What changed in this filing

/stocks — the workspaceLOADING

Item 1A. Risk Factors

2024-03-05 compared with 2023-03-30 · 482 added, 509 removed, 898 unchanged (52% of the section changed)

12 unchanged sentences

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

history of recurring losses and negative cash flows from operating activities, significant future commitments and the uncertainty regarding

the adequacy of our liquidity to pursue our complete business objectives, and substantial doubt regarding our ability to continue as

a going concern;

will need to raise additional capital to meet our business requirements in the future, and such capital raising may be costly or difficult

to obtain and could dilute our stockholders’ ownership interests;

failure to satisfy regulatory requirements of the

new European Medical Device Regulation may prevent us from marketing CGuard EPS in countries requiring the CE mark.

we may become subject to claims by much larger and better capitalized competitors

enforcing their intellectual property rights against us or seeking to invalidate our intellectual property or our rights thereto;

clinical trials for CGuard EPS in the United States require meeting a number of regulatory requirements and must be conducted in

compliance with the FDA’s IDE regulations.

Failure to maintain compliance with IDE regulations could have a material adverse

effect on our business;

clinical trials necessary to support a pre-market

approval application will be lengthy and expensive and will require the enrollment of a large number of patients, and suitable patients

may be difficult to identify and recruit.

Any such delay or failure of clinical trials could prevent us from commercializing our stent

products, which would materially and adversely affect our results of operations and the value of our business;

the results of our clinical trials may be insufficient

to obtain regulatory approval for our product candidates;

our products may in the future be subject to product notifications, recalls,

or voluntary market withdrawals that could harm our reputation, business and financial results;

history of recurring losses and negative cash flows from operating activities, significant future commitments and the uncertainty

regarding the adequacy of our liquidity to pursue our complete business objectives,

will need to raise additional capital to meet our business requirements in the future, and such capital raising may be costly or

difficult to obtain and could dilute our stockholders’ ownership interests;

may become subject to claims by much larger and better capitalized competitors enforcing their intellectual property rights against

us or seeking to invalidate our intellectual property or our rights thereto;

clinical trials for CGuard Carotid Stent System and SwitchGuard NPS in the United States require meeting a number of regulatory

requirements and must be conducted in compliance with the FDA’s IDE regulations.

Failure to maintain compliance with IDE

regulations could have a material adverse effect on our business;

trials necessary to support a pre-market approval application will be lengthy and expensive and will require the enrollment of a

large number of patients, and suitable patients may be difficult to identify and recruit.

Any such delay or failure of clinical trials

could prevent us from commercializing our stent products, which would materially and adversely affect our results of operations and

the value of our business;

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

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

business and financial results;

may be subject, directly or indirectly, to applicable U.S.

12 unchanged sentences

our financial condition and results of operations venue;

our business, operating results and growth rates may

be adversely affected by current or future unfavorable economic and market conditions and adverse developments with respect to financial

institutions and associated liquidity risk;

there are inherent limitations in all control systems, and misstatements

due to error or fraud may occur and not be detected;

business, operating results and growth rates may be adversely affected by current or future unfavorable economic and market conditions

and adverse developments with respect to financial institutions and associated liquidity risk;

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

anticipate being subject to fluctuations in currency exchange rates because we expect a substantial portion of our revenues will

4 unchanged sentences

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

the market prices of our common stock and our publicly

traded warrants are subject to fluctuation and have been and may continue to be volatile, which could result in substantial losses for

our common stock could be delisted from the Nasdaq Stock Market if we fail

to meet its continued listing requirements, including requirements with respect to the market value of publicly-held-shares, market value

of listed shares, minimum bid price per share, and minimum stockholder’s equity, among others, and requirements relating to board

and committee independence.

market prices of our common stock and our publicly traded warrants are subject to fluctuation and have been and may continue to be

volatile, which could result in substantial losses for investors;

common stock could be delisted from the Nasdaq Stock Market if we fail to meet its continued

listing requirements, including requirements with respect to the market value of publicly-held-shares,

market value of listed shares, minimum bid price per share, and minimum stockholder’s

equity, among others, and requirements relating to board and committee independence.

Related to Our Financial Condition

7 unchanged sentences

no assurance that we will be able to achieve sufficient revenues throughout the year or be profitable in the future.

has concluded that there is substantial doubt about our ability to continue as a going concern, and the report of our independent registered

public accounting firm contains an explanatory paragraph as to our ability to continue as a going concern, which could prevent us from

obtaining new financing on reasonable terms or at all.

we have had recurring losses and negative cash flows from operating activities, substantial doubt exists regarding our ability to remain

as a going concern at the same level at which we are currently performing.

Accordingly, the report of Kesselman & Kesselman, our

independent registered public accounting firm, with respect to our financial statements for the year ended December 31, 2022, includes

an explanatory paragraph as to our potential inability to continue as a going concern.

The doubts regarding our potential ability to

continue as a going concern may adversely affect our ability to obtain new financing on reasonable terms or at all.

will need to raise additional capital to meet our business requirements in the future, and such capital raising may be costly or difficult

4 unchanged sentences

accomplish the following:

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

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

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

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

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

4 unchanged sentences

compliance with applicable laws.

May 2023, we issued four series of Warrants that expire upon the earlier of five years and 20 trading days following the occurrence of

certain milestones specific to each series.

If the Warrants are exercised in cash in full, this would result in $71.4 million of gross

There can be no assurance that we will achieve any of the milestones set forth in the Warrants or that the Warrants will be

exercised in cash in full.

additional capital raised through the sale of equity or equity-backed securities may dilute our stockholders’ ownership percentages

9 unchanged sentences

we derive most of our revenue from the sale of CGuard EPS in CE marked countries, our ability to generate significant revenues and achieve

profitability depends, among other things, on our ability to receive FDA approval of CGuard EPS and other products we may develop, such

as CGuard Prime™ and SwitchGuard™.

If we fail to obtain FDA approval for CGuard EPS or any other products we may develop,

our results of operations and the value of our business would be materially and adversely affected.

profitability depends, among other things, on our ability to receive FDA approval of CGuard Prime and SwitchGuard and other products

we may develop.

If we fail to obtain FDA approval for CGuard Prime, SwitchGuard or any other products we may develop, our results of

operations and the value of our business would be materially and adversely affected.

derive most of our revenue from sales of our CGuard EPS in CE marked countries and certain other select jurisdictions.

We have not received

approvals in the United States and other jurisdictions and there can be no assurance that we will be able to receive regulatory approvals

to commence marketing and sales for our CGuard EPS and other products we may develop, such as CGuard Prime™ and SwitchGuard™

in the United States or in such other jurisdictions.

Our ability to generate significant revenues and achieve profitability depends on

our ability to successfully obtain required regulatory approvals in the U.S.

as well as to demonstrate sufficient clinical evidence and

manufacture commercial quantities of our CGuard EPS or any other products we may develop at an acceptable cost.

In addition, there may

be insufficient demand for CGuard EPS or any other products we develop, such as CGuard Prime™ and SwitchGuard™.

to generate sufficient revenues from these products, our results of operations and the value of our business and securities would be

materially and adversely affected.

future success of our business cannot be determined at this time, and we do not anticipate generating significant revenues from product

sales for the foreseeable future.

In addition, we have no experience in commercializing our CGuard EPS on a mass scale and face a number

of challenges with respect to our commercialization efforts, including, among others, that:

may not have adequate financial or other resources to demonstrate adequate clinical results,

attain required regulatory approvals and licensures, and begin the commercialization efforts

for our CGuard EPS in our target markets;

may fail to obtain or maintain required regulatory approvals and licensures for our CGuard

EPS in our target markets or may face adverse regulatory or legal actions relating to our

products even if regulatory approval is obtained;

may not demonstrate adequate clinical safety and clinical effectiveness results from our

CGuard EPS, to support regulatory body approval or market acceptance and adoption;

may not be able to scale up the manufacture of our CGuard EPS to commercial quantities at

an adequate quality or at an acceptable cost;

approvals in the United States and certain other jurisdictions for CGuard Prime and have not received any approvals for SwitchGuard and

there can be no assurance that we will be able to receive regulatory approvals to commence marketing and sales for our products in any

jusrisdiction where we are seeking approvals.

Our ability to generate significant revenues and achieve profitability depends on our ability

to successfully obtain required regulatory approvals in the U.S.

as well as to demonstrate sufficient clinical evidence and manufacture

commercial quantities of our CGuard Prime, SwitchGuard and any other products we may develop at an acceptable cost.

In addition, there

may be insufficient demand for CGuard Prime, SwitchGuard and any other products we develop.

If we fail to generate sufficient revenues

from these products, our results of operations and the value of our business and securities would be materially and adversely affected.

future success of our business cannot be determined at this time, and we do not anticipate generating significant revenues from

product sales for the foreseeable future.

In addition, we have no experience in commercializing our CGuard Prime or any other

product we develop on a mass scale and face a number of challenges with respect to our commercialization efforts, including, among

others, that:

may not have adequate financial or other resources to demonstrate adequate clinical results, attain required regulatory approvals

and licensures, and begin the commercialization efforts for our CGuard Prime, SwitchGuard or any other product we develop in our

target markets;

may fail to obtain or maintain required regulatory approvals and licensures for our CGuard Prime, SwitchGuard or any other product

we develop in our target markets or may face adverse regulatory or legal actions relating to our products even if regulatory approval

may not demonstrate adequate clinical safety and clinical effectiveness results from our CGuard Prime, SwitchGuard or any other

product we develop to support regulatory body approval or market acceptance and adoption;

may not be able to scale up the manufacture of our CGuard Prime, SwitchGuard or any other product we develop to commercial quantities

at an adequate quality or at an acceptable cost;

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

professionals and patients may not accept our CGuard EPS;

technological may reduce the demand for our CGuard EPS;

alliances between existing market participants and the entrance of new market participants

may interfere with our market penetration efforts;

and private third-party payors may not agree to provide coding, coverage and payment adequate

to reimburse healthcare providers and patients for any or all of the purchase price of CGuard

EPS, which may adversely affect healthcare providers’ and patients’ willingness

to purchase our C-Scan system;

● uncertainty

as to market demand may result in inefficient pricing of our CGuard EPS;

may not be able to adequately protect our intellectual property or may face third-party claims

of intellectual property infringement;

are dependent upon the results of ongoing clinical studies relating to our CGuard EPS and

the products of our competitors.

we are unable to meet any one or more of these challenges successfully, our ability to effectively commercialize our CGuard EPS system

could be limited, which in turn could have a material adverse effect on our business, financial condition and results of operations.

we are nearing completion of enrollment in our C-Guardian trial of CGuard EPS study, the outcome of the study is inherently uncertain.

September 8, 2020, we received approval from the FDA of our IDE for C-Guardian trial of CGuard EPS and we expect to complete enrollment

in the second quarter of 2023.

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

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

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

and private third-party payors may not agree to provide coding, coverage and payment adequate to reimburse healthcare providers and

patients for any or all of the purchase price of CGuard Prime, SwitchGuard or any other product we develop which may adversely affect

healthcare providers’ and patients’ willingness to purchase our C-Scan system;

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

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

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

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

condition and results of operations.

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

June 2023, we completed enrollment in the C-GUARDIANS trial.

We anticipate reporting primary endpoint results from the C-GUARDIANS

trial in mid 2024 that may support the submission of a PMA application in the third quarter of 2024 with a view to potential FDA

approval of the CGuard Prime stent system in the first half of 2025.

Although we reported positive 30-day follow-up data in November

2023, there can be no assurance that the primary endpoint results will be sufficient to support a PMA application or FDA approval,

Clinical failure can occur at any stage of clinical development.

Our clinical trials have been conducted

under differing protocols, while using specific inclusion criteria and we cannot assure you that its actual clinical performances will

be satisfactory to support proposed indications and regulatory approvals and clinical acceptance and adoption, or that its use will not

result in unanticipated complications.

Furthermore, the results of our clinical trials are subject to human analyses and interpretation

of the data accumulated, which could be affected by various errors due to, among others, lack of sufficient clinical experience with

CGuard EPS, assumptions used in the statistical analysis of results, and interpretation errors in the analysis of the clinical trials

Our clinical trials have been conducted under differing protocols,

while using specific inclusion criteria and we cannot assure you that its actual clinical performances will be satisfactory to

support proposed indications and regulatory approvals and clinical acceptance and adoption, or that its use will not result in

unanticipated complications.

Furthermore, the results of our clinical trials are subject to human analyses and interpretation of the

data accumulated, which could be affected by various errors due to, among others, lack of sufficient clinical experience with CGuard

EPS, SwitchGuard or any other product we develop, assumptions used in the statistical analysis of results, and interpretation errors

in the analysis of the clinical trials results.

Failure can occur at any time during the clinical trial process.

If CGuard EPS does not function as expected over time, we may

not achieve regulatory clearances, and may not be widely adopted by healthcare providers and patients.

If CGuard EPS,

SwitchGuard or any other product we develop does not function as expected over time, we may not achieve regulatory clearances, and

may not be widely adopted by healthcare providers and patients.

plan on self-commercializing CGuard Prime in the U.S.

if we receive FDA approval and historically have no experience selling, marketing

or distributing products in the U.S.

plan on self-commercializing CGuard Prime in the U.S., subject to receipt of FDA approval.

As part of our plan, we intend to build out

manufacturing, sales, marketing and distribution capabilities.

Historically we have not had experience in manufacturing, selling, marketing

or distributing products in the U.S.

To be able to commercialize CGuard Prime upon approval, if at all, we must either develop internal

manufacturing, sales, marketing and distribution capabilities, which is expensive and time-consuming, or enter into arrangements with

third parties to perform these services.

are risks involved with establishing our own manufacturing, sales, marketing and distribution capabilities.

We must commit significant

financial and managerial resources to develop a manufacturing facility and marketing and sales force with technical expertise and with

supporting distribution capabilities.

Factors that may inhibit our efforts to commercialize our products directly and without strategic

partners include:

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

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

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

difficulty of obtaining reimbursement from governmental and commercial payers;

lack of complementary products to be offered by sales personnel, which may put us at a competitive disadvantage relative to companies

with more extensive product lines;

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

may not be successful in recruiting the manufacturing, sales and marketing personnel necessary to sell CGuard Prime upon approval, if

at all, and, even if we do build a sales force, we may not be successful in marketing CGuard Prime, which would have a material adverse

effect on our business, financial condition and results of operations.

we are unable to establish our own manufacturing, sales, marketing and distribution capabilities or enter into successful arrangements

with third parties to perform these services, any future product revenues and our profitability, may be materially adversely affected.

may not widely adopt our products unless they determine, based on experience, long-term clinical data and published peer reviewed journal

16 unchanged sentences

will be published.

to satisfy regulatory requirements of the new European Medical Device Regulation may prevent us from marketing CGuard EPS in countries

requiring the CE mark.

the European Union nations, medical devices must obtain a CE mark before they may be placed on the market.

In order to obtain and

maintain the CE mark, we must comply with EU law on medical devices, which, until May 26, 2021 was governed by the MDD, by

presenting comprehensive technical files for our products demonstrating safety and efficacy of the product to be placed on the

market and passing initial and annual quality management system audit as per ISO 13485 standard by a European Notified Body.

obtained ISO 13485 quality system certification and CGuard EPS that we currently distribute into the European Union, displays the

required CE mark.

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

Body auditors.

The European Union replaced the MDD with the new MDR regulations.

The MDR entered into force after a transitional

period of three years and a one year extension of that transition period due to the COVID-19 pandemic on May 26, 2021 and which

changes several aspects of the regulatory framework in the European Union.

Manufacturers had the duration of the transition period

to update their technical documentation and processes to meet the new requirements in order to obtain a CE Mark.

In our specific

case, our CE mark for CGuard EPS under the MDD expired on November 12, 2022, and we are in the final stages of technical

documentation review by the Notified Body auditor to meet the MDR requirements for recertification.

In the meantime, on February 14,

2023, we received a derogation per Article 97 paragraph 1 of Regulation 2017/745 from the Agency for Medicines and Health Products

(FAMHP) allowing us to continue marketing CGuard EPS in the EU until August 15, 2023, subject to certain procedural requirements.

Subsequently, on March 20, 2023 Regulation

(EU) 2023/607 was published allowing us to continue marketing CGuard EPS in EU countries under the MDD directive until December 31,

As a result of the foregoing, we may market and sell CGuard EPS in the EU and certain other jurisdictions subject to certain procedural requirements while our MDR CE

recertification is pending.

We continue to expedite the review process for recertification under the MDR however no assurance can be

provided as to the length of time it will take to obtain recertification.

If we are unable to obtain recertification in the future

then this could have a material adverse effect on our business, financial condition, results of operations or cash flows.

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

currently manufacture our CGuard EPS at our facility in Tel Aviv, Israel.

currently manufacture CGuard at our facility in Tel Aviv, Israel.

If there were a disruption to our existing manufacturing facility,

we would have no other means of manufacturing our CGuard EPS stents until we were able to restore the manufacturing capability at our

we would have no other means of manufacturing CGuard until we were able to restore the manufacturing capability at our

facility or develop alternative manufacturing facilities.

If we were unable to produce sufficient quantities of our CGuard EPS stents

to meet market demand or for use in our current and planned clinical trials, or if our manufacturing process yields substandard stents,

our development and commercialization efforts would be delayed.

manufacture our CGuard EPS in quantities to meet anticipated market demand if we were to receive FDA approval, we will need to increase

manufacturing capacity, which will involve significant challenges.

In addition, the development of U.S.

commercial-scale, regulation-compliant

manufacturing capabilities will require us to invest substantial additional funds and hire and retain the technical personnel who have

the necessary manufacturing experience.

We may not successfully complete any required increase to existing manufacturing processes in

a timely manner, or at all.

If we were unable to produce sufficient quantities of CGuard,

SwitchGuard or any other product we develop to meet market demand or for use in our current and planned clinical trials, or if our manufacturing

process yields substandard stents, our development and commercialization efforts would be delayed.

manufacture CGuard, SwitchGuard and any other product we develop in quantities to meet anticipated market demand if we were to

receive FDA approval, we will need to increase manufacturing capacity, which will involve significant challenges.

In addition, the development

commercial-scale, regulation-compliant manufacturing capabilities will require us to invest substantial additional funds and

hire and retain the technical personnel who have the necessary manufacturing experience.

We may not successfully complete any required

increase to existing manufacturing processes in a timely manner, or at all.

Additionally,

any damage to or destruction of our Tel Aviv facility or its equipment, prolonged power outage or contamination at our facility would

significantly impair our ability to produce CGuard EPS stents.

significantly impair our ability to produce CGuard.

the production of our stents must occur in a highly controlled, clean environment to minimize particles and other yield and quality-limiting

4 unchanged sentences

our clinical development and commercialization efforts could be delayed, which would harm our business and results of operations.

EPS is a complex medical device that requires training for qualified personal.

EPS is a complex medical device that requires training for qualified personal, including physicians.

Although our distributors will be

required to ensure that CGuard EPS is prescribed only by trained clinicians, the potential for misuse of CGuard EPS still exists due

to its complexity.

Such misuse could result in adverse medical consequences for patients that could damage our reputation, subject us

to costly product liability litigation and otherwise have a material adverse effect on our business, financial condition and results

of operations.

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

CGuard and SwitchGuard are complex medical devices that requires training for qualified personal, including physicians.

Although our distributors

will be required to ensure that CGuard and SwitchGuard is prescribed only by trained clinicians, the potential for misuse of CGuard and SwitchGuard still exists due to its complexity.

Such misuse could result in adverse medical consequences for patients that could

damage our reputation, subject us to costly product liability litigation and otherwise have a material adverse effect on our business,

financial condition and results of operations.

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

6 unchanged sentences

Abbott Laboratories, Boston Scientific

Corporation, Covidien Ltd.

(currently part of Medtronic, Inc.), Cordis Corporation and Terumo Medical Corporation produce a polytetrafluoroethylene

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

Most of our current and potential competitors, including but not limited

to those listed above, have, and will continue to have, substantially greater financial, technological, research and development, regulatory

and clinical, manufacturing, marketing and sales, distribution and personnel resources than we do.

There can be no assurance that we

will have sufficient resources to successfully commercialize our products, if and when they are approved for sale.

The worldwide market

for stent products is characterized by intensive development efforts and rapidly advancing technology.

For example, during the second

quarter of 2022 we ceased sales of our MGuard Prime EPS following a phase out period due to a shift in industry preferences.

success will depend largely upon our ability to anticipate and keep pace with those developments and advances.

Current or future competitors

could develop alternative technologies, products or materials that are more effective, easier to use or more economical than what we

or any potential licensee develop.

If our technologies or products become obsolete or uncompetitive, our related product sales and licensing

revenue would decrease.

Corporation, Medtronic, Cordis Corporation and Terumo Medical Corporation produce a polytetrafluoroethylene mesh-covered stent and a

double layer metal stent, respectively As we develop and seek regulatory approval in the United States and Europe for our new TCAR neuroprotection

system SwitchGuard and continue to seek greater market share for CGuard, we expect to compete with Silk Road Medical in the total

carotid artery revascularization market that comprises CAS, TCAR and CEA.

Most of our current and potential competitors, including but

not limited to those listed above, have, and will continue to have, substantially greater financial, technological, research and development,

regulatory and clinical, manufacturing, marketing and sales, distribution and personnel resources than we do.

There can be no assurance

that we will have sufficient resources to successfully commercialize our products, if and when they are approved for sale.

The worldwide

market for stent products is characterized by intensive development efforts and rapidly advancing technology.

For example, during the

second quarter of 2022 we ceased sales of our MGuard Prime EPS following a phase out period due to a shift in industry preferences.

future success will depend largely upon our ability to anticipate and keep pace with those developments and advances.

Current or future

competitors could develop alternative technologies, products or materials that are more effective, easier to use or more economical than

what we or any potential licensee develop.

If our technologies or products become obsolete or uncompetitive, our related product sales

and licensing revenue would decrease.

This would have a material adverse effect on our business, financial condition and results of operations.

15 unchanged sentences

All the major companies

in the field of stents and related markets, including Boston Scientific Corporation, C.R.

in the field of stents and related markets, including Boston Scientific, C.R.

Bard, Inc., W.L.

Gore & Associates, Inc.

and Medtronic, Inc., have been repeatedly involved in patent litigation relating to stents since at least 1997.

The field of stents and

related markets have experienced rapid technological change and obsolescence in the past, and our competitors have strong incentives

to stop or delay the introduction of new products and technologies.

We may pose a competitive threat to many of the companies in these

Accordingly, these companies will have a strong incentive to take steps, through patent litigation or otherwise, to prevent

us from distributing our products.

Such litigation or claims would divert attention and resources away from the development and/or commercialization

of our products and could result in an adverse court judgment that would make it impossible or impractical to sell our products in one

or more territories.

Gore & Associates and Medtronic, have

been repeatedly involved in patent litigation relating to stents since at least 1997.

The field of stents and related markets have experienced

rapid technological change and obsolescence in the past, and our competitors have strong incentives to stop or delay the introduction

of new products and technologies.

We may pose a competitive threat to many of the companies in these markets.

Accordingly, these companies

will have a strong incentive to take steps, through patent litigation or otherwise, to prevent us from distributing our products.

litigation or claims would divert attention and resources away from the development and/or commercialization of our products and could

result in an adverse court judgment that would make it impossible or impractical to sell our products in one or more territories.

we fail to maintain or establish satisfactory agreements or arrangements with suppliers or if we experience an interruption of the supply

6 unchanged sentences

similar components from other suppliers that are acceptable to the FDA or foreign regulatory authorities if it becomes necessary.

the last year our mesh supplier informed us that it will not be able to supply the polymer fiber in the future due to issues with raw

materials, therefore we purchased inventory which should be sufficient to support our production needs in the next 2.5 years.

currently in the process of finding and qualifying another supplier or other material source which could take up to a year.

we have to switch to a replacement supplier, we will face additional regulatory delays and the interruption of the manufacture and delivery

of our stents for an extended period of time, which would delay completion of our clinical trials or commercialization of our products.

In addition, we will be required to obtain prior regulatory approval from the FDA or foreign regulatory authorities to use different

suppliers or components that may not be as safe or as effective.

As a result, regulatory approval of our products may not be received

on a timely basis or at all.

addition, we rely on a third-party vendor to perform the sterilization process.

A third-party vendor’s failure to properly sterilize

a component may cause delays or disruptions in our manufacturing process.

COVID-19 pandemic has caused interruptions or delays of our business plan and if there is a renewed outbreak it may have a significant

adverse effect on our business.

the past, we have been impacted by the COVID-19 pandemic which has caused interruptions or delays of our business plan.

In particular,

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

shifted resources to patients affected by COVID-19.

If there is a renewed outbreak of COVID-19 it may result in restrictions and safety

measures that could cause fluctuations in sales of our products, ability to manufacture, as well as potential disruptions to our supply

2022, our mesh supplier informed us that it will not be able to supply the polymer fiber in the future due to issues with raw materials,

therefore we purchased inventory which should be sufficient to support our production needs until the middle of 2028.

We are currently

testing a different source of PET showing equivalent mechanical properties of the original raw material however there can be no assurance

that the alternative source will result in successful validation and if we are unable to timely source an alternative supplier this could

result regulatory delays and the interruption of our manufacturing and delivery of stents for an extended period of time which would

delay completion of our clinical trials or commercialization of our products.

addition, we will be required to obtain prior regulatory approval from the FDA or foreign regulatory authorities to use different suppliers

or components that may not be as safe or as effective.

As a result, regulatory approval of our products may not be received on a timely

basis or at all.

we rely on a third-party vendor to perform the sterilization process.

A third-party vendor’s failure to properly sterilize a component

may cause delays or disruptions in our manufacturing process.

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

the past, we were impacted by the COVID-19 pandemic, which has caused interruptions or delays of our business plan.

If there is a renewed

outbreak of COVID-19 it may result in restrictions and safety measures that could cause fluctuations in sales of our products, ability

to manufacture, as well as potential disruptions to our supply chain.

addition, if there is a renewed outbreak of COVID-19, this may cause disruptions that could have a material adverse impact on our FDA

6 unchanged sentences

that may affect the transport of clinical trial materials;

in local regulations as part of a response to the COVID-19 pandemic which may require us to change the ways in which our clinical trials

are conducted, which may result in unexpected costs, or to discontinue the clinical trials altogether;

in local regulations as part of a response to the COVID-19 pandemic which may require us to change the ways in which our clinical

trials are conducted, which may result in unexpected costs, or to discontinue the clinical trials altogether;

of healthcare resources away from the conduct of clinical trials, including the diversion of hospitals serving as our clinical trial

2 unchanged sentences

sites and hospital staff supporting the conduct of our clinical trials;

of key clinical trial activities, such as clinical trial site monitoring, due to limitations on travel imposed or recommended by federal

or state governments, employers and others, or interruption of clinical trial subject visits and study procedures, the occurrence of

which could affect the integrity of clinical trial data;

that participants enrolled in our clinical trials will acquire COVID-19 while the clinical trial is ongoing, which could impact the results

of the clinical trial, including by increasing the number of observed adverse events;

in necessary interactions with local regulators, ethics committees and other third parties and contractors due to limitations in employee

resources or forced furlough of government employees;

of key clinical trial activities, such as clinical trial site monitoring, due to limitations on travel imposed or recommended by

federal or state governments, employers and others, or interruption of clinical trial subject visits and study procedures, the occurrence

of which could affect the integrity of clinical trial data;

that participants enrolled in our clinical trials will acquire COVID-19 while the clinical trial is ongoing, which could impact the

results of the clinical trial, including by increasing the number of observed adverse events;

in necessary interactions with local regulators, ethics committees and other third parties and contractors due to limitations in

employee resources or forced furlough of government employees;

in employee resources that would otherwise be focused on the conduct of our clinical trials, including because of sickness of employees

15 unchanged sentences

Related to our Clinical Trials and Regulatory Matters

clinical trials for CGuard EPS in the United States require meeting a number of regulatory requirements and must be conducted in compliance

with the FDA’s IDE regulations.

Failure to maintain compliance with IDE regulations could have a material adverse effect on our

trials involve use of a medical device candidate (or drug, biological, or other product candidate, as applicable) on human subjects under

the supervision of qualified investigators in accordance with current Good Clinical Practices, including the requirement that all research

subjects provide informed consent for their participation in the clinical study.

The FDA classifies medical device candidates into “significant

risk” and “non-significant risk” devices.

Significant risk devices present a potential for serious risk to the health,

safety, or welfare of a subject.

Examples may include implants, devices that support or sustain human life, and devices that are substantially

important in diagnosing, curing, mitigating, or treating disease or in preventing impairment to human health.

If a medical device candidate

presents a significant risk, an IDE application must be submitted and approved prior to commencing any human clinical trials in the United

States in connection with such device.

The FDA may approve, conditionally approve, or deny an IDE or it may require further information

and, thus, delay approval.

On September 8, 2020, we received IDE approval for CGuard™ Carotid Stent System, CARENET-III.

clinical trials for CGuard, SwitchGuard or any other product we develop in the United States require meeting a number of regulatory

requirements and must be conducted in compliance with the FDA’s IDE regulations.

Failure to maintain compliance with IDE regulations

could have a material adverse effect on our business.

trials involve use of a medical device on human subjects under the supervision of qualified investigators in accordance with current

Good Clinical Practices, including the requirement that all research subjects provide informed consent for their participation in the

clinical study.

The FDA classifies medical device candidates into “significant risk” and “non-significant risk”

Significant risk devices present a potential for serious risk to the health, safety, or welfare of a subject.

Examples may include

implants, devices that support or sustain human life, and devices that are substantially important in diagnosing, curing, mitigating,

or treating disease or in preventing impairment to human health.

If a medical device candidate presents a significant risk, an IDE application

must be submitted and approved prior to commencing any human clinical trials in the United States in connection with such device.

addition to our IDE approval, we must apply for and obtain IRB approval in connection with each clinical site before commencing any study

1 unchanged sentence

criteria, is also required before we may initiate or conduct the trial.

the CGuard EPS clinical trial and any others that we may conduct in the future, must be conducted in accordance with the FDA’s

the C-GUARDIANS trial and any others that we are conducting or may conduct in the future, must be conducted in accordance with the FDA’s

IDE regulations, which, among other things, establish requirements for investigational device labeling, prohibit pre-approval promotion

6 unchanged sentences

condition and results of operations.

certainty that clinical trials will meet desired endpoints, produce meaningful or useful data, and be free of unexpected adverse effects,

or that the FDA will accept the validity of foreign clinical study data, as applicable, cannot be guaranteed, and such uncertainty could

preclude or delay regulatory approvals and commercialization, resulting in significant financial costs and reduced revenue.

the timing of the commencement, continuation, and completion of any future clinical trial may be subject to significant delays attributable

to various causes, including, but not limited to, scheduling conflicts with participating clinicians and clinical institutions, difficulties

in identifying and enrolling patients who meet trial eligibility criteria, failure of patients to complete the clinical trial, delay

in or failure to meet regulatory and/or IRB requirements to conduct a clinical trial at a one or more prospective sites, and shortages

of supply in the investigational device.

trials necessary to support a pre-market approval application are lengthy and expensive and require the enrollment of a large number

of patients, and suitable patients may be difficult to identify and recruit.

Any such delay or failure of clinical trials could prevent

us from commercializing our stent products, which would materially and adversely affect our results of operations and the value of our

trials necessary to support a pre-market approval application to the FDA for our products, including CGuard EPS stent are expensive and

require the enrollment of a large number of patients, and suitable patients may be difficult to identify and recruit, which may cause

a delay in the development and commercialization of our product candidates.

Patient enrollment in clinical trials and the ability to

successfully complete patient follow-up depends on many factors, including the size of the patient population, the nature of the trial

protocol, the proximity of patients to clinical sites, the eligibility criteria for the clinical trial and patient compliance.

patients may be discouraged from enrolling in our clinical trials if the trial protocol requires them to undergo extensive post-treatment

procedures or follow-up to assess the safety and efficacy of our products, or they may be persuaded to participate in contemporaneous

clinical trials of competitive products.

In addition, patients participating in our clinical trials may die before completion of the

trial or suffer adverse medical events unrelated to or related to our products.

Delays in patient enrollment or failure of patients to

continue to participate in a clinical trial may cause an increase in costs and delays or result in the failure of the clinical trial.

certainty that clinical trials must meet FDA requirements, including desired endpoints, produce meaningful or useful data, and be

free of unexpected adverse effects, or that the FDA will accept the validity of foreign clinical study data, as applicable, cannot

be guaranteed, and such uncertainty could preclude or delay regulatory approvals and commercialization, resulting in significant

financial costs and reduced revenue.

Moreover, the timing of the commencement, continuation, and completion of any future clinical

trial may be subject to significant delays attributable to various causes, including, but not limited to, scheduling conflicts with

participating clinicians and clinical institutions, difficulties in identifying and enrolling patients who meet trial eligibility

criteria, failure of patients to complete the clinical trial, delay in or failure to meet regulatory and/or IRB requirements to

conduct a clinical trial at a one or more prospective sites, and shortages of supply in the investigational device.

trials necessary to support a PMA application are lengthy and expensive and require the enrollment of a large number of patients, and

suitable patients may be difficult to identify and recruit.

Any such delay or failure of clinical trials could prevent us from commercializing

our stent products, which would materially and adversely affect our results of operations and the value of our business.

trials necessary to support a pre-market approval application to the FDA for our products, including CGuard, SwitchGuard and any

other product we develop stent are expensive and require the enrollment of a large number of patients, and suitable patients may be difficult

to identify and recruit, which may cause a delay in the development and commercialization of our products.

Patient enrollment in clinical

trials and the ability to successfully complete patient follow-up depends on many factors, including the size of the patient population,

the nature of the trial protocol, the proximity of patients to clinical sites, the eligibility criteria for the clinical trial and patient

For example, patients may be discouraged from enrolling in our clinical trials if the trial protocol requires them to undergo

extensive post-treatment procedures or follow-up to assess the safety and efficacy of our products, or they may be persuaded to participate

in contemporaneous clinical trials of competitive products.

In addition, patients participating in our clinical trials may die before

completion of the trial or suffer adverse medical events unrelated to or related to our products.

Delays in patient enrollment or failure

of patients to continue to participate in a clinical trial, including during a follow-up period, may cause an increase in costs and delays

or result in the failure of the clinical trial.

addition, the length of time required to complete clinical trials for pharmaceutical and medical device products varies substantially

5 unchanged sentences

and clinical trials.

results of our clinical trials may be insufficient to obtain regulatory approval for our product candidates.

will only receive regulatory approval to commercialize a product candidate if we can demonstrate to the satisfaction of the FDA or the

applicable foreign regulatory agency, in well designed and conducted clinical trials, that the product candidate is safe and effective.

If we are unable to demonstrate that a product candidate is safe and effective in advanced clinical trials involving large numbers of

patients, we will be unable to submit the necessary application to receive regulatory approval to commercialize the product candidate.

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

will only receive regulatory approval to commercialize CGuard Prime, SwitchGuard or any other product we develop if we can demonstrate

to the satisfaction of the FDA or the applicable foreign regulatory agency, in well designed and conducted clinical trials, that the

product is safe and effective.

If we are unable to demonstrate that a product is safe and effective in advanced clinical trials involving

large numbers of patients, we will be unable to submit the necessary application to receive regulatory approval to commercialize the

We face risks that:

product candidate may not prove to be safe or effective;

product candidate’s benefits may not outweigh its risks;

product may not prove to be safe or effective;

product’s benefits may not outweigh its risks;

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

3 unchanged sentences

timeline for completion of our development programs.

trials for our product candidates require sufficient patient enrollment.

We may not be able to enroll a sufficient number of patients

in a timely or cost-effective manner.

Patients enrolled in our clinical studies may discontinue their participation at any time during

the study as a result of a number of factors, including withdrawing their consent or experiencing adverse clinical events, which may

or may not be judged to be related to our product candidates under evaluation.

If a large number of patients in a study discontinue their

participation in the study, the results from that study may not be positive or may not support a filing for regulatory approval of the

product candidate.

trials for our products require sufficient patient enrollment.

We may not be able to enroll a sufficient number of patients in a timely

or cost-effective manner.

Patients enrolled in our clinical studies may discontinue their participation at any time during the study

as a result of a number of factors, including withdrawing their consent or experiencing adverse clinical events, which may or may not

be judged to be related to our products under evaluation.

If a large number of patients in a study discontinue their participation in

the study, the results from that study may not be positive or may not support a filing for regulatory approval of the product.

addition, the time required to complete clinical trials is dependent upon, among other factors, the rate of patient enrollment.

6 unchanged sentences

patient eligibility criteria for the study.

if CGuard Prime, SwitchGuard or any other product we develop receives marketing approval, we or others may later discover that the product

is less effective than previously believed or causes undesirable side effects that were not previously identified, which could compromise

our ability or that of any collaborators to market the product, and could cause regulatory authorities to take certain regulatory actions.

is possible that our clinical trials may indicate an apparent positive effect of a product that is greater than the actual positive effect,

if any, or alternatively fail to identify undesirable side effects.

For example, we, or others, may discover that our products are less

safe and effective than previously believed.

If, we, or others, discover that a product is less effective than previously believed or

causes undesirable side effects that were not previously identified, any of the following adverse events could occur:

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

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

clinical trials;

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

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

authorities may require the addition of labeling statements, such as a “black box” warning or a contraindication

including with the product;

or any of our collaborators, may be required to create a Medication Guide outlining the risks of the previously unidentified side

effects for distribution to patients;

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

and patients may stop using our product;

reputation may suffer.

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

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

1 unchanged sentence

regulatory approval has been obtained for medical device products, the product and the manufacturer are subject to continual review,

including the review of adverse events and clinical results that are reported after our products are made available to patients,

and there can be no assurance that such approval will not be withdrawn or restricted.

including the review of adverse events and clinical results that are reported after our products are made available to patients, and

there can be no assurance that such approval will not be withdrawn or restricted.

Regulators may also subject approvals to restrictions

27 unchanged sentences

our costs, cause us to lose revenue and materially and adversely affect our results of operations and the value of our business.

long-term success measures have not been completely validated for our products, especially CGuard EPS, regulatory agencies may take a

significant amount of time in evaluating product approval applications.

Treatments may exhibit a favorable measure using one metric and

an unfavorable measure using another metric.

Any change in accepted metrics may result in reconfiguration of, and delays in, our clinical

Additionally, we have only limited experience in filing and prosecuting the applications necessary to gain regulatory approvals,

and our clinical, regulatory and quality assurance personnel are currently composed of only five employees.

As a result, we may experience

delays in connection with obtaining regulatory approvals for our products.

long-term success measures have not been completely validated for our products, especially CGuard, SwitchGuard and any other product

we may develop, regulatory agencies may take a significant amount of time in evaluating product approval applications.

Treatments may

exhibit a favorable measure using one metric and an unfavorable measure using another metric.

Any change in accepted metrics may result

in reconfiguration of, and delays in, our clinical trials.

Additionally, we have only limited experience in filing and prosecuting the

applications necessary to gain regulatory approvals, and our clinical, regulatory and quality assurance personnel are currently composed

of only ten employees.

As a result, we may experience delays in connection with obtaining regulatory approvals for our products.

addition, the products we and any potential licensees license, develop, manufacture and market are subject to complex regulatory requirements,

26 unchanged sentences

other things:

on the marketing or manufacturing of our product candidates, withdrawal of the product from the market, or voluntary or mandatory

product recalls;

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

warning letters, or untitled letters;

2 unchanged sentences

revocation of license approvals;

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

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

the imposition of civil penalties or criminal prosecution.

21 unchanged sentences

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

market our products in international markets.

In order to market our products in other foreign jurisdictions, we must obtain separate

regulatory approvals from the appropriate governing body in each applicable country.

The approval processes vary among countries and

can involve additional testing, and the time required to obtain approval may differ from that required to obtain CE mark or FDA approval.

market CGuard EPS in certain international markets.

In order to market any our products in other foreign jurisdictions, we must obtain

separate regulatory approvals from the appropriate governing body in each applicable country.

The approval processes vary among countries

and can involve additional testing, and the time required to obtain approval may differ from that required to obtain CE mark or FDA approval.

Foreign regulatory approval processes may include all of the risks associated with obtaining CE mark or FDA approval in addition to other

125 unchanged sentences

if one or more of our products are approved by the FDA, we may fail to obtain an adequate level of reimbursement for our products by

third party payors, such that there may be no commercially viable markets for our products, or the markets, may be much smaller than expected.

third party payors, such that there may be no commercially viable markets for our products, or the markets, may be much smaller than

availability and levels of reimbursement by governmental and other third-party payors affect the market for our products.

24 unchanged sentences

other legislation or judicial interpretations of existing or future healthcare laws and/or regulations.

The Affordable Care Act, signed

into law in the United States in March 2010, contains certain provisions which can be modified through the regulatory process and for

which it is unclear what the full impact and changes will be under the law.

law also focuses on a number of provisions aimed at improving quality, broadening access to health insurance, enhancing remedies

for fraud and abuse, adding transparency requirements, and decreasing healthcare costs, among others.

Uncertainties remain regarding

what negative unintended consequences these provisions will have on patient access to new technologies, pricing and the market for our

products, and the healthcare industry in general.

The Affordable Care Act includes provisions affecting the Medicare program, such as

value-based payment programs, increased funding of comparative effectiveness research, reduced hospital payments for avoidable readmissions

and hospital acquired conditions, and pilot programs to evaluate alternative payment methodologies that promote care coordination (such

as bundled physician and hospital payments).

Additionally, the provisions include a reduction in the annual rate of inflation for hospitals

which started in 2011 and the establishment of an independent payment advisory board to recommend ways of reducing the rate of growth

in Medicare spending.

Any reduction in reimbursement from Medicare or other government programs may result in a similar reduction in

payments from private payors.

Since its enactment, there have

been judicial and Congressional challenges to certain aspects of the Affordable Care Act, to modify, repeal or otherwise invalidate all,

or certain provisions of, the Affordable Care Act.

Following the enactment of the Tax Act, on December 14, 2018 in a case in the United

States District Court for the Northern District of Texas, a federal judge ruled that the individual mandate imposed by the Affordable

Care Act is unconstitutional and inseverable from the other provisions of the Affordable Care Act and, therefore, the remaining provisions

of the Affordable Care Act are invalid.

On November 10, 2020, the United States Supreme Court heard arguments on whether the Affordable

Care Act is constitutional, in whole or in part, and determined that the case lacked standing..

The regulatory process of implementation

of the Affordable Care Act will remain ongoing and may also increase our regulatory burdens and operating costs.

Litigation and legislation

related to the Affordable Care Act are likely to continue, with unpredictable and uncertain results.

We cannot predict with certainty

what affect further changes to the Affordable Care Act, and other similar health care laws that are enacted, would have on our business.

Affordable Care Act, signed into law in the United States in March 2010, contains certain provisions which can be modified through the

regulatory process and for which it is unclear what the full impact and changes will be under the law.

law also focuses on a number of provisions aimed at improving quality, broadening access to health insurance, enhancing remedies for

fraud and abuse, adding transparency requirements, and decreasing healthcare costs, among others.

Uncertainties remain regarding what

negative unintended consequences these provisions will have on patient access to new technologies, pricing and the market for our products,

and the healthcare industry in general.

The Affordable Care Act includes provisions affecting the Medicare program, such as value-based

payment programs, increased funding of comparative effectiveness research, reduced hospital payments for avoidable readmissions and hospital

acquired conditions, and pilot programs to evaluate alternative payment methodologies that promote care coordination (such as bundled

physician and hospital payments).

Additionally, the provisions include a reduction in the annual rate of inflation for hospitals which

started in 2011 and the establishment of an independent payment advisory board to recommend ways of reducing the rate of growth in Medicare

Any reduction in reimbursement from Medicare or other government programs may result in a similar reduction in payments from

private payors.

its enactment, there have been judicial and Congressional challenges to certain aspects of the Affordable Care Act, to modify, repeal

or otherwise invalidate all, or certain provisions of, the Affordable Care Act.

Following the enactment of the Tax Act, on December 14,

2018 in a case in the United States District Court for the Northern District of Texas, a federal judge ruled that the individual mandate

imposed by the Affordable Care Act is unconstitutional and inseverable from the other provisions of the Affordable Care Act and, therefore,

the remaining provisions of the Affordable Care Act are invalid.

On November 10, 2020, the United States Supreme Court heard arguments

on whether the Affordable Care Act is constitutional, in whole or in part, and determined that the case lacked standing.

The regulatory

process of implementation of the Affordable Care Act will remain ongoing and may also increase our regulatory burdens and operating costs.

Litigation and legislation related to the Affordable Care Act are likely to continue, with unpredictable and uncertain results.

predict with certainty what affect further changes to the Affordable Care Act, and other similar health care laws that are enacted, would

have on our business.

addition, other legislative changes have been proposed and adopted since the Affordable Care Act was enacted.

23 unchanged sentences

these matters will have on our customers’ purchasing decisions.

cannot predict the impact that such actions against the Affordable Care Act and other laws enacted after its enactment will have on

our business, and there is uncertainty as to what healthcare programs and regulations may be implemented or changed at the federal

and/or state level in the United States, or the effect of any future legislation or regulation.

Furthermore, we cannot predict what

actions the Biden administration will implement in connection with laws impacting us.

However, it is possible that such

initiatives could have an adverse effect on our ability to obtain approval and/or successfully commercialize products in the United

States in the future.

For example, any changes that reduce, or impede the ability to obtain, reimbursement for the type of products

we intend to commercialize in the United States (or our products more specifically, if approved) or reduce medical procedure volumes

could adversely affect our business plan to introduce our products in the United States.

In May 2017, the European parliament

and the council of the European Union approved the MDR which has replaced the existing medical device directives (93/42/EEC).

regulations entered into full application in May 26, 2021.

The new Medical Device Regulation imposes stricter requirements on medical

device manufacturers and strengthens the supervising competences of the competent authorities of European Union member states, the notified

bodies and the authorized representatives.

If we fail to comply with the modified regulation and requirements, it can adversely affect

our business, operating results and prospects.

Any new regulations or revisions or reinterpretations of existing regulations may impose

additional costs or lengthen review times of future products.

See “Risk Factors – “Failure to satisfy regulatory requirements

of the new European Medical Device Regulation may prevent us from marketing CGuard EPS in countries requiring the CE mark.”

cannot predict the impact that such actions against the Affordable Care Act and other laws enacted after its enactment will have on our

business, and there is uncertainty as to what healthcare programs and regulations may be implemented or changed at the federal and/or

state level in the United States, or the effect of any future legislation or regulation.

Furthermore, we cannot predict what actions

the Biden administration will implement in connection with laws impacting us.

However, it is possible that such initiatives could have

an adverse effect on our ability to obtain approval and/or successfully commercialize products in the United States in the future.

example, any changes that reduce, or impede the ability to obtain, reimbursement for the type of products we intend to commercialize

in the United States (or our products more specifically, if approved) or reduce medical procedure volumes could adversely affect our

business plan to introduce our products in the United States.

May 2017, the European parliament and the council of the European Union approved the MDR which has replaced the existing medical device

directives (93/42/EEC).

The regulations entered into full application in May 26, 2021.

The MDR provided a transitional period for placing on the market or putting into service of medical devices, which

period was further extended on March 20.

2023, but such transitional provisions are not relevant to our products where already certified

under the The MDR imposes

stricter requirements on medical device manufacturers and strengthens the supervising competences of the competent authorities of European

Union member states, the notified bodies and the authorized representatives.

If we fail to comply with the modified regulation and requirements,

it can adversely affect our business, operating results and prospects.

Any new regulations or revisions or reinterpretations of existing

regulations may impose additional costs or lengthen review times of future products.

Factors Related to Our Intellectual Property

32 unchanged sentences

Therefore, we cannot be certain that we were the first to invent, or the first to file patent applications relating to, our stent technologies

Third parties may initiate adversarial proceedings, known as an inter-partes review (IPR) in the U.S.

Patent and Trademark Office to

challenge the validity of our patent claims in the United States.

It is possible that we may be unsuccessful in the proceedings, resulting

in a loss of some portion or all of our patent rights in the United States.

and related surgical technologies that we are developing.

Third parties may initiate adversarial proceedings, known as an inter-partes

review (IPR) in the U.S.

Patent and Trademark Office to challenge the validity of our patent claims in the United States.

It is possible

that we may be unsuccessful in the proceedings, resulting in a loss of some portion or all of our patent rights in the United States.

addition, statutory differences in patentable subject matter among jurisdictions may limit the protection we can obtain on certain of

26 unchanged sentences

property rights of third parties could adversely affect our ability to commercialize our products and services, and we might be required

to litigate or obtain licenses from third parties in order to develop or market our product candidates.

Such litigation or licenses could

be costly or not available on commercially reasonable terms.

to litigate or obtain licenses from third parties in order to develop or market our products.

Such litigation or licenses could be costly

or not available on commercially reasonable terms.

is inherently difficult to conclusively assess our freedom to operate without infringing on third-party rights.

Our competitive position

may be adversely affected if existing patents or patents resulting from patent applications issued to third parties or other third-party

intellectual property rights are held to cover our products or services or elements thereof, or our manufacturing or uses relevant to

our development plans.

In such cases, we may not be in a position to develop or commercialize products or services or our product candidates

(and any relevant services) unless we successfully pursue litigation to nullify or invalidate the third-party intellectual property right

concerned or enter into a license agreement with the intellectual property right holder, if available on commercially reasonable terms.

There may also be pending patent applications that if they result in issued patents, could be alleged to be infringed by our new products

If such an infringement claim should be brought and be successful, we may be required to pay substantial damages, be forced

to abandon our new products or services or seek a license from any patent holders.

No assurances can be given that a license will be

available on commercially reasonable terms, if at all.

Our competitive

position may be adversely affected if existing patents or patents resulting from patent applications issued to third parties or

other third-party intellectual property rights are held to cover our products or services or elements thereof, or our manufacturing

or uses relevant to our development plans.

In such cases, we may not be in a position to develop or commercialize products or

services unless we successfully pursue litigation to nullify or invalidate the third-party intellectual property right concerned or

enter into a license agreement with the intellectual property right holder, if available on commercially reasonable terms.

also be pending patent applications that if they result in issued patents, could be alleged to be infringed by our new products or

If such an infringement claim should be brought and be successful, we may be required to pay substantial damages, be

forced to abandon our new products or services or seek a license from any patent holders.

No assurances can be given that a license

will be available on commercially reasonable terms, if at all.

is also possible that we have failed to identify relevant third-party patents or applications.

For example, U.S.

For example, certain U.S.

patent applications

filed before November 29, 2000, and certain U.S.

patent applications filed after that date that will not be filed outside the United States

remain confidential until patents issue.

Patent applications in the United States and elsewhere are published approximately 18 months

after the earliest filing for which priority is claimed, with such earliest filing date being commonly referred to as the priority date.

Therefore, patent applications covering our new products or services could have been filed by others without our knowledge.

Additionally,

pending patent applications which have been published can, subject to certain limitations, be later amended in a manner that could cover

our services, our new products or the use of our new products.

Third-party intellectual property right holders may also actively bring

infringement claims against us.

We cannot guarantee that we will be able to successfully settle or otherwise resolve such infringement

If we are unable to successfully settle future claims on terms acceptable to us, we may be required to engage in or continue

costly, unpredictable and time-consuming litigation and may be prevented from or experience substantial delays in pursuing the development

of and/or marketing our new products or services.

If we fail in any such dispute, in addition to being forced to pay damages, we may

be temporarily or permanently prohibited from commercializing our new products or services that are held to be infringing.

if possible, also be forced to redesign our new products so that we no longer infringe the third-party intellectual property rights.

Any of these events, even if we were ultimately to prevail, could require us to divert substantial financial and management resources

that we would otherwise be able to devote to our business.

that will not be filed outside the United States remain confidential until patents issue.

Patent applications in the United States and

elsewhere are published approximately 18 months after the earliest filing for which priority is claimed, with such earliest filing date

being commonly referred to as the priority date.

Therefore, patent applications covering our new products or services could have been

filed by others without our knowledge.

Additionally, pending patent applications can, subject to certain limitations, be later amended

in a manner that could cover our services, our new products or the use of our new products.

Third-party intellectual property right holders

may also actively bring infringement claims against us.

We cannot guarantee that we will be able to successfully settle or otherwise

resolve such infringement claims.

If we are unable to successfully settle future claims on terms acceptable to us, we may be required

to engage in or continue costly, unpredictable and time-consuming litigation and may be prevented from or experience substantial delays

in pursuing the development of and/or marketing our new products or services.

If we fail in any such dispute, in addition to being forced

to pay damages, we may be temporarily or permanently prohibited from commercializing our new products or services that are held to be

We might, if possible, also be forced to redesign our new products so that we no longer infringe the third-party intellectual

property rights.

Any of these events, even if we were ultimately to prevail, could require us to divert substantial financial and management

resources that we would otherwise be able to devote to our business.

policy and rule changes could increase the uncertainties and costs surrounding the prosecution of our patent applications and the enforcement

16 unchanged sentences

The Leahy-Smith Act also includes a number

of significant changes that affect the way patent applications will be prosecuted and may also affect patent litigation.

the Leahy-Smith Act and its implementation could increase the uncertainties and costs surrounding the prosecution of our patent applications

and the enforcement or defense of any issued patents, all of which could have a material adverse effect on our business and financial

of significant changes that affect the way patent applications are prosecuted and also affect patent litigation.

In general, the Leahy-Smith

Act and its implementation could increase the uncertainties and costs surrounding the prosecution of our patent applications and the

enforcement or defense of any issued patents, all of which could have a material adverse effect on our business and financial condition.

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

1 unchanged sentence

If we were to initiate legal proceedings against a third-party to enforce a patent covering one

of our new products or services, the defendant could counterclaim that the patent covering our product candidate is invalid and/or unenforceable.

In patent litigation in the United States, defendant counterclaims alleging invalidity and/or unenforceability are commonplace.

of our products or services, the defendant could counterclaim that the patent covering our product is invalid and/or unenforceable.

patent litigation in the United States, defendant counterclaims alleging invalidity and/or unenforceability are commonplace.

for a validity challenge could be an alleged failure to meet any of several statutory requirements, including lack of novelty, obviousness,

3 unchanged sentences

Under the Leahy-Smith Act, the validity of U.S.

patents may also be challenged in post-grant proceedings before the USPTO.

following legal assertions of invalidity and unenforceability is unpredictable.

proceedings initiated by third parties or brought by us may be necessary to determine the priority of inventions and/or their scope with

respect to our patent or patent applications or those of our licensors.

An unfavorable outcome could require us to cease using the related

technology or to attempt to license rights to it from the prevailing party.

Our business could be harmed if the prevailing party does

not offer us a license on commercially reasonable terms.

Our defense of litigation or interference proceedings may fail and, even if

successful, may result in substantial costs and distract our management and other employees.

In addition, the uncertainties associated

with litigation could have a material adverse effect on our ability to raise the funds necessary to continue our clinical trials, continue

our research programs, license necessary technology from third parties, or enter into development partnerships that would help us bring

our new products or services to market.

patents may also be challenged in post-grant and inter partes review proceedings before

The outcome following legal assertions of invalidity and unenforceability is unpredictable.

and interference proceedings initiated by third parties or brought by us may be necessary to determine the priority and ownership of

inventions and/or their scope with respect to our patent or patent applications or those of our licensors.

An unfavorable outcome could

require us to cease using the related technology or to attempt to license rights to it from the prevailing party.

Our business could

be harmed if the prevailing party does not offer us a license on commercially reasonable terms.

Our defense of litigation or interference

proceedings may fail and, even if successful, may result in substantial costs and distract our management and other employees.

the uncertainties associated with litigation could have a material adverse effect on our ability to raise the funds necessary to continue

our clinical trials, continue our research programs, license necessary technology from third parties, or enter into development partnerships

that would help us bring our new products or services to market.

because of the substantial amount of discovery required in connection with intellectual property litigation, there is a risk that some

58 unchanged sentences

example, in the past we have been impacted by the COVID-19 pandemic which has caused interruptions or delays of our business plan.

particular, 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 shifted resources to patients affected by COVID-19.

If there is a renewed outbreak of COVID-19 it may result in restrictions

and safety measures that could cause fluctuations in sales of our products, ability to manufacture, as well as potential disruptions

to our supply chain.

there is a renewed outbreak of COVID-19 it may result in restrictions and safety measures that could cause fluctuations in sales of our

products, ability to manufacture, as well as potential disruptions to our supply chain.

International

55 unchanged sentences

If the conditions in the global economies remain uncertain or continue

to be volatile, or if they deteriorate, including as a result of the impact of military conflict, such as the war between Russia and

Ukraine, terrorism or other geopolitical events, our business, operating results and financial condition may be materially adversely

Economic weakness, inflation and increases in interest rates, limited availability of credit, liquidity shortages and constrained

capital spending have at times in the past resulted, and may in the future result, in challenging and delayed sales cycles, slower adoption

of new technologies and increased price competition, and could negatively affect our ability to forecast future periods, which could

result in an inability to satisfy demand for our products and a loss of market share.

to be volatile, or if they deteriorate, including as a result of the impact of military conflict, such as the war between Israel and

Hamas and Russia and Ukraine, terrorism or other geopolitical events, our business, operating results and financial condition may be

materially adversely affected.

Economic weakness, inflation and increases in interest rates, limited availability of credit, liquidity

shortages and constrained capital spending have at times in the past resulted, and may in the future result, in challenging and delayed

sales cycles, slower adoption of new technologies and increased price competition, and could negatively affect our ability to forecast

future periods, which could result in an inability to satisfy demand for our products and a loss of market share.

addition, increases in inflation raise our costs for commodities, labor, materials and services and other costs required to grow and

1 unchanged sentence

Additionally, increases

in inflation, along with the uncertainties surrounding COVID-19, geopolitical developments and global supply chain disruptions, have

caused, and may in the future cause, global economic uncertainty and uncertainty about the interest rate environment, which may make

it more difficult, costly or dilutive for us to secure additional financing.

A failure to adequately respond to these risks could have

a material adverse impact on our financial condition, results of operations or cash flows.

recently, the closures of SVB and Signature Bank and their placement into receivership with the FDIC created bank-specific and broader

financial institution liquidity risk and concerns.

Although the Department of the Treasury, the Federal Reserve and the FDIC jointly

released a statement that depositors at SVB and Signature Bank would have access to their funds, even those in excess of the standard

FDIC insurance limits, under a systemic risk exception, future adverse developments with respect to specific financial institutions or

the broader financial services industry may lead to market-wide liquidity shortages, impair the ability of companies to access near-term

working capital needs, and create additional market and economic uncertainty.

There can be no assurance that future credit and financial

market instability and a deterioration in confidence in economic conditions will not occur.

Our general business strategy may be adversely

affected by any such economic downturn, liquidity shortages, volatile business environment or continued unpredictable and unstable market

If the current equity and credit markets deteriorate, or if adverse developments are experienced by financial institutions,

it may cause short-term liquidity risk and also make any necessary debt or equity financing more difficult, more costly, more onerous

with respect to financial and operating covenants and more dilutive.

Failure to secure any necessary financing in a timely manner and

on favorable terms could have a material adverse effect on our growth strategy, financial performance and stock price and could require

us to alter our operating plans.

In addition, there is a risk that one or more of our service providers, financial institutions, manufacturers,

suppliers and other partners may be adversely affected by the foregoing risks, which could directly affect our ability to attain our

operating goals on schedule and on budget.

in inflation, along with the uncertainties surrounding any resurgence of COVID-19, geopolitical developments and global supply chain

disruptions, have caused, and may in the future cause, global economic uncertainty and uncertainty about the interest rate environment,

which may make it more difficult, costly or dilutive for us to secure additional financing.

A failure to adequately respond to these

risks could have a material adverse impact on our financial condition, results of operations or cash flows.

can be no assurance that future credit and financial market instability and a deterioration in confidence in economic conditions will

Our general business strategy may be adversely affected by any such economic downturn, liquidity shortages, volatile business

environment or continued unpredictable and unstable market conditions.

If the current equity and credit markets deteriorate, or if adverse

developments are experienced by financial institutions, it may cause short-term liquidity risk and also make any necessary debt or equity

financing more difficult, more costly, more onerous with respect to financial and operating covenants and more dilutive.

Failure to secure

any necessary financing in a timely manner and on favorable terms could have a material adverse effect on our growth strategy, financial

performance and stock price and could require us to alter our operating plans.

In addition, there is a risk that one or more of our service

providers, financial institutions, manufacturers, suppliers and other partners may be adversely affected by the foregoing risks, which

could directly affect our ability to attain our operating goals on schedule and on budget.

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

66 unchanged sentences

a number of armed conflicts have occurred between Israel and its Arab neighbors.

June 2021, July and August 2014 and November 2012, Israel was engaged in an armed conflict with Hamas, a militia group and political

party which controls the Gaza Strip, and during the summer of 2006, Israel was engaged in an armed conflict with Hezbollah, a Lebanese

Islamist Shiite militia group and political party.

These conflicts involved missile strikes against civilian targets in various parts

of Israel, including areas in which our employees and some of our consultants are located, and negatively affected business conditions

We cannot predict if or when armed conflict will take place and the duration of each conflict.

October 2023, Hamas terrorists infiltrated Israel’s southern border from the Gaza Strip and conducted a series of attacks on civilian

and military targets.

Hamas also launched extensive rocket attacks on Israeli population and industrial centers located along Israel’s

border with the Gaza Strip and in other areas within the State of Israel.

These attacks resulted in extensive deaths, injuries and kidnapping

of civilians and soldiers.

Following the attack, Israel’s security cabinet declared war against Hamas and a military campaign against

these terrorist organizations commenced in parallel to their continued rocket and terror attacks.

In addition, since the commencement

of these events, there have been continued hostilities along Israel’s northern border with Lebanon (with the Hezbollah terror organization)

and southern border (with the Houthi movement in Yemen, as described below).

It is possible that hostilities with Hezbollah in Lebanon

will escalate, and that other terrorist organizations, including Palestinian military organizations in the West Bank as well as other

hostile countries, such as Iran, will join the hostilities.

Such clashes may escalate in the future into a greater regional conflict.

connection with the Israeli security cabinet’s declaration of war against Hamas and possible hostilities with other

organizations, several hundred thousand Israeli military reservists were drafted to perform immediate military service, including

five full time employees in Israel of ours.

Although many of such military reservists have since been released, including all our

employees, they may be called up for additional reserve duty, depending on developments in the war in Gaza and along Israel’s

other borders.

Military service call ups that result in absences of personnel from us for an extended period of time may materially

and adversely affect our business, prospects, financial condition and results of operations.

As of the date hereof, we currently

have 56 full-time employees located in Israel.

the war broke out on October 7, 2023, our operations have not been adversely affected by this situation, and we have not experienced

disruptions to our clinical studies.

None of the clinical sites currently participating in our clinical studies are located in Israel

however we currently manufacture our CGuard at our facility in Tel Aviv, Israel.

If there were a disruption to our existing manufacturing

facility or our ability to procure raw materials and ship our products, we would have no other means of manufacturing and distributing CGuard until we were able to restore the manufacturing and distribution capability at our facility or develop alternative

manufacturing facilities and distribution capabilities.

intensity and duration of Israel’s current war against Hamas is difficult to predict at this stage, as are such war’s economic

implications on the Company’s business and operations and on Israel’s economy in general.

If the war extends for a long period

of time or expands to other fronts, such as Lebanon, Syria and the West Bank, our operations may be adversely affected.

commercial insurance does not cover losses that may occur as a result of events associated with war and terrorism.

13 unchanged sentences

could adversely affect our business, financial condition and results of operations.

most recent general elections were held on April 9, 2019, September 17, 2019, March 2, 2020, March 23, 2021 and November 1, 2022.

addition, proposed judicial reform has sparked widespread protests across Israel.

Uncertainty surrounding future elections and the outcome

of the judicial reform in Israel may continue and the political situation in Israel may further deteriorate.

Actual or perceived political

instability in Israel or any negative changes in the political environment, may individually or in the aggregate adversely affect the

Israeli economy and, in turn, our business, financial condition, results of operations and growth prospects.

operations could be disrupted as a result of the obligation of certain of our personnel residing in Israel to perform military service.

of our officers and employees reside in Israel and may be required to perform annual military reserve duty.

Currently, all male adult

citizens and permanent residents of Israel under the age of 40 (or older, depending on their position with the Israeli Defense Forces

reserves), unless exempt, are obligated to perform military reserve duty annually and are subject to being called to active duty at any

time under emergency circumstances.

Our operations could be disrupted by the absence for a significant period of one or more of our key

officers and employees due to military service.

Any such disruption could have a material adverse effect on our business, results of

operations and financial condition.

political conditions within Israel may affect our operations.

Israel has held five general elections between 2019 and 2022, and prior

to October 2023, the Israeli government pursued extensive changes to Israel’s judicial system, which sparked extensive political

debate and unrest.

To date, these initiatives have been substantially put on hold.

Actual or perceived political instability in Israel

or any negative changes in the political environment, may individually or in the aggregate adversely affect the Israeli economy and,

in turn, our business, financial condition, results of operations and growth prospects.

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

49 unchanged sentences

directors or officers.

tax benefits that are currently available to us under Israeli law require us to satisfy specified conditions.

If we fail to satisfy these

conditions, we may be required to pay increased taxes and would likely be denied these benefits in the future.

has been granted a “Beneficiary Enterprise” status by the Investment Center in the Israeli Ministry of Industry Trade

and Labor, and we are therefore eligible for tax benefits under the Israeli Law for the Encouragement of Capital Investments, 1959.

main benefit is a two-year exemption from corporate tax, commencing when we begin to generate net income derived from the beneficiary

activities in facilities located in Israel, and a reduced corporate tax rate for an additional five to eight years, depending on the

level of foreign investment in each year.

In addition, under the January 1, 2011 amendment to the Israeli Law for the Encouragement of

Capital Investments, 1959, a uniform corporate tax rate of 16% applies to all qualifying income of “Preferred Enterprise,”

which we may be able to apply as an alternative tax benefit.

tax benefits available to a Beneficiary Enterprise or a Preferred Enterprise are dependent upon the fulfillment of conditions stipulated

under the Israeli Law for the Encouragement of Capital Investments, 1959 and its regulations, as amended, which include, among other

things, maintaining our manufacturing facilities in Israel.

If we fail to comply with these conditions, in whole or in part, the tax

benefits could be cancelled and we could be required to refund any tax benefits that we received in the past.

If we are no longer eligible

for these tax benefits, our Israeli taxable income would be subject to regular Israeli corporate tax rates.

The standard corporate tax

rate for Israeli companies in 2019 and thereafter is 23% of taxable income.

The termination or reduction of these tax benefits would

increase our tax liability, which would reduce our profits.

addition to losing eligibility for tax benefits currently available to us under Israeli law, if we do not maintain our manufacturing

facilities in Israel, we will not be able to realize certain tax credits and deferred tax assets, if any, including any net operating

losses to offset against future profits.

tax benefits available to Beneficiary Enterprises may be reduced or eliminated in the future.

This would likely increase our tax liability.

Israeli government may reduce or eliminate in the future tax benefits available to Beneficiary Enterprises and Preferred Enterprises.

Our Beneficiary Enterprise status and the resulting tax benefits may not continue in the future at their current levels or at any level.

The tax benefit period is twelve years from the year of election, which means that after a year of election, the two-year exemption and

eight years of reduced tax rate can only be used within the next twelve years.

The Company elected the year 2007, as a year of election

and 2011 as an additional year of election.

The 2011 amendment regarding Preferred Enterprise may not be applicable to us or may not

fully compensate us for the change.

The termination or reduction of these tax benefits would likely increase our tax liability.

if any, by which our tax liability would increase will depend upon the rate of any tax increase, the amount of any tax benefit reduction,

and the amount of any taxable income that we may earn in the future.

Related to Our Common Stock, Preferred Stock and Warrants

92 unchanged sentences

disposing of our preferred stock and our warrants.

Unresolved Staff Comments.

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 1A. Risk Factors