NSPR US Equity☆

UNITED

STATES

SECURITIES

AND EXCHANGE COMMISSION

WASHINGTON

D.C. 20549

FORM

10-K

(Mark

One)

For

the fiscal year ended December 31, 2023

OR

COMMISSION

FILE NUMBER: 001-35731

InspireMD,

Inc.

(Exact

name of registrant as specified in its charter)

4 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

Indicate

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

Indicate

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 ☒

Indicate

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 ☐

Indicate

by check mark whether the registrant has submitted electronically every Interactive Data File required to be submitted pursuant to Rule

405 of Regulation S-T (§ 232.405 of this chapter) during the preceding 12 months (or for such shorter period that the registrant

was required to submit such files). Yes ☒ No ☐

Indicate

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

Indicate

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. ☐

Indicate

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). ☐

Indicate

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.

Indicate

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

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

PART I 5

Item 1. Business. 5

Item 1A. Risk Factors. 29

Item 1B. Unresolved Staff Comments. 57

Item 1C. Cybersecurity. 57

Item 2. Properties. 58

Item 3. Legal Proceedings. 58

Item 4. Mine Safety Disclosures. 58

Item 6. [Reserved] 59

Item 7A. Quantitative and Qualitative Disclosures About Market Risk. 66

Item 8. Financial Statements and Supplementary Data. 66

Item 9A. Controls and Procedures. 66

Item 9B. Other Information. 67

Item 9C. Disclosure Regarding Foreign Jurisdictions that Prevent Inspections 67

PART III 67

Item 10. Directors, Executive Officers and Corporate Governance. 67

Item 11. Executive Compensation. 67

Item 14. Principal Accounting Fees and Services. 68

Item 15. Exhibits and Financial Statement Schedules. 68

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:

● market acceptance 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 adequately protect our intellectual property;

● inability to carry out research, development and commercialization plans;

● loss of a key customer or supplier;

● product malfunctions;

● price increases for supplies and components;

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.

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 MicroNetTM 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

CGuardTM 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 CGuardTM 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 CGuardTM 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, SwitchGuardTM 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.

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.

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 (https://www.who.int/cardiovascular_diseases/resources/atlas/en/)

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.

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 CGuardTM

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 CGuardTM 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.

CGuard

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 μm 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.

CGuard

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.

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.

MACCE (MI, stroke, 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.

Subjects with new Acute Ischemic Lesions (“AIL”) 10 1

Incidence of new lesions 37.0 % 4.0 %

Total number new AIL 83 1

Permanent AIL at 30 days — 1

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:

● All but one lesion had resolved completely by 30 days.

Physician-Sponsored

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

PARADIGM-101

(Prospective evaluation of All-comer peRcutaneous cArotiD revascularization

In symptomatic and increased-risk asymptomatic carotid artery stenosis, using CGuardTM Mesh-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.

● Periprocedural death/major stroke/ myocardial infarction (“MI”) rates were 0%;

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.

Clinical

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

findings from the study are as follows:

● 100% success in implanting CGuard EPS without residual stenosis;

● No peri- or post-procedural complications;

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

Additionally,

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), https://doi.org/10.1016/j.ejvs.2017.09.015.

Key

findings from the study are as follows:

● 100% success in implanting CGuard EPS;

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

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

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;

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

● 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.

Key

findings from the study were as follows:

● 100% technical success in implanting CGuard EPS;

● No neurological events within 30 days;

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

findings from the study are as follows:

● 100% procedural success in implanting CGuard EPS;

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

findings from the study are as follows:

● 100% technical success was achieved in all patients:

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

The

SIBERIA Trial for Carotid Artery Stenosis: A Randomized Controlled Trial of Conventional Versus MicronetTM-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 MicronetTM-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 AcculinkTM.

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 CGuardTM MicronetTM-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, AcculinkTM, versus the MicroNet-Covered Stent, CGuardTM.

Key

findings from the study are as follows:

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.

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 MicroNetTM 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