performance
Obligations"), 3) we can determine the transaction price for the goods or services to be transferred, 4) the contract has commercial
substance and 5) it is probable that we will collect the consideration to which it will be entitled in exchange for the goods or services
that will be transferred to the customer. Revenues are recorded in the amount of consideration to which we expect to be entitled in exchange
for Performance Obligations upon transfer of control to the customer, excluding sales taxes.

 Revenue
from sales of goods, including sales to distributors, is recognized when the customer obtains control of the product, once we have a
present right to payment, legal title, and risk and rewards of ownership are obtained by the customer. This occurs when products are
shipped.

 We
recognize the incremental costs of obtaining contracts as an expense since the amortization period of the assets that we otherwise would
have recognized is one year or less. The costs are recorded under selling and marketing expenses.

 We
recognize revenue net of value added tax (VAT).

 - 62 -

 Share-based
compensation

 Employee
option awards are classified as equity awards and accounted for using the grant-date fair value method. The fair value of share-based
awards is estimated using the Black-Scholes valuation model and expensed over the requisite service period, net of estimated forfeitures.
We elected to account for forfeitures as they occur.

 We
elected to recognize compensation expenses for awards with only service conditions that have graded vesting schedules using the accelerated
multiple option approach.

 The
attribution for nonemployee awards is in the same manner as if we had paid cash for the goods or services.

 In
addition, certain of our share-based awards to service providers are performance based, i.e., the vesting of these awards depends upon
achieving certain goals. We recognize compensation expenses for awards with performance conditions when we conclude that it is probable
that the performance condition will be achieved.

 Results
of Operations

 Twelve
months ended December 31, 2023 compared to the twelve months ended December 31, 2022

 Revenues.
For the twelve months ended December 31, 2023, revenue increased by $1,034,000, or 20.0%, to $6,205,000, from $5,171,000 during the
twelve months ended December 31, 2022. This increase was predominantly driven by a 21.1% increase in sales volume of CGuard EPS, from
$5,123,000 during the twelve months ended December 31, 2022, to $6,205,000 during the twelve months ended December 31, 2023. This sales
increase was mainly due to growth in existing and new markets.

 With
respect to regions, the increase in revenue was primarily attributable to a $1,036,000 increase in Europe, a $76,000 increase in Asia
and $24,000 increase in Latin America. This growth was mainly due to growth in existing and new markets. This increase was offset by
a $92,000 decline in revenue in the U.S. as less stents were used in our C-GUARDIANS FDA study as trial enrollment ended in June 2023
as well as a $10,000 decline in other markets.

 Gross
Profit. For the twelve months ended December 31, 2023, gross profit (revenue less cost of revenues) increased by 61.8%, or $690,000,
to $1,807,000, compared to a gross profit of $1,117,000 for the same period in 2022. This increase in gross profit resulted from a $484,000
increase in revenues less the associated related material and labor costs, a decrease in write-offs of $179,000 and a decrease of $27,000
in miscellaneous expenses. Gross margin (gross profits as a percentage of revenue) increased to 29.1% during the twelve months ended
December 31, 2023, from 21.6% during the twelve months ended December 31, 2022, driven by the reasons mentioned above.

 Research
and Development Expenses. For the twelve months ended December 31, 2023, research and development expenses increased by 2.2%, or
$171,000, to $7,981,000, from $7,810,000 during the twelve months ended December 31, 2022. This increase resulted primarily from an increase
of compensation expenses to employees and consultants of $638,000 mainly due to an increase of approximately $341,000 of share-based
compensation-related expenses due to the expense recognition of grants made during the second quarter of 2023, an increase of $165,000
in expenses related to the SwitchGuard regulatory and approval process, and an increase of $513,000 in miscellaneous expenses offset,
in part, by a decrease of $1,145,000 in expenses related to the C-GUARDIANS FDA study as we completed enrollment in June 2023.

 Selling
and Marketing Expenses. For the twelve months ended December 31, 2023, selling and marketing expenses increased by 5.5%, or $201,000,
to $3,865,000, from $3,664,000 during the twelve months ended December 31, 2022. This increase resulted primarily from an increase of
compensation expenses of $151,000 mainly due to an increase of share-based compensation-related expenses due to the expense recognition
of grants made during the second quarter of 2023 and an increase of $50,000 in miscellaneous expenses.

 General
and Administrative Expenses. For the twelve months ended December 31, 2023, general and administrative expenses increased by 32.9%,
or $2,748,000, to $11,104,000, from $8,356,000 during the twelve months ended December 31, 2022. This increase resulted primarily from
an increase in compensation expenses of $2,177,000, mainly due to an increase of approximately $1,585,000 of share-based compensation-related
expenses due to the expense recognition of grants made during the second quarter of 2023 and an increase in salary expenses and related
accruals of $592,000 mainly due to hiring of a General Manager of North America and VP of Global Marketing (who was subsequently promoted
to the Company's Chief Commercial Officer in the third quarter of 2023), an increase in legal expenses of $292,000 and an increase
of $279,000 in miscellaneous expenses.

 - 63 -

 Financial
Income (Expenses). For the twelve months ended December 31, 2023, financial income increased by $1,042,000, to $1,292,000 from $250,000
during the twelve months ended December 31, 2022. The increase in financial income primarily resulted from a $1,152,000 increase in interest
income from investment in marketable securities, money market funds and short-term bank deposits.

 Tax
Expenses. For the twelve months ended December 31, 2023, tax increased by $37,000 compared to the twelve months ended December 31,
2022. Our expenses for income taxes reflect primarily the tax liability due to potential tax exposure.

 Net
Loss. Our net loss increased by $1,425,000, or 7.7%, to $19,916,000 for the twelve months ended December 31, 2022, from $18,491,000
during the twelve months ended December 31, 2022. The increase in net loss resulted primarily from an increase of $3,120,000 in operating
expenses, offset by an increase of $1,042,000 in financial income and increase of $690,000 in gross profit.

 Liquidity
and Capital Resources

 As
of the date of issuance of the consolidated financial statements, we have the ability to fund our planned operations for at least the
next 12 months. However, we expect to continue incurring losses and negative cash flows from operations until our products (primarily
CGuard reaches commercial profitability. Therefore, in order to fund our operations until such time that we can generate substantial
revenues, we may need to raise additional funds.

 Our
plans include continued commercialization of our products and raising capital through sale of additional equity securities, debt or capital
inflows from strategic partnerships. There are no assurances, however, that we will be successful in obtaining the level of financing
needed for our operations. If we are unsuccessful in commercializing our products or raising capital, we may need to reduce activities,
curtail or cease operations.

 In
May 2023, we closed a Private Placement Offering that resulted in aggregate gross proceeds of approximately $42.2 million, before deducting
fees payable to the placement agent and other offering expenses payable by the Company. If the Warrants from the Private Placement Offering
are exercised in cash in full this would result in an additional $71.4 million of gross proceeds. There can be no assurance that we will
achieve any of the milestones set forth in the Warrants or that the Warrants will be exercised in cash in full.

 Twelve
months ended December 31, 2023 compared to the twelve months ended December 31, 2022

 General.
At December 31, 2023, we had cash and cash equivalents of $9,640,000 and marketable securities of $29,383,000 as compared to $4,632,000
of cash and cash equivalents and $13,171,000 Short-term bank deposits as of December 31, 2022. We have historically met our cash needs
through a combination of issuing new shares, borrowing activities and product sales. Our cash requirements are generally for research
and development, marketing and sales activities, finance and administrative cost, capital expenditures and general working capital.

 For
the twelve months ended December 31, 2023, net cash used in our operating activities increased by $834,000 to $16,376,000, from $15,542,000
during the same period in 2022. The primary reason for the increase in cash used in our operating activities was an increase of $731,000
in payments for third party related expenses and for professional services, an increase of $937,000 in salary and bonus payments from
$8,558,000 in the twelve months ended December 31, 2022 to $9,495,000 during the same period in 2022, offset, in part, by an increase
of $137,000 in payments received from customers to $5,470,000 during the twelve months ended December 31, 2023, from $5,333,000 during
the same period in 2022 and an increase of $697,000 in interest income received from marketable securities, money market funds and short-term
bank deposits

 Cash
used by our investing activities was $16,092,000 during the twelve months ended December 31, 2023, compared to cash provided by our investing
activities of $8,441,000 during the twelve months ended December 31, 2022. The primary reason for the increase in cash used by our investing
activities is an investment in marketable securities, net of withdrawal of $28,644,000, offset by an increase in withdrawal from short-term
bank deposits, net of investment in short-term deposits, of $4,000,000, and a decrease of $92,000 in payments made for purchase of property,
plant and equipment during the twelve months ended December 31, 2023.

 - 64 -

 Cash
provided by financing activities for the twelve months December 31, 2023, was $37,534,000. The principal source of the cash provided
by financing activities during the twelve months ended December 31, 2023 were the proceeds from the Private Placement Offering in May
2023 that resulted in approximately $37,534,000 of aggregate net proceeds. Cash used by financing activities for the twelve months ended
December, 2022 was $140,000, the cash used by financing activities during the twelve months ended December, 2022 were due to issuance
costs associated with a shelf registration statement on Form S-3 filed with the SEC on June 3, 2022.

 As
of December 31, 2023, our current assets exceeded our current liabilities by a multiple of 7.3. Current assets increased by $22,833,000
during the period and current liabilities increased by $950,000 during the period. As a result, our working capital increased by $21,883,000
to $38,139,000 as of December 31, 2023.

 Contractual
Obligations

 Operating
lease payments represent our commitment for future rent made under non-cancelable lease for our offices in Israel. The total future payments
for our operating lease obligation at December 31, 2023 were approximately $1,815,000 and are due in the next twelve months. For additional
details regarding our lease, see Note 7_ to our consolidated financial statements included in this Annual Report on Form 10-K.

 Off
Balance Sheet Arrangements

 We
have no off-balance sheet transactions, arrangements, obligations (including contingent obligations), or other relationships with unconsolidated
entities or other persons that have, or may have, a material effect on our financial condition, changes in financial condition, revenues
or expenses, results of operations, liquidity, capital expenditures or capital resources.

 Recent
Accounting Pronouncements

 In
June 2016, the FASB issued ASU 2016-13, Financial Instruments-Credit Losses (Topic 326)-Measurement of Credit Losses on Financial Instruments.
This guidance replaces the current incurred loss impairment methodology. Under the new guidance, on initial recognition and at each reporting
period, an entity is required to recognize an allowance that reflects its current estimate of credit losses expected to be incurred over
the life of the financial instrument based on historical experience, current conditions and reasonable and supportable forecasts. In
November 2019, the FASB issued ASU No. 2019-10, Financial Instruments - Credit Losses (Topic 326), Derivatives and Hedging (Topic 815),
and Leases (Topic 842): Effective Dates ("ASU 2019-10"). The purpose of this amendment is to create a two tier rollout of
major updates, staggering the effective dates between larger public companies and all other entities. This granted certain classes of
companies, including Smaller Reporting Companies ("SRCs"), additional time to implement major FASB standards, including ASU
2016-13. Larger public companies had an effective date of December 15, 2019, including interim periods within those fiscal years. +All
other entities are permitted to defer adoption of ASU 2016-13, and its related amendments, until the earlier of fiscal periods beginning
after December 15, 2022. Under the current SEC definitions, we meet the definition of an SRC and are adopting the deferral period for
ASU 2016-13. The guidance requires a modified retrospective transition approach through a cumulative-effect adjustment to retained earnings
as of the beginning of the period of adoption. We adopted the provisions of this update as of January 1, 2023 with no material impact
on our consolidated financial statements.

 - 65 -

 In
November 2023, the FASB issued ASU 2023-07 "Segment Reporting: Improvements to Reportable Segment Disclosures". This
guidance expands public entities 'segment disclosures primarily by requiring disclosure of significant segment expenses that
are regularly provided to the chief operating decision maker and included within each reported measure of segment profit or loss, an
amount and description of its composition for other segment items, and interim disclosures of a reportable segment's profit or
loss and assets. Public entities with a single reportable segment are required to provide the new disclosures and all the
disclosures required under ASC 280. The guidance is effective for fiscal years beginning after December 15, 2023, and interim
periods within fiscal years beginning after December 15, 2024, with early adoption permitted. The amendments are required to be
applied retrospectively to all prior periods presented in an entity's financial statements. We are currently evaluating this
guidance to determine the impact it may have on our consolidated financial statements related disclosures. In December 2023, the
FASB issued ASU 2023-09 "Income Taxes (Topic 740): Improvements to Income Tax Disclosures". This guidance is intended to
enhance the transparency and decision-usefulness of income tax disclosures. The amendments in ASU 2023-09 address investor requests
for enhanced income tax information primarily through changes to disclosure regarding rate reconciliation and income taxes paid both
in the U.S. and in foreign jurisdictions. ASU 2023-09 is effective for fiscal years beginning after December 15, 2024 on a
prospective basis, with the option to apply the standard retrospectively. Early adoption is permitted. We are currently evaluating
this guidance to determine the impact it may have on our consolidated financial statements related disclosures.

 Factors
That May Affect Future Operations

 We
believe that our future operating results will continue to be subject to quarterly variations based upon a wide variety of factors, including
the cyclical nature of the ordering patterns of our distributors, timing of regulatory approvals, the implementation of various phases
of our clinical trials and manufacturing efficiencies due to the learning curve of utilizing new materials and equipment. Our operating
results could also be impacted by a weakening of the Euro and strengthening of the NIS, both against the U.S. dollar. Lastly, other economic
conditions we cannot foresee may affect customer demand, such as individual country reimbursement policies pertaining to our products.

 Item
7A. Quantitative and Qualitative Disclosures About Market Risk.

 Not

 Item
8. Financial Statements and Supplementary Data.

 The
following financial statements are included as part of this Report (See Item 15):

 Report of Kesselman & Kesselman, Independent Registered Public Accounting Firm

 Consolidated Balance Sheets as of December 31, 2023 and 2021

 Consolidated Statements of Operations for the Years Ended December 31, 2023 and 2021

 Consolidated Statements of Changes in Equity for the Years Ended December 31, 2023 and 2021

 Consolidated Statements of Cash Flows for the Years Ended December 31, 2023 and 2021

 Notes to Consolidated Financial Statements

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

 Not

 Item
9A. Controls and Procedures.

 Management's
Conclusions Regarding Effectiveness of Disclosure Controls and Procedures

 We
conducted an evaluation of the effectiveness of our "disclosure controls and procedures", as defined by Rules 13a-15(e) and
15d-15(e) of the Securities Exchange Act of 1934, as amended, as of December 31, 2023, the end of the period covered by this Annual Report
on Form 10-K. The disclosure controls and procedures evaluation was done under the supervision and with the participation of management,
including our chief executive officer and chief financial officer. There are inherent limitations to the effectiveness of any system
of disclosure controls and procedures. Accordingly, even effective disclosure controls and procedures can only provide reasonable assurance
of achieving their control objectives. Based upon this evaluation, our chief executive officer and chief financial officer have concluded
that our disclosure controls and procedures were effective at the reasonable assurance level as of December 31, 2023.

 - 66 -

 Management's
Report on Internal Control Over Financial Reporting

 Management
is responsible for establishing and maintaining adequate internal control over financial reporting, as defined in Rules 13a-15(f) and
15d-15(f) under the Securities Exchange Act of 1934, as amended. Our internal control over financial reporting is designed to provide
reasonable assurance regarding the reliability of financial reporting and the preparation of the consolidated financial statements for
external reporting purposes in accordance with generally accepted accounting principles.

 Because
of its inherent limitations, internal control over financial reporting may not prevent or detect misstatements. Also, projections of
any evaluation of effectiveness of internal control over financial reporting to future periods are subject to the risk that controls
may become inadequate because of changes in conditions or that the degree of compliance with the policies or procedures may deteriorate
over time.

 Management,
including our chief executive officer and our chief financial officer, assessed the effectiveness of our internal control over financial
reporting as of December 31, 2023. In making this assessment, management used the criteria set forth by the Committee of Sponsoring Organizations
of the Treadway Commission in Internal Control—Integrated Framework 2013. Based on its assessment and those criteria, management
has concluded that we maintained effective internal control over financial reporting as of December 31, 2023.

 Changes
in Internal Control over Financial Reporting

 There
have been no changes in our internal control over financial reporting during the fiscal quarter ended December 31, 2023, that have materially
affected, or are reasonably likely to materially affect, our internal control over financial reporting.

 Item
9B. Other Information.

 None.

 Item
9C. Disclosure Regarding Foreign Jurisdictions that Prevent Inspections.

 Not

 PART
III

 Item
10. Directors, Executive Officers and Corporate Governance.

 Code
of Ethics

 We
have adopted a code of ethics and business conduct that applies to our officers, directors and employees, including our principal executive
officer, principal financial officer and principal accounting officer, which is posted on our website at www.inspiremd.com. We
intend to disclose future amendments to certain provisions of the code of ethics, or waivers of such provisions granted to executive
officers and directors, on this website within four business days following the date of such amendment or waiver.

 Other
Information

 The
remaining information required by this Item 10 will be included in our definitive Proxy Statement for the 2024 Annual Meeting of Stockholders
and is incorporated herein by reference.

 Item
11. Executive Compensation.

 The
information required by this Item 11 will be included in our definitive Proxy Statement for the 2024 Annual Meeting of Stockholders and
is incorporated herein by reference.

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

 The
information required by this Item 12 will be included in our definitive Proxy Statement for the 2024 Annual Meeting of Stockholders and
is incorporated herein by reference.

 - 67 -

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

 The
information required by this Item 13 will be included in our definitive Proxy Statement for the 2024 Annual Meeting of Stockholders and
is incorporated herein by reference.

 Item
14. Principal Accountant Fees and Services.

 The
information required by this Item 13 will be included in our definitive Proxy Statement for the 2024 Annual Meeting of Stockholders and
is incorporated herein by reference.

 PART
IV

 Item
15. Exhibits and Financial Statement Schedules.

 Documents
filed as part of report:

 1.
 Financial Statements

 The
following financial statements are included herein:

 Report of Kesselman & Kesselman, Independent Registered Public Accounting Firm

 Consolidated Balance Sheets as of December 31, 2023 and 2022

 Consolidated Statements of Operations for the Years Ended December 31, 2023 and 2022

 Consolidated Statements of Changes in Equity for the Years Ended December 31, 2023 and 2022

 Consolidated Statements of Cash Flows for the Years Ended December 31, 2023 and 2022

 Notes to Consolidated Financial Statements

 2.
 Financial Statement Schedules

 None

 3.
 Exhibits

 See
Index to Exhibits

 Item
16. Form 10-K Summary

 Not

 - 68 -

to Exhibits

 Exhibit
 No.

 Description

 3.1

 Amended and Restated Certificate of Incorporation (incorporated by reference to Exhibit 3.1 to Quarterly Report on Form 10-Q filed with the Securities and Exchange Commission on November 9, 2015)

 3.2

 Amended and Restated Bylaws (incorporated by reference to Exhibit 3.2 to Current Report on Form 8-K filed with the Securities and Exchange Commission on June 29, 2021).

 3.3

 Certificate of Amendment to Amended and Restated Certificate of Incorporation of InspireMD, Inc. (incorporated by reference to Exhibit 3.1 to the Current Report on Form 8-K filed on May 25, 2016)

 3.4

 Certificate of Amendment to Amended and Restated Certificate of Incorporation of InspireMD, Inc. (incorporated by reference to Exhibit 3.1 to the Current Report on Form 8-K filed on September 29, 2016)

 3.5

 Certificate of Designation of Preferences, Rights and Limitations of Series C Convertible Preferred Stock (incorporated by reference to Exhibit 3.1 to the Current Report on Form 8-K filed on March 15, 2017)

 3.6

 Certificate of Amendment to Certificate of Designation of Preferences, Rights and Limitation of Series C Convertible Preferred Stock (incorporated by reference to Exhibit 3.1 to the Current Report on Form 8-K filed on November 29, 2017)

 3.7

 Certificate of Amendment to Certificate of Designation of Preferences, Rights and Limitation of Series B Convertible Preferred Stock (incorporated by reference to Exhibit 3.1 to the Current Report on Form 8-K filed on December 12, 2017)

 3.8

 Certificate of Amendment to Amended and Restated Certificate of Incorporation of InspireMD, Inc. (incorporated by reference to Exhibit 3.1 to the Current Report on Form 8-K filed on February 7, 2018)

 3.9

 Certificate of Amendment to Certificate of Designation of Preferences, Rights and Limitation of Series D Convertible Preferred Stock (incorporated by reference to Exhibit 3.1 to the Current Report on Form 8-K filed on March 1, 2018)

 3.10

 Certificate of Amendment to Certificate of Designation of Preferences, Rights and Limitation of Series D Convertible Preferred Stock (incorporated by reference to Exhibit 3.1 to the Current Report on Form 8-K filed on April 3, 2018)

 3.11

 Certificate of Amendment to Amended and Restated Certificate of Incorporation of InspireMD, Inc., dated March 27, 2019 (incorporated by reference to Exhibit 3.1 to the Current Report on Form 8-K filed on March 28, 2019)

 3.12

 Certificate of Amendment to Amended and Restated Certificate of Incorporation of InspireMD, Inc., dated April 14, 2021 (incorporated by reference to Exhibit 3.1 to Quarterly Report on Form 10-Q filed with the Securities and Exchange Commission on May 10, 2021)

 3.13

 Form of Common Stock Certificate (incorporated by reference to Exhibit 4.1 to Amendment No. 3 to Registration Statement on Form S-1 filed with the Securities and Exchange Commission on March 5, 2013)

 3.15

 Form of Series B Warrant Agent Agreement and Form of Series B Warrant (incorporated by reference to Exhibit 4.3 to Amendment No.3 to Registration Statement on Form S-1 filed with the Securities and Exchange Commission on March 6, 2017)

 4.1*

 Description of Securities

 - 69 -

 10.1+

 Form of Indemnity Agreement between InspireMD, Inc. and each of the directors and executive officers thereof (incorporated by reference to Exhibit 10.22 to Amendment No. 1 to Registration Statement on Form S-1 filed with the Securities and Exchange Commission on August 26, 2011)

 10.2+

 InspireMD, Inc. 2013 Long-Term Incentive Plan (incorporated by reference to Exhibit 10.1 to Current Report on Form 8-K filed with the Securities and Exchange Commission on December 20, 2013)

 10.3+

 Amended and Restated Employment Agreement, dated May 5, 2014, by and between InspireMD, Inc. and Craig Shore (incorporated by reference to Exhibit 10.2 to Quarterly Report on Form 10-Q filed with the Securities and Exchange Commission on May 7, 2014)

 10.4+

 First Amendment to the InspireMD, Inc. Amended and Restated 2011 UMBRELLA Option Plan (incorporated by reference to Exhibit 10.3 to Quarterly Report on Form 10-Q filed with the Securities and Exchange Commission on May 7, 2014)

 10.5+

 Form of Incentive Stock Option Award Agreement under the InspireMD, Inc. 2013 Long-Term Incentive Plan (incorporated by reference to Exhibit 99.2 to Registration Statement on Form S-8 filed with the Securities and Exchange Commission on June 5, 2014)

 10.6+

 Form of Nonqualified Stock Option Award Agreement under the InspireMD, Inc. 2013 Long-Term Incentive Plan (incorporated by reference to Exhibit 99.3 to Registration Statement on Form S-8 filed with the Securities and Exchange Commission on June 5, 2014)

 10.7+

 Form of Restricted Stock Award Agreement under the InspireMD, Inc. 2013 Long-Term Incentive Plan (incorporated by reference to Exhibit 99.4 to Registration Statement on Form S-8 filed with the Securities and Exchange Commission on June 5, 2014)

 10.8+

 Form of Restricted Stock Unit Award Agreement under the InspireMD, Inc. 2013 Long-Term Incentive Plan (incorporated by reference to Exhibit 99.5 to Registration Statement on Form S-8 filed with the Securities and Exchange Commission on June 5, 2014)

 10.9+

 Form of Section 3(i) Stock Option Award Agreement under the InspireMD, Inc. 2013 Long-Term Incentive Plan (Israeli) (incorporated by reference to Exhibit 99.6 to Registration Statement on Form S-8 filed with the Securities and Exchange Commission on June 5, 2014)

 10.10+

 Form of Section 102 Capital Gain Stock Option Award Agreement under the InspireMD, Inc. 2013 Long-Term Incentive Plan (Israeli) (incorporated by reference to Exhibit 99.7 to Registration Statement on Form S-8 filed with the Securities and Exchange Commission on June 5, 2014)

 10.11+

 Form of Section 102 Capital Gain Restricted Stock Award Agreement under the InspireMD, Inc. 2013 Long-Term Incentive Plan (Israeli) (incorporated by reference to Exhibit 99.8 to Registration Statement on Form S-8 filed with the Securities and Exchange Commission on June 5, 2014)

 10.12+

 Form of Stock Option Award Agreement under the InspireMD, Inc. 2013 Long-Term Incentive Plan (European) (incorporated by reference to Exhibit 99.9 to Registration Statement on Form S-8 filed with the Securities and Exchange Commission on June 5, 2014)

 10.13+

 Form of Restricted Stock Award Agreement under the InspireMD, Inc. 2013 Long-Term Incentive Plan (European) (incorporated by reference to Exhibit 99.10 to Registration Statement on Form S-8 filed with the Securities and Exchange Commission on June 5, 2014)

 - 70 -

 10.14+

 Form of Stock Option Award Agreement outside the InspireMD, Inc. 2013 Long-Term Incentive Plan (incorporated by reference to Exhibit 99.11 to Registration Statement on Form S-8 filed with the Securities and Exchange Commission on June 5, 2014)

 10.15+

 First Amendment to Amended and Restated Employment Agreement, dated January 5, 2015, by and between InspireMD, Inc. and Craig Shore (incorporated by reference to Exhibit 10.3 to Current Report on Form 8-K filed with the Securities and Exchange Commission on January 6, 2015)

 10.16+

 First Amendment to the InspireMD, Inc. 2013 Long-Term Incentive Plan (incorporated by reference to Exhibit 10.1 to the Current Report on Form 8-K filed on September 9, 2015)

 10.17+

 Second Amendment to the InspireMD, Inc. 2013 Long-Term Incentive Plan (incorporated by reference to Exhibit 10.1 to the Current Report on Form 8-K filed on May 25, 2016)

 10.18+

 Second Amendment to Amended and Restated Employment Agreement, dated July 25, 2016, by and between InspireMD, Inc. and Craig Shore agent (incorporated by reference to Exhibit 10.1 to the Current Report on Form 8-K filed on July 29, 2016)

 10.19+

 Third Amendment to the InspireMD, Inc. 2013 Long-Term Incentive Plan (incorporated by reference to Exhibit 10.1 to the Current Report on Form 8-K filed on September 29, 2016)

 10.20+

 Director Offer Letter, between InspireMD, Inc. and Thomas J. Kester, dated September 6, 2016

 10.21+

 Fourth Amendment to the InspireMD, Inc. 2013 Long-Term Incentive Plan (incorporated by reference to Exhibit 10.1 to the Current Report on Form 8-K filed on October 26, 2018)

 10.22+

 Fifth Amendment to the InspireMD, Inc. 2013 Long-Term Incentive Plan (incorporated by reference to Exhibit 10.1 to the Current Report on Form 8-K filed on March 21, 2019)

 10.23+

 Third Amendment to Amended and Restated Employment Agreement, dated March 25, 2019, by and between InspireMD, Inc. and Craig Shore (incorporated by reference to Exhibit 10.1 to the Current Report on Form 8-K filed on March 28, 2019)

 10.24

 Form of Underwriter Warrant, dated April 8, 2019 (incorporated by reference to Exhibit 10.1 to the Current Report on Form 8-K filed on April 8, 2019)

 10.25

 Form of Series E Warrant (incorporated by reference to Exhibit 4.3 to the Company's Registration Statement on Form S-1, Amendment No. 1, filed with the SEC on September 13, 2019 (File No. 333-233432)).

 10.26

 Form of Underwriter Warrant (incorporated by reference to Exhibit 4.5 to the Company's Registration Statement on Form S-1, Amendment No. 1, filed with the SEC on September 13, 2019 (File No. 333-233432)).

 10.27+

 Employment Agreement, dated December 9, 2019, by and between the Company and Marvin Slosman (incorporated by reference to Exhibit 10.2 to the Current Report on Form 8-K filed on December 10, 2019).

 10.28+

 First Amendment to Employment Agreement, dated December 31, 2019, by and between the Company and Marvin Slosman (incorporated by reference to Exhibit 10.2 to the Current Report on Form 8-K filed on January 6, 2020).

 - 71 -

 10.29+

 Nonqualified Stock Option Agreement, by and between the Company and Marvin Slosman (incorporated by reference to Exhibit 10.60 to the Annual Report on Form 10-K filed on March 10, 2020)

 10.30+

 Restricted Stock Unit Award agreement, by and between the Company and Marvin Slosman (incorporated by reference to Exhibit 10.61 to the Annual Report on Form 10-K filed on March 10, 2020)

 10.31

 Form of Series F Warrant (incorporated by reference to Exhibit 4.5 to the Company's Registration Statement on Form S-1, Amendment No. 1, filed with the SEC on June 1, 2020 (File No. 333-238247)).

 10.32

 Form of Underwriter Warrant (incorporated by reference to Exhibit 1.1 to the Company's Registration Statement on Form S-1, Amendment No. 1, filed with the SEC on June 1, 2020 (File No. 333-238247))

 10.33

 Form of Series G Warrant (incorporated by reference to Exhibit 4.5 to the Company's Registration Statement on Form S-1, Amendment No. 1, filed with the SEC on February 3, 2021 (File No. 333-238247))

 10.34

 Form of Underwriter Warrant (incorporated by reference to Exhibit 4.6 to the Company's Registration Statement on Form S-1, Amendment No. 1, filed with the SEC on February 3, 2021 (File No. 333-238247))

 10.35+

 Sixth Amendment to the InspireMD, Inc. 2013 Long-Term Incentive Plan (incorporated by reference to Exhibit 10.1 to the Current Report on Form 8-K filed on August 31, 2020)

 10.36+

 Seventh Amendment to the InspireMD, Inc. 2013 Long-Term Incentive Plan (incorporated by reference to Exhibit 10.1 to the Quarterly Report on Form 10-Q filed on August 9, 2021)

 10.37+

 First Amendment to Employment Agreement, dated November 8, 2021, by and between InspireMD, Inc. and Marvin Slosman (incorporated by reference to Exhibit 10.1 to the Quarterly Report on Form 10-Q filed on November 8, 2021).

 10.38+

 Fifth Amendment to Employment Agreement, dated November 4, 2021, by and between InspireMD, Inc. and Craig Shore (incorporated by reference to Exhibit 10.2 to the Quarterly Report on Form 10-Q filed on November 8, 2021).

 10.39+

 Sixth Amendment to Employment Agreement, dated January 17, 2022, by and between InspireMD, Inc. and Craig Shore (incorporated by reference to Exhibit 10.51 to the Annual Report on Form 10-K filed on March 7, 2022)

 10.40+

 2021 Equity Compensation Plan (incorporated by reference to Annex A to the registrant's Proxy Statement on Schedule 14A filed with the Commission on August 12, 2021).

 10.41+

 Form of Nonqualified Stock Option Agreement for U.S. employees under the 2021 Equity Incentive Plan (incorporated by reference to Exhibit 10.53 to the Annual Report on Form 10-K filed on March 7, 2022)

 10.42+

 Form of Nonqualified Stock Option Agreement for European employees under the 2021 Equity Incentive Plan (incorporated by reference to Exhibit 10.54 to the Annual Report on Form 10-K filed on March 7, 2022)

 10.43+

 Form of Nonqualified Stock Option Agreement for consultants under the 2021 Equity Incentive Plan (incorporated by reference to Exhibit 10.55 to the Annual Report on Form 10-K filed on March 7, 2022)

 - 72 -

 10.44+

 Form of Nonqualified Stock Option Agreement for Israeli employees under the 2021 Equity Incentive Plan (incorporated by reference to Exhibit 10.56 to the Annual Report on Form 10-K filed on March 7, 2022)

 10.45+

 Form of Nonqualified Stock Option Agreement for U.S. directors under the 2021 Equity Incentive Plan (incorporated by reference to Exhibit 10.57 to the Annual Report on Form 10-K filed on March 7, 2022)

 10.46+

 Form of Restricted Stock Award Agreement for U.S. employees under the 2021 Equity Incentive Plan (incorporated by reference to Exhibit 10.58 to the Annual Report on Form 10-K filed on March 7, 2022)

 10.47+

 Form of Restricted Stock Award Agreement for U.S. directors under the 2021 Equity Incentive Plan (incorporated by reference to Exhibit 10.59 to the Annual Report on Form 10-K filed on March 7, 2022)

 10.48+

 Form of Restricted Stock Award Agreement for Israeli employees under the 2021 Equity Incentive Plan (incorporated by reference to Exhibit 10.60 to the Annual Report on Form 10-K filed on March 7, 2022)

 10.49+

 Form of Restricted Stock Award Agreement for European employees under the 2021 Equity Incentive Plan (incorporated by reference to Exhibit 10.61 to the Annual Report on Form 10-K filed on March 7, 2022)

 10.50+

 Form of Restricted Stock Unit Award Agreement under the 2021 Equity Incentive Plan (incorporated by reference to Exhibit 10.62 to the Annual Report on Form 10-K filed on March 7, 2022)

 10.51

 Sales Agreement by and between InspireMD, Inc. and A.G.P./Alliance Global Partners, dated June 3, 2022 (incorporated by reference to Exhibit 1.2 of the Registration Statement on Form S-3 as filed on June 3, 2022).

 10.52+

 Third Amendment to Employment Agreement, dated January 5, 2023, by and between InspireMD, Inc. and Marvin Slosman (incorporated by reference to Exhibit 10.64 to the Annual Report on Form 10-K filed on March 30, 2023)

 10.53+

 Seventh Amendment to Employment Agreement, dated January 18, 2023, by and between InspireMD, Inc. and Craig Shore (incorporated by reference to Exhibit 10.65 to the Annual Report on Form 10-K filed on March 30, 2023)

 10.54+^

 Employment Agreement, dated November 2, 2020, by and between the Company and Andrea Tommasoli (incorporated by reference to Exhibit 10.66 to the Annual Report on Form 10-K filed on March 30, 2023)

 10.55

 Form of Securities Purchase Agreement dated as of May 12, 2023 between the Company and purchaser identified therein (incorporated by reference to Exhibit 10.1 of the Current Report on Form 8-K dated May 15, 2023)

 10.56

 Form of Pre-Funded Warrant dated May 15, 2023 (incorporated by reference to Exhibit 10.2 of the Current Report on Form 8-K dated May 15, 2023)

 10.57

 Form of Series H Warrant dated May 15, 2023 (incorporated by reference to Exhibit 10.3 of the Current Report on Form 8-K dated May 15, 2023)

 10.58

 Form of Series I Warrant dated May 15, 2023 (incorporated by reference to Exhibit 10.4 of the Current Report on Form 8-K dated May 15, 2023)

 - 73 -

 10.59

 Form of Series J Warrant dated May 15, 2023 (incorporated by reference to Exhibit 10.5 of the Current Report on Form 8-K dated May 15, 2023)

 10.60

 Form of Series K Warrant dated May 15, 2023 (incorporated by reference to Exhibit 10.6 of the Current Report on Form 8-K dated May 15, 2023)

 10.61

 Form of Registration Rights Agreement dated as of May 12, 2023 between the Company and purchaser identified therein (incorporated by reference to Exhibit 10.7 of the Current Report on Form 8-K dated May 15, 2023)

 10.62+*

 Fourth Amendment to Employment Agreement, dated August 14, 2020, by and between InspireMD, Inc. and Craig Shore

 21.1

 List of Subsidiaries (incorporated by reference to Exhibit 21.1 to Current Report on Form 8-K filed with the Securities and Exchange Commission on April 6, 2011)

 23.1*

 Consent of Kesselman & Kesselman, Certified Public Accountants

 31.1*

 Certification of Chief Executive Officer Pursuant to Section 302 of Sarbanes-Oxley Act of 2002

 31.2*

 Certification of Chief Financial Officer Pursuant to Section 302 of Sarbanes-Oxley Act of 2002

 32.1*

 Certification of Chief Executive Officer Pursuant to Section 18 U.S.C. Section 1350, as Adopted Pursuant to Section 906 of the Sarbanes-Oxley Act of 2002

 32.2*

 Certification of Chief Financial Officer Pursuant to Section 18 U.S.C. Section 1350, as Adopted Pursuant to Section 906 of the Sarbanes-Oxley Act of 2002

 97.1*

 InspireMD, Inc. Executive Officer Clawback Policy

 101.INS*

 101.SCH*

 101.CAL*

 101.DEF*

 101.LAB*

 101.PRE*

 Cover

 *
Filed herewith.

 +
Management contract or compensatory plan or arrangement.

 ^
Portions of this exhibit (indicated by asterisks) have been omitted under rules of the U.S. Securities and Exchange Commission permitting
the confidential treatment of select information.

 - 74 -

 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.

 INC.

 Date:
 March 5, 2024

 By:

 /s/
 Marvin Slosman

 Marvin
 Slosman

 President
 and Chief Executive Officer

 Pursuant
to the requirements of the Securities Exchange Act of 1934, this report has been signed below by the following persons on behalf of the
registrant and in the capacities and on the dates indicated.

 Signature

 Title

 Date

 /s/
 Marvin Slosman

 President,
 Chief Executive Officer and Director

 March

 Marvin
 Slosman

 (principal
 executive officer)

 /s/
 Craig Shore

 Chief
 Financial Officer, Chief Administrative Officer, Secretary and Treasurer

 March

 Craig
 Shore

 (principal
 financial and accounting officer)

 /s/
 Paul Stuka

 Chairman
 of the Board of Directors

 March

 Paul
 Stuka

 /s/
 Michael Berman

 Director

 March

 Michael
 Berman

 /s/
 Thomas J. Kester

 Director

 March

 Thomas
 J. Kester

 /s/
 Gary Roubin

 Director

 March

 Gary
 Roubin

 /s/
 Kathryn Arnold

 Director

 March

 Kathryn
 Arnold

 - 75 -

INC.

FINANCIAL STATEMENTS

 AS
OF AND FOR THE YEAR ENDED DECEMBER 31, 2023

 TABLE
OF CONTENTS

 Page

 REPORT OF INDEPENDENT REGISTERED PUBLIC ACCOUNTING FIRM (PCAOB name: Kesselman & Kesselman C.P.A.s and PCAOB ID: 1309)

 FINANCIAL STATEMENTS:

 Consolidated Balance Sheets

 Consolidated Statements of Operations

 Consolidated Statements of Changes in Equity

 - F-7

 Consolidated Statements of Cash Flows

 Notes to the Consolidated Financial Statements

 - F-27

 F- 1

 Report
 of Independent Registered Public Accounting Firm

 To
the board of directors and shareholders of InspireMD Inc.

 Opinion
on the Financial Statements

 We
have audited the accompanying consolidated balance sheets of InspireMD Inc. and its subsidiaries (the "Company") as of December
31, 2023 and 2022, and the related consolidated statements of operations, changes in equity and cash flows for the years then ended,
including 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 financial position of the Company as of December 31, 2023 and 2022,
and the results of its operations and its cash flows for the years then ended 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 of these consolidated financial statements 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.

 Critical
Audit Matters

 Critical
audit matters are matters arising from the current period audit of the consolidated financial statements that were communicated or required
to be communicated to the audit committee and that (i) relate to accounts or disclosures that are material to the consolidated financial
statements and (ii) involved our especially challenging, subjective, or complex judgments.

 We determined there are no critical audit
matters.

 /s/
 Kesselman & Kesselman

 Certified
 Public Accountants (Isr.)

 A
 member of PricewaterhouseCoopers International Limited

 Tel-Aviv,

 March

 We
have served as the Company's auditor since 2010

 F- 2

INC.

BALANCE SHEETS

 (U.S.
dollars in thousands)

 2023

 2022

 2023

 2022

 ASSETS

 CURRENT ASSETS:

 Cash and cash equivalents

 $
 9,640

 $
 4,632

 Short-term bank deposits

 -

 13,171

 Marketable securities

 -

 Accounts receivable:

 Trade, net

 1,804

 1,034

 Other

 Prepaid expenses

 Inventory

 2,106

 1,621

 TOTAL CURRENT ASSETS

 44,159

 21,326

 NON-CURRENT ASSETS:

 Property, plant and equipment, net

 1,060

 Operating lease right of use assets

 1,473

 1,554

 Fund in respect of employee rights upon retirement

 TOTAL NON-CURRENT ASSETS

 3,484

 3,327

 TOTAL ASSETS

 $
 47,643

 $
 24,653

 F- 3

 2023

 2022

 LIABILITIES AND EQUITY

 CURRENT LIABILITIES:

 Accounts payable and accruals:

 Trade

 Other

 5,081

 4,411

 TOTAL CURRENT LIABILITIES

 6,020

 5,070

 LONG-TERM LIABILITIES:

 Operating lease liabilities

 1,038

 1,195

 Liability for employee rights upon retirement

 1,084

 TOTAL LONG-TERM LIABILITIES

 2,122

 2,190

 COMMITMENTS AND CONTINGENT LIABILITIES (Note 8)

 TOTAL LIABILITIES

 8,142

 7,260

 EQUITY:

 Common stock, par value $ 0.0001 per share; 150,000,000 shares authorized at December 31, 2023 and 2022; 21,841,215 and 8,330,918 shares issued and outstanding at December 31, 2023 and 2022, respectively

 Preferred C shares, par value $ 0.0001 per share;
 1,172,000 shares authorized at December 31, 2023 and 2022; 1,718 shares issued and outstanding at December 31, 2023 and 2022;

 - *

 - *

 Additional paid-in capital

 261,000

 218,977

 Accumulated deficit

 ( 221,501
)

 ( 201,585
)

 Total equity

 39,501

 17,393

 Total liabilities and equity

 $
 47,643

 $
 24,653

 *
 Represents an amount
less than $1

 The
accompanying notes are an integral part of the consolidated financial statements.

 F- 4

INC.

STATEMENTS OF OPERATIONS

 (U.S.
dollars in thousands, except per share data)

 2023

 2022

 Year Ended December 31,

 2023

 2022

 REVENUES

 $
 6,205

 $
 5,171

 COST OF REVENUES

 4,398

 4,054

 GROSS PROFIT

 1,807

 1,117

 OPERATING EXPENSES:

 Research and development

 7,981

 7,810

 Selling and marketing

 3,865

 3,664

 General and administrative

 11,104

 8,356

 Total operating expenses

 22,950

 19,830

 LOSS FROM OPERATIONS

 ( 21,143
)

 ( 18,713
)

 FINANCIAL INCOME, net:

 1,292

 LOSS BEFORE TAX EXPENSES

 ( 19,851
)

 ( 18,463
)

 TAX EXPENSES

 NET LOSS

 $
 ( 19,916
)

 $
 ( 18,491
)

 NET LOSS PER SHARE - basic and diluted

 ( 0.82
)

 ( 2.35
)

 WEIGHTED AVERAGE NUMBER OF ORDINARY SHARES USED IN COMPUTING NET LOSS PER SHARE - basic and diluted

 24,268,181

 7,871,814

 The
accompanying notes are an integral part of the consolidated financial statements.

 F- 5

INC.

STATEMENTS OF CHANGES IN EQUITY

 (U.S.
dollars in thousands, except share data)

 deficit

 equity

 Common stock

 Series C
 Convertible
 Preferred Stock

 Additional paid-in

 Accumulated

 Total

 deficit

 equity

 BALANCE as of January 1, 2022

 8,296,256

 1,718

 - *

 216,625

 ( 183,094
)

 33,532

 Net loss

 -

 -

 ( 18,491
)

 ( 18,491
)

 Share-based compensation related to restricted stock, restricted stock units and stock options award, net of forfeitures of 10,832 shares

 34,662

 -

 -

 2,352

 2,352

 BALANCE as of December 31, 2022

 8,330,918

 1,718

 - *

 218,977

 ( 201,585
)

 17,393

 *
 Represents an amount
less than $1

 F- 6

INC.

STATEMENTS OF CHANGES IN EQUITY

 (U.S.
dollars in thousands, except share data)

 deficit

 equity

 Common stock

 Series C
 Convertible
 Preferred Stock

 Additional paid-in

 Accumulated

 Total

 deficit

 equity

 BALANCE as of January 1, 2023

 8,330,918

 1,718

 - *

 218,977

 ( 201,585
)

 17,393

 Net loss

 ( 19,916
)

 ( 19,916
)

 Exercise of pre-funded warrants

 307,260

 - *

 -

 -

 -

 -

 Issuance of common shares, pre-funded warrants and warrants, net of $ 4,635 issuance costs

 10,266,270

 -

 -

 37,533

 37,534

 Share-based compensation related to stock, restricted stock,
 restricted stock units and stock options award, net of forfeitures of 29,695
 shares

 2,936,767

 -*

 -

 -

 4,490

 4,490

 Share-based compensation related to stock, restricted stock,
restricted stock units and stock options award, net of forfeitures

 2,936,767

 -*

 -

 -

 4,490

 4,490

 BALANCE as of December 31, 2023

 21,841,215

 1,718

 - *

 261,000

 ( 221,501
)

 39,501

 *
 Represents an amount
less than $1

 F- 7

INC.

STATEMENTS OF CASH FLOWS

 (U.S.
dollars in thousands)

 2023

 2022

 2023

 2022

 CASH FLOWS FROM OPERATING ACTIVITIES:

 Net loss

 $
 ( 19,916
)

 $
 ( 18,491
)

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

 Depreciation and amortization

 Gain from sale of property, plant and equipment

 ( 6
)

 -

 Change in fair value of markable securities, net of interest received

 ( 739
)

 -

 Change in liability for employees rights upon retirement

 ( 57
)

 Other financial expense

 Change in operating right of use asset and operating leasing liability

 ( 60
)

 Share-based compensation expenses

 4,490

 2,352

 Decrease (increase) in interest receivable on short term deposits

 ( 135
)

 Loss (gain) on amounts funded in respect of employee rights upon retirement, net

 ( 16
)

 Changes in operating asset and liability items:

 Decrease in prepaid expenses

 Decrease (increase) in trade receivables

 ( 770
)

 Increase in other receivables

 ( 435
)

 ( 48
)

 Increase in inventory

 ( 485
)

 ( 478
)

 Increase (decrease) in trade payables

 ( 234
)

 Increase in other payables

 Net cash used in operating activities

 ( 16,376
)

 ( 15,542
)

 CASH FLOWS FROM INVESTING ACTIVITIES:

 Purchase of property, plant and equipment

 ( 381
)

 ( 473
)

 Proceeds from sale of property, plant and equipment

 -

 Investment in short-term bank deposits

 ( 5,500
)

 ( 19,000
)

 Investments in marketable securities

 ( 34,644
)

 -

 Proceeds from matured marketable securities

 6,000

 -

 Amounts funded in respect of employee rights upon retirement

 ( 79
)

 ( 86
)

 Withdrawal from short-term bank deposits

 18,500

 28,000

 Net cash provided by (used in) investing activities

 ( 16,092
)

 8,441

 CASH FLOWS FROM FINANCING ACTIVITIES:

 Issuance costs of At The Market offering

 -

 ( 140
)

 Proceeds from issuance of shares and warrants net of $ 4,635 issuance costs,

 37,534

 -

 Net cash provided by (used in) financing activities

 37,534

 ( 140
)

 EFFECT OF EXCHANGE RATE CHANGES ON CASH AND CASH EQUIVALENTS

 ( 58
)

 ( 131
)

 INCREASE (DECREASE) IN CASH AND CASH EQUIVALENTS

 5,008

 ( 7,372
)

 BALANCE OF CASH AND CASH EQUIVALENTS AT BEGINNING OF YEAR

 4,632

 12,004

 BALANCE OF CASH AND CASH EQUIVALENTS AT END OF YEAR

 9,640

 $
 4,632

 SUPPLEMENTAL NON-CASH INVESTING AND FINANCING ACTIVITIES:

 Acquisition of right-of-use assets by means of lease liabilities

 Non-cash lease incentive

 -

 Decrease in right-of-use assets and lease liabilities due to shortening lease term

 -

 The
accompanying notes are an integral part of the consolidated financial statements.

 F- 8

INC.

 NOTES
TO THE CONSOLIDATED FINANCIAL STATEMENTS

 NOTE
1 - DESCRIPTION OF BUSINESS

 a.

 General

 InspireMD,
 Inc., a Delaware corporation (the "Company"), together with its subsidiaries, is a medical device company focusing on
 the development and commercialization of its proprietary MicroNet stent platform technology for the treatment of complex vascular
 and coronary disease. MicroNet, a micron mesh sleeve, is wrapped over a stent to provide embolic protection in stenting procedures.

 The
 Company's carotid product (CGuard EPS) combines MicroNet and a self-expandable nitinol stent in a single device to treat
 carotid artery disease.

 The
 Company ceased sales of the Company's MGuard Prime EPS in the beginning of 2022.

 The
 Company market its products through distributors in international markets, mainly in Europe.

 As
of the date of issuance of these consolidated financial statements, the Company has the ability to fund its planned operations for at
least the next 12 months. However, the Company expects to continue incurring losses and negative cash flows from operations until its
product, CGuard EPS, reaches commercial profitability. Therefore, in order to fund the Company's operations until such time
that the Company can generate substantial revenues, the Company may need to raise additional funds.

 b.

 Status
 of European Medical Device Regulation for marketing CGuard EPS in countries requiring the
 CE Mark.

 For
 the European Union ("EU") nations, medical devices must obtain a CE mark before they may be placed on the market. In
 order to obtain and maintain the CE mark, the Company must comply with EU law on medical devices, which, until May 26, 2021 was governed
 by the Medical Device Directive 93/42/EEC ("MDD"), by presenting comprehensive technical files for the Company's
 products demonstrating safety and efficacy of the product to be placed on the market and passing initial and annual quality management
 system audit as per ISO 13485 standard by a European Notified Body. The Company has obtained ISO 13485 quality system certification
 and CGuard EPS that the Company currently distribute into the European Union, displays the required CE mark. In order to maintain
 certification, the Company is required to pass an annual surveillance audit conducted by Notified Body auditors. The European Union
 replaced the MDD with the new European Medical Device Regulation (MDR 2017/745) ("MDR") regulations. The MDR entered
 into force after a transitional period of three years and a one year extension of that transition period due to the COVID-19 pandemic
 on May 26, 2021 and which changes several aspects of the regulatory framework in the EU. Manufacturers had the duration of the transition
 period to update their technical documentation and processes to meet the new requirements in order to obtain a CE Mark.

 In
 the Company's specific case, the Company's CE mark for CGuard EPS under the MDD expired on November 12, 2022. On February
 14, 2023, the Company received a derogation per Article 97 paragraph 1 of Regulation 2017/745 from the Agency for Medicines and Health
 Products (FAMHP) allowing the Company to continue marketing CGuard EPS in the EU until August 15, 2023. Subsequently, on March 20,
 2023 Regulation (EU) 2023/607 was published allowing the Company to continue marketing CGuard EPS in EU countries under the MDD directive
 until December 31, 2027.

 In
 January 2024, the Company received CE mark recertification for the CGuard EPS under the EU's Medical Device Regulation
 regulatory framework and can market Cguard permanently in EU countries as long as the Company is able to maintain its regulatory
 approvals.

 c.

 Risks
 Related to Our Operations in Israel including the recent attack by Hamas and other terrorist
 organizations from the Gaza Strip and Israel's war against them.

 In
October 2023, Israel was attacked by a terrorist organization and entered a state of war. As of the date of these consolidated financial
statements, the war in Israel is ongoing and continues to evolve. The Company operations including the production facility are located
in Israel. Currently, such activities in Israel remain largely unaffected. During the year ended December 31, 2023, the impact of this
war on the Company's results of operations and financial condition was immaterial, but such impact may increase, which could be
material, as a result of the continuation, escalation or expansion of such war.

 d.

 Risks
 Related to the Geopolitical and Military Tensions Between Russia and Ukraine in Europe

 The
 Company derived approximately 13.5 % and 12.1 % in the years ended December 31, 2023 and 2022,
 respectively, of total sales in Russia and Belarus. The escalation of geopolitical instability
 in Russia and Ukraine as well as currency fluctuations in the Russian Ruble could negatively
 impact the Company's operations, sales, and future growth prospects in that region.

 As
 a result of the crisis in Ukraine, the United States and the EU have implemented sanctions against certain Russian individuals and
 entities and have made it more difficult for the Company to collect on outstanding accounts receivable from customers in this region.
 The Company cannot provide assurance that potential future changes in sanctions will not have a material impact on the Company's
 operations in Russia and Belarus or on the Company's financial results.

 F- 9

INC.

 NOTES

 NOTE
2 - SIGNIFICANT ACCOUNTING POLICIES

 a. Use of estimates

 The
preparation of financial statements in conformity with U.S. GAAP requires management to make estimates using assumptions that affect
the reported amounts of assets and liabilities, the disclosure of contingent liabilities at the date of the financial statements and
the reported amounts of revenues and expenses during the reporting periods. Actual results could differ from those estimates.

 As
applicable to these consolidated financial statements, the most significant estimates and assumptions relate to inventory valuations
and assessing the likelihood of exercise of options to extend the lease term.

 b. Functional currency

 The currency of the primary economic environment in which the operations of the Company and its subsidiaries are conducted is the
U.S. dollar ("$" or "dollar"). Accordingly, the functional currency of the Company and its subsidiaries is the
U.S. dollar.

 The dollar figures are determined as follows: transactions and balances originally denominated in dollars are presented in their original
amounts. Balances in foreign currencies are translated into dollars using historical and current exchange rates for non-monetary and
monetary balances, respectively. The resulting translation gains or losses are recorded as financial income or expense, as appropriate.
For transactions reflected in the statements of operations in foreign currencies, the exchange rates at transaction dates are used. Depreciation
and changes in inventories and other changes deriving from non-monetary items are based on historical exchange rates.

 c. Principles of consolidation

 The consolidated financial statements include the accounts of the Company and of its subsidiaries. Intercompany transactions and
balances have been eliminated upon consolidation.

 d. Cash and cash equivalents

 The Company considers all highly liquid investments purchased with original maturities of three months or less from the purchase
date to be cash equivalents. As of December 31, 2023, cash and cash equivalents consisted of cash, short-term deposits (up to three months
from the date of deposit) and money market funds. As of December 31, 2022, this balance consisted solely of cash.

 e. Marketable securities

 Marketable securities consist of debt securities. The Company elected the fair value option to measure and recognize its investments
in debt securities in accordance with ASC 825, Financial Instruments as the Company manages its portfolio and evaluates the performance
on a fair value basis. Changes in fair value, realized gains and losses on sales of marketable securities, are reflected in the statements
of operation as finance expense (income), net.

 Marketable
securities are classified under current assets in the consolidated balance sheet as they represent the investment of funds available
for the Company's current operations.

 F- 10

INC.

 NOTES

 NOTE
2 - SIGNIFICANT ACCOUNTING POLICIES (continued):

 f. Short-term bank deposits

 Bank deposits with original maturities of more than three months but less than one year are presented as part of short-term bank
deposits. Deposits are presented at their cost which approximates market values including accrued interest. Interest on deposits is recorded
as financial income.

 g. Concentration of credit risk and allowance for doubtful accounts

 Financial instruments that may potentially subject the Company to a concentration of credit risk consist of cash and cash equivalents
and short-term bank deposits, which are deposited in major financially sound institutions in the U.S, Israel and Germany, and trade accounts
receivable and other receivables. The Company's trade accounts receivable is derived from revenues earned from customers from various
countries. The Company performs ongoing credit evaluations of its customers' financial condition and, requires no collateral from
its customers. The Company also has a credit insurance policy for some of its customers. The Company maintains the allowance for estimated
losses resulting from the inability of the Company's customers to make required payments. The allowance represents the current
estimate of lifetime expected credit losses over the remaining duration of existing accounts receivable considering current market conditions
and supportable forecasts when appropriate. The estimate is a result of the Company's ongoing evaluation of collectability, customer
creditworthiness, historical levels of credit losses, and future expectations. The allowance for expected credit losses was immaterial
during the periods presented.

 h. Inventory

 Inventories are stated at the lower of cost (cost is determined on a "first-in, first-out" basis) or net realizable
value. The Company's inventories generally have a limited shelf life and are subject to impairment as they approach their expiration
dates. The Company regularly evaluates the carrying value of its inventory and when, based on such evaluation, factors indicate that
impairment has occurred, the Company impairs the inventories' carrying value.

 i. Leases

 Operating leases are included in operating lease right-of-use ("ROU") assets. Short-term balances regarding lease liabilities are included in accounts payable and accruals - Other and long-term balances regarding lease liabilities are included in operating lease liabilities. ROU assets represent Company's right to use an underlying asset for the lease term and lease liabilities represent obligation to make lease payments arising from the lease. Operating lease ROU assets and liabilities are recognized at the lease commencement date based on the present value of lease payments over the lease term. In determining the present value of lease payments, the Company uses the incremental borrowing rate based on the information available at the lease commencement date as the rate implicit in the lease is not readily determinable. The determination of the incremental borrowing rate requires management judgment based on information available at lease commencement. The lease terms may include periods covered by options to extend the lease when it is reasonably certain that the Company will exercise such options, and periods covered by options to terminate the lease when it is reasonably certain that the Company will not exercise such options. Operating lease cost is recognized on a straight-line basis over the lease term. Lease agreements that include lease and non-lease components are accounted for as a single lease component. The Company elected the short-term lease recognition exemption for leases with a lease term of 12 months or less.

 j. Property, plant and equipment

 Property, plant and equipment are stated at cost, net of accumulated depreciation and amortization. Depreciation is calculated
using the straight-line method over the estimated useful lives of the related assets: over three years for computers and other electronic
equipment, and seven to fifteen years for office furniture and equipment and machinery and equipment (mainly seven years). Leasehold
improvements are amortized on a straight-line basis over the term of the lease, which is shorter than the estimated life of the improvements.

 k. Impairment in value of long-lived assets

 The Company tests long-lived tangible assets for impairment whenever events or circumstances present an indication of impairment.
If the sum of expected future cash flows (undiscounted and without interest charges) of the long-lived assets is less than the carrying
amount of such assets, an impairment would be recognized, and the assets would be written down to their estimated fair values, based
on expected future discounted cash flows.

 F- 11

INC.

 NOTES

 NOTE
2 - SIGNIFICANT ACCOUNTING POLICIES (continued):

 l. Revenue recognition

 A contract with a customer exists only when: 1) the parties to the contract have approved it and are committed to perform their
respective obligations, 2) the Company can identify each party's rights regarding the distinct goods or services to be transferred
("Performance Obligations"), 3) the Company can determine the transaction price for the goods or services to be transferred,
4) the contract has commercial substance and 5) it is probable that the Company will collect the consideration to which it will be entitled
in exchange for the goods or services that will be transferred to the customer. Revenues are recorded in the amount of consideration
to which the Company expects to be entitled in exchange for Performance Obligations upon transfer of control to the customer, excluding
sales taxes.

 Revenue from sales of goods, including sales to distributors, is recognized when the customer obtains control of the product, once
the Company has a present right to payment and the customer has legal title, and risk and rewards of ownership are obtained by the customer.
Generally, this occurs when products are shipped. In few cases when products are directly sold to medical centers on consignment basis,
revenue is recognized when the product is consumed.

 The Company recognizes the incremental costs of obtaining contracts as an expense since the amortization period of the assets that
the Company otherwise would have recognized is one year or less. The costs are recorded under selling and marketing expenses. Disaggregated
revenue is disclosed in Note 13.

 The Company recognizes revenue net of value added tax (VAT).

 m. Research and development costs

 Research and development costs, including the costs of the Company's US based clinical trial costs were approximately $ 3,300,000
 and $ 4,468,000
 for the years ended December 31, 2023 and 2022,
respectively, and charged to the statement of operations as incurred.

 n. Share-based compensation

 The Company has equity incentive plans under which the Company grants equity awards, including stock options, restricted stock
and restricted stock units ("RSUs") to employees, directors and service providers. Employee and service providers equity
awards are accounted for using the grant-date fair value method. The Company determines compensation expense associated with restricted
stock and RSUs based on the fair value of our common stock on the date of grant. The fair value of option awards is estimated using the
Black-Scholes valuation model and expensed over the requisite service period. The Company elected to account for forfeitures as they
occur.

 The
Company elected to recognize compensation expenses for awards to employees with only service conditions that have graded vesting schedules
using the accelerated multiple option approach. The attribution for nonemployee awards is in the same manner as if the Company
had paid cash for the goods or services.

 In addition, certain of our share-based awards to service providers are performance based, i.e.,
the vesting of these awards depends upon achieving certain goals. The company recognizes compensation expenses for awards with performance
conditions when the company concludes that it is probable that the performance condition will be achieved.

 o. Uncertain tax positions

 The Company follows a two-step approach to recognizing and measuring uncertain tax positions. The first step is to evaluate the
tax position for recognition by determining if the weight of available evidence indicates that it is more likely than not that the position
will be sustained on audit. If under the first step a tax position is assessed to be more likely than not of being sustained on audit,
the second step is performed, under which the
tax benefit is measured as the largest amount that is more than 50% likely to be realized upon ultimate settlement. Such
liabilities are classified as long-term, unless the liability is expected to be resolved within twelve months from the balance sheet
date. The Company's policy is to include interest related to unrecognized tax benefits within "Financial expenses - net".

 F- 12

INC.

 NOTES

 NOTE
2 - SIGNIFICANT ACCOUNTING POLICIES (continued):

 p. Deferred
income taxes

 Deferred taxes are determined utilizing the "asset and liability" method based on the estimated future tax effects
of differences between the financial accounting and tax bases of assets and liabilities under the applicable tax laws, and on tax rates
anticipated to be in effect when the deferred taxes are expected to be paid or realized. The Company assesses realization of deferred
income tax assets and, based on all available evidence, concludes whether it is more likely than not that the net deferred income tax
assets will be realized. A valuation allowance is provided for the amount of deferred income tax assets not considered to be realizable.

 The Company may incur an additional tax liability in the event of intercompany dividend distributions by its subsidiaries. Such
additional tax liability in respect of these foreign subsidiaries has not been provided for in these financial statements as it is the
Company's policy to permanently reinvest the subsidiaries' earnings and to consider distributing dividends only in connection
with a specific tax opportunity that may arise.

 Taxes that would apply in the event of disposal of investments in a foreign subsidiary have not been taken into account in computing
the deferred taxes, as it is the Company's intention to hold, and not to realize, these investments.

 q. Advertising

 Costs related to advertising and promotion of products are charged to sales and marketing expense as incurred. Advertising expenses
were approximately $ 426,000 and
$ 359,000 for
the years ended December 31, 2023 and 2022, respectively.

 r. Net loss per share

 Basic
and diluted net loss per share is computed by dividing the net loss for the period by the weighted average number of shares of common
stock, pre-funded warrants and fully vested restricted stock units outstanding during the period. The calculation of diluted net loss
per share excludes the effect of potential dilution of share options, warrants, and unvested restricted stocks, unvested restricted stock
units and Series C preferred stock as the effect is anti-dilutive.

 For the purpose of calculating basic net loss per share, the
additional shares of common stock that are issuable upon exercise of the Pre-funded Warrants have been included since the shares are
issuable for a negligible consideration, as determined by the Company according to ASC 260-10-45-13, and have no vesting or other contingencies
associated with them. For the year ended December 31, 2023, we had weighted average Pre-funded Warrants to purchase 9,612,502
 share of common stock, which was used in the
computation of net loss per share for the year.

 The total number of shares of common stock related to outstanding options, warrants,
unvested restricted stock, unvested restricted stock units and Series C Preferred Stock, which were excluded from the calculations of
diluted loss per share were 74,978,006
 and 2,741,355
 for the years ended December 31, 2023 and 2022,
respectively. This amount includes 3,054,086
 and 355,951
 of unvested restricted stock included in the
number of issued and outstanding shares as of December 31, 2023 and 2022, respectively.

 s. Segment reporting

 The Company has one operating and reportable segment.

 t. Fair value measurement

 The Company measures fair value and discloses fair value measurements for financial assets and liabilities. Fair value is based
on the price that would be received to sell an asset or paid to transfer a liability in an orderly transaction between market participants
at the measurement date.

 The accounting standard establishes a fair value hierarchy that prioritizes observable and unobservable inputs used to measure
fair value into three broad levels, which are described below:

 Level 1: Quoted prices (unadjusted) in active markets that are accessible at the measurement date for assets or liabilities. The
fair value hierarchy gives the highest priority to Level 1 inputs.

 Level 2: Observable prices that are based on inputs not quoted on active markets but corroborated by market data.

 Level 3: Unobservable inputs are used when little or no market data is available. The fair value hierarchy gives the lowest priority
to Level 3 inputs.

 In
determining fair value, the Company utilizes valuation techniques that maximize the use of observable inputs and minimize the use of
unobservable inputs to the extent possible and considers counterparty credit risk in its assessment of fair value.

 F- 14

INC.

 NOTES

 NOTE
2 - SIGNIFICANT ACCOUNTING POLICIES (continued):

 u. Recently adopted accounting pronouncement

In June 2016, the FASB issued ASU 2016-13, Financial Instruments-Credit Losses (Topic 326)-Measurement of Credit Losses on Financial Instruments. This guidance replaces the incurred loss impairment methodology. Under the new guidance, on initial recognition and at each reporting period, an entity is required to recognize an allowance that reflects its current estimate of credit losses expected to be incurred over the life of the financial instrument based on historical experience, current conditions and reasonable and supportable forecasts. In November 2019, the FASB issued ASU No. 2019-10, Financial Instruments - Credit Losses (Topic 326), Derivatives and Hedging (Topic 815), and Leases (Topic 842): Effective Dates ("ASU 2019-10"). The purpose of this amendment is to create a two-tier rollout of major updates, staggering the effective dates between larger public companies and all other entities. This granted certain classes of companies, including Smaller Reporting Companies ("SRCs"), additional time to implement major FASB standards, including ASU 2016-13. Larger public companies had an effective date for fiscal years beginning after December 15, 2019, including interim periods within those fiscal years. All other entities are permitted to defer adoption of ASU 2016-13, and its related amendments, until the earlier of fiscal periods beginning after December 15, 2022. Under the current SEC definitions, the Company met the definition of an SRC and adopted the deferral period for ASU 2016-13. The guidance requires a modified retrospective transition approach through a cumulative-effect adjustment to retained earnings as of the beginning of the period of adoption. The Company adopted the provisions of this update as of January 1, 2023 with no material impact on its consolidated financial statements.

 v. Recently issued accounting pronouncement, not yet adopted

 1)

 In
November 2023, the FASB issued ASU 2023-07 "Segment Reporting: Improvements to Reportable Segment Disclosures". This guidance
expands public entities segment disclosures primarily by requiring disclosure of significant segment expenses that are regularly
provided to the chief operating decision maker and included within each reported measure of segment profit or loss, an amount and description
of its composition for other segment items, and interim disclosures of a reportable segment's profit or loss and assets. Public
entities with a single reportable segment are required to provide the new disclosures and all the disclosures required under ASC 280.
The guidance is effective for fiscal years beginning after December 15, 2023, and interim periods within fiscal years beginning after
December 15, 2024, with early adoption permitted. The amendments are required to be applied retrospectively to all prior periods presented
in an entity's financial statements. The Company is currently evaluating this guidance to determine the impact it may have on its
consolidated financial statements related disclosures.

 2)

 In December 2023, the FASB issued ASU 2023-09 "Income Taxes (Topic 740): Improvements to Income Tax Disclosures". This
 guidance is intended to enhance the transparency and decision-usefulness of income tax disclosures. The amendments in ASU 2023-09
 address investor requests for enhanced income tax information primarily through changes to disclosure regarding rate reconciliation
 and income taxes paid both in the U.S. and in foreign jurisdictions. ASU 2023-09 is effective for fiscal years beginning after
 December 15, 2024 on a prospective basis, with the option to apply the standard retrospectively. Early adoption is permitted. The
 Company is currently evaluating this guidance to determine the impact it may have on its consolidated financial statements
 disclosures.

 3)

 In
August 2020, the FASB issued ASU 2020-06 "Debt – Debt with Conversion and Other Options (Subtopic 470-20) and Derivatives
and Hedging – Contracts in Entity's Own Equity (Subtopic 815 – 40)." This guidance simplifies the accounting
for certain financial instruments with characteristics of liabilities and equity, including convertible instruments and contracts on
an entity's own equity. This ASU is effective for the Company for fiscal years beginning after December 15, 2023, and interim periods
within those fiscal years. The initial adoption of ASU 2020-06 is not expected to have a material impact on the Company's consolidated
financial statements.

 F- 15

INC.

 NOTES

 NOTE
3 – FAIR VALUE MEASUREMENTS

 As
of December 31, 2023, the carrying amounts of accounts payable, accounts receivable and other receivable approximate their fair values
due to the short-term maturities of these instruments.

 The
Company's financial assets subject to fair value measurements on a recurring basis and the level of inputs used in such measurements
were as follows:

OF FINANCIAL ASSETS SUBJECT TO FAIR VALUE MEASUREMENTS

 Total

 Level 1

 Level 2

 Level 3

 As of December 31, 2023

 Total

 Level 1

 Level 2

 Level 3

 Assets:

 Cash equivalents-

 Money market funds

 $
 7,094

 $
 7,094

 $
 -

 $
 -

 Cash
 equivalents

 $
 7,094

 $
 7,094

 $
 -

 $
 -

 Marketable securities-

 U.S government bonds

 $

 $
 -

 $

 $
 -

 Marketable
securities

 $

 $
 -

 $

 $
 -

 The
Company's debt securities are classified within Level 2 because it uses quoted market prices or alternative pricing sources and
models utilizing market observable inputs to determine their fair value.

 The
cost of Marketable securities as of December 31, 2023 is $ 28,727,000.

 NOTE
4 - MARKETABLE SECURITIES

 The
following table sets forth the Company's marketable securities for the indicated period:

OF MARKETABLE SECURITIES

 December 31, 2023

 U.S government bonds

 $

 Marketable securities

 $

 The
following table summarizes the fair value of the Company's marketable securities classified by maturity as of December 31, 2023:

OF FAIR VALUE OF MARKETABLE SECURITIES CLASSIFIED BY MATURITY

 December 31, 2023

 Amounts maturing within one year

 $
 24,523

 Amounts maturing after one year through two years

 4,860

 $

 The
table below sets forth a summary of the changes in the fair value of the Company's marketable securities for the year ended December
31, 2023:

OF CHANGES IN FAIR VALUE OF MARKETABLE SECURITIES

 Year ended

 2023

 Balance at beginning of the period

 $
 -

 Additions

 34,644

 Sale or maturity

 ( 6,000
)

 Interest Received

 ( 38
)

 Changes in fair value

 Balance at end of the period

 F- 16

INC.

 NOTES

 NOTE
5 - PROPERTY, PLANT AND EQUIPMENT

 a.
 Composition of
assets, grouped by major classifications, is as follows:

OF PROPERTY PLANT AND EQUIPMENT

 2023

 2022

 2023

 2022

 Cost:

 Computer equipment

 $

 $

 Office furniture and equipment

 Machinery and equipment

 1,702

 1,704

 Leasehold improvements

 Property
 plant and equipment, gross

 3,100

 2,825

 Less - accumulated depreciation and amortization

 ( 2,040
)

 ( 1,908
)

 Net carrying amount

 $
 1,060

 $

 b.

 Depreciation
 and amortization expenses totaled approximately $ 232,000 and $ 188,000 for the years ended December 31, 2023 and 2022, respectively.

 NOTE
6 - LIABILITY FOR EMPLOYEES RIGHT UPON RETIREMENT

 Israeli
labor law generally requires payment of severance pay upon dismissal of an employee or upon termination of employment in certain other
circumstances.

 Pursuant
to section 14 of the Israeli Severance Compensation Act, 1963, most of the Company's employees are entitled to have monthly deposits,
at a rate of 8.33 % of their monthly salary, made in their name with insurance companies. Payments in accordance with section 14 relieve
the Company from any future severance payments to these employees. The severance pay expenses for such employees were approximately $ 256,000
and $ 241,000 for the years ended December 31, 2023 and 2022, respectively.

 The
severance pay liability of the Company for the rest of its Israeli employees, which reflects the undiscounted amount of the liability,
is based upon the number of years of service and the latest monthly salary. The severance pay liability is partly covered by insurance
policies and by regular deposits with recognized severance payment funds. The Company may only withdraw funds previously deposited for
savings in connection with the payment of severance. The severance pay expenses for such employees were approximately $ 116,000 and $ 68,000
for the years ended December 31, 2023 and 2022, respectively.

 F- 17

INC.

 NOTES

 NOTE
7 – LEASE AGREEMENTS

 1)

 The
Company's Israeli subsidiary had a lease agreement for a facility in Israel, which expired on December 31, 2022 with an option
to extend the agreement for two additional years until December 31, 2024. On May 25, 2022 the Company amended the agreement mentioned
above and extended it until December 31, 2026 as well as leasing of additional space in the facility. On August 24, 2023, the Company amended the lease agreement mentioned above, leasing additional space in the facility and shortened the lease term of another space in the building. The balances of right of use assets and lease liabilities increased due to the newly leased space and decreased due to the lease that was shortened.

 2)

 Operating
 lease cost for the years ended December 31, 2023 and 2022 was $ 433,000
 and $ 442,000 respectively.

 Supplemental
information related to leases are as follows:

 SCHEDULE OF SUPPLEMENTAL INFORMATION RELATED TO LEASES

 2023

 2022

 2023

 2022

 ($
in thousands)

 Operating lease right-of-use assets

 1,473

 1,554

 Current Operating lease liabilities

 ( 557
)

 ( 419
)

 Non-current operating lease liabilities

 ( 1,038
)

 ( 1,195
)

 Other
information:

 Operating cash flows from operating leases (cash paid in thousands)

 ( 429
)

 ( 436
)

 Weighted Average Remaining Lease Term

 Weighted Average Discount Rate

 9.73
 %

 8.69
 %

 Maturities
of lease liabilities are as follows:

 SCHEDULE OF MATURITIES OF LEASE LIABILITIES

 2024

 2025

 2026

 Total lease payments

 1,816

 Less imputed interest

 ( 221
)

 Total

 1,595

 F- 18

INC.

 NOTES

 NOTE
8 - COMMITMENTS AND CONTINGENT LIABILITIES:

 Distribution
Agreement with Chinese Partner

 On
February 3, 2021, the Company entered into a distribution agreement (the "Distribution Agreement") with three China-based
partners, pursuant to which the Chinese partners will be responsible for conducting the necessary registration trials for commercial
approval of the Company's products in China, followed by an eight-year exclusive distribution right to sell the Company's
products in China with the term of the agreement continuing on a year-to-year basis unless terminated. Under the Distribution Agreement,
the China-based partners will be subject to minimum purchase obligations. The Distribution Agreement may be terminated for cause upon
failure to meet minimum purchase obligations, failure to obtain regulatory approvals or for other material breaches.

 In
addition, the agreement stipulates that if the Distributor fails to obtain the Regulatory Approvals by the time stipulated in the agreement
due to the failure of the clinical trials, and this Agreement was terminated as a result of such failure to obtain Regulatory Approvals,
InspireMD shall reimburse Distributor in an amount which is 50 % of Distributor's direct out of pocket costs to 3rd parties for
conducting the clinical trials, which reimbursement will not exceed USD 1,000,000. The financial statements include a liability, based
on 50 % of the Distributor costs incurred until December 31, 2023. The liability at December 31, 2023 is immaterial.

 NOTE
9 - EQUITY

 a.

 Share

 The
Company's common stock are listed on the Nasdaq Capital Market.

 Private
Placement

 On
 May 12, 2023, the Company entered into a securities purchase agreement (the "Purchase Agreement") pursuant to which the
 Company agreed to sell and issue in a private placement (the "Private Placement Offering) an aggregate of 10,266,270 shares
 (the "Private Placement Shares") of the Company's common stock, pre-funded warrants (the "Pre-Funded Warrants")
 to purchase up to 15,561,894 shares of common stock and warrants to purchase up to an aggregate of 51,656,328 shares of common stock,
 consisting of Series H warrants to purchase up to 12,914,086 shares of common stock (the "Series H Warrants"), Series
 I warrants to purchase up to 12,914,078 shares of common stock (the "Series I Warrants"), Series J warrants to purchase
 up to 12,914,086 shares of Common Stock (the "Series J Warrants") and Series K warrants to purchase up to 12,914,078
 shares of common stock (the "Series K Warrants" and together with the Series H Warrants, Series I Warrants and Series
 J Warrants, the "Warrants"), at an offering price of $ 1.6327 per Private Placement Share and associated Warrants and
 an offering price of $ 1.6326 per Pre-Funded Warrant and associated Warrants. The Private Placement Offering closed on May 16, 2023.

 Aggregate
 gross proceeds to the Company in respect of the Private Placement Offering were $ 42.2 million, before deducting fees payable to the
 placement agent and other offering expenses payable by the Company which amounted to approximately $ 4.6 million. If the Warrants
 are exercised in cash in full this would result in an additional $ 71.4 million of gross proceeds.

 F- 19

INC.

 NOTES

 NOTE 9 – EQUITY (continued):

 The
 Pre-Funded Warrants are immediately exercisable at an exercise price of $ 0.0001 per share and will not expire until exercised in
 full. The Warrants are immediately exercisable upon issuance at an exercise price of $ 1.3827 per share. The Warrants have a term
 of the earlier of (i) five years from the date of issuance and (ii) (A) in the case of the Series H Warrants, 20 trading days following
 the Company's public release of primary and secondary end points related to one year follow up study results from the Company's
 C-Guardians pivotal trial, (B) in the case of the Series I Warrants, 20 trading days following the Company's announcement of
 receipt of Premarket Approval (PMA) from the Food and Drug Administration, or FDA, for the CGuard Prime Carotid Stent System (135
 cm), (C) in the case of the Series J Warrants, 20 trading days following the Company's announcement of receipt of FDA approval
 for the SwitchGuard transcarotid system and CGuard Prime 80 cm and (D) in the case on the Series K Warrants, 20 trading days following
 the end of the fourth fiscal quarter after the fiscal quarter in which the first commercial sales of the CGuard Carotid Stent System
 in the United States begin. The Warrants may be exercised on a cashless basis if there is no effective registration statement registering
 the shares underlying the warrants.

 The
 Company issued a total of 307,260 shares of its common stock in connection with the exercise of Pre-Funded Warrants to purchase 307,271
 shares of common stock on a cashless basis. As of December 31, 2023, there are Pre-Funded Warrants to purchase an aggregate
 of 15,254,623 share of common stock outstanding.

 Pursuant
 to the full ratchet anti-dilution adjustment provisions in the respective certificate of designation for the Company's Series
 C Preferred Stock, the conversion price of the outstanding shares of the Series C Preferred Stock was reduced to $ 1.3827 per share,
 effective as of the date of the securities purchase agreement entered for the Offering, and the number of shares of common stock
 issuable upon conversion of the Series C Preferred Stock increased by 5,668 additional shares of common stock upon conversion of
 the Series C Preferred Stock, based on 1,718 shares of Series C Preferred Stock outstanding as of May 16, 2023.

 As
 of December 31, 2023 and 2022, there were 1,718 shares of Series C Preferred Stock outstanding, convertible into an aggregate of
 7,952 and 2,284 shares of the Company's common stock, respectively with a total stated value of $ 10,997.

 As
of December 31, 2023, the Company has outstanding warrants to purchase an aggregate of 53,396,008 shares of common stock as follows:

 SCHEDULE OF ISSUANCE OF WARRANTS TO PURCHASE COMMON STOCK

 Number of underlying

 Common stock

 Exercise

 price

 Series E Warrants

 198,159

 $
 27.0000

 Series F Warrants

 433,878

 $
 7.4250

 Series G Warrants

 1,092,344

 $
 10.2300

 Series H Warrants

 12,914,086

 $
 1.3827

 Series I Warrants

 12,914,078

 $
 1.3827

 Series J Warrants

 12,914,086

 $
 1.3827

 Series K Warrants

 12,914,078

 $
 1.3827

 Underwriter Warrants

 15,299

 $
 7.4250

 Total Warrants

 53,396,008

 $

 As
of December 31, 2023, the Company has 155,000,000 authorized shares of capital stock, par value $ 0.0001 per share, of which 150,000,000
are shares of common stock and 5,000,000 are shares of "blank check" preferred stock.

 F- 20

INC.

 NOTES

 NOTE
9 – EQUITY (continued):

 b.

 Share-Based
 Compensation

 1)

 On
 September 30, 2021, at our 2021 annual meeting of stockholders, our stockholders approved
 our 2021 Equity Incentive Plan.

 The
 Company's. 2021 Equity Incentive Plan provides for the granting of incentive stock options, nonqualified stock options, stock
 appreciation rights, restricted stock, restricted stock units, performance awards, dividend equivalent rights, and other awards,
 which may be granted singly, in combination, or in tandem.

 As
 of December 31, 2023, we had 7,731,618 shares of common stock available for future issuance under our 2021 Equity Incentive Plan.

 5)

 The
 following table summarizes information about stock options granted to employees:

 SCHEDULE OF STOCK OPTIONS GRANTED

 2023

 2022

 Number of options

 Weighted
 average
 exercise price

 Number of options

 Weighted average exercise price

 Outstanding - beginning of period

 294,712

 5.21

 289,408

 $
 5.29

 Granted

 1,097,250

 1.89

 7,841

 2.61

 Forfeited

 ( 12,266
)

 4.00

 ( 2,537
)

 5.70

 Outstanding- end of period

 1,379,696

 2.58

 294,712

 $
 5.21

 Exercisable at the end of the period

 215,709

 5.38

 123,115

 5.51

 6)

 The
 following table summarizes information about stock options granted to non-employees:

 2023

 2022

 Number of options

 Weighted average exercise price

 Number of options

 Weighted average exercise price

 Outstanding - beginning of period

 166,669

 3.37

 20,002

 6.90

 Granted

 625,000

 1.71

 146,667

 2.89

 Outstanding - end of period

 791,669

 2.06

 166,669

 3.37

 Exercisable at the end of the period

 84,667

 3.42

 35,667

 3.61

 7)

 The
 following table summarizes information about restricted stock granted to employees:

 SCHEDULE OF RESTRICTED STOCK GRANTED TO EMPLOYEES

 2023

 2022

 Number of restricted stock

 Outstanding - beginning of period

 355,951

 527,668

 Granted

 2,914,340

 45,494

 Forfeited

 ( 29,695
)

 ( 10,832
)

 Vested

 ( 186,510
)

 ( 206,379
)

 Outstanding - end of period

 3,054,086

 355,951

 F- 21

INC.

 NOTES

 NOTE
9 – EQUITY (continued):

 8)

 The
 following table summarizes information about RSUs granted to employees:

 SCHEDULE OF RESTRICTED STOCK UNIT GRANTED TO EMPLOYEES

 2023

 2022

 Number of RSUs

 Outstanding - beginning of period

 237,078

 237,078

 Granted

 1,045,150

 -

 Outstanding - end of period

 1,282,228

 237,078

 9)

 The
 following table provides additional information about all options outstanding and exercisable:

 SCHEDULE OF ADDITIONAL INFORMATION ABOUT ALL OPTIONS OUTSTANDING AND EXERCISABLE

 Outstanding as of December 31, 2023

 Exercise
 price

 Options outstanding

 Weighted average remaining contractual life (years)

 Options exercisable

 $ 1.15 - 2.97

 1,786,211

 9.28

 73,946

 $ 3.30 - 4.12

 227,932

 8.53

 95,075

 $ 4.95 - 10.05

 153,169

 7.00

 127,303

 $ 16.50

 4,053

 6.01

 4,053

 2,171,365

 9.03

 300,376

 The
weighted average of the remaining contractual life of total vested and exercisable options as of December 31, 2023 was 7.54 years.

 The
aggregate intrinsic value of the total exercisable options as of December 31, 2023 was approximately $ 10,983.

 The
weighted average fair value of options granted to employees was $ 1.65 and $ 2.33 for the years ended December 31, 2023 and 2022, respectively.
The weighted average fair value of options granted was estimated using the Black-Scholes option-pricing model.

 The
weighted average fair value of options granted to consultants was $ 1.50 and $ 2.57 for the years ended December 31, 2023 and 2022, respectively.
The weighted average fair value of options granted was estimated using the Black-Scholes option-pricing model.

 The
weighted average fair value of restricted stock granted was $ 1.95 and $ 2.42 for the years ended December 31, 2023 and 2022, respectively.

 The
weighted average fair value of RSU granted was $ 1.76 for the year ended December 31, 2023.

 The
vesting period for outstanding stock options, restricted stock, and RSUs is typically three years, with one-third of the awards vesting
annually. Additionally, some of our share-based awards to service providers are performance-based, vesting upon the achievement of specified
performance criteria related to clinical or marketing activities.

 F- 22

INC.

 NOTES

 NOTE
9 – EQUITY (continued):

 10)

 The
 following table sets forth the assumptions that were used in determining the fair value of options granted to employees for the year
 December 31, 2023 and 2022:

 SCHEDULE OF FAIR VALUE OF OPTIONS GRANTED TO EMPLOYEES

 2023

 2022

 Expected life

 5.125 - 6.5 years

 5.125 - 6.5 years

 Risk-free interest rates

 3.58 %- 4.73 %

 1.79 %- 2.88 %

 Volatility

 109.62 %- 125.61 %

 127.43 %- 130.93 %

 Dividend yield

 -

 -

 The
Company does not have sufficient historical exercise data to provide a reasonable basis upon which to estimate expected term. Accordingly,
as to ordinary course options granted, the expected term was determined using the simplified method, which takes into consideration the
option's contractual life and the vesting periods (for non-employees, the expected term is equal to the option's contractual
life).

 The
annual risk-free rates are based on the yield rates of zero coupon non-index linked U.S. Federal Reserve treasury bonds as both the exercise
price and the share price are in dollar terms. The Company's expected volatility is derived from its historical data.

 11)

 As
 of December 31, 2023, the total unrecognized compensation cost on employee and non-employee stock options, restricted stock and RSUs,
 related to unvested stock-based compensation, amounted to approximately $ 7.18 million. This cost is expected to be recognized over
 a weighted-average period of approximately 0.97 years. This expected cost does not include the impact of any future stock-based compensation
 awards.

 12)

 The
 following table summarizes the allocation of total share-based compensation expense in the consolidated statements of operations:

 SCHEDULE OF ALLOCATION OF TOTAL SHARE-BASED COMPENSATION EXPENSE

 2023

 2022

 Cost of revenues

 $

 $

 Research and development

 Sales and marketing

 General and administrative

 3,332

 1,380

 $
 4,490

 $
 2,352

 F- 23

INC.

 NOTES

 NOTE
10 – RELATED PARTIES TRANSACTIONS

 1)

 During
 the twelve months ended December 31, 2023 and 2022, a consulting company whose founder and CEO is our board member provided certain
 marketing services in the amount of $ 788 and $ 9,645, respectively.

 2)

 On
 September 15, 2023, the board approved the company's entry into a consultancy agreement with a member of the immediate family
 of the CEO for certain administrative projects in connection with the Company's expansion to the U.S. until a full-time Company
 employee is retained in such capacity. Pursuant to the Consultancy Agreement, the Company will pay a fixed hourly fee of $ 50 for
 a maximum of 20 hours per week and customary expenses. The Company may terminate this Agreement for any reason or no reason, at any
 time, upon 30 days prior written notice to consultant.

 Consulting
expenses for the year ended December 31, 2023, were $ 11,440.

 3)

 Election to
Receive Shares of Common Stock in lieu of Cash Compensation

 For
the year 2023, certain non-employee directors elected to receive all or a portion of their cash retainer amount in shares of the Company's
common stock under the 2021 Equity Incentive Plan. For a director that made that election, a stock award under the 2021 Equity Incentive
Plan was paid quarterly on the first day of each next quarter ("Issuance Dates") and became fully vested on the Issuance
Dates. The stock award was determined by dividing (x) the product of the cash retainer amount and percentage of the cash retainer amount
elected to be taken in shares by (y) the "Fair Market Value" (as defined in the 2021 Equity Incentive Plan) of a share on
the Issuance Dates.

 During
the years ended December 31, 2023 the Company issued 52,129 shares of common stock to non-employee directors who elected to receive all
or a portion of their cash retainer amount for the nine months ended September 30, 2023 in shares of the Company's common stock
under the 2021 Equity Incentive Plan.

 As
of December 31, 2023, there was an accrual for $ 55,000 for director's fees for the three months ended December 31, 2023.
Out of this an amount of $ 22,875 was paid in cash and $ 32,125 was issued in shares of the Company's common stock under the 2021
Equity Incentive Plan. On January 1, 2024 the Company issued 11,854 shares of common stock.

 NOTE
11 - TAXES ON INCOME:

 a.

 Tax
 laws applicable to the Company and its subsidiaries

 Taxation
in the United States

 InspireMD,
Inc. is taxed under U.S. tax laws. Accordingly, the applicable federal corporate tax rate in 2023 is 21 %. the applicable state income tax rate in 2023 is 3.42%.

 Taxation
in Israel

 InspiredMD,
Ltd is taxed under Israeli tax laws. Accordingly, the applicable corporate tax rate in 2023 is 23 %.

 Taxation
in Germany

 InspireMD
GmbH is taxed according to the tax laws in Germany. Accordingly, the applicable tax rates are corporate tax rate of 15.825 % and trade
tax rate of 17.15 %.

 F- 24

INC.

 NOTES

 NOTE
11 - TAXES ON INCOME: (continued):

 b.

 Tax
 benefits under the Law for the Encouragement of Capital Investments, 1959 (the "Law"):

 On
December 29, 2016, the Investment Law was amended ("73 Amendment"), which includes, inter alia, two new tax incentive opportunities.
These are the Preferred Technological Enterprise ("PTE") and Special Preferred Technological Enterprise ("SPTE").
In order to benefit from either of these options, a Company must meet certain qualifications and receive formal approval from the Israel
Innovation Authority ("IIA") which allows the Company to use the reduced corporate tax rate of 12 % on its "Preferred
Technological Income" (earned from enterprises located in Development outside of Zone A) in the case of a "preferred technology
enterprise", or 6 % on its "preferred technology income" (earned from enterprises located in Development Zone A or outside
it) in the case of a "special preferred technology enterprise". Additionally, any "technology income", as this
term is defined by the Law, not classified as "preferred technology income" is subject to the corporate tax rate.

 Furthermore,
according to the provisions regarding "preferred technology enterprise" and "special preferred technology enterprise"
in the Law and the regulations thereunder, and to the extent the income is attributable to manufacturing, this income is classified as
"preferred income" and is taxed at 7.5 % or 16 % according to the development zone. To the extent the income is from an intangible
asset used for marketing, it is subject to the normal corporate tax rate.

when income of a company originating from "preferred technology income" is distributed as dividend to a foreign-resident
corporation, tax withholding from the dividend is 4 %, provided that 90 % or more of that company's shares are directly held by one
or more foreign corporations, and the profits resulted after they acquired the shares.

 c.

 Carry
 forward tax losses

 As
of December 31, 2023, the Company had a net carry forward tax loss of approximately $ 54 million, of which approximately $ 35 million (arising
before January 1, 2018), expires until 2038, and approximately $ 19 million, which does not expire, but is limited to offset 80 % of the
net income in the year it is utilized.

 Under
the U.S. tax laws, for net operating losses (NOLs) arising after December 31, 2017, the Tax Cuts and Jobs Act enacted on December 22,
2017 (the "2017 Act") limits a taxpayer's ability to utilize NOL carryforwards to 80% of taxable income.

 In
addition, NOLs arising after 2017 can be carried forward indefinitely, but carryback is generally prohibited. NOLs generated in tax years
beginning before January 1, 2018, will not be subject to the foregoing taxable income limitation and will continue to have a two-year
carryback and twenty-year carryforward period.

 As
of December 31, 2023, InspireMD Ltd., an Israeli subsidiary, had a net carry forward tax loss of approximately $ 107 million. Under Israeli
tax laws, the carry forward tax losses can be utilized indefinitely.

 The
Israeli subsidiary is taxed in the New Israeli Shekel ("NIS"), which is different from its functional currency (U.S. Dollar).
The change in the Israeli subsidiary NOL's for tax purposes is partly resulted by such rate differences.

 d.

 Loss
 before income taxes

 The
components of loss before income taxes are as follows:

 SCHEDULE OF COMPONENTS OF LOSS BEFORE INCOME TAXES

 2023

 2022

 Loss before taxes on income:

 InspireMD, Inc.

 $
 ( 5,772
)

 $
 ( 4,773
)

 Subsidiaries

 ( 14,079
)

 ( 13,690
)

 $
 ( 19,851
)

 $
 ( 18,463
)

 F- 25

INC.

 NOTES

 NOTE
11 - TAXES ON INCOME (continued):

 e.

 Current
 taxes on income

 The
main reconciling item between the statutory tax rate of the Company and the effective tax rate is the change in valuation allowance in
respect of tax benefits from carried forward tax losses due to uncertainty of the realization of such tax benefits.

 The
changes in the valuation allowance for the year ended December 31, 2023 and 2022 were as follows:

 SCHEDULE OF CHANGES IN VALUATION ALLOWANCE

 2023

 2022

 Balance at the beginning of the year

 $
 40,071

 $
 39,212

 Changes during the year:

 Losses during the year (including foreign exchange rate effect)

 2,580

 Balance at the end of the year

 $
 42,651

 $
 40,071

 f.

 Accounting
 for Uncertain Tax position

 The
following is a reconciliation of the total amounts of the Company's uncertain tax positions during the year ended December 31,
2023 and 2022 were as follows:

 SCHEDULE OF RECONCILIATION OF UNCERTAIN TAX POSITIONS

 2023

 2022

 Balance at beginning of period

 $

 $

 Increase in uncertain tax positions because of tax positions taken during the year

 Balance at end of period

 $

 $

 A
summary of open tax years by major jurisdiction is presented below:

 SCHEDULE OF OPEN TAX YEARS BY MAJOR JURISDICTION

 Jurisdiction

 Years

 U.S.

 2020 - 2023

 2019 - 2023

 Germany

 2020 - 2023

 g.

 Deferred
 income tax:

 SCHEDULE OF DEFERRED INCOME TAX

 2023

 2022

 2023

 2022

 Provision for vacation and recreation pay

 R&D expenses

 1,691

 1,452

 Operating lease right of use assets

 ( 339
)

 ( 357
)

 Operating lease liabilities

 Share-based compensation

 3,492

 3,021

 Carry forward tax losses

 37,342

 35,507

 Accrued severance pay, net

 Deferred
 tax assets noncurrent

 42,651

 40,071

 Less-valuation allowance

 ( 42,651
)

 ( 40,071
)

 Deferred
 tax assets

 -

 -

 F- 26

INC.

 NOTES

 NOTE
12 - SUPPLEMENTARY FINANCIAL STATEMENT INFORMATION:

 Balance
sheets:

 Inventory:

OF INVENTORIES

 2023

 2022

 2023

 2022

 Finished goods

 $

 $

 Work in process

 Raw materials and supplies

 1,334

 Total
 inventory

 $
 2,106

 $
 1,621

OF ACCOUNTS PAYABLE AND ACCRUALS - OTHER

 a.

 Accounts
 payable and accruals-other:

 2023

 2022

 2023

 2022

 Employees and employee institutions

 $
 2,188

 $
 1,853

 Accrued vacation and recreation pay

 Accrued expenses

 1,115

 Clinical trial accrual

 1,258

 Current Operating lease liabilities

 Other

 Accounts
 Payable and Accruals - Other

 $
 5,081

 $
 4,411

 NOTE
13 – DISAGGREGATED REVENUE AND ENTITY WIDE DISCLOSURES:

 Revenues
are attributed to geographic areas based on the location of the customers. The following is a summary of revenues:

 SCHEDULE OF REVENUES ATTRIBUTED TO GEOGRAPHIC AREAS

 2023

 2022

 Italy

 $
 1,195

 $

 Germany

 Russia

 Other

 3,376

 2,954

 $
 6,205

 $
 5,171

 By
product:

 SCHEDULE OF REVENUES ATTRIBUTED TO GEOGRAPHIC AREAS BY PRODUCT

 2023

 2022

 CGuard EPS

 $
 6,205

 $
 5,123

 MGuard Prime EPS

 -

 $
 6,205

 $
 5,171

 By
principal customers:

OF REVENUES ATTRIBUTED TO GEOGRAPHIC AREAS BY PRINCIPAL CUSTOMERS

 2023

 2022

 Customer A

 %

 %

 Customer B

 %

 %

 All
tangible long lived assets are located in Israel.

 NOTE 14 - SUBSEQUENT EVENTS:

 On
January 23, 2024, the Company granted 1,528,316 restricted shares of the Company's common stock to employees and directors.
The shares to employees are subject to a three-year vesting period, with one-third of such awards vesting each year. The shares to directors
are subject to a one-year vesting period.

 On
January 23, 2024, the Company granted 563,499 restricted share units of the Company's common stock to the chief executive
officer. The shares are subject to a three-year vesting period, with one-third of such awards vesting each year.

 On
January 23, 2024, the Company granted to employees and directors options to purchase a total of 669,464 shares of the Company's
common stock. The options have an exercise prices of $3.14 per share, which was the fair market value of the Company's common
stock on the date of the grant. The options to employees are subject to a three-year vesting period, with one-third of such awards vesting
each year. The options to directors are subject to a one-year vesting period.

 F- 27