What changed in this filing

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Item 1. Business

2022-03-07 compared with 2021-03-08 · 968 added, 1204 removed, 228 unchanged (91% of the section changed)

are a medical device company focusing on the development and commercialization of our proprietary MicroNet™

stent platform

technology for the treatment of complex vascular and coronary disease.

A stent is an expandable “scaffold-like”

usually constructed of a metallic material, that is inserted into an artery to expand the inside passage and improve blood flow.

Our MicroNet, a micron mesh sleeve, is wrapped over a stent to provide embolic protection in stenting procedures.

CGuard™

carotid embolic prevention system (“CGuard EPS”) combines MicroNet and a self-expandable nitinol stent

in a single device for use in carotid artery applications.

Our CGuard EPS received CE mark approval in the European Union in March

2013 and was fully launched in Europe in September 2015.

Subsequently, we launched CGuard EPS in Russia and certain countries

in Latin America and Asia, including India.

In September 2020, we launched CGuard EPS in Brazil after receiving regulatory approval

in July 2020 and, as discussed below, on February 3, 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.

are a medical device company focusing on the development and commercialization of our proprietary MicroNet™ stent platform technology

for the treatment of complex vascular and coronary disease.

A stent is an expandable “scaffold-like” device, usually constructed

of a metallic material, that is inserted into an artery to expand the inside passage and improve blood flow.

MicroNet, a micron mesh

sleeve, is wrapped over a stent to provide embolic protection in stenting procedures.

CGuard™ carotid embolic prevention system (“CGuard EPS”) combines MicroNet and a self-expandable nitinol stent in a

single device for use in carotid artery applications.

Our CGuard EPS received CE mark approval in the European Union in March 2013 and

was fully launched in Europe in September 2015.

Subsequently, we launched CGuard EPS in Russia and certain countries in Latin America

and Asia, including India.

In September 2020, we launched CGuard EPS in Brazil after receiving regulatory approval in July 2020 and as

discussed below, on February 3, 2021, we executed a distribution agreement with Chinese partners for the purpose of expanding our presence

Currently, we are seeking strategic partners for a potential launch of CGuard EPS in Japan and other Asian countries.

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,

CARENET-III, for prevention of stroke in patients in the United States.

CARENET-lll 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 trial will enroll approximately 315 subjects

in a maximum of 40 study sites located in the United States.

Additional sites in Europe may also participate in the study, contributing

a maximum of ~50% of the total enrollees.

The primary endpoint of the study will be the composite of the following:

of the following major adverse events:

death (all- cause mortality), all stroke, and myocardial infarction (DSMI) through 30-days

post-index procedure, based on the clinical events committee (CEC) adjudication or ipsilateral stroke from 31-365 day follow-up,

based on Clinical Events Committee (CEC) adjudication.

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.

The trial was designed to enroll approximately 315 subjects in a maximum of 40 study

sites located in the United States and Europe.

Study sites in Europe may contribute a maximum of approximately 50% of the total enrollees.

The primary endpoint of the study will be the composite of incidence of death (all-cause mortality), all stroke, and myocardial infarction

(DSMI) through 30-days post-index procedure, based on the clinical events committee (CEC) adjudication and ipsilateral stroke from 31-365

day follow-up, based on Clinical Events Committee (CEC) adjudication.

July 23, 2021, we announced the initiation of enrollment and successful completion of the first cases of our C-Guardian trial of CGuard

The first patients, who were under the care of principal investigator, Chris Metzger, M.D., system chair of clinical research at

Ballard Health System in Eastern Tennessee, were successfully implanted with the CGuard EPS stent device.

These are the first of 315

patients who are expected to be enrolled in the trial and receive CGuard EPS in the treatment of carotid artery stenosis in symptomatic

and asymptomatic patients undergoing carotid artery stenting.

We are currently continuing with the enrollment phase.

Additionally,

we intend to continue to invest in current and future potential product and manufacturing enhancements for CGuard EPS that are

expected to reduce cost of goods and/or provide the best-in-class performing delivery system.

In furtherance of our strategy that

focuses on establishing CGuard EPS as a viable alternative to vascular surgery, we are exploring adding new delivery systems and

accessory solutions for procedural protection to our portfolio.

consider the addressable market for our CGuard EPS to be individuals with diagnosed, symptomatic high-grade carotid artery stenosis

(HGCS, ≥70% occlusion) 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

Assuming full penetration of the intervention caseload by CGuard EPS, we estimate that the addressable market for

CGuard EPS was approximately $1.0 billion in 2017 (source:

Health Research International 2017 Results of Update Report on Global

Carotid Stenting Procedures and Markets by Major Geography and Addressable Markets).

MGuard™

embolic protection system (“MGuard Prime EPS”) is marketed for use in patients with acute

coronary syndromes, notably acute myocardial infarction (heart attack) and saphenous vein graft coronary interventions (bypass

MGuard Prime EPS combines MicroNet with a bare-metal cobalt-chromium based stent.

MGuard Prime EPS received CE mark

approval in the European Union in October 2010 for improving luminal diameter and providing embolic protection.

However, as a

result of a shift in industry preferences away from bare-metal stents in favor of drug-eluting (drug-coated) stents, in 2014 we

decided to curtail further development of this product in order to focus on the development of a drug-eluting stent product, MGuard

Due to limited resources, however, our efforts have been limited to testing drug-eluting stents manufactured by potential

partners for compatibility with MicroNet and seeking to incorporate MicroNet onto a drug-eluting stent manufactured by a potential

The FDA has clarified that the primary mode of action for drug-eluting cardiovascular stents, which are regulated as

combination products, is that of the device component and has assigned the FDA Center for Devices and Radiological Health (CDRH)

primary responsibility for premarket review and regulation, providing some clarity about what to expect regarding the regulatory

framework related to the development of MGuard DES™.

also intend to develop a pipeline of other products and additional applications by leveraging our MicroNet technology to new applications

to improve peripheral vascular and neurovascular procedures, such as the treatment of the superficial femoral artery disease,

vascular disease below the knee and neurovascular stenting to seal aneurysms in the brain.

none of our products may be sold or marketed in the United States.

we intend to continue to invest in current and future potential product and manufacturing enhancements for CGuard EPS that are expected

to reduce cost of goods and/or provide the best-in-class performing delivery system.

In furtherance of our strategy that focuses on establishing

CGuard EPS as a viable alternative to vascular surgery, we are exploring adding new delivery systems and accessory solutions for procedural

protection to our portfolio.

consider the current addressable market for our CGuard EPS to be individuals with diagnosed, symptomatic high-grade carotid artery stenosis

(HGCS, ≥70% occlusion) 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 EPS, we estimate that the addressable market for CGuard EPS will be

approximately $666 million in 2022 (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).

According to this same report,

assuming full penetration of the caseload for all individuals diagnosed with high-grade carotid artery stenosis, we estimate that the

total available market for CGuard EPS in 2022 will be approximately $5 billion.

MGuard™ Prime™ embolic protection system (“MGuard Prime EPS”) is marketed for use in patients with acute coronary

syndromes, notably acute myocardial infarction (heart attack) and saphenous vein graft coronary interventions, or bypass surgery.

Prime EPS combines MicroNet with a bare-metal cobalt-chromium based stent.

MGuard Prime EPS received CE mark approval in the European

Union in October 2010 for improving luminal diameter and providing embolic protection.

Over the past years there has been a shift in

industry preferences away from bare-metal stents, such as MGuard Prime EPS in ST-Elevation Myocardial Infarction (“STEMI”)

As a result of declining sales of the MGuard Prime EPS, which we believe this is largely driven by the predominant industry

preferences favoring drug-eluting, or drug-coated, stents, we intend to phase out future sales of our MGuard Prime EPS in 2022.

also intend to develop a pipeline of other products and indications by leveraging our MicroNet technology to improve peripheral procedures

such as the treatment of the superficial femoral artery disease and vascular disease below the knee as well as neurovascular procedures,

such as the treatment of acute stroke.

none of our products may be sold or marketed in the United States, but we do derive revenues from the use of our products in the currently

ongoing trials.

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

February 8, 2021, we closed an underwritten public offering of 29,032,258 units, with each such unit being comprised of one share

of our common stock, par value $0.0001 per share, and one Series G Warrant to purchase one-half of one share of common stock (the

“February 2021 Offering”).

February 8, 2021, we closed an underwritten public offering of 1,935,484 units, with each such unit being comprised of one share of our

common stock, par value $0.0001 per share, and one Series G Warrant to purchase one-half of one share of common stock (the “February

2021 Offering”).

The offering price to the public was $9.30 per unit.

The Series G Warrants were immediately

exercisable at a price of $0.682 per share, subject to adjustment in certain circumstances, and expire five years from the date

We also granted the underwriter of the offering an option to purchase an additional 4,354,838 shares of common stock

and Series G Warrants to purchase 2,177,419 shares of common stock, which the underwriter exercised in full.

, In connection with

the offering we granted to the underwriter a compensation warrant to purchase up to 1,669,355 shares of common stock with an exercise

price of $0.682 per share and which are exercisable for five years from February 3, 2021.

Our net proceeds from the offering,

after giving effect to the exercise of the underwriter’s over-allotment option, were approximately $18.9 million, after

deducting underwriting discounts and commissions and payment of other expenses associated with the offering, but excluding the

proceeds, if any, from the exercise of Series G Warrants sold in the offering.

June 5, 2020, we closed an underwritten public offering of (i) 7,635,800 Units, with each Unit being comprised of one share of

our common stock, par value $0.0001 per share, and one Series F warrant to purchase one share of common stock, and (ii) 14,586,400

Pre-Funded Units, with each Pre-Funded Unit being comprised of one Pre-Funded Warrant to purchase one share of common stock and

one Series F Warrant.

In connection with this public offering, the underwriter exercised the option practically in full, for 3,333,300

shares of common stock and 3,333,300 Series F Warrants.

The offering price to the public was $0.45 per Unit and $0.449 per Pre-Funded

Our net proceeds from the offering and the exercise of the underwriter’s over-allotment option were approximately

$10.7 million, after deducting underwriting discounts and commissions and payment of other estimated expenses associated with

the offering, but excluding the proceeds, if any, from the exercise of Series F Warrants and the Pre-Funded Warrants sold in the

The Series G Warrants were immediately exercisable at a price

of $10.23 per share, subject to adjustment in certain circumstances, and expire five years from the date of issuance.

We also granted

the underwriter of the offering an option to purchase an additional 290,322 shares of common stock and Series G Warrants to purchase

145,161 shares of common stock, which the underwriter exercised in full.

In connection with the offering we granted to the underwriter

a compensation warrant to purchase up to 111,290 shares of common stock with an exercise price of $10.23 per share and which are exercisable

for five years from February 3, 2021.

Our net proceeds from the offering, after giving effect to the exercise of the underwriter’s

over-allotment option, were approximately $18.9 million, after deducting underwriting discounts and commissions and payment of other

expenses associated with the offering, but excluding the proceeds, if any, from the exercise of Series G Warrants sold in the offering.

and Purchase Agreement with Chinese Partners

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 eight-year exclusive distribution right to sell our products in China with the term of the agreement continuing on a year-to-year

basis unless terminated.

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 eight-year

exclusive distribution right to sell our 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.

addition, and on the same day, we entered into an investment transaction with QIDI, which included (i) an SPA, pursuant to which

QIDI agreed to invest $900,000 in exchange for shares of our common stock at a purchase price of $0.6708 per share, and (ii) an

IRA, whereby QIDI was provided certain customary registration rights, including a commitment by us to file a registration statement

with the SEC on Form S-1 or Form S-3 and have such registration statement become effective not later than 150 days following the

closing of the transactions under the SPA.

The Distribution Agreement

may be terminated for cause upon failure to meet minimum purchase obligations, failure to obtain regulatory approvals or for other material

addition, and on the same day, we entered into an investment transaction with QIDI, which included (i) an SPA, pursuant to which QIDI

agreed to invest $900,000 in exchange for shares of our common stock at a purchase price of $10.062 per share, and (ii) an IRA, whereby

QIDI was provided certain customary registration rights, including a commitment by us to file a registration statement with the SEC on

Form S-1 or Form S-3 and have such registration statement become effective not later than 150 days following the closing of the transactions

under the SPA.

transactions closed on February 5, 2021.

Amendment to the InspireMD, Inc.

2013 Long-Term Incentive Plan

as of August 31, 2020, our stockholders approved the Sixth Amendment to the Plan and, accordingly, increased the number of shares

of common stock available for issuance pursuant to awards under such Plan by 6,500,000 shares, to a total of 7,178,395 shares

of common stock.

Compliance with New York Stock Exchange

August 7, 2019, we received a notification from the NYSE American that we did not meet the continued listing standards of the

NYSE American as set forth in Part 10 of the Company Guide.

Specifically, we were not in compliance with Section 1003(a)(iii)

of the Company Guide because we reported stockholders’

equity of less than $6 million as of September 30, 2019, and net

losses in our five most recent fiscal years ended December 31, 2018.

As a result, we became subject to the procedures and requirements

of Section 1009 of the Company Guide.

On October 11, 2019, the NYSE American accepted our plan to regain compliance with Section

1003(a)(iii) of the Company Guide by August 7, 2020.

August 7, 2020, following our submission to the NYSE American of our plan for regaining compliance, the NYSE American approved

such plan and, accordingly and as of such date, we are compliant with all of the NYSE American LLC continued listing standards

set forth in Part 10 of the NYSE American Company Guide.

In particular, we regained compliance with the continued listing requirement

under NYSE American Company Guide Section 1003(a)(iii).

The return to compliance was achieved as a result of our recently-consummated

public offering, in which we raised approximately $10.7 million of net proceeds from the sale of units and pre-funded units.

Approval of IDE

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, CARENET-III, for prevention of stroke in patients in the United States.

July 28, 2020, we entered into a Sales Agreement with A.G.P.

pursuant to which we may offer and sell, from time to time, at our

option, through or to A.G.P., up to an aggregate of approximately $9,300,000 of shares of common stock (the “ATM Facility”).

Any shares to be offered and sold under the Sales Agreement will be issued and sold pursuant to the Company’s Registration

Statement on Form S-3 (File No.

333-223130), filed with the SEC on February 21, 2018 and the prospectus supplement thereto filed

with the SEC on July 28, 2020, by methods deemed to be an “at the market offering”

as defined in Rule 415(a)(4) promulgated

under the Securities Act of 1933, as amended, or if specified by us, by any other method permitted by law.

On January 11, 2021,

we increased the aggregate amount of our shares of common stock that may be sold under the Sales Agreement from $9,300,000 to

$10,382,954, and, as a result, utilized and sold the maximum amount allowable under the ATM Facility, which resulted in an aggregate

amount of $10,381,958.

Clearance for CGuard™

MicroNet ®

July 23, 2020, we announced that we obtained registration from the Brazilian registration authority, Agéncia Nacional de

Vigiláncia Sanitária (ANVISA), for our CGuard MicroNet covered stent, clearing it for sale and distribution in Brazil.

Trial Results for CGuard EPS

June 10, 2020, we reported the publication of the results of our PARADIGM trial in the EuroIntervention journal.

trial, 101 unselected consecutive real-life patients were treated with our CGuard MicroNET covered stent for carotid stenosis

and were monitored for postprocedural neurologic events for a period of 12 months.

The results displayed sustained protection

against any such neurologic events.

At 30 days, only one adverse event occurred (a minor transient stroke with no other strokes,

myocardial infarctions, or deaths).

Furthermore, those study results showed that no strokes occurred between 30 days and twelve

June 25, 2020, we reported the results from an investigator-initiated SIBERIA randomized clinical trial of our CGuard EPS, which

evaluated 30-day silent brain infarcts associated with the use of the Acculink™

conventional open-cell nitinol stent vs.

our CGuard Micronet-covered stent.

Those results displayed that CGuard had a statistically significant (greater than three-fold)

reduction in the procedure-generated mean cerebral lesion volume relative to Acculink.

At 30 days, there were zero new cerebral

lessons in the CGuard arm, compared to six in the Acculink arm, also statistically significant.

September 3, 2020 we reported the award for Best ESC Congress Poster for the presentation of updated data from the large, long-term

PARADIGM-EXTEND study of the CGuard™

Embolic Prevention System (EPS), as part of the European Society of Cardiology 2020

Carotid Update e-presentation at the European Society of Cardiology (ESC) Congress 2020.

PARADIGM/EXTEND is an investigator-driven

on-going study performed with CGuard Carotid stent for primary and secondary stroke prevention in a large, consecutive all-comers

population, with 5 years (60 months) follow-up.

The results for 480 patients of the expected total of 550 that completed the 30-day

follow-up were presented were no peri-procedural major strokes or death.

The total death/stroke /myocardial incidence at 30 days

was 1.04% (5/480) due to two minor strokes, one myocardial infarction and two stent-unrelated deaths.

In the study, 354/480 patients

completed the 12-month follow-up with only 1 patient experiencing in-stent restenosis, 0.28% (1/354).

At the 12-month follow-up

there were no other device-related adverse clinical events.

Finally, 46/480 patients completed the 60-month follow-up period with

one more case of in-stent restenosis and no additional cases of device-related stroke.

Gary Roubin, M.D.

to our Board of Directors

October 12, 2020, our board of directors, or the Board, appointed Dr.

Roubin as a Class I member of the Board, effective

as of that date, with a term expiring at the Company’s 2021 annual meeting of stockholders.

Roubin is an internationally

renowned interventional cardiologist recognized for his pioneering work in carotid stenting and embolic and protection devices.

He is also acknowledged for the development of coronary stenting and the first FDA-approved coronary stent.

In connection with

his appointment, Dr.

Roubin was granted options to purchase 79,650 shares of common stock and 238,950 shares of restricted stock.

Shortly after his appointment as a director, and on October 16, 2020, Dr.

Roubin invested $100,000 in the Company in exchange

for 222,223 units consisting of (i) one share of common stock and (ii) one warrant to purchase our common stock with an exercise

price of $0.495.

For additional biographical information about Dr.

Roubin, please see “Management”

an effort to contain and mitigate the spread of COVID-19, which the World Health Organization, or WHO, declared to be a pandemic

on March 12, 2020, many countries have imposed unprecedented restrictions on travel, quarantines and other public health safety

As of the beginning of the second quarter of 2020, we began to experience a significant COVID-19 related impact on our

financial condition and results of operations, which we primarily attribute to the postponement of CGuard EPS procedures (non-emergency

procedures), as hospitals shifted resources to patients affected by COVID-19.

To our knowledge, most European countries in which

we operate are slowly reinstating elective procedures, but we do not know when the hospitals will resume to normal pre-pandemic

levels with such procedures in light of recent increases in COVID-19 cases in the territories we sell into.

We anticipate that

the continuation of the pandemic and related restrictions and safety measures would likely result in continued fluctuations in

sales of our products for the upcoming periods.

For more discussion on our risks related to COVID-19, please see risk factors

included under “Item 1A.

Risk Factors”

response to significant market volatility and uncertainties relating to COVID-19, the fees and salaries of our Board, management

and most of our employees were reduced in order to alleviate corporate operating expenses.

April 1, 2020, the Board approved a 50% decrease in the annual cash compensation for non-employee directors from an aggregate

amount of $154,000 to $77,000.

April 21, 2020, Marvin Slosman, our President, Chief Executive Officer and Director, signed a waiver reducing his monthly base

salary from $33,333 to $16,666 for the period beginning April 1, 2020 and ending on such date as Mr.

Slosman was to determine,

and Craig Shore, our Chief Financial Officer, Chief Administrative Officer, Secretary and Treasurer, signed a waiver reducing

his monthly base salary from NIS 80,125 to NIS 40,063 for the period beginning April 1, 2020 and ending on such date as Mr.

was to determine.

April 1, 2020, we reduced the annual salaries of most of our employees by 20% to 30% until further notice.

on a determination made by each of Mr.

Slosman and Mr.

Shore on June 10, 2020, following the closing of our underwritten public

offering in June 2020, as described above, each of Mr.

Slosman’s and Mr.

Shore’s monthly base salaries were reinstated

to $33,333 and NIS 80,125, respectively, effective as of June 1, 2020.

Each of the salaries for the remaining officers, directors

and employees was similarly reinstated by no later than June 30, 2020.

a result of the reduction of those fees and salaries during the second quarter of 2020, our operating expenses were reduced by

approximately $235,000 in the second quarter of 2020.

from Former Underwriter

terms of our engagement of the underwriter for our September 2019 financing contained a purported 12 month right of first refusal

in favor of such underwriter with respect to future financings.

Due to, among other things, difficulties in the relationship with

that prior underwriter and our need to raise additional funds to finance our ongoing operations, we engaged A.G.P./Alliance Global

Partners in May 2020 as underwriter for our June 2020 public offering, and again in July 2020 for an ATM Facility.

July 28, 2020, we entered into a settlement agreement and release with that prior underwriter, under which it provided us a final,

unconditional release from any further obligations arising out of or related to the engagement agreements, underwriting agreements

and placement agency agreements which we had been party to with it and with respect to any services which it had provided to us.

We, in turn, provided the prior underwriter a final, unconditional release from any further obligations arising out of or related

to the prior agreements and services.

consideration for the final release provided to us, we paid to the prior underwriter $400,000 in cash and reduced, to $0.495,

the exercise price per share of warrants to purchase 274,029 shares of our common stock that had been issued by us to the prior

underwriter in various offerings that took place between March 2018 and September 2019.

That reduced exercise price represents

the exercise price for the Series F Warrants that we issued in our June 2020 public offering.

The warrants that were repriced

had existing exercise prices per share ranging from $187.50 to $2.25 and a weighted average exercise price per share of $7.32.

All other terms of those warrants remained unchanged.

The related increase in expenses of $400,000 was recorded during the three

months ended June 30, 2020 to “General and Administrative expense”

within the Consolidated Statements of Operations.

Equity Incentive Plan

September 30, 2021, at our 2021 annual meeting of stockholders, our stockholders approved our 2021

Equity Incentive Plan.

July 28, 2020, we entered into a Sales Agreement with Alliance Global Partners (“A.G.P.”) pursuant to which we may offer

and sell, from time to time, at our option, through or to A.G.P., up to an aggregate of approximately $9,300,000 of shares of common

stock (the “ATM Facility”).

Any shares to be offered and sold under the Sales Agreement will be issued and sold pursuant

to the Company’s Registration Statement on Form S-3 (File No.

333-223130), filed with the SEC on February 21, 2018 and the prospectus

supplement thereto filed with the SEC on July 28, 2020, by methods deemed to be an “at the market offering” as defined in

Rule 415(a)(4) promulgated under the Securities Act of 1933, as amended, or if specified by us, by any other method permitted by law.

On January 11, 2021, we increased the aggregate amount of our shares of common stock that may be sold under the Sales Agreement from

$9,300,000 to $10,382,954, and, as a result, utilized and sold the maximum amount allowable under the ATM Facility, which resulted in

an aggregate amount of $10,381,958.

April 14, 2021, our stockholders approved a reverse stock split of our common stock, following which, and on the same date, our board

of directors approved a ratio of 1-for-15 for the reverse stock split, or the Reverse Stock Split.

On April 14, 2021, the Delaware Secretary

of State approved our Certificate of Amendment to our Amended and Restated Certificate of Incorporation, which set an effective date

of April 26, 2021, for the Reverse Stock Split.

The post-Reverse Stock Split CUSIP number for our common stock is 45779A 846.

the April 26, 2021, the total number of shares of our common stock held by each stockholder was converted automatically into the number

of whole shares of common stock equal to (i) the number of issued and outstanding shares of common stock held by such stockholder immediately

prior to the Reverse Stock Split, divided by (ii) 15.

fractional shares were issued in connection with the Reverse Stock Split, and no cash or other consideration was be paid.

issued one whole share of the post-Reverse Stock Split common stock to any shareholder who otherwise would have received a fractional

share as a result of the Reverse Stock Split.

of Kathryn Arnold to our Board of Directors

May 10, 2021, the board of directors appointed Ms.

Kathryn Arnold as a Class III member of the Board, effective as of that date, with

a term expiring at the Company’s 2023 annual meeting of stockholders.

In connection with her appointment, on May 10, 2021, Ms.

Arnold was granted (a) options to purchase 3,512 shares of Common Stock (the “Options”), and (b) 10,536 shares of restricted

stock (the “Restricted Stock”, together with the Options the “Arnold Grant”).

The Options have an exercise price

equal to the closing fair market value of the Common Stock on the date of grant, subject to the terms and conditions of the Company’s

2013 Long-Term Incentive Plan (the “Plan”).

The Options and the Restricted Stock will vest and become exercisable in three

equal annual installments beginning on the one-year anniversary of the date of the Arnold Grant, provided that in the event that Ms.

Arnold is either (i) not reelected as a director at the Company’s 2023 annual meeting of stockholders, or (ii) not nominated for

reelection as a director at the Company’s 2023 annual meeting of stockholders, any unvested Options or Restricted Stock will vest

in full and become exercisable on the date of the decision not to reelect or nominate her (as applicable).

The Options have a term of

10 years from the date of grant.

May 10, 2021, we announced that our shares that previously traded on the NYSE American were approved for listing on the Nasdaq Capital

Market (“Nasdaq”) and such shares began trading on Nasdaq on May 21, 2021 under the symbol, “NSPR.” On May 27,

2021, we announced that our warrants that previously traded on the NYSE American were approved for listing on Nasdaq, and such warrants

began trading on June 8, 2021.

On July 7, 2021, our Series A warrants that previously traded under symbol “NSPRW” expired.

Commission for the Evaluation of Medical Devices and Health Technologies

October 13, 2021, we announced that our CGuard EPS stent system received a positive opinion from the National Commission for the Evaluation

of Medical Devices and Health Technologies (CNEDIMTS) of the French National Authority for Health (HAS) regarding reimbursement in France,

and the CGuard EPS was being added to the list of reimbursed medical products (LPPR) effective October 25, 2021.

This was the final step

to full commercial launch of CGuard EPS following CNEDIMTS’ positive opinion for reimbursement received by the Company on May 11,

2021 for the treatment of symptomatic and non-symptomatic lesions when surgery is not indicated.

COVID-19 global pandemic has led governments and authorities around the globe to take various precautionary measures in order to limit

the spread of COVID-19, including government-imposed quarantines, lockdowns, and other public health safety measures.

We experienced

a significant COVID-19 related impact on our financial condition and results of operations, primarily during the year ended December

31, 2020, which we primarily attribute to the postponement of CGuard EPS procedures (non-emergency procedures), as hospitals have shifted

resources to patients affected by COVID-19.

To the best of our knowledge, there are European countries in which we operate reinstated

non-emergency procedures.

However, new COVID-19 variants, and potentially increasing infection rates make the current COVID-related environment

highly volatile and uncertain and we anticipate that the continuation of the pandemic and related restrictions and safety measures will

likely result in continued fluctuations in sales of our products, potentially enrollments in our studies as well as potential disruptions

to our supply chain for the upcoming periods.

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.

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

In carotid artery disease, plaque accumulates in the artery walls, narrowing the artery and disrupting the blood supply to the

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

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.

2017, 2.2 million people were diagnosed with carotid artery disease, of which, approximately 600,000 patients had high grade carotid

stenosis requiring intervention for carotid artery disease (2017 Health Research International Market Report ).

artery stenting is a minimally invasive treatment option for carotid artery disease and an alternative to carotid endarterectomy,

where a surgeon accesses the blocked carotid artery though an incision in the neck, and then surgically removes the plaque.

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.

and patients may select from a variety of treatments to address coronary artery disease, including pharmaceutical therapy, balloon

angioplasty, stenting with bare metal or drug-eluting stents, and coronary artery bypass graft procedures, with the selection

often depending upon the stage of the disease.

global market for coronary stents is estimated at $5.5 billion and projected to grow to $8 billion by 2025.

(Global Market Insights,

Nov 06, 2019).

Growth will be driven by a continued increases in incidence (Coronary heart disease burden is projected to

rise from around 47 million DALYs globally in 1990 to 82 million DALYs (Disability Adjusted Life Year)in 2020 –

Burden of Coronary Heart Disease) –

especially in developing countries).

However, this market is dominated by drug eluting

stents (DES) which limits the opportunity for MGuard.

Neurovascular

neurovascular market focuses on catheter-delivered products used to treat strokes that already happened or unruptured brain aneurysms

that could lead to strokes.

In the latter case, coils are wound into blood vessel bulges to block blood flow entering the aneurysms

to prevent the aneurysms from rupturing.

Endovascular treatment of arterial aneurysm has evolved substantially over the past two

decades, transitioning from an investigational therapy into routine clinical practice and ultimately emerging as the treatment

of choice for many lesions (source:

Medtech Ventures 2009, Aneurysm Flow Modulating Device Market).

We believe that the

market for aneurysm flow modulating devices is still in the embryonic stage with windows of opportunities for early entrance.

neurovascular market includes over-the-wire, flow-guided microcatheters, guiding catheters, coil and liquid embolics, neurovascular

stents and flow diversion stents.

According to iData Research, the market is expected to be driven by the conversion from surgical

procedures to endovascular techniques in the treatment of aneurysms and arteriovenous malformations.

vascular diseases (“PVD”) are caused by the formation of atherosclerotic plaques in arteries, which carry blood to

organs, limbs and head.

2021, 2.8 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 380,000 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 two current intervention treatments used for carotid artery disease.

is a carotid endarterectomy where a surgeon accesses the blocked carotid artery though an incision in the neck, and then surgically removes

The second 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.

vascular diseases (“PVD”) are caused by the formation of atherosclerotic plaques in arteries, which carry blood to organs,

limbs and head.

It is also known as peripheral artery occlusive disease or peripheral artery disease.

It comprises diseases

pertaining to both peripheral veins and peripheral arteries, affecting the peripheral and cardiac circulation in the body.

includes diseases outside of the heart and brain, but most times refers to the leg and foot.

stents are more often used in combination with balloon angioplasty to open the veins, so that blood can flow through the blocked

veins in the body.

It comprises diseases pertaining

to both peripheral veins and peripheral arteries, affecting the peripheral and cardiac circulation in the body.

PVD includes diseases

outside of the heart and brain, but most times refers to the leg and foot.

stents are more often used in combination with balloon angioplasty to open the veins, so that blood can flow through the blocked veins

growing prevalence of PVD is expected to cause increased demand for treatment options.

4 unchanged sentences

is a summary of our current products and products under development, and their intended applications.

is our proprietary circular knitted mesh which wraps around a stent to protect patients from plaque debris flowing downstream

upon deployment.

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.

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 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.

– Carotid Applications

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.

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.

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.

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.

CGuard EPS with over-the-wire delivery system received CE mark approval in the European Union in March 2013.

In October 2014,

we initiated a limited market release of CGuard EPS with over-the-wire delivery system for use in carotid artery applications

in Germany, Poland and Italy.

September 2014, we reported the results of the CGuard CARENET trial at the Transcatheter Cardiovascular Therapeutics (“TCT”)

conference in Washington D.C.

In the CARENET trial, the CGuard EPS system demonstrated better results over historical data using

conventional commercially available carotid stents.

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.

the first quarter of 2015, we introduced CGuard RX, the new rapid exchange delivery system for CGuard EPS.

The rapid exchange

delivery system has a guidewire that passes through the delivery system, running through the guiding catheter.

It has one port,

and thus, can be operated by one operator, while an over-the-wire-delivery system has two lumens and ports and requires two operators

to perform the procedure.

Our rapid exchange delivery system received CE mark approval in January 2015.

We launched our CGuard

EPS in Europe with the rapid exchange delivery system in multiple medical specialties that perform carotid artery stenting.

customers include interventional cardiologists, vascular surgeons, interventional neuroradiologists and interventional radiologists.

September 2015, we announced full market launch of CGuard EPS in Europe.

Subsequently, we launched CGuard EPS in Russia and certain

countries in Latin America and Asia, including India.

In September, 2020, we launched CGuard EPS in Brazil after receiving regulatory

approval in July 2020, and we are seeking strategic partners for a potential launch of CGuard EPS in Japan and China.

April 2017, we had a pre-IDE submission meeting with the FDA regarding CGuard EPS where we presented materials that we believed

would support a formal IDE submission seeking approval to conduct a human clinical trial in the United States which included our

draft synopsis for the clinical trial design.

The FDA agreed to our pre-clinical test plan and clinical trial design.

26, 2019, we submitted an IDE application for CGuard EPS.

In connection with such application, on August 23, 2019, we received

a request for additional information from the FDA in support of our application.

On September 8, 2020, we received IDE approval

for CGuard™

Carotid Stent System, CARENET-III.

Additionally,

we intend to continue to evaluate potential product enhancements and manufacturing enhancements for CGuard EPS expected to reduce

cost of goods and/or provide the best-in-class performing delivery system.

We cannot give any assurance that we will receive sufficient

(or any) proceeds from future financings or the timing of such financings, if ever for potential product enhancements and manufacturing

enhancements.

In addition, such additional financings may be costly or difficult to complete.

Even if we receive sufficient proceeds

from future financings, there is no assurance that we will be able to timely apply for CE mark approval following our receipt

of such proceeds.

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.

Products–

Coronary Applications

(“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.

CGuard™ carotid embolic prevention system (“CGuard EPS”) combines MicroNet and a self-expandable nitinol stent in a

single device for use in carotid artery applications.

Our CGuard EPS received CE mark approval in the European Union in March 2013 and

was fully launched in Europe in September 2015.

Subsequently, we launched CGuard EPS in Russia and certain countries in Latin America

and Asia, including India.

In September 2020, we launched CGuard EPS in Brazil after receiving regulatory approval in July 2020 and on

February 3, 2021, we executed a distribution agreement with Chinese partners for the purpose of expanding our presence in China.

13, 2021, we announced that our CGuard EPS stent system received a positive opinion regarding reimbursement in France.

Currently, we

are seeking strategic partners for a potential launch of CGuard EPS in Japan.

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 trial was designed to enroll approximately

315 subjects in a maximum of 40 study sites located in the United States and Europe.

Study sites in Europe may contribute a maximum of

approximately 50% of the total enrollees.

The primary endpoint of the study will be the composite of incidence of death (all-cause mortality),

all stroke, and myocardial infarction (DSMI) through 30-days post-index procedure, based on the clinical events committee (CEC) adjudication

and ipsilateral stroke from 31-365 day follow-up, based on Clinical Events Committee (CEC) adjudication.

July 23, 2021, we announced the initiation of enrollment and successful completion of the first cases of our C-Guardian trial of CGuard

The first patients, who were under the care of principal investigator, Chris Metzger, M.D., system chair of clinical research at

Ballard Health System in Eastern Tennessee, were successfully implanted with the CGuard EPS stent device.

These are the first of 315

patients who are expected to be enrolled in the trial and receive CGuard EPS in the treatment of carotid artery stenosis in symptomatic

and asymptomatic patients undergoing carotid artery stenting.

We are currently continuing with the enrollment phase.

Additionally, we

intend to continue to invest in current and future potential product and manufacturing enhancements for CGuard EPS that are expected

to reduce cost of goods and/or provide the best-in-class performing delivery system.

In furtherance of our strategy that focuses on establishing

CGuard EPS as a viable alternative to vascular surgery, we are exploring adding new delivery systems and accessory solutions for procedural

protection to our portfolio.

Products– Coronary Applications

Stent MGuard Product.

&emsp;Our MGuard Prime EPS coronary product is comprised of MicroNet wrapped around a cobalt-chromium

based bare-metal stent.

In comparison to a conventional bare-metal stent, we believe our MGuard Prime EPS coronary product with

MicroNet mesh provides protection from dangerous embolic showers in patients experiencing ST-segment elevation myocardial infarction,

the most severe form of a heart attack, referred to as STEMI.

Our MGuard Prime EPS coronary product is comprised of MicroNet wrapped around a cobalt-chromium based

bare-metal stent.

In comparison to a conventional bare-metal stent, we believe our MGuard Prime EPS coronary product with MicroNet mesh

provides protection from dangerous embolic showers in patients experiencing ST-segment elevation myocardial infarction, the most severe

form of a heart attack, referred to as STEMI.

Standard stents were not engineered for heart attack patients.

they were designed for treating stable angina patients whose occlusion is different from that of an occlusion in a heart attack

In acute heart attack patients, the plaque or thrombus is unstable and often breaks up as the stent is implanted causing

downstream blockages in a significant portion of heart attack patients.

Our MGuard Prime EPS is integrated with a precisely engineered

micro net mesh that is designed to prevent the unstable arterial plaque and thrombus that caused the heart attack blockage from

breaking off.

Neurovascular Applications

began developing a neurovascular flow diverter, which we refer to as NGuard, which is an endovascular device that diverts blood

flow away from cerebral aneurysms and ultimately seals the aneurysms.

We have tested early flow diverter prototypes in initial

pre-clinical testing in both simulated aneurysm bench models using various MicroNet configurations with varying aperture sizes,

as well as in standard in vivo pre-clinical models, in which we observed aneurysm sealing and also wide open side branch vessels

across which the device was placed.

We have suspended all further development activity of NGuard until we obtain sufficient funding

for such purpose.

Rather, they were designed

for treating stable angina patients whose occlusion is different from that of an occlusion in a heart attack patient.

In acute heart

attack patients, the plaque or thrombus is unstable and often breaks up as the stent is implanted causing downstream blockages in a significant

portion of heart attack patients.

Our MGuard Prime EPS is integrated with a precisely engineered micro net mesh that is designed to prevent

the unstable arterial plaque and thrombus that caused the heart attack blockage from breaking off.

Over the past years there has been

a shift in industry preferences away from bare-metal stents, such as MGuard Prime EPS in ST-Elevation Myocardial Infarction STEMI patients.

As a result of declining sales of the MGuard Prime EPS, which we believe this is largely driven by the predominant industry preferences

favoring drug-eluting, or drug-coated, stents, we intend to phase out future sales of our MGuard Prime EPS in 2022.

— Peripheral Vascular Applications

intend to develop our MicroNet mesh sleeve and a self-expandable stent for use in peripheral vascular applications, to which we

refer to as PVGuard.

intend to develop our MicroNet mesh sleeve and a self-expandable stent for use in peripheral vascular applications, to which we refer

to as PVGuard.

PVDs are usually characterized by the accumulation of plaque in arteries in the legs.

This accumulation can

lead to the need for amputation or even death, when untreated.

PVD is treated either by trying to clear the artery of the blockage,

or by implanting a stent in the affected area to push the blockage out of the way of normal blood flow.

in carotid procedures, peripheral procedures are characterized by the necessity of controlling embolic showers both during and

post-procedure.

Controlling embolic showers is so important in these indications that physicians often use fully covered stents,

at the risk of blocking branching vessels, to ensure that emboli do not fall into the bloodstream and move to the brain.

that our MicroNet design will provide substantial advantages over existing therapies in treating peripheral artery stenosis.

as we plan to focus our resources on the further expansion of our sales and marketing activities for CGuard EPS and, provided

that we have sufficient resources, potential product enhancements and manufacturing enhancements for CGuard EPS expected to reduce

cost of goods and/or provide the best-in-class performing delivery system and its submission for CE mark approval, we do not intend

to pursue the development of PVGuard in the near future.

This accumulation can lead to the

need for amputation or even death, when untreated.

PVD is treated either by trying to clear the artery of the blockage, or by implanting

a stent in the affected area to push the blockage out of the way of normal blood flow.

in carotid procedures, peripheral procedures are characterized by the necessity of controlling embolic showers both during and post-procedure.

Controlling embolic showers is so important in these indications that physicians often use fully covered stents, at the risk of blocking

branching vessels, to ensure that emboli do not fall into the bloodstream and move to the brain.

We believe that our MicroNet design

will provide substantial advantages over existing therapies in treating peripheral artery stenosis.

as we plan to focus our resources on the further expansion of our sales and marketing activities for CGuard EPS and potential product

enhancements and manufacturing enhancements for CGuard EPS expected to reduce cost of goods and/or provide the best-in-class performing

delivery system and its submission for CE mark approval, we do not intend to pursue the development of PVGuard in the near future.

Clinical Trials for CGuard EPS

CARENET trial was the first multi-center study of CGuard EPS following the receipt of CE mark of this device in March 2013.

CARENET trial was designed to evaluate feasibility and safety of CGuard EPS in treatment of carotid lesions in consecutive patients

suitable for coronary artery stenting (“CAS”) in 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

(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)

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.

trial was designed to evaluate feasibility and safety of CGuard EPS in treatment of carotid lesions in consecutive patients suitable

for coronary artery stenting (“CAS”) in 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,

In the third quarter of 2015, the results of the CGuard CARENET trial were published in the Journal of the American College of

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.

(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.

(MI, stroke, death)

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

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”)

Incidence of new lesions

Total number new AIL

Where there is a second number shown below after a ± symbol, it

indicates the potential error in the measurement.

with new Acute Ischemic Lesions (“AIL”)

of new lesions

number new AIL

number new AIL per patient

3.19 ±

0.04 ±

Average lesion volume (cm 3 )

0.039 ±

0.08 ±

Maximum lesion volume (cm 3 )

Permanent AIL at 30 days

lesion volume (cm 3 )

AIL at 30 days

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 ±

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.

8 unchanged sentences

Physician-Sponsored

Clinical Trials for CGuard—PARADIGM-101 Study

( 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.

Clinical Trials for CGuard—PARADIGM-101 Study

( 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.

findings from the PARADIGM-101 study and the follow-up data are as follows:

1 unchanged sentence

The clinical evaluation also found no device foreshortening or elongation;

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%;

event was adjudicated by the Clinical Events Committee as a minor stroke (0.9%), with no change in NIH Stroke Scale or modified

Ranking scale;

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.

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

event was adjudicated by the Clinical Events Committee as a minor stroke (0.9%), with no change in NIH Stroke Scale or modified Ranking

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.

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.

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.

findings from the study are as follows:

4 unchanged sentences

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

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.

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

Additionally,

based on engineering evaluations, the study concluded that CGuard EPS provides a high radial force and strong support in stenotic

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.

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.

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

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.

2017, 30-day results were presented at the Leipzig Interventional Course (LINC) 2017 and published in the Journal of EuroIntervention

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.

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elimination of post-procedural neurologic complications by 30 days;

performed pre-procedure and between 24 and 72 hours post-procedure in 61 patients, indicated that 12 patients had new micro

emboli (19%).

performed pre-procedure and between 24 and 72 hours post-procedure in 61 patients, indicated that 12 patients had new micro emboli

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

3 unchanged sentences

Randomized trial comparing CGuard stent vs.

WallStent™

WallStent™ Study

study was an independent investigator-led single center randomized clinical trial, comparing CGuard EPS vs.

WallStent™,

intended to evaluate the incidence of peri-procedural diffusion-weighted-magnetic-resonance-imaging (DW-MRI) new brain lesions

after carotid artery stenting.

Sixty-one consecutive patients referred for carotid revascularization (between January 2015 and

October 2016) were eligible for the study.

The results of the 3PCAS study was published in the International Journal of Cardiology

in September 2018.

The discussion distinguished between peri-procedural (from procedure to 48h -72h) and post-procedural periods

(72h to 30 days) where the CGuard EPS demonstrated a reduction in the post-procedural embolic effect during the carotid plaque

healing period.

In contrast, there was no difference between the two stent groups during the peri-procedural stage because of,

according to the published article, the presence of bilateral/contralateral lesions (lesions resulting from the contralateral

artery from the non-treated carotid) which suggest that the peri-procedural neurological damage may have originated from extra-carotid

sources (outside of the artery which was treated and outside the stent itself).

WallStent™, intended

to evaluate the incidence of peri-procedural diffusion-weighted-magnetic-resonance-imaging (DW-MRI) new brain lesions after carotid artery

Sixty-one consecutive patients referred for carotid revascularization (between January 2015 and October 2016) were eligible

for the study.

The results of the 3PCAS study was published in the International Journal of Cardiology in September 2018.

The discussion

distinguished between peri-procedural (from procedure to 48h -72h) and post-procedural periods (72h to 30 days) where the CGuard EPS

demonstrated a reduction in the post-procedural embolic effect during the carotid plaque healing period.

In contrast, there was no difference

between the two stent groups during the peri-procedural stage because of, according to the published article, the presence of bilateral/contralateral

lesions (lesions resulting from the contralateral artery from the non-treated carotid) which suggest that the peri-procedural neurological

damage may have originated from extra-carotid sources (outside of the artery which was treated and outside the stent itself).

Clinical Study of the New CGuard EPS MicroNet Covered Carotid Stent:

“One Size Fits All”

“Initial

“One Size Fits All”

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.

‘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.

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.

findings from the study were as follows:

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

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).

Results from a Prospective Real-World Multicenter Clinical Practice of Carotid Artery Stenting Using the CGuard Embolic Prevention

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).

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

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

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.

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.

findings from the study are as follows:

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;

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;

minor stroke, 4 TIAs, 2 AMIs and 8 deaths (the 2 mentioned AMIs, 4 malignancies, 1 suicide and 1 undefined complication in

Guillain-Barré

minor stroke, 4 TIAs, 2 AMIs and 8 deaths (the 2 mentioned AMIs, 4 malignancies, 1 suicide and 1 undefined complication in Guillain-Barré

Syndrome) between 30 days and 1 year.

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

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

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 results of the study were

presented in a late-breaking session at the EuroPCR in June 2020.

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

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 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.

covered stent significantly reduced periprocedural and abolished post procedural cerebral embolism in relation to a conventional carotid

This is consistent with the MicroNet covered stent’s sustained embolism prevention, translating into cerebral protection

not only during but after carotid artery stenting.

findings from the study are as follows:

Procedure (24-48 hours), the CGuard™

arm was observed to have a 78% reduction in the average volume of new cerebral

lesions (157 mm3 vs.

Procedure, the CGuard™ arm was observed to have a 57% reduction in new cerebral lesion average volume per patient (171 mm 3

73 mm 3 ), a statistically significant improvement (p=0.017) and 222 mm 3 vs.

84 mm 3 (p=0.038);

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);

30 days, DW-MRI showed zero new cerebral lessons in the CGuard™

arm versus six in the Acculink™

arm (p=0.03);

30 days, there were zero strokes, myocardia infarctions or deaths in the CGuard arm and three events the Acculink™

(two strokes and one myocardial infarction).

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

30 days, there were zero strokes, myocardia infarctions or deaths in the CGuard arm and three events the Acculink™ arm (two

strokes and one myocardial infarction).

Clinical Trials for MGuard Bare-Metal Coronary Products

have completed eight clinical trials with respect to our first generation stainless steel-based MGuard coronary device and our

cobalt-chromium based MGuard Prime EPS stent.

Our first generation MGuard stent combining the MicroNet with a stainless steel

stent received CE mark approval for the treatment of coronary artery disease in the European Union in October 2007.

We subsequently

replaced the stainless steel stent with a more advanced cobalt-chromium based stent for MGuard Prime EPS.

have completed eight clinical trials with respect to our first generation stainless steel-based MGuard coronary device and our cobalt-chromium

based MGuard Prime EPS stent.

Our first generation MGuard stent combining the MicroNet with a stainless steel stent received CE mark

approval for the treatment of coronary artery disease in the European Union in October 2007.

We subsequently replaced the stainless steel

stent with a more advanced cobalt-chromium based stent for MGuard Prime EPS.

First in Men (FIM) study conducted in Germany from the fourth quarter of 2006 through the second quarter of 2008 focused on patients

with occlusion in their stent graft.

This group is considered to be in “high risk”

for complications during and shortly

after the procedure due to the substantial risk of occurrence of a thromboembolic event.

The study demonstrated MGuard’s

safety in this high risk group.

This study was followed by the GUARD study in Brazil in 2007 with a similar patient population

which reinforced the safety profile of MGuard in patients prone to procedural complications.

The MAGICAL study was a pilot study

in STEMI patients conducted in Poland from 2008 through 2012 which demonstrated safety, measured by MACE rates at 30 days following

the procedure, as well as efficacy results, measured by the ability of MGuard to reestablish blood flow into the infarcted area

of the muscle.

Furthermore, we conducted three registries (iMOS, IMR and iMOS Prime) that confirmed the feasibility of MGuard

and MGuard Prime EPS for the treatment of STEMI patients and the safety of MGuard and MGuard Prime EPS in the STEMI patient group.

Safety was repeatedly demonstrated in these trials and registries by the low mortality rate in the first month after the procedure.

the second calendar quarter of 2011, we began the MGuard for Acute ST Elevation Reperfusion Trial (which we refer to as our “MASTER

I trial”), a prospective, randomized study, which demonstrated that among patients with acute STEMI undergoing emergency

PCI, patients treated with MGuard had superior rates of epicardial coronary flow (blood flow within the vessels that run along

the outer surface of the heart) and complete ST-segment resolution, or restoration of blood flow to the heart muscle after a heart

attack, compared to those treated with commercially-approved bare metal or drug-eluting stents.

The results of this trial are

summarized in greater detail below.

the MASTER II trial, which we initially initiated as part of our efforts to seek approval of our MGuard Prime EPS by the FDA,

was discontinued at our election in its current form in light of market conditions moving toward the use of drug-eluting stents

over bare-metal stents.

Analysis of the patients already enrolled in the MASTER II trial prior to its suspension, however, reconfirmed

the MASTER I safety results due to a continued low mortality rate.

the second calendar quarter of 2011, we began the MASTER I trial, a prospective, randomized study in Europe, South America and

Israel to compare the MGuard with commercially-approved bare metal and drug-eluting stents in achieving superior myocardial reperfusion

(the restoration of blood flow) in primary angioplasty for the treatment of acute STEMI, the most severe form of heart attack.

The MASTER I trial enrolled 433 subjects, 50% of whom were treated with MGuard and 50% of whom were treated with a commercially-approved

bare metal or drug-eluting stents.

The detailed acute and 30 days results from the trial were presented at the TCT conference

on October 24, 2012 and published (Prospective, Randomized, Multicenter Evaluation of a Polyethylene Terephthalate Micronet Mesh–Covered

Stent (MGuard) in ST-Segment Elevation Myocardial Infarction, Stone et.

This group is considered to be in “high risk” for complications during and shortly after

the procedure due to the substantial risk of occurrence of a thromboembolic event.

The study demonstrated MGuard’s safety in this

high risk group.

This study was followed by the GUARD study in Brazil in 2007 with a similar patient population which reinforced the

safety profile of MGuard in patients prone to procedural complications.

The MAGICAL study was a pilot study in STEMI patients conducted

in Poland from 2008 through 2012 which demonstrated safety, measured by MACE rates at 30 days following the procedure, as well as efficacy

results, measured by the ability of MGuard to reestablish blood flow into the infarcted area of the muscle.

Furthermore, we conducted

three registries (iMOS, IMR and iMOS Prime) that confirmed the feasibility of MGuard and MGuard Prime EPS for the treatment of STEMI

patients and the safety of MGuard and MGuard Prime EPS in the STEMI patient group.

Safety was repeatedly demonstrated in these trials

and registries by the low mortality rate in the first month after the procedure.

the second calendar quarter of 2011, we began the MGuard for Acute ST Elevation Reperfusion Trial (which we refer to as our “MASTER

I trial”), a prospective, randomized study, which demonstrated that among patients with acute STEMI undergoing emergency PCI, patients

treated with MGuard had superior rates of epicardial coronary flow (blood flow within the vessels that run along the outer surface of

the heart) and complete ST-segment resolution, or restoration of blood flow to the heart muscle after a heart attack, compared to those

treated with commercially-approved bare metal or drug-eluting stents.

The results of this trial are summarized in greater detail below.

the MASTER II trial, which we initially initiated as part of our efforts to seek approval of our MGuard Prime EPS by the FDA, was discontinued

at our election in its current form in light of market conditions moving toward the use of drug-eluting stents over bare-metal stents.

Analysis of the patients already enrolled in the MASTER II trial prior to its suspension, however, reconfirmed the MASTER I safety results

due to a continued low mortality rate.

the second calendar quarter of 2011, we began the MASTER I trial, a prospective, randomized study in Europe, South America and Israel

to compare the MGuard with commercially-approved bare metal and drug-eluting stents in achieving superior myocardial reperfusion (the

restoration of blood flow) in primary angioplasty for the treatment of acute STEMI, the most severe form of heart attack.

I trial enrolled 433 subjects, 50% of whom were treated with MGuard and 50% of whom were treated with a commercially-approved bare metal

or drug-eluting stents.

The detailed acute and 30 days results from the trial were presented at the TCT conference on October 24, 2012

and published (Prospective, Randomized, Multicenter Evaluation of a Polyethylene Terephthalate Micronet Mesh–Covered Stent (MGuard)

in ST-Segment Elevation Myocardial Infarction, Stone et.

al, JACC , 60;

The results were as follows:

primary endpoint of post-procedure complete ST-segment resolution (restoration of blood flow to the heart muscle after a heart

attack) was statistically significantly improved in patients randomized to the MGuard compared to patients receiving a commercially-approved

primary endpoint of post-procedure complete ST-segment resolution (restoration of blood flow to the heart muscle after a heart attack)

was statistically significantly improved in patients randomized to the MGuard compared to patients receiving a commercially-approved

bare metal or drug-eluting stent (57.8% vs.

receiving MGuard exhibited superior rates of thrombolysis in myocardial infarction (TIMI) 3 flow, which evidences normal coronary

blood flow that fills the distal coronary bed completely, as compared to patients receiving a commercially-approved bare metal

or drug-eluting stent (91.7% vs.

blood flow that fills the distal coronary bed completely, as compared to patients receiving a commercially-approved bare metal or

drug-eluting stent (91.7% vs.

82.9%), with comparable rates of myocardial blush grade 2 or 3 (83.9% vs.

84.7%) and corrected

TIMI frame count (cTFC) (17.0 vs.

success rates (attainment of <50% final residual stenosis of the target lesion and final TIMI 3 flow) were higher in the

MGuard group compared to commercially-approved bare metal or drug-eluting stents (91.7% vs 82.4%).

84.7%) and corrected TIMI

frame count (cTFC) (17.0 vs.

success rates (attainment of <50% final residual stenosis of the target lesion and final TIMI 3 flow) were higher in the MGuard

group compared to commercially-approved bare metal or drug-eluting stents (91.7% vs 82.4%).

1.9%) and major adverse cardiac events (1.8% vs.

2.3%) at 30 days post procedure were not statistically significantly

different between patients randomized to MGuard as opposed to patients randomized to commercially-approved bare metal or drug-eluting

All other major adverse cardiac event components, as well as stent thrombosis, were comparable between the MGuard

and commercially-approved bare metal or drug-eluting stents.

six month results from the MASTER I trial were presented at the 2013 EuroPCR Meeting, the official annual meeting of the European

Association for Percutaneous Cardiovascular Interventions, on May 23, 2013 in Paris, France.

2.3%) at 30 days post procedure were not statistically significantly different

between patients randomized to MGuard as opposed to patients randomized to commercially-approved bare metal or drug-eluting stents.

All other major adverse cardiac event components, as well as stent thrombosis, were comparable between the MGuard and commercially-approved

bare metal or drug-eluting stents.

six month results from the MASTER I trial were presented at the 2013 EuroPCR Meeting, the official annual meeting of the European Association

for Percutaneous Cardiovascular Interventions, on May 23, 2013 in Paris, France.

The results were as follows:

1 unchanged sentence

3.4%) at 6 months post procedure were not statistically significantly

different between patients randomized to the MGuard as compared to patients randomized to commercially-approved bare metal

or drug-eluting stents.

All other major adverse cardiac event components, as well as stent thrombosis, were comparable between

patients treated with MGuard and those treated with commercially-approved bare metal or drug-eluting stents.

twelve month results from the MASTER I trial were presented at the TCT conference on October 29, 2013 and published (Mesh-Covered

Embolic Protection Stent Implantation in ST-Segment–Elevation Myocardial Infarction Final 1-Year Clinical and Angiographic

Results From the MGUARD for Acute ST Elevation Reperfusion Trial, Dudek et.

different between patients randomized to the MGuard as compared to patients randomized to commercially-approved bare metal or drug-eluting

All other major adverse cardiac event components, as well as stent thrombosis, were comparable between patients treated with

MGuard and those treated with commercially-approved bare metal or drug-eluting stents.

twelve month results from the MASTER I trial were presented at the TCT conference on October 29, 2013 and published (Mesh-Covered Embolic

Protection Stent Implantation in ST-Segment–Elevation Myocardial Infarction Final 1-Year Clinical and Angiographic Results From

the MGUARD for Acute ST Elevation Reperfusion Trial, Dudek et.

al, Coronary Interventions , 2014).

were as follows:

The results were as follows:

3.3%) and major adverse cardiac events (9.1% vs.

3.3%) at 12 months post procedure were not statistically significantly

different between patients randomized to the MGuard as opposed to those randomized to commercially-approved bare metal or

drug-eluting stents.

All other major adverse cardiac events, as well as stent thrombosis, were comparable between the MGuard

and commercially-approved bare metal or drug-eluting stents.

summary, the MASTER I trial demonstrated that among patients with acute STEMI undergoing emergency PCI patients treated with MGuard

had superior rates of epicardial coronary flow (blood flow within the vessels that run along the outer surface of the heart) and

complete ST-segment resolution compared to those treated with commercially-approved bare metal or drug-eluting stents.

patients treated with MGuard showed a slightly lower mortality rate and a slightly higher major adverse cardiac event rate as

compared to patients treated with commercially-approved bare metal or drug-eluting stents six and twelve months post procedure.

different between patients randomized to the MGuard as opposed to those randomized to commercially-approved bare metal or drug-eluting

All other major adverse cardiac events, as well as stent thrombosis, were comparable between the MGuard and commercially-approved

bare metal or drug-eluting stents.

summary, the MASTER I trial demonstrated that among patients with acute STEMI undergoing emergency PCI patients treated with MGuard had

superior rates of epicardial coronary flow (blood flow within the vessels that run along the outer surface of the heart) and complete

ST-segment resolution compared to those treated with commercially-approved bare metal or drug-eluting stents.

In addition, patients treated

with MGuard showed a slightly lower mortality rate and a slightly higher major adverse cardiac event rate as compared to patients treated

with commercially-approved bare metal or drug-eluting stents six and twelve months post procedure.

detailed table with the results from the MASTER I trial is set forth below.

The “p-Value”

refers to the probability

of obtaining a given test result.

The “p-Value” refers to the probability of obtaining

a given test result.

Any p value less than 0.05 is considered statistically significant.

Bare Metal Stents/Drug

Eluting Stents

Number of Patients

Myocardial blush grade 0-1

Myocardial blush grade 3

ST segment resolution >70

Metal Stents/Drug

blush grade 0-1

blush grade 3

segment resolution >70

day major adverse cardiac event

5 unchanged sentences

These trials would be designed to facilitate market acceptance and expand the use of the product.

We expect to be

able to rely upon CE mark approval of the product and other supporting clinical data to obtain local approvals.

We expect to be able to

rely upon CE mark approval of the product and other supporting clinical data to obtain local approvals.

do not anticipate conducting additional post-marketing clinical trials for our bare-metal MGuard coronary products.

primary business objective is to utilize our proprietary MicroNet technology and products to become the industry standard for

treatment of stroke, complex vascular and coronary disease 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.

primary business objective is to utilize our proprietary MicroNet technology and products to become the industry standard for treatment

of stroke, complex vascular and coronary disease 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

the adoption of CGuard EPS .

We are seeking to expand the population of CGuard EPS patients in those countries in which

CGuard EPS is commercially available.

In particular, our focus is on establishing CGuard EPS as a viable alternative (in appropriate

cases) to conventional carotid stents and vascular surgery within the applicable medical communities.

We intend to accomplish

this goal by continuing to publish and present our clinical data, support investigator-initiated clinical registries and exploring

addition of a procedural protection device to our portfolio incorporating the principal of reverse flow of the carotid artery

as an adjuctive alternative to femoral access.

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 EPS.

We are seeking to expand the population of CGuard EPS patients in those countries in which CGuard

EPS is commercially available.

In particular, our focus is on establishing CGuard EPS as a viable alternative (in appropriate cases)

to conventional carotid stents and vascular surgery within the applicable medical communities.

We intend to accomplish this goal

by continuing to publish and present our clinical data, support investigator-initiated clinical registries and exploring addition

of a procedural protection device to our portfolio incorporating the principal of reverse flow of the carotid artery as an adjuctive

alternative to femoral access.

We have partnered and will continue to seek out partnerships with organizations focused on the treatment

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 EPS.

expansion and pipeline development We will continue to invest in advancing our portfolio with new delivery system alternatives

to facilitate the use of CGuard by all physicians.

Our delivery systems will enable all endovascular access points including accessory

devices for Arterial Venous (AV) shunting .

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 a comprehensive marketing and clinical education programs.

2018, we obtained approval for reimbursement and commercial sale for CGuard EPS in Australia and immediately launched the

We are also pursuing additional product registrations and distribution contracts with local distributors in other

countries in Europe, Asia and Latin America.

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 a comprehensive marketing and clinical education programs.

In additional we have begun

to sell direct to hospitals in certain markets and continue to evaluate the transition to a direct selling to hospitals 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.

February 2021, we executed a distribution agreement with Chinese partners for the purpose of expanding our presence in China.

we are seeking strategic partners for a potential launch of CGuard EPS in Japan.

In addition, we are conducting a pivotal study of

our CGuard™ Carotid Stent System, C-Guardians, for prevention of stroke in patients in the United States.

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 patients’

We continue to broadly develop and protect intellectual property using our mesh technology.

Examples of some areas include

peripheral vascular disease, neurovascular disease, renal artery disease and bifurcation disease.

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 patients’ 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.

relationships with collaborative and development partners to fully develop and market our existing and future products.

are seeking strategic partners for collaborative research, development, marketing, distribution, or other agreements, which

could assist with our development and commercialization efforts for CGuard EPS and MGuard DES, and other potential products

that are based on our MicroNet technology.

development and successfully commercialize MGuard DES.

While we have limited the focus of product development to our carotid

products, if we resume development of our coronary products, we plan to evaluate opportunities to further develop MGuard DES.

expansion and pipeline development We will continue to invest in advancing our portfolio with new delivery system alternatives

to facilitate the use of CGuard by all physicians.

Our delivery systems will enable all endovascular access points including

accessory devices for Arterial Venous (AV) shunting .

seeking strategic partners for collaborative research, development, marketing, distribution, or other agreements, which could assist

with our development and commercialization efforts for CGuard EPS and other potential products that are based on our MicroNet technology.

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

of industry participants.

carotid stent markets in the United States and Europe are dominated by Abbott Laboratories, Boston Scientific Corporation, Covidien

carotid stent markets in the United States and Europe are dominated by Abbott Laboratories, Boston Scientific Corporation, Covidien Ltd.

(currently part of Medtronic, Inc.), and Cordis Corporation (currently part of Cardinal Health, Inc.).

Gore Medical and Terumo

Medical Corporation produce a polytetrafluoroethylene mesh-covered stent and a double layer metal stent, respectively.

these larger companies have substantially 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 and relationships with our target customers, as well as worldwide distribution methods that are more

effective than ours.

However, we believe that the European market is somewhat fragmented, and, in our opinion, smaller competitors

may be able to gain market share with greater flexibility.

bare-metal stent and the drug-eluting stent markets in the United States and Europe are dominated by Abbott Laboratories, Boston

Scientific Corporation, and Medtronic, Inc.

In Europe, the market is now almost exclusively dominated by drug eluding stents and

is rapidly becoming so in the rest of the world.

(Catheter Cardiovasc Interv.

2018 Oct 1;(92(4):E262-E270.

10.1002/ccd.27375.

Epub 2017 Oct 13.

https://www.ncbi.nlm.nih.gov/pubmed/29027735 ).

We believe physicians look to next-generation stent technology

to compete with existing therapies.

Such next-generation technologies include bio-absorbable stents, stents that focus on treating

bifurcated lesions, and stents with superior polymer and drug coatings, and many industry participants are working to improve

stenting procedures as the portfolio of available stent technologies rapidly increases.

to the MEDTECH OUTLOOK, the three major players (Abbott Laboratories, Boston Scientific Corporation and Medtronic, Inc.) in the

worldwide coronary stent market have a combined total market share of approximately 92%.

To date, our sales are not significant

enough to register in market share.

As such, one of the challenges we face to further our product growth is the competition from

numerous pharmaceutical and biotechnology companies in the therapeutics area, as well as competition from academic institutions,

government agencies and research institutions.

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.

Due to ongoing consolidation

in the industry, there are high barriers to entry for small manufacturers in the European and the U.S.

markets and the rest of

Gore Medical and Terumo Medical

Corporation produce a polytetrafluoroethylene mesh-covered stent and a double layer metal stent, respectively.

All of these larger companies

have substantially 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 and relationships

with our target customers, as well as worldwide distribution methods that are more effective than ours.

However, we believe that the

European market is somewhat fragmented, and, in our opinion, smaller competitors may be able to gain market share with greater flexibility.

Neurovascular

1 unchanged sentence

and mergers are increasingly used as a strategy for product portfolio expansion and to grow footprint.

(Global Market Insights,

(Global Market Insights, Inc.

- Devices Market Share 2018-2024 Industry Size Report.

3 unchanged sentences

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.

2017, we decided to shift our commercial strategy to focus 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 transition vascular surgeons from carotid endarterectomy procedures

to carotid stenting with CGuard EPS, 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 if and when they

become available.

In addition, we are using international trade shows and industry conferences to gain market exposure and brand

We continue to work with leading physicians to enhance our marketing effort and are developing relationships with

new key opinion leaders to champion our technology and work with us in clinical studies

we are actively selling our MGuard coronary products with a bio-stable MicroNet through local distributors in Europe, Latin America,

the Middle East and Asia.

treating carotid artery disease, we believe that there is an opportunity to enter the market with bare-metal stent platform and

to become a competitive player without a drug-eluting stent platform.

Therefore, we believe that CGuard EPS is poised for commercial

growth in 2020 as more and more positive clinical data is presented.

2015, we announced full market launch of CGuard EPS in Europe.

Since 2017 we are focusing 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

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 EPS 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 if and when they become available.

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 effort and are developing relationships with new key opinion leaders to champion our technology

and work with us in clinical studies.

In additional we have begun to sell direct to hospitals in certain markets, such as France and

the United Kingdom, in order to increase our growth in the market and gross profit margins.

a result of declining sales of the MGuard Prime EPS, which we believe is largely driven by the predominant industry preferences favoring

drug-eluting stents rather than bare metal stents such as MGuard Prime EPS in STEMI patients, we intend to phase out future sales of

our MGuard Prime EPS in 2022.

treating carotid artery disease, 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.

Additionally,

we intend to continue to evaluate potential product enhancements and manufacturing enhancements for CGuard EPS expected to reduce

cost of goods or provide the best-in-class performing delivery system.

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.

Finally, we do

not expect that it would be crucial to use a drug-eluting stent platform to compete in certain new markets such as the neurovascular

we intend to continue to evaluate potential product enhancements and manufacturing enhancements for CGuard EPS 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.

we do not expect that it would be crucial to use a drug-eluting stent platform to compete in certain new markets such as the neurovascular

market, and hence, we plan to continue to explore this area of opportunity.

MGuard coronary products have initially penetrated the market by entering segments with indications that present high risks of

embolic dislodgement, notably acute MI and saphenous vein graft coronary interventions.

Even though MGuard technology has demonstrated

its advantages with clinical data, it is based on a bare-metal platform while the market demand has shifted away from bare-metal

stents in favor of drug-eluting stents.

Reimbursement

most countries, a significant portion of a patient’s medical expenses is covered by third-party payors.

Third-party payors

can include both government funded insurance programs and private insurance programs.

While each payor develops and maintains

its own coverage and reimbursement policies, payors, in many instances, have similarly established policies, and in the U.S.,

for example, coverage policies and reimbursement rates of private payors are often influenced by those established by the U.S.

Department of Health and Human Services Centers for Medicare and Medicaid Services (CMS).

The CGuard products and MGuard coronary

products sold to-date in applicable foreign countries have been designed and labeled to facilitate the utilization of existing

reimbursement codes for such countries, and we intend to continue to design and label our present and future products in a manner

consistent with this goal.

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

have 52 issued patents, including 14 patents issued in the U.S., and seven pending patent applications, four of which are pending

in the United States.

most countries, a significant portion of a patient’s medical expenses is covered by third-party payors.

Third-party payors can

include both government-funded insurance programs and private insurance programs.

While each payor develops and maintains its own coverage

and reimbursement policies, payors, in many instances, have similarly established policies, and in the U.S., for example, coverage policies

and reimbursement rates of private payors are often influenced by those established by the U.S.

Department of Health and Human Services

Centers for Medicare and Medicaid Services (CMS).

The CGuard products and MGuard coronary products sold to-date in applicable foreign

countries have been designed and labeled to facilitate the utilization of existing reimbursement codes for such countries, and we intend

to continue to design and label our present and future products in a manner consistent with this goal.

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.

have 53 issued patents, including 16 patents issued in the U.S., and 17 pending patent applications, 7 of which are pending in the United

Many of these patents and applications cover aspects of our CGuard and MGuard technology.

Patents outside

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:

Patents outside the U.S.

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:

Title of Patent Family

4 unchanged sentences

Israel 260,945

for Two-Stage Deployment of a Stent

Visualization

of blood flow in a venous/arterial shunting system

(Provisional)

for shunting blood between the arterial and venous systems of a patient

(provisional)

air from fluid in vascular and/or arterial delivery lines or blood circuits

(provisional)

Vivo Filter Assembly

1 unchanged sentence

Canada 2,666,728

Canada 2,887,189

China ZL200780046697.4

China ZL201210320950.3

Israel 198,190

(Germany, France, & UK

)US 10,137,015

Canada 3,013,758

China ZL201210454357.8

5 unchanged sentences

US 10,406,008

US 11,051,959

(validated in 9 countries:

14 unchanged sentences

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.

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.

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.

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.

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

InspireMD ®

(US, European Union, and UK)

1 unchanged sentence

(US, European Union, and UK)

Prime ® (US, European Union, and UK)

(US, European Union)

(US, European Union, and UK)

Micronet®

Micronet Protection logo) (European Union and UK)

)European Union and UK)

SmartFit™

Carenet®)European

Union and UK)

Logo (EP, UK, US);

CN & JP in preparation

Prime (EP, UK, US)

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.

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.

use and may have common-law rights to various trademarks, trade names, and service marks.

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.

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 the Medical Device Directive

93/42/EEC (“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 an European Notified Body.

We have obtained ISO 13485 quality system certification and the products we currently distribute

into the European Union display 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 European Medical Devices Regulation,

or MDR (MDR 2017/745).

The MDR will apply after a transitional period of three years ending on May 26, 2020, which is expected

to change several aspects of the existing regulatory framework in Europe.

Manufacturers have 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.

After May 26,

2020, medical devices can still be placed on the market under the provision of the MDD until May 27, 2024;

provided the CE Mark

was issued prior to this date and the manufacturer continues to comply with this directive.

By May 27, 2024, all medical devices

entering the EU will need to have a CE Mark under the MDR, even if they have been on the market previously under the MDD.

case, CGuard and MGuard can continue to be marketed under the MDD until November 12, 2022.

Specifically, the EU MDR will require

changes in the clinical evidence required for medical devices, post-market clinical follow-up evidence, annual reporting of safety

information for Class III products, Unique Device Identification (“UDI”) for all products, submission of core data

elements to a European UDI database prior to placement of a device on the market, and multiple other labeling changes.

for certain of our currently-marketed products could be curtailed or withdrawn as a result of the implementation and recertification

process of the EU MDR and acquiring approvals for new products could be more challenging, time consuming and costly.

noted below, we have or had regulatory approval and made sales of CGuard EPS, MGuard Prime EPS or both products either through

distributors pursuant to distribution agreements or directly, in the following countries:

Argentina, Australia, Austria, Belarus,

Belgium, Brazil, Bulgaria, Chile, Colombia, Croatia, Cyprus, Czech Republic, Denmark, Ecuador, Estonia, Finland, France, Germany,

Hong Kong, Hungary, Ireland, Israel, Italy, Latvia, Lithuania, Luxembourg, Malaysia, Malta, Mexico, Netherlands, New Zealand,

Norway, Peru, Poland, Portugal, Romania, Russia, Saudi Arabia, Serbia, Slovakia, Slovenia, South Africa, Spain, Sweden, Switzerland,

Turkey Vietnam and the United Kingdom In addition, we are awaiting regulatory approval to sell our products in Taiwan.

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 above-listed countries that are not members of the European Union 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.

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 the Medical Device Directive 93/42/EEC (“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 the products we currently distribute into the European Union display the required CE mark.

In order to maintain certification, we are required to pass an annual surveillance audit conducted by Notified Body auditors.

Union replaced the MDD with the new European Medical Devices Regulation, or MDR (MDR 2017/745, Council Directive 93/42/EEC).

will apply after a transitional period of three years ending on May 26, 2021, which is expected to change several aspects of the existing

regulatory framework in Europe.

Manufacturers have 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.

After May 26, 2021, medical devices can still be placed on the market

under the provision of the MDD until May 26, 2024;

provided the CE Mark was issued prior to this date and the manufacturer continues

to comply with this directive.

By May 26, 2024, all medical devices entering the EU will need to have a CE Mark under the MDR, even if

they have been on the market previously under the MDD.

In our case, CGuard and MGuard Prime can continue to be marketed under the MDD

until November 12, 2022.

Specifically, the EU MDR will require changes in the clinical evidence required for medical devices, post-market

clinical follow-up evidence, annual reporting of safety information for Class III products, Unique Device Identification (“UDI”)

for all products, submission of core data elements to a European UDI database prior to placement of a device on the market, and multiple

other labeling changes.

Approvals for certain of our currently-marketed products could be curtailed or withdrawn as a result of the implementation

and recertification process of the EU MDR and acquiring approvals for new products could be more challenging, time consuming and costly.

noted below, we have or had regulatory approval and made sales of CGuard EPS, MGuard Prime EPS or both products either through distributors

pursuant to distribution agreements or directly, in the following countries:

Argentina, Australia, Austria, Belarus, Belgium, Brazil,

Bulgaria, Chile, Colombia, Croatia, Cyprus, Czech Republic, Denmark, Ecuador, Estonia, Finland, France, Germany, Hong Kong, Hungary,

India Ireland, Israel, Italy, Latvia, Lithuania, Luxembourg, Malaysia, Malta, Mexico, Netherlands, New Zealand, Norway, Peru, Poland,

Portugal, Romania, Russia, Saudi Arabia, Serbia, Slovakia, Slovenia, South Africa, Spain, Sweden, Switzerland, Turkey, Vietnam, Taiwan

and the United Kingdom.

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.

while we believe that certain of the above-listed countries that are not members of the European Union accept the CE mark as a primary

requirement for marketing approval, each such country requires additional regulatory requirements for final marketing approval of our

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.

October 2007, our first generation MGuard stent combining the MicroNet with a stainless steel stent received CE mark approval

for the treatment of coronary artery disease in the European Union.

We subsequently replaced the first generation MGuard product

with MGuard Prime EPS, which uses a more advanced cobalt-chromium based stent.

Our MGuard Prime EPS received CE mark approval

in the European Union in October 2010 and marketing approval in those countries listed in the table below.

CGuard EPS received CE mark approval in the European Union on March 14, 2013 and marketing approval in the countries listed in

the table below.

We are currently seeking marketing approval for CGuard EPS in, South Korea and Taiwan.

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

and Sales of MGuard Prime EPS and CGuard EPS on a Country-by-Country Basis

Prime EPS Sales

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.

October 2007, our first generation MGuard stent combining the MicroNet with a stainless-steel stent received CE mark approval for the

treatment of coronary artery disease in the European Union.

We subsequently replaced the first generation MGuard product with MGuard

Prime EPS, which uses a more advanced cobalt-chromium based stent.

Our MGuard Prime EPS received CE mark approval in the European Union

in October 2010 and marketing approval in those countries listed in the table below.

CGuard EPS received CE mark approval in the European Union on March 14, 2013 and marketing approval in the countries listed in the table

We are currently seeking marketing approval for CGuard EPS in, South Korea.

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

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

Liechtenstein

approval expired and per management decision it was decided not to renew it.

is a non-regulated market, the health system in Chile only relies on CE mark or FDA certificates.

approval expired and per management decision it was decided not to renew it.

approval expired in November 2017.

We have not had sales of MGuard Prime EPS in Saudi Arabia since 2014.

certificate evidencing regulatory approval for MGuard Prime EPS in South Africa was held by our former distributor in South

Africa, and we cannot guarantee that it is in full force and effect.

Our distribution agreement with the distributor in South

Africa expired pursuant to the terms of such distribution agreement on February 1, 2015, and we have not had sales of MGuard

Prime EPS in South Africa since 2015

to temporary approval to import limited amount of units (400) to Kazakhstan.

Refers to units used in our ongoing FDA trial.

Government Regulation of Medical Devices for Human Subjects

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.

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.

Approval/Clearance Requirements

the United States, Class II or III medical devices must be cleared or approved by the FDA prior to commercialization.

exemption applies, each medical device that we market or wish to market in the United States must receive 510(k) clearance or

premarket approval.

Medical devices that receive 510(k) clearance are “cleared”

by the FDA to market, distribute,

and sell in the United States.

Medical devices that obtain a premarket approval by the FDA are “approved”

distribute, and sell in the United States.

We anticipate filing a premarket approval application in the future and do not anticipate

filing a 510(k) premarket notification.

Even though we do not anticipate filing a 510(k), we cannot be certain that the FDA will

find it more appropriate for us to file a 510(k) premarket notification instead of a premarket approval application.

we cannot be sure that we will ever obtain premarket approval.

Descriptions of the premarket approval and 510(k) clearance processes

are provided below.

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.

II devices are subject to the FDA’s General Controls, and any other special controls as deemed necessary by the FDA

to ensure the safety and effectiveness of the device.

Premarket review and clearance by the FDA for Class II devices is accomplished

through the 510(k) process.

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.

The FDA has recently indicated that it intends to modernize the 510(k) process and has issued new guidance

documents that may change the way that devices are cleared by the FDA.

the United States, most Class II or III medical devices must be cleared or approved by the FDA prior to commercialization.

exemption applies, each medical device that we market or wish to market in the United States must receive 510(k) clearance or premarket

Medical devices that receive 510(k) clearance are “cleared” by the FDA to market, distribute, and sell in the United

Medical devices that obtain a premarket approval by the FDA are “approved” to market, distribute, and sell in the

United States.

We anticipate filing a premarket approval application, or PMA, in the future for our product and do not anticipate filing

a 510(k) premarket notification, provided that the FDA will not instruct us otherwise.

We cannot guarantee that we will obtain premarket

approval, which will likely include clinical testing.

Descriptions of the premarket approval and 510(k) clearance processes are provided

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.

II devices are subject to the FDA’s General Controls, and any other special controls as deemed necessary by the FDA to ensure

the safety and effectiveness of the device.

Premarket review and clearance by the FDA for Class II devices is accomplished through the

510(k) process.

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.

The FDA has recently indicated that it intends to modernize the 510(k) process and has issued new guidance documents that may change

the way that devices are cleared by the FDA.

III includes devices with the greatest risk.

Devices in this class must meet all of the requirements in Classes I and II.

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 MDFUMA, premarket approval applications (and supplemental

premarket approval applications) are subject to significantly higher user fees than 510(k) applications, and they also require

considerably more time and resources.

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, that is either in Class I, Class II, or is a Class III device that was in commercial distribution before May 28,

1976, for which the FDA has not yet called for submission of a premarket approval application.

expect that unless an exemption applies, each medical device that we market or wish to market in the United States must receive

510(k) clearance or premarket approval.

Medical devices that receive 510(k) clearance are “cleared”

by the FDA to

market, distribute, and sell in the United States.

Medical devices that obtain a premarket approval by the FDA are “approved”

to market, distribute, and sell in the United States.

We anticipate that each device that we wish to commercialize will be considered

a Class III device by the FDA and therefore we anticipate filing a premarket approval application in the future and do not anticipate

filing a 510(k) premarket notification.

Even though we do not anticipate filing a 510(k), we cannot be certain that the FDA will

find it more appropriate for us to file a 510(k) premarket notification instead of a premarket approval application or that applications

of our technology may not be considered Class II devices.

Further, we cannot be sure that we will ever obtain a premarket approval.

Descriptions of the premarket approval and 510(k) clearance processes are provided below.

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 MDFUMA, PMAs (and supplemental PMAs) are subject to significantly higher user fees than

510(k) applications, and they also require considerably more time and resources.

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, that is either in Class I, Class II, or is a Class III 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

The De Novo request allows a regulatory pathway to classify novel medical devices 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.

expect that unless an exemption applies, each medical device that we market or wish to market in the United States must receive 510(k)

clearance or premarket approval.

Medical devices that receive 510(k) clearance are “cleared” by the FDA to market, distribute,

and sell in the United States.

Medical devices that obtain a premarket approval by the FDA are “approved” to market, distribute,

and sell in the United States.

We anticipate that each device that we wish to commercialize will be considered a Class III device by

the FDA and therefore we anticipate filing a PMA in the future and do not anticipate filing a 510(k) premarket notification, provided

that the FDA will not instruct us otherwise.

We cannot guaranty that we will obtain a premarket approval.

Descriptions of the premarket

approval and 510(k) clearance processes are provided below.

Approval Pathway

expect that current and future applications of our technology will result in medical devices that are considered Class III devices

subject to premarket approval.

A premarket approval application must be submitted if a device cannot be cleared through the 510(k)

A premarket approval application 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 for its intended use.

Before a premarket approval application is submitted, a manufacturer

must apply for an IDE.

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 enrollment

of human subjects for clinical trials.

The IDE provides the manufacturer with a legal pathway to perform clinical trials on human

subjects where without the IDE, only approved medical devices may be used on human subjects.

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.

If the clinical trial design is deemed to have “non-significant risk,”

the clinical trial may be eligible for “abbreviated”

IDE requirements.

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.

a premarket approval application is sufficiently complete, 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.

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.

expect that current and future applications of our technology will result in medical devices that are considered Class III devices subject

to premarket approval.

A PMA must be submitted if a device cannot be cleared through the 510(k) process, unless FDA permits a De Novo

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

for its intended use.

Before a premarket approval application is submitted, a manufacturer must 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 enrollment of

human subjects for clinical trials.

The IDE provides the manufacturer with a legal pathway to perform clinical trials on human subjects

where without the IDE, only approved medical devices may be used on human subjects.

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.

If the clinical trial design is deemed to

have “non-significant risk,” the clinical trial may be eligible for “abbreviated” IDE requirements.

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.

a PMA is sufficiently complete, the FDA will accept the application and begin an in-depth review of the submitted information.

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.

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.

Clearance Pathway

do not currently market, distribute, or sell any products that have market clearance by the FDA under its 510(k) process.

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.

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.

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.

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.

and Continuing FDA Regulation

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”

Class II devices also can have special controls such as performance standards, post-market surveillance, patient registries, and

FDA guidelines that do not apply to Class I devices.

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 FDA guidelines that do not

apply to Class I devices.

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

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

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;

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;

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

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;

of product modifications that affect the safety or effectiveness of one of our cleared devices;

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;

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);

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

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

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data for the device;

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;

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;

pertaining to voluntary recalls;

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do not currently have a registered 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 must will be required to register our establishments

with the FDA.

As such, we and our manufacturing facilities will be subject to FDA inspections for compliance with the FDA’s

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.

As such, 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.

Additionally, some of our subcontractors may also be subject to FDA announced and unannounced inspections

for compliance with the FDA’s Quality System Regulation.

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.

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.

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.

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.

regulations also govern product labeling and prohibit a manufacturer from marketing a medical device for unapproved applications.

CGuard EPS is classified as a Class III medical device by the FDA.

Class III medical devices are generally the highest risk devices

and are therefore subject to the highest level of regulatory control 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 unless or until the FDA approves

a premarket approval application.

Class III medical devices are generally the highest risk devices and

are therefore subject to the highest level of regulatory control 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.

either approve or deny a premarket approval application and we cannot market a device unless or until the FDA approves a premarket approval

expect the approval process in the U.S.

to take a significant amount of time, require the expenditure of significant resources,

involve rigorous clinical investigations and testing, and potentially require changes to products.

The approval process may result

in limitations on the indicated uses of the medical devices for which we are able to obtain approval (since the FDA can take action

against a company that promotes off-label uses) and will also require increased post-market surveillance.

to take a significant amount of time, require the expenditure of significant resources, involve

rigorous clinical investigations and testing, and potentially require changes to products.

The approval process may result in limitations

on the indicated uses of the medical devices for which we are able to obtain approval (since the FDA can take action against a company

that promotes off-label uses) and will also require increased post-market surveillance.

Healthcare Laws and Regulations

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.

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.

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/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 enforcement by 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 program, such as Medicare and Medicaid) for reimbursement,

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:

federal Anti-Kickback Statute, which prohibits the offer, payment, solicitation or receipt of any form of remuneration in

return for referring, ordering, leasing, purchasing or arranging for, or recommending the ordering, purchasing or leasing

of, items or services payable by Medicare, Medicaid or any other federal healthcare program;

false claims laws and civil monetary penalty laws, including the False Claims Act, that 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;

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;

as amended by the Health Information Technology for Economic and Clinical Health Act of 2009, and its implementing regulations,

also imposes 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;

federal transparency requirements under the Affordable Care Act, including the provision commonly referred to as the 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;

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.

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

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;

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;

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;

as amended by the Health Information Technology for Economic and Clinical Health Act of 2009, and its implementing regulations, also

imposes 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;

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;

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

customer base is varied.

We began shipping our product to customers in Europe in January 2008 and have since expanded our global

distribution network to Southeast Asia, India, Latin America and Israel.

We currently have distribution agreements for our CE

mark-approved MGuard Prime EPS and/or CGuard EPS with medical product distributors based in Europe, the Middle East, Asia Pacific

and Latin America.

We began shipping our MGuard product to customers in Europe in January 2008 and CGuard product to customers

in Europe in 2014 and have since expanded our global distribution network to Southeast Asia, India, Latin America and Israel.

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.

of our current agreements with our distributors stipulate that, and we expect our future agreements with our distributors to 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 most cases, all sales costs, including sales representatives, incentive programs, and marketing trials, will be borne by the

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.

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 marketing trials, 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.

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.

have also recently engaged in direct sales in certain geographic markets such as United Kingdom and France.

Manufacturing

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supplies us with catheters that help create the base for our CGuard EPS stents.

Our agreement with Natec Medical

Ltd., as amended, may be terminated by us upon eight months’

On August 1, 2017, we amended the agreement with Natec

Medical Ltd., so that we are responsible for purchasing and handling inventory of CGuard EPS delivery system, and Natec Medical

Ltd.is responsible for the manufacturing process.

Our agreement with Natec Medical Ltd., as

amended, may be terminated by us upon eight months’ notice.

On August 1, 2017, we amended the agreement with Natec Medical Ltd.,

so that we are responsible for purchasing and handling inventory of CGuard EPS delivery system, and Natec Medical Ltd.is responsible

for the manufacturing process.

supplies us with catheters that help create the base for our MGuard Prime EPS.

Our agreement with Natec Medical Ltd.,

which may be terminated by either party upon six months’

notice, calls for non-binding minimum orders.

Our agreement with Natec Medical Ltd., which

may be terminated by either party upon six months’ notice, calls for non-binding minimum orders.

cobalt-chromium stent for our MGuard Prime EPS was designed by Svelte Medical Systems Inc.

We have an agreement with Svelte Medical

Systems Inc., as amended, that grants us a non-exclusive, worldwide license for production and use of the MGuard Prime cobalt-chromium

stent for the life of the stent’s patent, subject to the earlier termination of the agreement upon the bankruptcy of either

party or the uncured default by either party under any material provision of the agreement.

Our royalty payments to Svelte Medical

We have an agreement with Svelte Medical Systems

Inc., as amended, that grants us a non-exclusive, worldwide license for production and use of the MGuard Prime cobalt-chromium stent

for the life of the stent’s patent, subject to the earlier termination of the agreement upon the bankruptcy of either party or

the uncured default by either party under any material provision of the agreement.

Our royalty payments to Svelte Medical Systems Inc.

are determined by the sales volume of MGuard Prime EPS.

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manufacture our CGuard EPS and MGuard Prime EPS at our own facility.

The bare-metal cobalt-chromium stents for our MGuard Prime

EPS and the self-expanding bare-metal stents for our CGuard EPS are being manufactured and supplied by MeKo Laserstrahl-Materialbearbeitung.

Our agreement with MeKo Laserstrahl-Materialbearbeitung for the production of electro polished L605 bare-metal stents for MGuard

Prime EPS and CGuard EPS is priced on a per-stent basis, subject to the quantity of stents ordered.

The complete assembly process

for MGuard Prime EPS and CGuard EPS, including knitting and securing the sleeve to the stent and the crimping of the sleeve stent

on to a delivery catheter, is done at our Israel manufacturing site.

Once MGuard Prime EPS and CGuard EPS 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.

the quarter ended March 31, 2019, our former third-party sterilizer’s equipment failures resulted in significant interruption

in sterilized product supply for the majority of the quarter.

As a result of this interruption in the delivery of sterilized products

and our limited inventory levels on hand prior to this interruption, we were unable to fulfill a significant portion of the orders

received during the three months ended March 31, 2019.

The bare-metal cobalt-chromium stents for our MGuard Prime EPS and

the self-expanding bare-metal stents for our CGuard EPS are being manufactured and supplied by MeKo Laserstrahl-Materialbearbeitung.

Our agreement with MeKo Laserstrahl-Materialbearbeitung for the production of electro polished L605 bare-metal stents for MGuard Prime

EPS and CGuard EPS is priced on a per-stent basis, subject to the quantity of stents ordered.

The complete assembly process for MGuard

Prime EPS and CGuard EPS, including knitting and securing the sleeve to the stent and the crimping of the sleeve stent on to a delivery

catheter, is done at our Israel manufacturing site.

Once MGuard Prime EPS and CGuard EPS 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.

MGuard stent is manufactured from two main components, the stent and the mesh polymer.

The stent is made out of cobalt chromium.

This material is readily available, and we acquire it in the open market.

material is readily available, and we acquire it in the open market.

The mesh is made from polyethylene terephthalate (polyester).

This material is readily available in the market as well, because it is used for many medical applications.

In the event that

our supplier can no longer supply this material in fiber form, we would need to qualify another supplier, which could take several

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 insure that their products meet our predetermined specifications.

material is readily available in the market as well, because it is used for many medical applications.

CGuard EPS consists of a CGuard stent and the delivery system.

2 unchanged sentences

This material is readily available and we acquire it in the open market.

is made from polyethylene terephthalate (polyester).

We have pending patent rights that cover the proposed CGuard stent with mesh.

This material is readily available in the market as well, because it is used for many medical applications.

In the event that

our supplier can no longer supply this material in fiber form, we would need to qualify another supplier, which could take several

The delivery system for CGuard is made out of polymer tubes we acquire from an original equipment manufacturer.

event that our supplier can no longer supply this material, we would need to qualify another supplier, which could take several

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 insure that their products meet our predetermined specifications.

headquarters are located in Tel Aviv, Israel, where we lease a 1,000 square meter office and manufacturing facility that has the

capacity to manufacture and assemble 1,200 stents per month, based upon the production schedule of one shift per day.

that our current facility is sufficient to meet anticipated future demand by adding additional shifts to our current production

time to time, we may be involved in litigation that arises through the normal course of business.

July 10, 2019, Bosti Trading Ltd., a former distributor in Russia (“Bosti”), filed suit with the Tel Aviv-Jaffa District

Court in Israel, or the Complaint, against InspireMD Ltd., claiming damages for alleged breaches by InspireMD Ltd.

under the Distribution

Agreement, dated May 26, 2011, between Bosti and InspireMD Ltd., in connection with the voluntary field corrective action of our

MGuard Prime EPS we initiated in 2014.

Bosti claimed that Bosti and its Russian subsidiary returned 1,830 units of MGuard Prime

EPS to InspireMD Ltd.

upon initiation of the voluntary filed action, and, since the Russian Ministry of Health prohibited distribution

of MGuard Prime EPS on August 28, 2014, and did not approve distribution MGuard Prime EPS until September 20, 2016, Bosti was

entitled to recover from InspireMD Ltd.

€1,830,000 (which is approximately $2 million), the amount Bosti was due to receive

from its Russian subsidiary, or alternatively, €1,024,000 (which is approximately $1.1 million), the amount Bosti paid to

InspireMD Ltd., for the MGuard Prime EPS returned to InspireMD Ltd.

On January 31, 2020, InspireMD Ltd.

filed with court its letter

of defense in which it contested this matter vigorously.

On January 21, 2021, we executed a Mediation Agreement with Bosti and

InspireMD Ltd., pursuant to which Bosti agreed to release the Company from all claims stated in the Complaint in exchange for

a payment of $580,000, which we paid on January 25, 2021.

of the date of this filing, we are not aware of any other material legal proceedings to which we or any of our subsidiaries is

a party or to which any of our property is subject, nor are we aware of any such threatened or pending litigation or any such

proceedings known to be contemplated by governmental authorities.

are not aware of any material proceedings in which any of our directors, officers or affiliates or any registered or beneficial

stockholder of more than 5% of our common stock, or any associate of any of the foregoing, is a party adverse to or has a material

interest adverse to, us or any of our subsidiaries.

The mesh is made

from polyethylene terephthalate (polyester).

We have patent rights that cover the proposed CGuard stent with mesh.

This material is readily

available in the market as well, because it is used for many medical applications.

In the event that our supplier can no longer supply

this material in fiber form, we would need to qualify another supplier, which could take several 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 several months.

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.

headquarters are located in Tel Aviv, Israel, where we lease a 1,000 square meter office and manufacturing facility that has the capacity

to manufacture and assemble 1,200 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.

Capital Management

of December 31, 2020, we had 48 employees 45 full-time and 3 part-time, consisting of two in executive management, five in research

and development, four in quality assurance and compliance, five in finance and accounting, 18 in operations/production, 11 in

sales, marketing and clinical, and three in all other miscellaneous roles, including business development, information technology

services, and administration.

Except for four of our employees in Europe, our employees are not party to any collective bargaining

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 two independent contractors in Poland.

of December 31, 2021, we had 52 employees 50 full-time and 2 part-time, consisting of 2 in executive management, 5 in research and development,

7 in quality assurance and compliance, 5 in finance and accounting, 20 in operations/production, 10 in sales, marketing and clinical,

and 3 in all other miscellaneous roles, Human resources, information technology services, 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 3 independent contractors

in Poland and 1 in Brazil.

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.

for qualified personnel with other medical device, biotechnology, pharmaceutical and healthcare companies, as well as universities

and non-profit research institutions.

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.

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.

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.

success of our business is fundamentally connected to the well-being of our people.

Accordingly, we are committed to the health

and safety of our employees.

In response to the COVID-19 pandemic, we implemented significant changes that we determined were

in the best interest of our employees, as well as the communities in which we operate, and which comply with government regulations.

This includes having employees work from home, while implementing additional safety measures for employees continuing critical

on-site work.

Accordingly, we are committed to the health and safety

of our employees.

In response to the COVID-19 pandemic, we follow government regulations which may include at certain periods having

employees work from home, while implementing additional safety measures for employees continuing critical on-site work.

consider our relations with our employees to be good.

Compared sentence by sentence after normalising whitespace, quotation marks, case and digits, so re-formatting and restated figures do not read as changed language. Wording changes appear as one removal and one addition. The current filing and the prior one are authoritative.

What changed 10-K

Item 1. Business