What changed in this filing

/stocks — the workspaceLOADING

Item 1A. Risk Factors

2022-03-07 compared with 2021-03-08 · 1170 added, 1179 removed, 172 unchanged (93% of the section changed)

1 unchanged sentence

are numerous and varied risks, known and unknown, that may prevent us from achieving our goals.

You should carefully consider

the risks described below and the other information included in this Annual Report on Form 10-K, including the consolidated financial

statements and related notes.

If any of the following risks, or any other risks not described below, actually occur, it is likely

that our business, financial condition, and/or operating results could be materially adversely affected.

The risks and uncertainties

described below include forward-looking statements and our actual results may differ from those discussed in these forward-looking

business is subject to numerous risks and uncertainties, including those highlighted in the section titled “Risk Factors”

You should carefully consider the risks

described below and the other information included in this Annual Report on Form 10-K, including the consolidated financial statements

and related notes.

If any of the following risks, or any other risks not described below, actually occur, it is likely that our business,

financial condition, and/or operating results could be materially adversely affected.

The risks and uncertainties described below include

forward-looking statements and our actual results may differ from those discussed in these forward-looking statements.

business is subject to numerous risks and uncertainties, including those highlighted in the section titled “Risk Factors”

immediately following this prospectus summary.

These risks include, among others, the following:

COVID-19 pandemic has caused interruptions or delays of our business plan and may have a significant adverse effect on our

COVID-19 pandemic has caused interruptions or delays of our business plan and may have a significant adverse effect on our business;

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

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;

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;

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

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;

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

reputation, business and financial results;

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;

necessary to pursue FDA premarket approval, pre-clinical and clinical trials are inherently lengthy and expensive and subject

to any number of regulatory and/or clinical difficulties that can cause further delays, additional costs, and/or rejection

by the FDA, and any such delay, added cost, or failure in connection with any future clinical trials could prevent us from

commercializing our MicroNet products in the United States, which would materially and adversely affect our results of operations

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;

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

business and financial results;

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;

necessary to pursue FDA premarket approval, pre-clinical and clinical trials are inherently lengthy and expensive and subject to

any number of regulatory and/or clinical difficulties that can cause further delays, additional costs, and/or rejection by the FDA,

and any such delay, added cost, or failure in connection with any future clinical trials could prevent us from commercializing our

products, including MicroNet products in the United States, which would materially and adversely affect our results of operations

and the value of our business;

1 unchanged sentence

federal and state anti-kickback, false claims laws, physician payment

transparency laws, fraud and abuse laws or similar healthcare and security laws and regulations, which could expose us to

criminal sanctions, civil penalties, contractual damages, reputational harm and diminished profits and future earnings;

transparency laws, fraud and abuse laws or similar healthcare and security laws and regulations, which could expose us to criminal

sanctions, civil penalties, contractual damages, reputational harm and diminished profits and future earnings;

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

4 unchanged sentences

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

we are unable to obtain and maintain intellectual property protection covering our products, others may be able to make, use

or sell our products, which would adversely affect our revenue;

are an international business, and we are exposed to various global and local risks that could have a material adverse effect

on our financial condition and results of operations venue;

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 NYSE American if we fail to meet the NYSE American’s stockholders’

continued listing standards.

Our ability to publicly or privately sell equity securities and the liquidity of our common stock

could be adversely affected if we are delisted from the NYSE American;

low trading price could lead the NYSE American to take actions toward delisting our common stock, including immediately suspending

trading in our common stock;

or availability for sale of a substantial number of shares of our common stock may cause the price of our publicly traded

securities to decline;

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

will be generated in Euros and U.S.

we are unable to obtain and maintain intellectual property protection covering our products, others may be able to make, use or sell

our products, which would adversely affect our revenue;

are an international business, and we are exposed to various global and local risks that could have a material adverse effect on

our financial condition and results of operations venue;

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;

or availability for sale of a substantial number of shares of our common stock may cause the price of our publicly traded securities

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

be generated in Euros and U.S.

dollars, while a significant portion of our expenses will be incurred in New Israeli Shekels;

there are significant shifts in the political, economic and military conditions in Israel and its neighbors, it could have

a material adverse effect on our business relationships and profitability;

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

there are significant shifts in the political, economic and military conditions in Israel and its neighbours, it could have a material

adverse effect on our business relationships and profitability;

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

Related to Our Business

COVID-19 pandemic has caused interruptions or delays of our business plan and may have a significant adverse effect on our business.

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

declared to be a pandemic on March 12, 2020, many countries have imposed unprecedented restrictions on travel, quarantines and

other public health safety measures.

At this point, the extent to which COVID-19 may impact our business cannot be estimated;

however, procedures with CGuard EPS, which are generally scheduled or non-emergency procedures, have mostly been postponed as

hospitals shift resources to patients affected by COVID-19, and it is highly plausible that this trend will continue.

We anticipate

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

in sales of our products for the upcoming periods.

component parts of our delivery system are sourced from countries that have been impacted by COVID-19, and the continued pandemic

and spreading of COVID-19 may adversely impact our suppliers and in turn our manufacture of CGuard EPS.

Although the manufacturing

of our products in Israel has not been materially impacted by COVID-19 as of February 2021, we cannot guarantee that we will continue

to manufacture at full capacity in the event that pandemic persists and further restrictions are imposed.

extent to which COVID-19 will impact our results will depend on future developments, which are highly uncertain and cannot be

predicted, including new information which may emerge concerning the severity of the coronavirus.

The actions to contain COVID-19

or treat its impact, the efficacy and scale of the various vaccines currently deployed across the world, among others.

COVID-19 has had indeterminable adverse effects on general commercial activity and the world economy, and our business and results

of operations could be adversely affected to the extent that COVID-19 or any other epidemic continues to harm the global economy

have been impacted by the COVID-19 pandemic, and we cannot predict the future impacts the COVID-19 pandemic, including the emergence

of new strains such as the Omicron or Delta variant, may have on its business, results of operations and financial condition.

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

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

We experienced a significant

COVID-19 related impact on our financial condition and results of operations, primarily during the year ended December 31, 2020, which

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

patients affected by COVID-19.

To the best of our knowledge, some European countries in which we operate reinstated non-emergency procedures.

In particular, in November 2021, the Government of Israel announced that non-Israeli residents or citizens, except for non-nationals

whose lives are based in Israel, are not allowed to enter Israel, New COVID-19 variants, and potentially increasing infection rates make

the current COVID-related environment highly volatile and uncertain, and we anticipate that the continuation of the pandemic and related

restrictions and safety measures will likely result in continued fluctuations in sales of our products, enrollments in our studies as

well as potential disruptions to our supply chain, for the upcoming periods.

this uncertain time, we are committed to the health and safety of our employees.

In response to the COVID-19 pandemic, we follow government

regulations which may include at certain periods having employees work from home, while implementing additional safety measures for employees

continuing critical on-site work.

mandates related to COVID-19 or other infectious diseases may impact, our personnel and personnel at third-party manufacturing facilities

in Israel and other countries, and the availability or cost of materials, which would disrupt our supply chain and/or reduce our margins.

Although the manufacturing of our products in Israel has not been materially impacted by COVID-19 as of February 2022, we cannot guarantee

that we will continue to manufacture at full capacity in the event that pandemic persists, and further restrictions are imposed.

we anticipate that the COVID-19 pandemic may impact clinical and regulatory matters.

COVID-19 is delaying enrollment in clinical trials

across the medical device industry and may affect any new trials we decide to pursue.

COVID-19 may cause disruptions that could have

a material adverse impact on our FDA clinical trial plans and timelines, including:

in receiving authorizations from local regulatory authorities, ethics committees and institutional

review boards to initiate planned clinical trials;

or difficulties in enrolling patients in our clinical trials;

or difficulties in clinical site initiation, including difficulties in recruiting clinical

site investigators and clinical site staff;

in clinical sites receiving the supplies and materials needed to conduct our clinical trials,

including interruptions in global shipping that may affect the transport of clinical trial

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 sites and hospital staff supporting the conduct

of our clinical trials;

of healthcare resources away from the conduct of clinical trials, including the diversion

of hospitals serving as our clinical trial sites and hospital staff supporting the conduct

of our clinical trials;

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

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

including because of sickness of employees or their families or the desire of employees to

avoid contact with large groups of people;

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

of these occurrences may significantly harm our business, financial condition and prospects.

In addition, many of the factors that cause,

or lead to, a delay in the commencement or completion of clinical trials may also ultimately lead to the delay or denial of regulatory

approvals or clearances of our product.

extent to which COVID-19 will impact our results will depend on future developments, which are highly uncertain and cannot be predicted,

including new information which may emerge concerning the severity of the coronavirus.

The actions to contain COVID-19 or treat its impact,

the efficacy and scale of the various vaccines currently deployed across the world, among others.

Moreover, COVID-19 has had indeterminable

adverse effects on general commercial activity and the world economy, and our business and results of operations could be adversely affected

to the extent that COVID-19 or any other epidemic continues to harm the global economy generally.

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

and some of the measures taken by or that may be taken by the governments in countries where we operate in an attempt to curb inflation

may have negative effects on the economies of those countries generally.

If the United States or other countries where we operate experience

substantial inflation in the future, our business may be adversely affected.

This could have a material adverse impact on our business,

financial condition, results of operations or cash flows.

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

have yet to establish any history of profitable operations.

We reported a net loss of $10.5 million for the fiscal year ended

December 31, 2020, and had a net loss of approximately $10 million during the fiscal year ended December 31, 2019.

We reported a net loss of $14.9 million for the fiscal year ended December

31, 2021, and had a net loss of approximately $10.5 million during the fiscal year ended December 31, 2020.

As of December 31, 2021,

1 unchanged sentence

We expect to incur additional operating losses for the foreseeable future.

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

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.

order for us to pursue our business objectives without materially curtailing our operations, we will need to raise additional

capital, which additional capital may not be available on reasonable terms or at all.

For instance, we will need to raise additional

funds to accomplish the following:

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

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.

order for us to pursue our business objectives without materially curtailing our operations, we will need to raise additional capital,

which additional capital may not be available on reasonable terms or at all.

For instance, we will need to raise additional funds to

accomplish the following:

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

6 unchanged sentences

compliance with applicable laws.

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

percentages and could also result in a decrease in the market value of our equity securities.

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

and could also result in a decrease in the market value of our equity securities.

terms of any securities issued by us in future capital transactions may be more favorable to new investors, and may include preferences,

superior voting rights and the issuance of warrants or other derivative securities, which may have a further dilutive effect on

the holders of any of our securities then outstanding.

addition, we may incur substantial costs in pursuing future capital financing, including investment banking fees, legal fees,

accounting fees, securities law compliance fees, printing and distribution expenses and other costs.

We may also be required to

recognize non-cash expenses in connection with certain securities we issue, such as convertible notes and warrants, which may

adversely impact our financial condition.

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

become obsolete or uncompetitive.

superior voting rights and the issuance of warrants or other derivative securities, which may have a further dilutive effect on the holders

of any of our securities then outstanding.

addition, we may incur substantial costs in pursuing future capital financing, including investment banking fees, legal fees, accounting

fees, securities law compliance fees, printing and distribution expenses and other costs.

We may also be required to recognize non-cash

expenses in connection with certain securities we issue, such as convertible notes and warrants, which may adversely impact our financial

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

obsolete or uncompetitive.

medical device market is highly competitive.

We compete with many medical device companies globally in connection with our current

products and products under development.

We face intense competition from numerous pharmaceutical and biotechnology companies

in the therapeutics area, as well as competition from academic institutions, government agencies and research institutions.

Laboratories, Boston Scientific Corporation, Medtronic, Inc., and Johnson and Johnson, Gore Medical 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.

Our future success will depend largely upon our ability to anticipate and keep pace with those

developments and advances.

Current or future competitors could develop alternative technologies, products or materials that are

more effective, easier to use or more economical than what we or any potential licensee develop.

If our technologies or products

become obsolete or uncompetitive, our related product sales and licensing revenue would decrease.

This would have a material adverse

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

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.

on the prolific litigation that has occurred in the stent industry and the fact that we may pose a competitive threat to some

large and well-capitalized companies that own or control patents relating to stents and their use, manufacture and delivery, we

believe that it is possible that one or more third parties will assert a patent infringement claim against the manufacture, use

or sale of our stents based on one or more of these patents.

These companies also own patents relating to the use of drugs to

treat restenosis, stent architecture, catheters to deliver stents, and stent manufacturing and coating processes and compositions,

as well as general delivery mechanism patents like rapid exchange, which might be alleged to cover one or more of our products.

In addition, it is possible that a lawsuit of which we are not aware asserting patent infringement, misappropriation of intellectual

property, or related claims may have already been filed against us.

As the number of competitors in the stent market grows and

as the geographies in which we commercially market grow in number and scope, the possibility of patent infringement by us, and/or

a patent infringement or misappropriation claim against us, increases.

We compete with many medical device companies globally in connection with our current products

and products under development.

We face intense competition from numerous pharmaceutical and biotechnology companies in the therapeutics

area, as well as competition from academic institutions, government agencies and research institutions.

Abbott Laboratories, Boston Scientific

Corporation, Medtronic, Inc., and Cardinal Health, Gore Medical 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.

Our future success will depend largely

upon our ability to anticipate and keep pace with those developments and advances.

Current or future competitors could develop alternative

technologies, products or materials that are more effective, easier to use or more economical than what we or any potential licensee

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.

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.

on the prolific litigation that has occurred in the stent industry and the fact that we may pose a competitive threat to some large and

well-capitalized companies that own or control patents relating to stents and their use, manufacture and delivery, we believe that it

is possible that one or more third parties will assert a patent infringement claim against the manufacture, use or sale of our stents

based on one or more of these patents.

These companies also own patents relating to the use of drugs to treat restenosis, stent architecture,

catheters to deliver stents, and stent manufacturing and coating processes and compositions, as well as general delivery mechanism patents

like rapid exchange, which might be alleged to cover one or more of our products.

In addition, it is possible that a lawsuit of which

we are not aware asserting patent infringement, misappropriation of intellectual property, or related claims may have already been filed

As the number of competitors in the stent market grows and as the geographies in which we commercially market grow in number

and scope, the possibility of patent infringement by us, and/or a patent infringement or misappropriation claim against us, increases.

competitors have maintained their positions in the market by, among other things, establishing intellectual property rights relating

to their products and enforcing these rights aggressively against their competitors and new entrants into the market.

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

All the major companies

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

Bard, Inc., W.L.

& Associates, Inc.

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 markets.

Accordingly, these companies will have a strong incentive to take steps, through

patent litigation or otherwise, to prevent us from distributing our products.

Such litigation or claims would divert attention

and resources away from the development and/or commercialization of our products and could result in an adverse court judgment

that would make it impossible or impractical to sell our products in one or more territories.

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

the supply of materials from suppliers, we may not be able to obtain materials that are necessary to develop our products.

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.

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

of materials from suppliers, we may not be able to obtain materials that are necessary to develop our products.

depend on outside suppliers for certain raw materials.

2 unchanged sentences

of the components of our products are currently provided by only one vendor, or a single-source supplier.

For CGuard EPS and MGuard

Prime EPS, we depend on MeKo Laserstrahl-Materialbearbeitung for the laser cutting of the stent, Natec Medical Ltd.

for the supply

of catheters, and Biogeneral Inc.

For CGuard EPS and MGuard Prime

EPS, we depend on MeKo Laserstrahl-Materialbearbeitung for the laser cutting of the stent, Natec Medical Ltd.

for the supply of catheters,

and Biogeneral Inc.

for the fiber.

We may have difficulty obtaining similar components from other suppliers that

are acceptable to the FDA or foreign regulatory authorities if it becomes necessary.

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.

We may have difficulty obtaining similar components from other suppliers that are acceptable to the

FDA or foreign regulatory authorities if it becomes necessary.

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.

During the fiscal year ended December 31,

2019, our third-party sterilizer’s equipment failures resulted in significant interruption in sterilized product supply

for the majority of the first quarter.

As a result of this interruption in the delivery of sterilized products and our limited

inventory levels on hand prior to this interruption, we were unable to fulfill a significant portion of the orders received during

the fiscal year ended December 31, 2019.

A third-party vendor’s failure to properly sterilize

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

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

are subject to reporting and other obligations under the Securities Exchange Act of 1934, as amended, including the requirements

of Section 404 of the Sarbanes-Oxley Act of 2002.

Section 404 requires us to conduct an annual management assessment of the effectiveness

of our internal controls over financial reporting.

These reporting and other obligations place significant demands on our management,

administrative, operational, internal audit and accounting resources.

Any failure to maintain effective internal controls could

have a material adverse effect on our business, operating results and stock price.

Moreover, effective internal control is necessary

for us to provide reliable financial reports and prevent fraud.

If we cannot provide reliable financial reports or prevent fraud,

we may not be able to manage our business as effectively as we would if an effective control environment existed, and our business

and reputation with investors may be harmed.

are subject to reporting and other obligations under the Securities Exchange Act of 1934, as amended, including the requirements of Section

404 of the Sarbanes-Oxley Act of 2002.

Section 404 requires us to conduct an annual management assessment of the effectiveness of our

internal controls over financial reporting.

These reporting and other obligations place significant demands on our management, administrative,

operational, internal audit and accounting resources.

Any failure to maintain effective internal controls could have a material adverse

effect on our business, operating results and stock price.

Moreover, effective internal control is necessary for us to provide reliable

financial reports and prevent fraud.

If we cannot provide reliable financial reports or prevent fraud, we may not be able to manage our

business as effectively as we would if an effective control environment existed, and our business and reputation with investors may be

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

ongoing internal control provisions of Section 404 of the Sarbanes-Oxley Act of 2002 require us to identify material weaknesses

in internal control over financial reporting, which is a process to provide reasonable assurance regarding the reliability of

financial reporting for external purposes in accordance with accounting principles generally accepted in the United States.

management, including our chief executive officer and chief financial officer, does not expect that our internal controls and

disclosure controls will prevent all errors and all fraud.

A control system, no matter how well conceived and operated, can provide

only reasonable, not absolute, assurance that the objectives of the control system are met.

In addition, the design of a control

system must reflect the fact that there are resource constraints and the benefit of controls must be relative to their costs.

Because of the inherent limitations in all control systems, no evaluation of controls can provide absolute assurance that all

control issues and instances of fraud, if any, in our company have been detected.

These inherent limitations include the realities

that judgments in decision-making can be faulty and that breakdowns can occur because of simple errors or mistakes.

Further, controls

can be circumvented by individual acts of some persons, by collusion of two or more persons, or by management override of the

The design of any system of controls is also based in part upon certain assumptions about the likelihood of future events,

and there can be no assurance that any design will succeed in achieving its stated goals under all potential future conditions.

Over time, a control may be inadequate because of changes in conditions, such as growth of the company or increased transaction

volume, or the degree of compliance with the policies or procedures may deteriorate.

Because of inherent limitations in a cost-effective

control system, misstatements due to error or fraud may occur and not be detected.

addition, discovery and disclosure of a material weakness, by definition, could have a material adverse impact on our financial

Such an occurrence could discourage certain customers or suppliers from doing business with us and adversely affect

how our stock trades.

ongoing internal control provisions of Section 404 of the Sarbanes-Oxley Act of 2002 require us to identify material weaknesses in internal

control over financial reporting, which is a process to provide reasonable assurance regarding the reliability of financial reporting

for external purposes in accordance with accounting principles generally accepted in the United States.

Our management, including our

chief executive officer and chief financial officer, does not expect that our internal controls and disclosure controls will prevent

all errors and all fraud.

A control system, no matter how well conceived and operated, can provide only reasonable, not absolute, assurance

that the objectives of the control system are met.

In addition, the design of a control system must reflect the fact that there are resource

constraints, and the benefit of controls must be relative to their costs.

Because of the inherent limitations in all control systems,

no evaluation of controls can provide absolute assurance that all control issues and instances of fraud, if any, in our company have

been detected.

These inherent limitations include the realities that judgments in decision-making can be faulty and that breakdowns can

occur because of simple errors or mistakes.

Further, controls can be circumvented by individual acts of some persons, by collusion of

two or more persons, or by management override of the controls.

The design of any system of controls is also based in part upon certain

assumptions about the likelihood of future events, and there can be no assurance that any design will succeed in achieving its stated

goals under all potential future conditions.

Over time, a control may be inadequate because of changes in conditions, such as growth

of the company or increased transaction volume, or the degree of compliance with the policies or procedures may deteriorate.

of inherent limitations in a cost-effective control system, misstatements due to error or fraud may occur and not be detected.

addition, discovery and disclosure of a material weakness, by definition, could have a material adverse impact on our financial statements.

Such an occurrence could discourage certain customers or suppliers from doing business with us and adversely affect how our stock trades.

This could in turn negatively affect our ability to access equity markets for capital.

Related to our Products, Clinical Trials and Regulatory Matters

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.

trials necessary to support a pre-market approval application to the FDA for our CGuard EPS stent will be expensive and will 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.

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.

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

and will 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.

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 may cause an increase in costs and delays or

result in the failure of the clinical trial.

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.

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

according to the degree of regulation and the type, complexity, novelty and intended use of a product, and can continue for several

years and cost millions of dollars.

The commencement and completion of clinical trials for our products under development may

be delayed by many factors, including governmental or regulatory delays and changes in regulatory requirements, policy and guidelines

or our inability or the inability of any potential licensee to manufacture or obtain from third parties materials sufficient for

use in preclinical studies and clinical trials.

according to the degree of regulation and the type, complexity, novelty and intended use of a product, and can continue for several years

and cost millions of dollars.

The commencement and completion of clinical trials for our products under development may be delayed by

many factors, including governmental or regulatory delays and changes in regulatory requirements, policy and guidelines or our inability

or the inability of any potential licensee to manufacture or obtain from third parties materials sufficient for use in preclinical studies

and clinical trials.

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.

We face risks that:

product candidate may not prove to be safe or effective;

product candidate’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;

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

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

may discontinue their participation in our clinical studies, which may negatively impact the results of these studies and extend the

timeline for completion of our development programs.

trials for our 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.

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

enrollment is a function of many factors, including the following:

size of the patient population;

nature of the clinical protocol requirements;

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

ability to recruit and manage clinical centers and associated trials;

proximity of patients to clinical sites;

patient eligibility criteria for the study.

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

business and financial results.

manufacturing and marketing of medical devices involves an inherent risk that our products may prove to be defective and cause

a health risk even after regulatory clearances have been obtained.

Medical devices may also be modified after regulatory clearance

is obtained to such an extent that additional regulatory clearance is necessary before the device can be further marketed.

these events, we may voluntarily implement a recall or market withdrawal or may be required to do so by a regulatory authority.

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

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

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

Regulators may also subject approvals to restrictions

or conditions or impose post-approval obligations on the holders of these approvals, and the regulatory status of such products may be

jeopardized if such obligations are not fulfilled.

If post-approval studies are required, such studies may involve significant time and

manufacturing and marketing of medical devices involves an inherent risk that our products may prove to be defective and cause a health

risk even after regulatory clearances have been obtained.

Medical devices may also be modified after regulatory clearance is obtained

to such an extent that additional regulatory clearance is necessary before the device can be further marketed.

In these events, we may

voluntarily implement a recall or market withdrawal or may be required to do so by a regulatory authority.

the European Economic Area, we must comply with the EU Medical Device Vigilance System.

Under this system, manufacturers are required

to take Field Safety Corrective Actions (“FSCAs”) to reduce a risk of death or serious deterioration in the state

of health associated with the use of a medical device that is already placed on the market.

A FSCA may include the recall, modification,

exchange, destruction or retrofitting of the device.

FSCAs must be communicated by the manufacturer or its legal representative

to its customers and/or to the end users of the device through Field Safety Notices.

to take Field Safety Corrective Actions (“FSCAs”) to reduce a risk of death or serious deterioration in the state of health

associated with the use of a medical device that is already placed on the market.

A FSCA may include the recall, modification, exchange,

destruction or retrofitting of the device.

FSCAs must be communicated by the manufacturer or its legal representative to its customers

and/or to the end users of the device through Field Safety Notices.

adverse event involving our products could result in other future voluntary corrective actions, such as recalls or customer notifications,

or agency action, such as inspection or enforcement action.

Adverse events have been reported to us in the past, and we cannot

guarantee that they will not occur in the future.

Any corrective action, whether voluntary or involuntary, as well as defending

ourselves in a lawsuit, would require the dedication of our time and capital, distract management from operating our business

and could harm our reputation and financial results.

expect to derive our revenue from sales of our CGuard EPS and MGuard Prime EPS stent products and other products we may develop,

such as CGuard EPS with enhancements.

If we fail to generate revenue from these sources, our results of operations and the value

of our business would be materially and adversely affected.

expect our revenue to be generated from sales of our CGuard EPS and MGuard Prime EPS stent products and other products we may

Future sales of CGuard EPS will be subject to the receipt of regulatory approvals and commercial and market uncertainties

that may be outside our control.

In addition, sales of MGuard Prime EPS have been hampered by weakened demand for bare metal stents,

which may never improve, and we may not be successful in developing a drug-eluting stent product.

In addition, there may be insufficient

demand for other products we are seeking to develop, such as CGuard EPS with enhancements.

If we fail to generate expected revenues

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

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

could be harmed.

Adverse events have been reported to us in the past, and we cannot guarantee

that they will not occur in the future.

Any corrective action, whether voluntary or involuntary, as well as defending ourselves in a

lawsuit, would require the dedication of our time and capital, distract management from operating our business and could harm our reputation

and financial results.

expect to derive our revenue from sales of our CGuard EPS stent product and other products we may develop, such as CGuard EPS with enhancements.

If we fail to generate revenue from these sources, our results of operations and the value of our business would be materially and adversely

expect our revenue to be generated from sales of our CGuard EPS stent products and other products we may develop.

Future sales of CGuard

EPS will be subject to the receipt of regulatory approvals and commercial and market uncertainties that may be outside our control.

addition, there may be insufficient demand for other products we are seeking to develop, such as CGuard EPS with enhancements.

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

be materially and adversely affected.

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 and MGuard Prime EPS products 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 or MGuard Prime EPS stents

until we were able to restore the manufacturing capability at our facility or develop alternative manufacturing facilities.

we were unable to produce sufficient quantities of our CGuard EPS or MGuard Prime 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.

If there were a disruption to

our existing manufacturing facility, we would have no other means of manufacturing our CGuard EPS or MGuard Prime EPS stents 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 or MGuard Prime 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.

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 either CGuard EPS or MGuard Prime EPS stents.

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 either CGuard EPS or MGuard Prime EPS stents.

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

contaminants.

In spite of stringent quality controls, weaknesses in process control or minute impurities in materials may cause

a substantial percentage of defective products in a lot.

If we are unable to maintain stringent quality controls, or if contamination

problems arise, our clinical development and commercialization efforts could be delayed, which would harm our business and results

of operations.

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.

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”

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.

FDA may approve, conditionally approve, or deny an IDE or it may require further information and, thus, delay approval.

8, 2020, we received IDE approval for CGuard™

Carotid Stent System, CARENET-III.

addition to our recent IDE approval for CGuard™

Carotid Stent System, CARENET-III, we must apply for and obtain IRB approval

of the proposed CGuard EPS clinical study in connection with each clinical site before commencing any study activities.

protocol with predefined end points, an appropriate sample size, and pre-determined patient inclusion and exclusion criteria,

is also required before we may initiate or conduct the CGuard EPS trial.

If we obtain IDE approval, IRB approval, and meet all

of the other applicable requirements that must be met before beginning clinical trials in the United States, we will, then, be

able to lawfully initiate the clinical investigation of the safety and effectiveness of CGuard EPS in the United States.

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

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

promotion of a device candidate, and specify recordkeeping, reporting, and monitoring responsibilities of study sponsors and study

investigators.

may not be able to obtain IRB approval to undertake clinical trials in the United States for CGuard EPS or any new devices we

intend to market in the United States in the future.

If we do obtain such approvals, we may not be able to conduct studies which

comply with the IDE and other regulations governing clinical investigations or the data from any such trials may not support clearance

or approval of the investigational device.

Failure to obtain such approvals or to comply with such regulations could have a material

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

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

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.

necessary to pursue FDA’s premarket approval, pre-clinical and clinical trials are inherently lengthy and expensive and

subject to any number of regulatory and/or clinical difficulties that can cause further delays, additional costs, and/or rejection

by the FDA, and any such delay, added cost, or failure in connection with any future clinical trials could prevent us from commercializing

our MicroNet products in the United States, which would materially and adversely affect our results of operations and the value

of our business.

part of the regulatory process, we must conduct clinical trials for each product candidate to demonstrate safety and efficacy

to the satisfaction of the regulatory authorities, including, if we seek in the future to sell our products in the United States,

Clinical trials are subject to rigorous regulatory requirements and are expensive and time-consuming to design and implement.

They 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.

In some trials, a greater number of patients

and a longer follow-up period may be required.

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.

In spite of stringent quality controls, weaknesses in process control or minute impurities in materials may cause a substantial

percentage of defective products in a lot.

If we are unable to maintain stringent quality controls, or if contamination problems arise,

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

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.

addition to our recent IDE approval for CGuard™ Carotid Stent System, CARENET-III, we must apply for and obtain IRB approval of

the proposed CGuard EPS clinical study in connection with each clinical site before commencing any study activities.

A written protocol

with predefined end points, an appropriate sample size, and pre-determined patient inclusion and exclusion criteria, is also required

before we may initiate or conduct the CGuard EPS trial.

If we obtain IDE approval, IRB approval, and meet all of the other applicable

requirements that must be met before beginning clinical trials in the United States, we will, then, be able to lawfully initiate the

clinical investigation of the safety and effectiveness of CGuard EPS in the United States.

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

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

of a device candidate, and specify recordkeeping, reporting, and monitoring responsibilities of study sponsors and study investigators.

may not be able to obtain IRB approval to undertake clinical trials in the United States for CGuard EPS or any new devices we intend

to market in the United States in the future.

If we do obtain such approvals, we may not be able to conduct studies which comply with

the IDE and other regulations governing clinical investigations or the data from any such trials may not support clearance or approval

of the investigational device.

Failure to obtain such approvals or to comply with such regulations could have a material adverse effect

on our business, financial condition and results of operations.

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.

necessary to pursue FDA’s premarket approval, pre-clinical and clinical trials are inherently lengthy and expensive and subject

to any number of regulatory and/or clinical difficulties that can cause further delays, additional costs, and/or rejection by the FDA,

and any such delay, added cost, or failure in connection with any future clinical trials could prevent us from commercializing our MicroNet

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

part of the regulatory process, we must conduct clinical trials for each product candidate to demonstrate safety and efficacy to the

satisfaction of the regulatory authorities, including, if we seek in the future to sell our products in the United States, the FDA.

trials are subject to rigorous regulatory requirements and are expensive and time-consuming to design and implement.

They 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.

In some trials, a greater number of patients and a longer follow-up

period may be required.

Patient enrollment in clinical trials and the ability to successfully complete patient follow-up depends on many

factors, including the size of the patient population, the nature of the trial protocol, the proximity of patients to clinical sites,

the eligibility criteria for the clinical trial and patient compliance.

For example, patients may be discouraged from enrolling in our

clinical trials if the trial protocol requires them to undergo extensive post-treatment procedures or follow-up to assess the safety

and efficacy of our products, or they may be persuaded to participate in contemporaneous clinical trials of competitive products.

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.

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

according to the degree of regulation and the type, complexity, novelty and intended use of a product, and can continue for several

years and cost millions of dollars.

The commencement and completion of clinical trials for our existing products and those under

development may be delayed by many factors, including governmental or regulatory delays and changes in regulatory requirements,

policy and guidelines or our inability or the inability of any potential licensee to manufacture or obtain from third parties

materials sufficient for use in preclinical studies and clinical trials.

In addition, market demand may change for products being

tested due to the length of time needed to complete requisite clinical trials.

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

journal articles, among other standard-of-care considerations, that the use of our stents provides a safe and effective alternative

to other existing treatments for coronary artery disease and carotid artery disease.

believe that physicians will not widely adopt our products unless they determine, based on experience, long-term clinical data,

published peer reviewed journal articles and payor coverage policies, among other factors, that the use of our products provide

a safe and effective alternative to other existing treatments for the conditions we are seeking to address.

we fail to demonstrate safety and efficacy that is at least comparable to existing and future therapies available on the market,

our ability to successfully market our products will be significantly limited.

Even if the data collected from clinical studies

or clinical experience indicate positive results, each physician’s actual experience with our products will vary.

trials conducted with our products may involve procedures performed by physicians who are technically proficient and are high-volume

stent users of such products.

Consequently, both short-term and long-term results reported in these clinical trials may be significantly

more favorable than typical results of practicing physicians, which could negatively affect rates of adoptions of our products.

We also believe that published peer-reviewed journal articles and recommendations and support by influential physicians regarding

our products will be important for market acceptance and adoption, and we cannot assure you that we will receive these recommendations

and support, or that supportive articles will be published.

currently consider drug-eluting stents to be the industry standard for treatment of coronary artery disease.

MGuard Prime EPS,

our current coronary product, is not drug-eluting, and this may adversely affect our business.

ability to attract customers depends to a large extent on our ability to provide goods that meet the customers’

market’s demands and expectations.

If we do not have a product that is expected by the market, we may lose customers.

market demand has shifted away from bare metal stents in favor of drug-eluting stents for coronary artery disease.

Prime EPS is a bare-metal stent product and has experienced no growth in sales over the past five years.

Such sales may never

grow and we do not currently have the resources to develop a drug-eluting stent product.

Our failure to provide industry standard

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

according to the degree of regulation and the type, complexity, novelty and intended use of a product, and can continue for several years

and cost millions of dollars.

The commencement and completion of clinical trials for our existing products and those under development

may be delayed by many factors, including governmental or regulatory delays and changes in regulatory requirements, policy and guidelines

or our inability or the inability of any potential licensee to manufacture or obtain from third parties materials sufficient for use

in preclinical studies and clinical trials.

In addition, market demand may change for products being tested due to the length of time

needed to complete requisite clinical trials.

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

articles, among other standard-of-care considerations, that the use of our stents provides a safe and effective alternative to other

existing treatments for coronary artery disease and carotid artery disease.

believe that physicians will not widely adopt our products unless they determine, based on experience, long-term clinical data, published

peer reviewed journal articles and payor coverage policies, among other factors, that the use of our products provide a safe and effective

alternative to other existing treatments for the conditions we are seeking to address.

we fail to demonstrate safety and efficacy that is at least comparable to existing and future therapies available on the market, our

ability to successfully market our products will be significantly limited.

Even if the data collected from clinical studies or clinical

experience indicate positive results, each physician’s actual experience with our products will vary.

Clinical trials conducted

with our products may involve procedures performed by physicians who are technically proficient and are high-volume stent users of such

Consequently, both short-term and long-term results reported in these clinical trials may be significantly more favorable than

typical results of practicing physicians, which could negatively affect rates of adoptions of our products.

We also believe that published

peer-reviewed journal articles and recommendations and support by influential physicians regarding our products will be important for

market acceptance and adoption, and we cannot assure you that we will receive these recommendations and support, or that supportive articles

will be published.

have only limited experience in regulatory affairs, which may affect our ability or the time required to navigate complex regulatory

requirements and obtain necessary regulatory approvals, if such approvals are received at all.

Regulatory delays or denials may

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

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 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 five

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, particularly in the United States, Europe and Asia, which can be costly and time-consuming.

There can be no assurance

that such approvals will be granted on a timely basis, if at all.

Furthermore, there can be no assurance of continued compliance

with all regulatory requirements necessary for the manufacture, marketing and sale of the products we will offer in each market

where such products are expected to be sold, or that products we have commercialized will continue to comply with applicable regulatory

requirements.

If a government regulatory agency were to conclude that we were not in compliance with applicable laws or regulations,

the agency could institute proceedings to detain or seize our products, issue a recall, impose operating restrictions, enjoin

future violations and assess civil and criminal penalties against us, our officers or employees and could recommend criminal prosecution.

Furthermore, regulators may proceed to ban, or request the recall, repair, replacement or refund of the cost of, any device manufactured

or sold by us.

Furthermore, there can be no assurance that all necessary regulatory approvals will be obtained for the manufacture,

marketing and sale in any market of any new product developed or that any potential licensee will develop using our licensed technology.

if our products are approved by regulatory authorities, if we or our suppliers fail to comply with ongoing regulatory requirements,

or if we experience unanticipated problems with our products, these products could be subject to restrictions or withdrawal from

regulatory approvals that we receive for our products will require surveillance to monitor the safety and efficacy of the product

and may require us to conduct post-approval clinical studies.

In addition, if a regulatory authority approves our products, the

manufacturing processes, labeling, packaging, distribution, adverse event reporting, storage, advertising, promotion, import,

export and recordkeeping for our products will be subject to extensive and ongoing regulatory requirements.

if we obtain regulatory approval for any of our products, we will only be permitted to market our products for the indication

approved by the regulatory authority, and such approval may involve limitations on the indicated uses or promotional claims we

may make for our products.

In addition, later discovery of previously unknown problems with our products, including adverse events

of unanticipated severity or frequency, or with our suppliers or manufacturing processes, or failure to comply with regulatory

requirements, may result in, among other things:

Regulatory delays or denials may increase

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

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.

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

particularly in the United States, Europe and Asia, which can be costly and time-consuming.

There can be no assurance that such approvals

will be granted on a timely basis, if at all.

Furthermore, there can be no assurance of continued compliance with all regulatory requirements

necessary for the manufacture, marketing and sale of the products we will offer in each market where such products are expected to be

sold, or that products we have commercialized will continue to comply with applicable regulatory requirements.

If a government regulatory

agency were to conclude that we were not in compliance with applicable laws or regulations, the agency could institute proceedings to

detain or seize our products, issue a recall, impose operating restrictions, enjoin future violations and assess civil and criminal penalties

against us, our officers or employees and could recommend criminal prosecution.

Furthermore, regulators may proceed to ban, or request

the recall, repair, replacement or refund of the cost of, any device manufactured or sold by us.

Furthermore, there can be no assurance

that all necessary regulatory approvals will be obtained for the manufacture, marketing and sale in any market of any new product developed

or that any potential licensee will develop using our licensed technology.

if our products are approved by regulatory authorities, if we or our suppliers fail to comply with ongoing regulatory requirements, or

if we experience unanticipated problems with our products, these products could be subject to restrictions or withdrawal from the market.

regulatory approvals that we receive for our products will require surveillance to monitor the safety and efficacy of the product and

may require us to conduct post-approval clinical studies.

In addition, if a regulatory authority approves our products, the manufacturing

processes, labeling, packaging, distribution, adverse event reporting, storage, advertising, promotion, import, export and recordkeeping

for our products will be subject to extensive and ongoing regulatory requirements.

if we obtain regulatory approval for any of our products, we will only be permitted to market our products for the indication approved

by the regulatory authority, and such approval may involve limitations on the indicated uses or promotional claims we may make for our

In addition, later discovery of previously unknown problems with our products, including adverse events of unanticipated severity

or frequency, or with our suppliers or manufacturing processes, or failure to comply with regulatory requirements, may result in, among

other things:

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

2 unchanged sentences

on clinical trials;

by the regulatory authority to approve pending applications or supplements to approved applications filed by us or suspension

or revocation of license approvals;

by the regulatory authority to approve pending applications or supplements to approved applications filed by us or suspension or

revocation of license approvals;

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

1 unchanged sentence

FDA also requires that our sales and marketing efforts, as well as promotions, be consistent with various laws and regulations.

Approved medical device promotions must be consistent with and not contrary to labeling, balanced, truthful and not false or misleading,

adequately substantiated (when required), and include adequate directions for use.

In addition to the requirements applicable

to approved products, we may also be subject to enforcement action in connection with any promotion of an investigational new

A sponsor or investigator, or any person acting on behalf of a sponsor or investigator, may not represent in a promotional

context that an investigational new device is safe or effective for the purposes for which it is under investigation or otherwise

promote the device.

the FDA investigates our marketing and promotional materials or other communications and finds that any of our investigational

devices, or future commercial products, if any, are being marketed or promoted in violation of the applicable regulatory restrictions,

we could be subject to the enforcement actions listed above, among others.

Any enforcement action (or related lawsuit, which could

follow such action) brought against us in connection with alleged violations of applicable device promotion requirements, or prohibitions,

could harm our business and our reputation, as well as the reputation of any devices that may be approved for marketing in the

in the future.

applicable regulatory authorities’

policies may change and additional government regulations may be enacted that could prevent,

medical device promotions must be consistent with and not contrary to labeling, balanced, truthful and not false or misleading, adequately

substantiated (when required), and include adequate directions for use.

In addition to the requirements applicable to approved products,

we may also be subject to enforcement action in connection with any promotion of an investigational new device.

A sponsor or investigator,

or any person acting on behalf of a sponsor or investigator, may not represent in a promotional context that an investigational new device

is safe or effective for the purposes for which it is under investigation or otherwise promote the device.

the FDA investigates our marketing and promotional materials or other communications and finds that any of our investigational devices,

or future commercial products, if any, are being marketed or promoted in violation of the applicable regulatory restrictions, we could

be subject to the enforcement actions listed above, among others.

Any enforcement action (or related lawsuit, which could follow such

action) brought against us in connection with alleged violations of applicable device promotion requirements, or prohibitions, could

harm our business and our reputation, as well as the reputation of any devices that may be approved for marketing in the U.S.

applicable regulatory authorities’ policies may change, and additional government regulations may be enacted that could prevent,

limit or delay regulatory approval of our products.

We cannot predict the likelihood, nature or extent of government regulation

that may arise from future legislation or administrative action, either in the United States or abroad.

If we are slow or unable

to adapt to changes in existing requirements or the adoption of new requirements or policies, or if we are not able to maintain

regulatory compliance, we may lose any marketing approval that we may have obtained and we may not achieve or sustain profitability.

We cannot predict the likelihood, nature or extent of government regulation that

may arise from future legislation or administrative action, either in the United States or abroad.

If we are slow or unable to adapt

to changes in existing requirements or the adoption of new requirements or policies, or if we are not able to maintain regulatory compliance,

we may lose any marketing approval that we may have obtained and we may not achieve or sustain profitability.

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

2 unchanged sentences

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

The approval processes vary among countries

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

FDA approval.

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

in addition to other risks.

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

We may not obtain foreign regulatory approvals on a timely basis, if at all.

CE mark approval or any

future FDA approval does not ensure approval by regulatory authorities in other countries.

We may not be able to file for regulatory

approvals and may not receive necessary approvals to commercialize our products in certain markets.

are, or may be, subject to federal, state and foreign healthcare laws and regulations and implementation of or changes to such

healthcare laws and regulations could adversely affect our business and results of operations.

both the United States and certain foreign jurisdictions, there are laws and regulations specific to the healthcare industry which

may affect all aspects of our business, including development, testing, marketing, sales, pricing, and reimbursement.

Additionally,

there have been a number of legislative and regulatory proposals in recent years to change the healthcare system in ways that

could impact our ability to sell our products.

If we are found to be in violation of any of these laws or any other federal or

state regulations, we may be subject to administrative, civil and/or criminal penalties, damages, fines, individual imprisonment,

exclusion from federal healthcare programs and the restructuring of our operations.

Any of these could have a material adverse

effect on our business and financial results.

Since many of these laws have not been fully interpreted by the courts, there is

an increased risk that we may be found in violation of one or more of their provisions.

Any action against us for violation of

these laws, even if we ultimately are successful in our defense, will cause us to incur significant legal expenses and divert

our management’s attention away from the operation of our business.

CE mark approval or any future FDA approval does

not ensure approval by regulatory authorities in other countries.

We may not be able to file for regulatory approvals and may not receive

necessary approvals to commercialize our products in certain markets.

are, or may be, subject to federal, state and foreign healthcare laws and regulations and implementation of or changes to such healthcare

laws and regulations could adversely affect our business and results of operations.

both the United States and certain foreign jurisdictions, there are laws and regulations specific to the healthcare industry which may

affect all aspects of our business, including development, testing, marketing, sales, pricing, and reimbursement.

Additionally, there

have been a number of legislative and regulatory proposals in recent years to change the healthcare system in ways that could impact

our ability to sell our products.

If we are found to be in violation of any of these laws or any other federal or state regulations,

we may be subject to administrative, civil and/or criminal penalties, damages, fines, individual imprisonment, exclusion from federal

healthcare programs and the restructuring of our operations.

Any of these could have a material adverse effect on our business and financial

Since many of these laws have not been fully interpreted by the courts, there is an increased risk that we may be found in violation

of one or more of their provisions.

Any action against us for violation of these laws, even if we ultimately are successful in our defense,

will cause us to incur significant legal expenses and divert our management’s attention away from the operation of our business.

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

federal and state anti-kickback, false claims laws, physician payment

transparency laws, fraud and abuse laws or similar healthcare and security laws and regulations, which could expose us to criminal

sanctions, civil penalties, contractual damages, reputational harm and diminished profits and future earnings.

providers, physicians and others will play a primary role in the recommendation, ordering and utilization of any products for

which we obtain regulatory approval.

federal and state anti-kickback, false claims laws, physician payment transparency

laws, fraud and abuse laws or similar healthcare and security laws and regulations, which could expose us to criminal sanctions, civil

penalties, contractual damages, reputational harm and diminished profits and future earnings.

providers, physicians and others will play a primary role in the recommendation, ordering and utilization of any products for which we

obtain regulatory approval.

If we obtain U.S.

Food & Drug Administration approval for any of our products and begin

commercializing those products in the United States, our operations may be subject to various federal and state fraud and abuse

laws, including, without limitation, the federal Anti-Kickback Statute, the federal False Claims Act, and physician payment sunshine

laws and regulations.

These laws may impact, among other things, our potential sales, marketing and education programs.

we may be subject to patient privacy regulation by both the federal government and the states in which we conduct our business.

The laws that may affect our ability to operate include:

the federal Anti-Kickback Statute, which prohibits, among other things, knowingly and willfully soliciting, receiving, offering

or paying any remuneration (including any kickback, bribe, or rebate), directly or indirectly, overtly or covertly, in cash or

in kind, to induce, or in return for, either the referral of an individual, or the purchase, lease, order or recommendation of

any good, facility, item or service for which payment may be made, in whole or in part, under a federal healthcare program, such

as the Medicare and Medicaid programs;

federal civil and criminal false claims laws and civil monetary penalty laws, including the False Claims Act, which may be pursued

through civil whistleblower or qui tam actions, impose criminal and civil penalties against individuals or entities for knowingly

presenting, or causing to be presented, to the federal government, claims for payment or approval from Medicare, Medicaid or other

third-party payors that are false or fraudulent or making a false statement to avoid, decrease or conceal an obligation to pay

money to the federal government;

federal criminal statutes created through the Health Insurance Portability and Accountability Act of 1996 (“HIPAA”),

which prohibit knowingly and willfully executing, or attempting to execute, a scheme to defraud any healthcare benefit program

or obtain, by means of false or fraudulent pretenses, representations, or promises, any of the money or property owned by, or

under the custody or control of, any healthcare benefit program, regardless of the payor (e.g., public or private) and knowingly

and willfully falsifying, concealing or covering up by any trick or device a material fact or making any materially false statements

in connection with the delivery of, or payment for, healthcare benefits, items or services relating to healthcare matters;

Food & Drug Administration approval for any of our products and begin commercializing

those products in the United States, our operations may be subject to various federal and state fraud and abuse laws, including, without

limitation, the federal Anti-Kickback Statute, the federal False Claims Act, and physician payment sunshine laws and regulations.

laws may impact, among other things, our potential sales, marketing and education programs.

In addition, we may be subject to patient

privacy regulation by both the federal government and the states in which we conduct our business.

The laws that may affect our ability

to operate include:

the federal Anti-Kickback Statute, which prohibits, among other things, knowingly and willfully soliciting, receiving, offering or paying

any remuneration (including any kickback, bribe, or rebate), directly or indirectly, overtly or covertly, in cash or in kind, to induce,

or in return for, either the referral of an individual, or the purchase, lease, order or recommendation of any good, facility, item or

service for which payment may be made, in whole or in part, under a federal healthcare program, such as the Medicare and Medicaid programs;

federal civil and criminal false claims laws and civil monetary penalty laws, including the False Claims Act, which may be pursued through

civil whistleblower or qui tam actions, impose criminal and civil penalties against individuals or entities for knowingly presenting,

or causing to be presented, to the federal government, claims for payment or approval from Medicare, Medicaid or other third-party payors

that are false or fraudulent or making a false statement to avoid, decrease or conceal an obligation to pay money to the federal government;

federal criminal statutes created through the Health Insurance Portability and Accountability Act of 1996 (“HIPAA”), which

prohibit knowingly and willfully executing, or attempting to execute, a scheme to defraud any healthcare benefit program or obtain, by

means of false or fraudulent pretenses, representations, or promises, any of the money or property owned by, or under the custody or

control of, any healthcare benefit program, regardless of the payor (e.g., public or private) and knowingly and willfully falsifying,

concealing or covering up by any trick or device a material fact or making any materially false statements in connection with the delivery

of, or payment for, healthcare benefits, items or services relating to healthcare matters;

HIPAA, as amended by the Health Information Technology for Economic and Clinical Health Act of 2009 and their respective implementing

regulations, which imposes requirements on certain covered healthcare providers, health plans, and healthcare clearinghouses as

well as their respective business associates that perform services for them that involve the use, or disclosure of, individually

identifiable health information, relating to the privacy, security and transmission of individually identifiable health information;

regulations, which imposes requirements on certain covered healthcare providers, health plans, and healthcare clearinghouses as well

as their respective business associates that perform services for them that involve the use, or disclosure of, individually identifiable

health information, relating to the privacy, security and transmission of individually identifiable health information;

the federal transparency requirements under The Patient Protection and Affordable Care Act and the Health Care and Education Reconciliation

Act, enacted into law in the United States in March 2010 (known collectively as the “Affordable Care Act”), including

the provision commonly referred to as the Physician Payments Sunshine Act, which requires manufacturers of drugs, biologics, devices

and medical supplies for which payment is available under Medicare, Medicaid or the Children’s Health Insurance Program

to report annually to the U.S.

Department of Health and Human Services information related to payments or other transfers of value

made to physicians and teaching hospitals, as well as ownership and investment interests held by physicians and their immediate

family members;

state and federal consumer protection and unfair competition laws, which broadly regulate marketplace activities and activities

that potentially harm consumers.

Act, enacted into law in the United States in March 2010 (known collectively as the “Affordable Care Act”), including the

provision commonly referred to as the Physician Payments Sunshine Act, which requires manufacturers of drugs, biologics, devices and

medical supplies for which payment is available under Medicare, Medicaid or the Children’s Health Insurance Program to report annually

Department of Health and Human Services information related to payments or other transfers of value made to physicians and

teaching hospitals, as well as ownership and investment interests held by physicians and their immediate family members;

state and federal consumer protection and unfair competition laws, which broadly regulate marketplace activities and activities that

potentially harm consumers.

Additionally,

we may be subject to state and non-U.S.

equivalents of each of the healthcare laws described above, among others, some of which

may be broader in scope and may apply regardless of the payor.

states have adopted laws similar to the federal Anti-Kickback

Statute, some of which apply to the referral of patients for healthcare services reimbursed by any source, not just governmental

payors, including private insurers.

Several states impose marketing restrictions or require medical device companies to make marketing

or price disclosures to the state.

There are ambiguities as to what is required to comply with these state requirements, and if

we fail to comply with an applicable state law requirement we could be subject to penalties.

of the breadth of these laws and the narrowness of the statutory exceptions and safe harbors available, it is possible that some

of our future business activities could be subject to challenge under one or more of such laws.

In addition, healthcare reform

legislation has strengthened these laws.

For example, the Affordable Care Act, among other things, amended the intent requirement

of the federal Anti-Kickback and criminal healthcare fraud statutes.

As a result of such amendment, a person or entity no longer

needs to have actual knowledge of these statutes or specific intent to violate them in order to have committed a violation.

the Affordable Care Act provides that the government may assert that a claim including items or services resulting from a violation

of the federal Anti-Kickback Statute constitutes a false or fraudulent claim for purposes of the False Claims Act.

equivalents of each of the healthcare laws described above, among others, some of which may be

broader in scope and may apply regardless of the payor.

states have adopted laws similar to the federal Anti-Kickback Statute,

some of which apply to the referral of patients for healthcare services reimbursed by any source, not just governmental payors, including

private insurers.

Several states impose marketing restrictions or require medical device companies to make marketing or price disclosures

to the state.

There are ambiguities as to what is required to comply with these state requirements, and if we fail to comply with an

applicable state law requirement, we could be subject to penalties.

of the breadth of these laws and the narrowness of the statutory exceptions and safe harbors available, it is possible that some of our

future business activities could be subject to challenge under one or more of such laws.

In addition, healthcare reform legislation has

strengthened these laws.

For example, the Affordable Care Act, among other things, amended the intent requirement of the federal Anti-Kickback

and criminal healthcare fraud statutes.

As a result of such amendment, a person or entity no longer needs to have actual knowledge of

these statutes or specific intent to violate them in order to have committed a violation.

Moreover, the Affordable Care Act provides

that the government may assert that a claim including items or services resulting from a violation of the federal Anti-Kickback Statute

constitutes a false or fraudulent claim for purposes of the False Claims Act.

of fraud and abuse laws may be punishable by criminal and/or civil sanctions, including penalties, fines and/or exclusion or suspension

from federal and state healthcare programs such as Medicare and Medicaid and debarment from contracting with the U.S.

In addition, private individuals have the ability to bring actions on behalf of the U.S.

government under the False Claims Act

as well, as under the false claims laws of several states.

to ensure that our business arrangements with third parties comply with applicable healthcare laws and regulations will involve

substantial costs.

It is possible that governmental authorities will conclude that our existing or future business practices do

not comply with current or future statutes, regulations or case law involving applicable fraud and abuse or other healthcare laws

and regulations.

Any such actions instituted against us could have a significant adverse impact on our business, including the

imposition of civil, criminal and administrative penalties, damages, disgorgement, monetary fines, possible exclusion from participation

in Medicare, Medicaid and other federal healthcare programs, contractual damages, reputational harm, diminished profits and future

earnings, and curtailment of our operations, any of which could adversely affect our ability to operate our business and our results

of operations.

Even if we are successful in defending against such actions, we may nonetheless be subject to substantial costs,

reputational harm and adverse effects on our ability to operate our business.

In addition, the approval and commercialization

of any of our products outside the United States will also likely subject us to non-U.S.

equivalents of the healthcare laws mentioned

above, among other non-U.S.

any of our employees, agents, or the physicians or other providers or entities with whom we expect to do business are found to

have violated applicable laws, we may be subject to criminal, civil or administrative sanctions, including exclusions from government

funded healthcare programs, or, if we are not subject to such actions, we may suffer reputational harm for conducting business

with persons or entities found, or accused of being, in violation of such laws.

Any such events could adversely affect our ability

to operate our business and our results of operations.

addition, private individuals have the ability to bring actions on behalf of the U.S.

government under the False Claims Act as well,

as under the false claims laws of several states.

to ensure that our business arrangements with third parties comply with applicable healthcare laws and regulations will involve substantial

It is possible that governmental authorities will conclude that our existing or future business practices do not comply with current

or future statutes, regulations or case law involving applicable fraud and abuse or other healthcare laws and regulations.

Any such actions

instituted against us could have a significant adverse impact on our business, including the imposition of civil, criminal and administrative

penalties, damages, disgorgement, monetary fines, possible exclusion from participation in Medicare, Medicaid and other federal healthcare

programs, contractual damages, reputational harm, diminished profits and future earnings, and curtailment of our operations, any of which

could adversely affect our ability to operate our business and our results of operations.

Even if we are successful in defending against

such actions, we may nonetheless be subject to substantial costs, reputational harm and adverse effects on our ability to operate our

In addition, the approval and commercialization of any of our products outside the United States will also likely subject us

equivalents of the healthcare laws mentioned above, among other non-U.S.

any of our employees, agents, or the physicians or other providers or entities with whom we expect to do business are found to have violated

applicable laws, we may be subject to criminal, civil or administrative sanctions, including exclusions from government funded healthcare

programs, or, if we are not subject to such actions, we may suffer reputational harm for conducting business with persons or entities

found, or accused of being, in violation of such laws.

Any such events could adversely affect our ability to operate our business and

our results of operations.

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

5 unchanged sentences

We have obtained product liability insurance coverage;

however such insurance may not provide full coverage for our

future clinical trials, products to be sold, and other aspects of our business.

Insurance coverage is becoming increasingly expensive

and we may not be able to maintain current coverage, or expand our insurance coverage to include future clinical trials or the

sale of new products or existing products in new territories, at a reasonable cost or in sufficient amounts to protect against

losses due to product liability or at all.

A successful product liability claim or series of claims brought against us could result

in judgments, fines, damages and liabilities that could have a material adverse effect on our business, financial condition and

results of operations.

We may incur significant expense investigating and defending these claims, even if they do not result in

Moreover, even if no judgments, fines, damages or liabilities are imposed on us, our reputation could suffer, which

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

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.

however ,such insurance may not provide full coverage for our future

clinical trials, products to be sold, and other aspects of our business.

Insurance coverage is becoming increasingly expensive, and we

may not be able to maintain current coverage, or expand our insurance coverage to include future clinical trials or the sale of new products

or existing products in new territories, at a reasonable cost or in sufficient amounts to protect against losses due to product liability

A successful product liability claim, or series of claims brought against us could result in judgments, fines, damages and

liabilities that could have a material adverse effect on our business, financial condition and results of operations.

We may incur significant

expense investigating and defending these claims, even if they do not result in liability.

Moreover, even if no judgments, fines, damages

or liabilities are imposed on us, our reputation could suffer, which could have a material adverse effect on our business, financial

condition and results of operations.

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.

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

efficacy, safety, performance and cost-effectiveness of our products and of any competing products are factors that may impact

the availability and level of reimbursement.

Reimbursement and healthcare payment systems in international markets vary significantly

by country and include both government sponsored healthcare and private insurance.

To obtain reimbursement or pricing approval

in some countries, we may be required to produce clinical data, which may involve one or more clinical trials that compares the

cost-effectiveness of our products to other available therapies.

We may not obtain international reimbursement or pricing approvals

in a timely manner, if at all.

Our failure to receive international reimbursement or pricing approvals would negatively impact

market acceptance of our products in the international markets in which those approvals are sought.

The efficacy,

safety, performance and cost-effectiveness of our products and of any competing products are factors that may impact the availability

and level of reimbursement.

Reimbursement and healthcare payment systems in international markets vary significantly by country and include

both government sponsored healthcare and private insurance.

To obtain reimbursement or pricing approval in some countries, we may be

required to produce clinical data, which may involve one or more clinical trials that compares the cost-effectiveness of our products

to other available therapies.

We may not obtain international reimbursement or pricing approvals in a timely manner, if at all.

to receive international reimbursement or pricing approvals would negatively impact market acceptance of our products in the international

markets in which those approvals are sought.

believe that future reimbursement may be subject to increased restrictions both in the U.S.

and in international markets.

is increasing pressure by governments worldwide to contain healthcare costs by limiting both the coverage and the level of reimbursement

for therapeutic products and by refusing, in some cases, to provide any coverage for products that have not been approved by the

relevant regulatory agency.

Future legislation, regulation or reimbursement policies of third party payors may adversely affect

the demand for our products and limit our ability to sell our products on a profitable basis.

In addition, third party payors

continually attempt to contain or reduce the costs of healthcare by challenging the prices charged for healthcare products and

If reimbursement for our products is unavailable or limited in scope or amount, or if pricing is set at unsatisfactory

levels, market acceptance of our products would be impaired, and future revenues, if any, would be adversely affected.

the United States and European Union, our business could be significantly and adversely affected by healthcare reform initiatives

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

There is increasing

pressure by governments worldwide to contain healthcare costs by limiting both the coverage and the level of reimbursement for therapeutic

products and by refusing, in some cases, to provide any coverage for products that have not been approved by the relevant regulatory

Future legislation, regulation or reimbursement policies of third party payors may adversely affect the demand for our products

and limit our ability to sell our products on a profitable basis.

In addition, third party payors continually attempt to contain or reduce

the costs of healthcare by challenging the prices charged for healthcare products and services.

If reimbursement for our products is

unavailable or limited in scope or amount, or if pricing is set at unsatisfactory levels, market acceptance of our products would be

impaired, and future revenues, if any, would be adversely affected.

the United States and European Union, our business could be significantly and adversely affected by healthcare reform initiatives and/or

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

Affordable Care Act, signed into law in the United States in March 2010, contains certain provisions which are not yet fully implemented

and for which it is unclear what the full impact will be from the legislation.

legislation 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.

of the provisions of the Affordable Care Act have yet to be implemented, and there have been judicial and Congressional challenges

to certain aspects of the Affordable Care Act, as well as recent efforts by the Trump presidential administration to repeal or

replace certain aspects of the Affordable Care Act.

Since January 2017, the president has signed two executive orders and other

directives designed to delay the implementation of certain provisions of the Affordable Care Act or otherwise circumvent some

of the requirements for health insurance mandated by the Affordable Care Act.

Congress has considered legislation that would repeal

or repeal and replace all or part of the Affordable Care Act.

While Congress has not passed comprehensive repeal legislation,

two bills affecting the implementation of certain taxes under the Affordable Care Act have been signed into law.

The TCJA includes

a provision repealing, effective January 1, 2019, the tax-based shared responsibility payment imposed by the Affordable Care Act

on certain individuals who fail to maintain qualifying health coverage for all or part of a year that is commonly referred to

as the “individual mandate.”

Additionally, the 2020 federal spending package permanently eliminated, effective January

1, 2020, the Affordable Care Act-mandated “Cadillac”

tax on high-cost employer-sponsored health coverage and medical

device tax and, effective January 1, 2021, also eliminates the health insurer tax.

The Bipartisan Budget Act of 2018, among other

things, amended the Affordable Care Act, effective January 1, 2019, to close the coverage gap in most Medicare plans, commonly

referred to as the “donut hole.”

In July 2018, the Centers for Medicare and Medicaid Services, or CMS, published a

final rule permitting further collections and payments to and from certain Affordable Care Act qualified health plans and health

insurance issuers under the Affordable Care Act risk adjustment program in response to the outcome of federal district court litigation

regarding the method CMS uses to determine this risk adjustment.

Trump administration has also taken executive actions to undermine or delay implementation of the Affordable Care Act.

Since January

2017, the President Trump has signed two Executive Orders designed to delay the implementation of certain provisions of the Affordable

Care Act or otherwise circumvent some of the requirements for health insurance mandated by the Affordable Care Act.

One Executive

Order directs federal agencies with authorities and responsibilities under the Affordable Care Act to waive, defer, grant exemptions

from, or delay the implementation of any provision of the Affordable Care Act that would impose a fiscal or regulatory burden

on states, individuals, healthcare providers, health insurers, or manufacturers of pharmaceuticals or medical devices.

Executive Order terminates the cost-sharing subsidies that reimburse insurers under the Affordable Care Act.

Several state Attorneys

General filed suit to stop the administration from terminating the subsidies, but their request for a restraining order was denied

by a federal judge in California on October 25, 2017.

In addition, CMS has recently proposed regulations that would give states

greater flexibility in setting benchmarks for insurers in the individual and small group marketplaces, which may have the effect

of relaxing the essential health benefits required under the Affordable Care Act for plans sold through such marketplaces.

on June 14, 2018, U.S.

Court of Appeals for the Federal Circuit ruled that the federal government was not required to pay more

than $12 billion in Affordable Care Act risk corridor payments to third-party payors who argued such payments were owed to them,

which the U.S.

Supreme Court is reviewing during its current term.

The effects of this gap in reimbursement on third-party payors,

the viability of the Affordable Care Act marketplace, providers, and potentially our business, are not yet known.

cannot predict the impact that such actions against the Affordable Care Act 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 the Affordable Care Act.

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.

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 a new Medical Device Regulation (EU) 2017/745

which has replaced the existing medical device directives (93/42/EEC).

The new regulations will come into full application in

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.

As a result, the new legislation can prevent or delay the CE marking and certifications of our products under development or impact

our ability to modify our currently CE marked products on a timely basis.

If we fail to comply with the modified regulation and

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

we are unable to obtain and maintain intellectual property protection covering our products, others may be able to make, use or

sell our products, which would adversely affect our revenue.

ability to protect our products from unauthorized or infringing use by third parties depends substantially on our ability to obtain

and maintain valid and enforceable patents.

Similarly, the ability to protect our trademark rights might be important to prevent

third party counterfeiters from selling poor quality goods using our designated trademarks, and trade names.

Due to evolving legal

standards relating to the patentability, validity and enforceability of patents covering medical devices and pharmaceutical inventions

and the scope of claims made under these patents, our ability to enforce patents is uncertain and involves complex legal and factual

Accordingly, rights under any of our pending patent applications and patents may not provide us with commercially meaningful

protection for our products or may not afford a commercial advantage against our competitors or their competitive products or

In addition, patents may not be issued from any pending or future patent applications owned by or licensed to us, and

moreover, patents that may be issued to us now or in the future may later be found invalid or unenforceable.

Further, even if

valid and enforceable, our patents may not be sufficiently broad to prevent others from marketing products like ours, despite

our patent rights.

legislation 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.

its enactment, there have been judicial and Congressional challenges to certain aspects of the Affordable Care Act, as well as efforts

by the Trump Administration to modify, repeal or otherwise invalidate all, or certain provisions of, the Affordable Care Act.

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 is

expected to rule in that case in early 2021.

Assuming entire Affordable Care Act is not ruled to be unconstitutional, the 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 would have on our business.

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

These changes included

aggregate reductions to Medicare payments to providers of up to two percent per fiscal year, which will remain in effect through 2027

unless additional Congressional action is taken.

It is unclear what impact new quality and payment programs may have on our business,

financial condition, results of operations or cash flows.

Individual states in the United States have also become increasingly aggressive

in passing legislation and implementing regulations designed to control product pricing, including price or patient reimbursement constraints,

and discounts, and require marketing cost disclosure and transparency measures.

We believe that additional state and federal health care

reform measures may be adopted in the future that could have a material adverse effect on our industry generally and on our customers.

Any changes in, or uncertainty with respect to, future reimbursement rates could impact our customers’ demand for our products,

which in turn could have a material adverse effect on our business, financial condition, results of operations, or cash flows.

the federal, state and local governments, Medicare, Medicaid, managed care organizations, and foreign governments have in the past considered,

are currently considering, and may in the future consider healthcare policies and proposals intended to curb rising healthcare costs,

including those that could significantly affect both private and public reimbursement for healthcare services.

Future significant changes

in the healthcare systems in the United States or other countries, including changes intended to reduce expenditures along with uncertainty

about whether and how changes may be implemented, could have a negative impact on the demand for our products.

We are unable to predict

with certainty whether other healthcare policies, including policies stemming from legislation or regulations affecting our business,

may be proposed or enacted in the future;

what effect such policies would have on our business;

or the effect ongoing uncertainty about

these matters will have on our customers’ purchasing decisions.

cannot predict the impact that such actions against the Affordable Care Act 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 the Affordable Care Act.

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.

May 2017, the European parliament and the council of the European Union approved a new Medical Device Regulation (EU) 2017/745 which

has replaced the existing medical device directives (93/42/EEC).

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

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.

As a result, the

new legislation can prevent or delay the CE marking and certifications of our products under development or impact our ability to modify

our currently CE marked products on a timely basis.

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.

we are unable to obtain and maintain intellectual property protection covering our products, others may be able to make, use or sell

our products, which would adversely affect our revenue.

ability to protect our products from unauthorized or infringing use by third parties depends substantially on our ability to obtain and

maintain valid and enforceable patents.

Similarly, the ability to protect our trademark rights might be important to prevent third party

counterfeiters from selling poor quality goods using our designated trademarks, and trade names.

Due to evolving legal standards relating

to the patentability, validity and enforceability of patents covering medical devices and pharmaceutical inventions and the scope of

claims made under these patents, our ability to enforce patents is uncertain and involves complex legal and factual questions.

rights under any of our pending patent applications and patents may not provide us with commercially meaningful protection for our products

or may not afford a commercial advantage against our competitors or their competitive products or processes.

In addition, patents may

not be issued from any pending or future patent applications owned by or licensed to us, and moreover, patents that may be issued to

us now or in the future may later be found invalid or unenforceable.

Further, even if valid and enforceable, our patents may not be sufficiently

broad to prevent others from marketing products like ours, despite our patent rights.

validity of our patent claims depends, in part, on whether prior art references exist that describe or render obvious our inventions

1 unchanged sentence

We may not have identified all prior art, such as U.S.

and foreign patents or

published applications or published scientific literature, that could adversely affect the patentability of our issued patents

and pending patent applications.

For example, some material references may be in a foreign language and may not be uncovered during

examination of our patent applications.

Additionally, patent applications in the United States are maintained in confidence for

up to 18 months after their filing.

and foreign patents or published

applications or published scientific literature, that could adversely affect the patentability of our issued patents and pending patent

applications.

For example, some material references may be in a foreign language and may not be uncovered during examination of our patent

applications.

Additionally, patent applications in the United States are maintained in confidence for up to 18 months after their filing.

In some cases, however, patent applications remain confidential in the U.S.

Patent and Trademark

Office for the entire time prior to issuance as a U.S.

Patent and Trademark Office for the entire time prior to

issuance as a U.S.

Patent applications filed in countries outside the U.S.

typically published until at least 18 months from their first filing date.

Similarly, publication of discoveries in the scientific

or patent literature often lags behind actual discoveries.

Therefore, we cannot be certain that we were the first to invent, or

the first to file patent applications relating to, our stent technologies.

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 the technologies we develop.

The laws of some foreign jurisdictions do not offer the same protection to, or may make it more

difficult to effect the enforcement of, proprietary rights as in the United States.

This risk may be exacerbated if we move our

manufacturing to certain countries in Asia.

If we encounter such difficulties or are otherwise precluded from effectively protecting

our intellectual property rights in any foreign jurisdictions, our business prospects could be substantially harmed.

initiation of litigation to enforce our patent rights may prompt adversaries in such litigation to challenge the validity, scope,

ownership, or enforceability of our patents.

Third parties can sometimes bring challenges against a patent holder to resolve these

issues, as well.

If a court decides that any such patents are not valid, not enforceable, not wholly owned by us, or are of a

limited scope, we may not have the right to stop others from using our inventions.

Also, even if our patent rights are determined

by a court to be valid and enforceable, they may not be sufficiently broad to prevent others from marketing products similar to

ours or designing around our patents, despite our patent rights, nor do they provide us with freedom to operate unimpeded by the

patent and other intellectual property rights of others that may cover our products.

We may be forced into litigation to uphold

the validity of the claims in our patent portfolio, as well as our ownership rights to such intellectual property, and litigation

is often an uncertain and costly process.

are not typically published until at least 18 months

from their first filing date.

Similarly, publication of discoveries in the scientific or patent literature often lags behind actual discoveries.

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

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

the technologies we develop.

The laws of some foreign jurisdictions do not offer the same protection to, or may make it more difficult

to effect the enforcement of, proprietary rights as in the United States.

This risk may be exacerbated if we move our manufacturing to

certain countries in Asia.

If we encounter such difficulties or are otherwise precluded from effectively protecting our intellectual

property rights in any foreign jurisdictions, our business prospects could be substantially harmed.

initiation of litigation to enforce our patent rights may prompt adversaries in such litigation to challenge the validity, scope, ownership,

or enforceability of our patents.

Third parties can sometimes bring challenges against a patent holder to resolve these issues, as well.

If a court decides that any such patents are not valid, not enforceable, not wholly owned by us, or are of a limited scope, we may not

have the right to stop others from using our inventions.

Also, even if our patent rights are determined by a court to be valid and enforceable,

they may not be sufficiently broad to prevent others from marketing products similar to ours or designing around our patents, despite

our patent rights, nor do they provide us with freedom to operate unimpeded by the patent and other intellectual property rights of others

that may cover our products.

We may be forced into litigation to uphold the validity of the claims in our patent portfolio, as well as

our ownership rights to such intellectual property, and litigation is often an uncertain and costly process.

may not be able to protect our trade secrets adequately.

Although we rely on non-disclosure and confidentiality agreements with

employees, consultants and other parties to protect, in part, trade secrets and other proprietary technology, these agreements

may be breached and we may not have adequate remedies for such breach.

Moreover, others may independently develop equivalent proprietary

information, and third parties may otherwise gain access to our trade secrets and proprietary knowledge.

Any disclosure of confidential

data into the public domain or to third parties could allow competitors to learn our trade secrets and use the information in

competition against us.

Although we rely on non-disclosure and confidentiality agreements with employees,

consultants and other parties to protect, in part, trade secrets and other proprietary technology, these agreements may be breached and

we may not have adequate remedies for such breach.

Moreover, others may independently develop equivalent proprietary information, and

third parties may otherwise gain access to our trade secrets and proprietary knowledge.

Any disclosure of confidential data into the

public domain or to third parties could allow competitors to learn our trade secrets and use the information in competition against us.

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.

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.

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

For example, 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.

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

or defense of any issued patents.

in either the patent laws or interpretation of the patent laws in the United States and other countries may diminish the value of any

patents that may issue from our patent applications or narrow the scope of our patent protection.

The laws of foreign countries may not

protect our rights to the same extent as the laws of the United States.

Publications of discoveries in the scientific literature often

lag behind the actual discoveries, and patent applications in the United States and other jurisdictions are typically not published until

18 months after filing, or in some cases not at all.

We therefore cannot be certain that we were the first to file the invention claimed

in our owned and licensed patent or pending applications, or that we or our licensor were the first to file for patent protection of

such inventions.

Assuming all other requirements for patentability are met, in the United States prior to March 15, 2013, the first to

make the claimed invention without undue delay in filing, is entitled to the patent, while generally outside the United States, the first

to file a patent application is entitled to the patent.

After March 15, 2013, under the Leahy-Smith America Invents Act, or the Leahy-Smith

Act, enacted on September 16, 2011, the United States has moved to a first to file system.

The Leahy-Smith Act also includes a number

of significant changes that affect the way patent applications 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

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

may infringe our intellectual property.

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.

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

or non-enablement.

Grounds for an unenforceability assertion could be an allegation that someone connected with prosecution of the patent

withheld relevant information from the United States Patent and Trademark Office, or USPTO, or made a misleading statement, during prosecution.

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

patents may also be challenged in post-grant 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.

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

of our confidential information could be compromised by disclosure during this type of litigation.

There could also be public announcements

of the results of hearings, motions, or other interim proceedings or developments.

If securities analysts or investors perceive these

results to be negative, it could have a material adverse effect on the price of our Ordinary Shares.

face risks associated with litigation and claims.

may, in the future, be involved in one or more lawsuits, claims or other proceedings.

These suits could concern issues including

contract disputes, employment actions, employee benefits, taxes, environmental, health and safety, fraud and abuse, personal injury

and product liability matters.

These suits could concern issues including contract

disputes, employment actions, employee benefits, taxes, environmental, health and safety, fraud and abuse, personal injury and product

liability matters.

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

the ordinary course of our business, we collect and store sensitive data, including intellectual property, research data, our

proprietary business information and that of our suppliers, technical information about our products, clinical trial plans and

employee records.

the ordinary course of our business, we collect and store sensitive data, including intellectual property, research data, our proprietary

business information and that of our suppliers, technical information about our products, clinical trial plans and employee records.

Similarly, our third-party providers possess certain of our sensitive data and confidential information.

secure maintenance of this information is critical to our operations and business strategy.

Despite the implementation of security

measures, our internal computer systems, and those of third parties on which we rely, are vulnerable to damage from computer viruses,

malware, ransomware, cyber fraud, natural disasters, terrorism, war, telecommunication and electrical failures, cyber-attacks

or cyber-intrusions over the Internet, attachments to emails, persons inside our organization, or persons with access to systems

inside our organization.

The risk of a security breach or disruption, particularly through cyber-attacks or cyber intrusion, including

by computer hackers, foreign governments, and cyber terrorists, has generally increased as the number, intensity and sophistication

of attempted attacks and intrusions from around the world have increased.

Any such breach could compromise our networks and the

information stored there could be accessed, publicly disclosed, encrypted, lost or stolen.

Any such access, inappropriate disclosure

of confidential or proprietary information or other loss of information, including our data being breached at third-party providers,

could result in legal claims or proceedings, liability or financial loss under laws that protect the privacy of personal information,

disruption of our operations or our product development programs and damage to our reputation, which could adversely affect our

For example, the loss of clinical trial data from completed or ongoing or planned clinical trials could result in delays

in our regulatory approval efforts and significantly increase our costs to recover or reproduce the data.

loss of key members of our senior management team or our inability to attract and retain highly skilled scientists and laboratory

and field personnel could adversely affect our business .

The secure maintenance of this

information is critical to our operations and business strategy.

Despite the implementation of security measures, our internal computer

systems, and those of third parties on which we rely, are vulnerable to damage from computer viruses, malware, ransomware, cyber fraud,

natural disasters, terrorism, war, telecommunication and electrical failures, cyber-attacks or cyber-intrusions over the Internet, attachments

to emails, persons inside our organization, or persons with access to systems inside our organization.

The risk of a security breach

or disruption, particularly through cyber-attacks or cyber intrusion, including by computer hackers, foreign governments, and cyber terrorists,

has generally increased as the number, intensity and sophistication of attempted attacks and intrusions from around the world have increased.

Any such breach could compromise our networks and the information stored there could be accessed, publicly disclosed, encrypted, lost

Any such access, inappropriate disclosure of confidential or proprietary information or other loss of information, including

our data being breached at third-party providers, could result in legal claims or proceedings, liability or financial loss under laws

that protect the privacy of personal information, disruption of our operations or our product development programs and damage to our

reputation, which could adversely affect our business.

For example, the loss of clinical trial data from completed or ongoing or planned

clinical trials could result in delays in our regulatory approval efforts and significantly increase our costs to recover or reproduce

loss of key members of our senior management team or our inability to attract and retain highly skilled scientists and laboratory and

field personnel could adversely affect our business .

depend on the skills, experience and performance of our senior management and research personnel.

The efforts of each of these

persons will be critical to us as we continue to further develop our products, increase sales and broaden our product offerings.

If we were to lose one or more of these key employees, we may experience difficulties in competing effectively, developing our

technologies and implementing our business strategies.

Our research and development programs and commercial laboratory operations

depend on our ability to attract and retain highly skilled scientists and technicians.

We may not be able to attract or retain

qualified scientists and technicians in the future due to the intense competition for qualified personnel among life science businesses.

There can be no assurance that we will be able to attract and retain necessary personnel on acceptable terms given the intense

competition among medical device, biotechnology, pharmaceutical and healthcare companies, universities and non-profit research

institutions for experienced management, scientists, researchers, sales and marketing and manufacturing personnel.

If we are unable

to attract, retain and motivate our key personnel to accomplish our business objectives, we may experience constraints that will

adversely affect our ability to support our operations, and our results of operations may be materially and adversely affected.

are an international business, and we are exposed to various global and local risks that could have a material adverse effect

on our financial condition and results of operations.

The efforts of each of these persons

will be critical to us as we continue to further develop our products, increase sales and broaden our product offerings.

If we were to

lose one or more of these key employees, we may experience difficulties in competing effectively, developing our technologies and implementing

our business strategies.

Our research and development programs and commercial laboratory operations depend on our ability to attract

and retain highly skilled scientists and technicians.

We may not be able to attract or retain qualified scientists and technicians in

the future due to the intense competition for qualified personnel among life science businesses.

There can be no assurance that we will

be able to attract and retain necessary personnel on acceptable terms given the intense competition among medical device, biotechnology,

pharmaceutical and healthcare companies, universities and non-profit research institutions for experienced management, scientists, researchers,

sales and marketing and manufacturing personnel.

If we are unable to attract, retain and motivate our key personnel to accomplish our

business objectives, we may experience constraints that will adversely affect our ability to support our operations, and our results

of operations may be materially and adversely affected.

are an international business, and we are exposed to various global and local risks that could have a material adverse effect on our

financial condition and results of operations.

operate globally and develop and market products in multiple countries.

1 unchanged sentence

in multiple jurisdictions, which may expose us to certain financial and other risks.

In addition, we are subject to global events

beyond our control, including war, public health crises, such as pandemics and epidemics, trade disputes and other international

Any of these changes could have a material adverse effect on our reputation, business, financial condition or results

of operations.

example, the COVID-19 pandemic has significantly affected most of the world, including each of our primary markets, resulting

in, among other things, government-imposed quarantines and other public health safety measures.

At this point, the extent to which

the coronavirus may impact our business cannot be estimated;

however, procedures with CGuard EPS, which are generally scheduled

or non-emergency procedures, have seen extended postponements since the onset of COVID-19 as hospitals shift resources to patients

affected by the coronavirus, and it is highly plausible that this trend will continue.

The extent to which COVID-19 impacts our

results will depend on future developments, which are highly uncertain and cannot be predicted, including new information which

may emerge concerning the severity of the coronavirus, the actions to contain COVID-19 or treat its impact, the efficacy and scale

of the various vaccines currently deployed across the world, among others.

Moreover, COVID-19 has had indeterminable adverse effects

on general commercial activity and the world economy, and our business and results of operations could be adversely affected to

the extent that COVID-19 or any other epidemic continues to harm the global economy generally.

In addition, we are subject to global events beyond

our control, including war, public health crises, such as pandemics and epidemics, trade disputes and other international events.

of these changes could have a material adverse effect on our reputation, business, financial condition or results of operations.

example, the COVID-19 pandemic has significantly affected most of the world, including each of our primary markets, resulting in, among

other things, government-imposed quarantines and other public health safety measures.

At this point, the extent to which the coronavirus

may impact our business cannot be estimated;

however, procedures with CGuard EPS, which are generally scheduled or non-emergency procedures,

have seen extended postponements since the onset of COVID-19 as hospitals shift resources to patients affected by the coronavirus, and

it is highly plausible that this trend will continue.

We anticipate that the COVID-19 pandemic may impact clinical and regulatory matters.

COVID-19 is delaying enrollment in clinical trials across the medical device industry and may affect any new trials we decide to pursue.

COVID-19 may cause disruptions that could have a material adverse impact on our FDA clinical trial plans and timelines.

The extent to

which COVID-19 impacts our results will depend on future developments, which are highly uncertain and cannot be predicted, including

new information which may emerge concerning the severity of the coronavirus, the actions to contain COVID-19 or treat its impact, the

efficacy and scale of the various vaccines currently deployed across the world, among others.

Moreover, COVID-19 has had indeterminable

adverse effects on general commercial activity and the world economy, and our business and results of operations could be adversely affected

to the extent that COVID-19 or any other epidemic continues to harm the global economy generally.

International

13 unchanged sentences

difficulty in protecting intellectual property;

risk of third party disputes over ownership of intellectual property and infringement of third party intellectual property

by our products;

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

economic and political conditions in these foreign markets.

3 unchanged sentences

operations may be limited by risks and uncertainties related to regional economic conditions, regulatory and reimbursement approvals,

competing products, infrastructure development, intellectual property rights protection and our ability to implement our overall

business strategy.

competing products, infrastructure development, intellectual property rights protection and our ability to implement our overall business

We expect these risks will increase as we pursue our strategy to expand operations into new geographic markets.

We may not succeed in developing and implementing effective policies and strategies in each location where we conduct business.

Any failure to do so may harm our business, results of operations and financial condition.

succeed in developing and implementing effective policies and strategies in each location where we conduct business.

Any failure to do

so may harm our business, results of operations and financial condition.

Environmental,

social and corporate governance (ESG) issues, including those related to climate change and sustainability, may have an adverse effect

on our business, financial condition and results of operations and damage our reputation.

is an increasing focus from certain investors, customers, consumers, employees and other stakeholders concerning ESG matters.

Additionally,

public interest and legislative pressure related to public companies’ ESG practices continue to grow.

If our ESG practices fail

to meet regulatory requirements or investor, customer, consumer, employee or other stakeholders’ evolving expectations and standards

for responsible corporate citizenship in areas including environmental stewardship, support for local communities, Board of Director

and employee diversity, human capital management, employee health and safety practices, product quality, supply chain management, corporate

governance and transparency, our reputation, brand and employee retention may be negatively impacted, and our customers and suppliers

may be unwilling to continue to do business with us.

consumers, investors and other stakeholders are increasingly focusing on environmental issues, including climate change, energy and water

use, plastic waste and other sustainability concerns.

Concern over climate change may result in new or increased legal and regulatory

requirements to reduce or mitigate impacts to the environment.

Changing customer and consumer preferences or increased regulatory requirements

may result in increased demands or requirements regarding plastics and packaging materials, including single-use and non-recyclable plastic

products and packaging, other components of our products and their environmental impact on sustainability, or increased customer and

consumer concerns or perceptions (whether accurate or inaccurate) regarding the effects of substances present in certain of our products.

Complying with these demands or requirements could cause us to incur additional manufacturing, operating or product development costs.

we do not adapt to or comply with new regulations, or fail to meet evolving investor, industry or stakeholder expectations and concerns

regarding ESG issues, investors may reconsider their capital investment in our Company, and customers and consumers may choose to stop

purchasing our products, which could have a material adverse effect on our reputation, business or financial condition.

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

derived approximately 8.2% of total sales in Russia in 2021.

The escalation of geopolitical instability in Russia and Ukraine as well

as currency fluctuations in the Russian Ruble could negatively impact our operations, sales, and future growth prospects in that region.

As a result of the crisis in Ukraine both the United States and the EU have implemented sanctions against certain Russian individuals

and entities.

Our global operations expose us to risks that could adversely affect our business, financial condition, results of operations,

cash flows or the market price of our securities, including the potential for increased tensions between the United States and Russia

resulting from the current situation involving Russia and Ukraine, tariffs, economic sanctions and import-export restrictions imposed

by either nation, and retaliatory actions by the other nation, as well as the potential negative impact on our business and sales in

Current geopolitical instability in Russia and Ukraine and related sanctions by the U.S.

government against certain companies

and individuals may hinder our ability to conduct business with potential or existing customers and vendors in these countries.

government has imposed sanctions through several executive orders restricting U.S.

companies from conducting business with specified

Russian and Ukrainian individuals and companies.

While we believe that the executive orders currently do not preclude us from conducting

business with our current customers or vendors in Russia, the sanctions imposed by the U.S.

government may be expanded in the future

to restrict us from engaging with them.

If we are unable to conduct business with new or existing customers or vendors or pursue business

opportunities in Russia or Ukraine, our business, including revenue, profitability and cash flows, and operations could be adversely

We cannot provide assurance that current sanctions or potential future changes in sanctions will not have a material impact

on our operations in Russia and the Ukraine or on our financial results.

Related to Operating in Israel

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

be generated in Euros and U.S.

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

in Euros and U.S.

dollars, while a significant portion of our expenses will be incurred in New Israeli Shekels.

2 unchanged sentences

principally salaries and related personnel expenses, is paid in New Israeli Shekels, or NIS.

As a result, we are exposed to the

risk that the rate of inflation in Israel will exceed the rate of devaluation of the NIS in relation to the Euro or the U.S.

or that the timing of this devaluation will lag behind inflation in Israel.

Because inflation has the effect of increasing the

dollar and Euro costs of our operations, it would therefore have an adverse effect on our dollar-measured results of operations.

The value of the NIS, against the Euro, the U.S.

dollar, and other currencies may fluctuate and is affected by, among other things,

changes in Israel’s political and economic conditions.

Any significant revaluation of the NIS may materially and adversely

affect our cash flows, revenues and financial condition.

Fluctuations in the NIS exchange rate, or even the appearance of instability

in such exchange rate, could adversely affect our ability to operate our business.

As a result, we are exposed to the risk

that the rate of inflation in Israel will exceed the rate of devaluation of the NIS in relation to the Euro or the U.S.

dollar, or that

the timing of this devaluation will lag behind inflation in Israel.

Because inflation has the effect of increasing the dollar and Euro

costs of our operations, it would therefore have an adverse effect on our dollar-measured results of operations.

The value of the NIS,

against the Euro, the U.S.

dollar, and other currencies may fluctuate and is affected by, among other things, changes in Israel’s

political and economic conditions.

Any significant revaluation of the NIS may materially and adversely affect our cash flows, revenues

and financial condition.

Fluctuations in the NIS exchange rate, or even the appearance of instability in such exchange rate, could adversely

affect our ability to operate our business.

there are significant shifts in the political, economic and military conditions in Israel and its neighbors, it could have a material

1 unchanged sentence

executive office, sole manufacturing facility and certain of our key personnel are located in Israel.

Our business is directly

affected by the political, economic and military conditions in Israel and its neighbors.

Since the establishment of the State

of Israel in 1948, a number of armed conflicts have occurred between Israel and its Arab neighbors.

A state of hostility, varying

in degree and intensity, has caused security and economic problems in Israel.

Although Israel has entered into peace treaties

with Egypt and Jordan, and various agreements with the Palestinian Authority, there has been a marked increase in violence, civil

unrest and hostility, including armed clashes, between the State of Israel and the Palestinians since September 2000.

The establishment

in 2006 of a government in the Gaza Strip by representatives of the Hamas militant group has created heightened unrest and uncertainty

in the region.

In mid-2006, Israel engaged in an armed conflict with Hezbollah, a Shiite Islamist militia group based in Lebanon,

and in June 2007, there was an escalation in violence in the Gaza Strip.

From December 2008 through January 2009 and again in

November and December 2012, Israel engaged in an armed conflict with Hamas, which involved missile strikes against civilian targets

in various parts of Israel and negatively affected business conditions in Israel.

In July and August 2014, an armed conflict took

place between Israel and Hamas, and since September 2015, there has been an increase in sporadic terror incidents conducted by

individuals not necessarily associated with terror organizations.

Political uprisings and social unrest in Syria are affecting

its political stability, which has led to the deterioration of the political relationship between Syria and Israel and have raised

new concerns regarding security in the region and the potential for armed conflict.

Similar civil unrest and political turbulence

is currently ongoing in many countries in the region.

The continued political instability and hostilities between Israel and its

neighbors and any future armed conflict, terrorist activity or political instability in the region could adversely affect our

operations in Israel and adversely affect the market price of our shares of common stock.

In addition, several countries restrict

doing business with Israel and Israeli companies have been and are today subjected to economic boycotts.

The interruption or curtailment

of trade between Israel and its present trading partners could adversely affect our business, financial condition and results

of operations.

addition, many of our officers or key employees may be called to active duty at any time under emergency circumstances for extended

periods of time.

See “—

Our operations could be disrupted as a result of the obligation of certain of our personnel

residing in Israel to perform military service.”

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

Our business is directly affected

by the political, economic and military conditions in Israel and its neighbors.

Since the establishment of the State of Israel in 1948,

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

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.

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

Although the Israeli

government currently covers the reinstatement value of direct damages that are caused by terrorist attacks or acts of war, we cannot

assure you that this government coverage will be maintained or that it will sufficiently cover our potential damages.

Any losses or damages

incurred by us could have a material adverse effect on our business.

Any armed conflicts or political instability in the region would

likely negatively affect business conditions and could harm our results of operations.

continued political instability and hostilities between Israel and its neighbors and any future armed conflict, terrorist activity or

political instability in the region could adversely affect our operations in Israel and adversely affect the market price of our shares

of common stock.

In addition, several organizations and countries may restrict doing business with Israel and Israeli companies have

been and are today subjected to economic boycotts.

The interruption or curtailment of trade between Israel and its present trading partners

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

addition, many of our officers or key employees may be called to active and reserve mandatory service duty at any time under emergency

circumstances for extended periods of time.

See “— Our operations could be disrupted as a result of the obligation of certain

of our personnel residing in Israel to perform military service.”

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.

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.

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

have non-competition agreements with most of our employees, many of which are governed by Israeli law.

These agreements generally

prohibit our employees from competing with us or working for our competitors for a specified period following termination of their

However, Israeli courts are reluctant to enforce non-compete undertakings of former employees and tend, if at all,

to enforce those provisions for relatively brief periods of time in restricted geographical areas and only when the employee has

unique value specific to that employer’s business and not just regarding the professional development of the employee.

such inability to enforce non-compete covenants may cause us to lose any competitive advantage resulting from advantages provided

to us by such confidential information.

may become subject to claims for remuneration or royalties for assigned service invention rights by our employees, which could

result in litigation and adversely affect our business.

significant portion of our intellectual property has been developed by our Israeli employees in the course of their employment

Under the Israeli Patent Law, 5727-1967 (the “Israeli Patent Law”), inventions conceived by an employee during

the term and as part of the scope of his or her employment with a company are regarded as “service inventions,”

belong to the employer, absent a specific agreement between the employee and employer giving the employee service invention rights.

The Israeli Patent Law also provides that if there is no such agreement between an employer and an employee, the Israeli Compensation

and Royalties Committee (the “C&R Committee”), a body constituted under the Israeli Patent Law, shall determine

whether the employee is entitled to remuneration for his inventions.

The C&R Committee (decisions of which have been upheld

by the Israeli Supreme Court) has held that employees may be entitled to remuneration for their service inventions despite having

specifically waived any such rights.

We generally enter into intellectual property assignment agreements with our employees pursuant

to which such employees assign to us all rights to any inventions created in the scope of their employment or engagement with

Although our employees have agreed to assign to us service invention rights and have specifically waived their right to receive

any special remuneration for such assignment beyond their regular salary and benefits, we may face claims demanding remuneration

in consideration for assigned inventions.

As a consequence of such claims, we could be required to pay additional remuneration

or royalties to our current or former employees, or be forced to litigate such claims, which could negatively affect our business.

These agreements generally prohibit

our employees from competing with us or working for our competitors for a specified period following termination of their employment.

However, Israeli courts are reluctant to enforce non-compete undertakings of former employees and tend, if at all, to enforce those provisions

for relatively brief periods of time in restricted geographical areas and only when the employee has unique value specific to that employer’s

business and not just regarding the professional development of the employee.

Any such inability to enforce non-compete covenants may

cause us to lose any competitive advantage resulting from advantages provided to us by such confidential information.

may become subject to claims for remuneration or royalties for assigned service invention rights by our employees, which could result

in litigation and adversely affect our business.

significant portion of our intellectual property has been developed by our Israeli employees in the course of their employment for us.

Under the Israeli Patent Law, 5727-1967 (the “Israeli Patent Law”), inventions conceived by an employee during the term and

as part of the scope of his or her employment with a company are regarded as “service inventions,” which belong to the employer,

absent a specific agreement between the employee and employer giving the employee service invention rights.

The Israeli Patent Law also

provides that if there is no such agreement between an employer and an employee, the Israeli Compensation and Royalties Committee (the

“C&R Committee”), a body constituted under the Israeli Patent Law, shall determine whether the employee is entitled to

remuneration for his inventions.

The C&R Committee (decisions of which have been upheld by the Israeli Supreme Court) has held that

employees may be entitled to remuneration for their service inventions despite having specifically waived any such rights.

enter into intellectual property assignment agreements with our employees pursuant to which such employees assign to us all rights to

any inventions created in the scope of their employment or engagement with us.

Although our employees have agreed to assign to us service

invention rights and have specifically waived their right to receive any special remuneration for such assignment beyond their regular

salary and benefits, we may face claims demanding remuneration in consideration for assigned inventions.

As a consequence of such claims,

we could be required to pay additional remuneration or royalties to our current or former employees, or be forced to litigate such claims,

which could negatively affect our business.

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

majority of our assets other than cash are located outside the U.S.

In addition, certain of our officers are nationals and/or

residents of countries other than the U.S., and all or a substantial portion of such persons’

assets are located outside

As a result, it may be difficult for investors to enforce within the United States any judgments obtained against us

or any of our non-U.S.

officers, including judgments predicated upon the civil liability provisions of the securities laws of

In addition, certain of our officers are nationals and/or residents

of countries other than the U.S., and all or a substantial portion of such persons’ assets are located outside the U.S.

it may be difficult for investors to enforce within the United States any judgments obtained against us or any of our non-U.S.

including judgments predicated upon the civil liability provisions of the securities laws of the U.S.

or any state thereof.

Additionally, it may be difficult to assert U.S.

securities law claims in actions originally instituted

outside of the U.S.

Israeli courts may refuse to hear a U.S.

securities law claim because Israeli courts may not be the most appropriate

forums in which to bring such a claim.

Even if an Israeli court agrees to hear a claim, it may determine that the Israeli law,

Additionally,

it may be difficult to assert U.S.

securities law claims in actions originally instituted outside of the U.S.

Israeli courts may refuse

to hear a U.S.

securities law claim because Israeli courts may not be the most appropriate forums in which to bring such a claim.

if an Israeli court agrees to hear a claim, it may determine that the Israeli law, and not U.S.

law, is applicable to the claim.

Further, if U.S.

law is found to be applicable, certain content of applicable U.S.

law must be proved as a fact, which can be a time-consuming and costly process, and certain matters of procedure would still be

governed by the Israeli law.

Consequently, you may be effectively prevented from pursuing remedies under U.S.

federal and state

securities laws against us or any of our non-U.S.

law must be proved as a fact, which can be a time-consuming

and costly process, and certain matters of procedure would still be governed by the Israeli law.

Consequently, you may be effectively

prevented from pursuing remedies under U.S.

federal and state securities laws against us or any of our non-U.S.

directors or officers.

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,

The 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,”

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

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.

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

2 unchanged sentences

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

This would likely increase our tax

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

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.

The amount, 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.

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

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.

market prices of our common stock and our Series A Warrants and Series B Warrants have been and are likely to continue to be highly

volatile and could fluctuate widely in response to various factors, many of which are beyond our control, including the following:

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.

market prices of our common stock and our Series B Warrants (which is intended to expire on March 14, 2022) have been and are likely

to continue to be highly volatile and could fluctuate widely in response to various factors, many of which are beyond our control, including

the following:

technological

8 unchanged sentences

fluctuations in our financial results.

addition, the securities markets have from time to time experienced significant price and volume fluctuations that are unrelated

to the operating performance of particular companies.

These market fluctuations may also significantly affect the market prices

of our common stock and our publicly traded warrants.

Planned Reverse Split may not result in a proportional increase in the per share price of our common stock.

intend to effect the Planned Reverse Split (as defined below) with the primary intent of increasing the price of our common stock

in order to meet the initial listing requirements of the Nasdaq Capital Market and, secondly, to provide appropriate flexibility

we require to issue shares in the event that our board of directors determines that it is necessary or appropriate to (i) raise

additional capital through the sale of equity securities, (ii) enter into strategic business transactions, (iii) provide equity

incentives to directors, officers and employees pursuant to equity compensation plans or (iv) further other corporate purposes.

The effect of the Planned Reverse Split on the market price for our common stock cannot be accurately predicted.

In particular,

we cannot assure you that the proportionate increase in the price of our common stock immediately after the Planned Reverse Split

from the price for shares of our common stock immediately before the Planned Reverse Split will be maintained for us to meet the

initial listing requirements of the Nasdaq Capital Market or that the such market prices will be maintained for a substantial

period of time.

It is not uncommon for the market price of a company’s common stock to decline in the period following a

reverse stock split.

If the market price of our common stock declines following the Planned Reverse Split, the percentage decline

may be greater than would occur in the absence of the Planned Reverse Split.

The market price of our common stock may also be

affected by other factors which may be unrelated to the Planned Reverse Split or the number of shares outstanding.

because some investors may view the Planned Reverse Split negatively, we cannot assure you that the Planned Reverse Split will

not adversely impact the market price of our common stock.

Accordingly, our total market capitalization after the Planned Reverse

Split may be lower than the market capitalization before the Planned Reverse Split.

common stock could be delisted from the NYSE American if we fail to meet the NYSE American’s stockholders’

continued listing standards.

addition, the securities markets have from time to time experienced significant price and volume fluctuations that are unrelated to the

operating performance of particular companies.

These market fluctuations may also significantly affect the market prices of our common

stock and our publicly traded warrants.

common stock could be delisted from the Nasdaq Capital Market if we fail to meet the Nasdaq Capital Market’s stockholders’

equity continued listing standards.

Our ability to publicly or privately sell equity securities and the liquidity of our common stock

could be adversely affected if we are delisted from the NYSE American.

August 7, 2019, we received a notice indicating that we do not meet certain of the NYSE American’s continued listing standards

as set forth in Part 10 of the Company Guide.

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

Guide because we reported stockholders’

equity of less than $6 million as of June 30, 2019, and had net losses in our five

most recent fiscal years ended December 31, 2018.

As a result, we had become subject to the procedures and requirements of Section

1009 of the Company Guide.

On August 25, 2019, we submitted a plan of compliance to NYSE Regulation, addressing how we intend

to regain compliance with Section 1003(a)(iii) of the Company Guide by August 7, 2020, and on October 11, 2019, NYSE American

accepted our plan.

On August 7, 2020, the NYSE American approved such plan and, accordingly and as of such date, we are compliant

with all of the NYSE American LLC continued listing standards set forth in Part 10 of the NYSE American Company Guide.

In particular,

we regained compliance with the continued listing requirement under NYSE American Company Guide Section 1003(a)(iii).

Notwithstanding

NYSE American’s approval of our plan, there is no assurance that we will be able to maintain compliance with Section 1003(a)(iii)

of the Company Guide moving forward.

Additionally, we will be subject to ongoing review for compliance with NYSE American requirements

and there can be no assurance that we will continue to remain in compliance with this standard.

the event the NYSE American issues a future notice and recommences proceedings against us, delisting from NYSE American would

adversely affect our ability to raise additional financing through the public or private sale of equity securities, would significantly

affect the ability of investors to trade our securities and would negatively affect the value and liquidity of our common stock.

Delisting could also have additional negative ramifications, including the potential loss of confidence by employees, the loss

of institutional investor interest and fewer business development opportunities.

low trading price could lead the NYSE American to take actions toward delisting our common stock, including immediately suspending

trading in our common stock.

January 7, 2019, we received notification from the NYSE American that our shares of common stock have been selling for a low price

per share for a substantial period of time.

Pursuant to Section 1003(f)(v) of the Company Guide, the NYSE American could take

action to delist our common stock in the event that our common stock trades at levels viewed as abnormally low for a substantial

period of time.

NYSE American advised us that if our common stock trades below $0.20 on a 30 trading day average, then it will

be considered non-compliant with NYSE American’s low selling price requirement.

On March 29, 2019, we effected a 1-for-50

reverse stock split of our common stock.

in the future we fall below the continued listing criterion of a minimum average share price of $0.20 over a 30-day trading period,

our common stock will be subject to immediate review by NYSE American.

There can be no assurance that the market price of our

common stock will remain above the levels viewed as abnormally low for a substantial period of time.

In any event, other factors

unrelated to the number of shares of our common stock outstanding, such as negative financial or operational results, could adversely

affect the market price of our common stock, causing it to fall below the level viewed as a low selling price for a substantial

period of time, and lead the NYSE American to immediately suspend trading in our common stock.

addition, the NYSE American has advised us that its policy is to immediately suspend trading in shares of, and commence delisting

procedures with respect to, a listed company if the market price of its shares falls below $0.06 per share at any time during

the trading day.

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

are subject to reporting and other obligations under the Securities Exchange Act of 1934, as amended, including the requirements

of Section 404 of the Sarbanes-Oxley Act of 2002.

Section 404 requires us to conduct an annual management assessment of the effectiveness

of our internal controls over financial reporting.

These reporting and other obligations place significant demands on our management,

administrative, operational, internal audit and accounting resources.

Any failure to maintain effective internal controls could

have a material adverse effect on our business, operating results and stock price.

Moreover, effective internal control is necessary

for us to provide reliable financial reports and prevent fraud.

If we cannot provide reliable financial reports or prevent fraud,

we may not be able to manage our business as effectively as we would if an effective control environment existed, and our business

and reputation with investors may be harmed.

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

ongoing internal control provisions of Section 404 of the Sarbanes-Oxley Act of 2002 require us to identify material weaknesses

in internal control over financial reporting, which is a process to provide reasonable assurance regarding the reliability of

financial reporting for external purposes in accordance with accounting principles generally accepted in the United States.

management, including our chief executive officer and chief financial officer, does not expect that our internal controls and

disclosure controls will prevent all errors and all fraud.

A control system, no matter how well conceived and operated, can provide

only reasonable, not absolute, assurance that the objectives of the control system are met.

In addition, the design of a control

system must reflect the fact that there are resource constraints and the benefit of controls must be relative to their costs.

Because of the inherent limitations in all control systems, no evaluation of controls can provide absolute assurance that all

control issues and instances of fraud, if any, in our company have been detected.

These inherent limitations include the realities

that judgments in decision-making can be faulty and that breakdowns can occur because of simple errors or mistakes.

Further, controls

can be circumvented by individual acts of some persons, by collusion of two or more persons, or by management override of the

The design of any system of controls is also based in part upon certain assumptions about the likelihood of future events,

and there can be no assurance that any design will succeed in achieving its stated goals under all potential future conditions.

Over time, a control may be inadequate because of changes in conditions, such as growth of the company or increased transaction

volume, or the degree of compliance with the policies or procedures may deteriorate.

Because of inherent limitations in a cost-effective

control system, misstatements due to error or fraud may occur and not be detected.

addition, discovery and disclosure of a material weakness, by definition, could have a material adverse impact on our financial

Such an occurrence could discourage certain customers or suppliers from doing business with us and adversely affect

how our stock trades.

This could in turn negatively affect our ability to access equity markets for capital.

law and our corporate charter and bylaws contain anti-takeover provisions that could delay or discourage takeover attempts that

stockholders may consider favorable.

board of directors is authorized to issue shares of preferred stock in one or more series and to fix the voting powers, preferences

and other rights and limitations of the preferred stock.

Accordingly, we may issue shares of preferred stock with a preference

over our common stock with respect to dividends or distributions on liquidation or dissolution, or that may otherwise adversely

affect the voting or other rights of the holders of common stock.

Issuances of preferred stock, depending upon the rights, preferences

and designations of the preferred stock, may have the effect of delaying, deterring or preventing a change of control, even if

that change of control might benefit our stockholders.

In addition, we are subject to Section 203 of the Delaware General Corporation

Section 203 generally prohibits a public Delaware corporation from engaging in a “business combination”

an “interested stockholder”

for a period of three years after the date of the transaction in which the person became

an interested stockholder, unless (i) prior to the date of the transaction, the board of directors of the corporation approved

either the business combination or the transaction which resulted in the stockholder becoming an interested stockholder;

the interested stockholder owned at least 85% of the voting stock of the corporation outstanding at the time the transaction commenced,

excluding for purposes of determining the number of shares outstanding (a) shares owned by persons who are directors and also

officers and (b) shares owned by employee stock plans in which employee participants do not have the right to determine confidentially

whether shares held subject to the plan will be tendered in a tender or exchange offer;

or (iii) on or subsequent to the date

of the transaction, the business combination is approved by the board and authorized at an annual or special meeting of stockholders,

and not by written consent, by the affirmative vote of at least 66 2/3% of the outstanding voting stock which is not owned by

the interested stockholder.

could be adversely affected if we are delisted from the Nasdaq Capital Market.

common stock is listed on the Nasdaq Capital Market, and we are therefore subject to its continued listing requirements, including requirements

with respect to the market value of publicly-held shares, market value of listed shares, minimum bid price per share, and minimum stockholders’

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

If we fail to satisfy one or more of the requirements,

we may be delisted from the Nasdaq Capital Market.

from the Nasdaq Capital Market may adversely affect our ability to raise additional financing through the public or private sale of equity

securities, may significantly affect the ability of investors to trade our securities and may negatively affect the value and liquidity

of our common stock.

Delisting also could have other negative results, including the potential loss of employee confidence, the loss

of institutional investors or interest in business development opportunities.

law and our corporate charter and bylaws contain anti-takeover provisions that could delay or discourage takeover attempts that stockholders

may consider favorable.

board of directors is authorized to issue shares of preferred stock in one or more series and to fix the voting powers, preferences and

other rights and limitations of the preferred stock.

Accordingly, we may issue shares of preferred stock with a preference over our common

stock with respect to dividends or distributions on liquidation or dissolution, or that may otherwise adversely affect the voting or

other rights of the holders of common stock.

Issuances of preferred stock, depending upon the rights, preferences and designations of

the preferred stock, may have the effect of delaying, deterring or preventing a change of control, even if that change of control might

benefit our stockholders.

In addition, we are subject to Section 203 of the Delaware General Corporation Law.

Section 203 generally prohibits

a public Delaware corporation from engaging in a “business combination” with an “interested stockholder” for

a period of three years after the date of the transaction in which the person became an interested stockholder, unless (i) prior to the

date of the transaction, the board of directors of the corporation approved either the business combination or the transaction which

resulted in the stockholder becoming an interested stockholder;

(ii) the interested stockholder owned at least 85% of the voting stock

of the corporation outstanding at the time the transaction commenced, excluding for purposes of determining the number of shares outstanding

(a) shares owned by persons who are directors and also officers and (b) shares owned by employee stock plans in which employee participants

do not have the right to determine confidentially whether shares held subject to the plan will be tendered in a tender or exchange offer;

or (iii) on or subsequent to the date of the transaction, the business combination is approved by the board and authorized at an annual

or special meeting of stockholders, and not by written consent, by the affirmative vote of at least 66, 2/3%, of the outstanding voting

stock which is not owned by the interested stockholder.

203 could delay or prohibit mergers or other takeover or change in control attempts with respect to us and, accordingly, may discourage

attempts to acquire us even though such a transaction may offer our stockholders the opportunity to sell their stock at a price

above the prevailing market price.

attempts to acquire us even though such a transaction may offer our stockholders the opportunity to sell their stock at a price above

the prevailing market price.

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

board of directors is divided into three classes, each of which serves for a staggered term of three years.

This division of our

board of directors could have the effect of impeding an attempt to take over our company or change or remove management, since

only one class will be elected annually.

Thus, only approximately one-third of the existing board of directors could be replaced

at any election of directors.

a former shell company, resales of shares of our restricted common stock in reliance on Rule 144 of the Securities Act are subject

to the requirements of Rule 144(i).

previously were a “shell company”

and, as such, sales of our securities pursuant to Rule 144 under the Securities

Act of 1933, as amended, cannot be made unless, among other things, at the time of a proposed sale, we are subject to the reporting

requirements of Section 13 or 15(d) of the Securities Exchange Act of 1934, as amended, and have filed all reports and other materials

required to be filed by Section 13 or 15(d) of the Securities Exchange Act of 1934 as amended, as applicable, during the preceding

12 months, other than Form 8-K reports.

Because, as a former shell company, the reporting requirements of Rule 144(i) will apply

regardless of holding period, restrictive legends on certificates for shares of our common stock cannot be removed except in connection

with an actual sale that is subject to an effective registration statement under, or an applicable exemption from the registration

requirements of, the Securities Act of 1933, as amended.

Because our unregistered securities cannot be sold pursuant to Rule 144

unless we continue to meet such requirements, any unregistered securities we issue will have limited liquidity unless we continue

to comply with such requirements.

securities and/or industry analysts fail to continue publishing research about our business, if they change their recommendations

adversely or if our results of operations do not meet their expectations, our stock price and trading volume could decline.

trading market for our common stock will be influenced by the research and reports that industry or securities analysts publish

about us or our business.

If one or more of these analysts cease coverage of our company or fail to publish reports on us regularly,

we could lose visibility in the financial markets, which in turn could cause our stock price or trading volume to decline.

addition, it is likely that in some future period our operating results will be below the expectations of securities analysts

or investors.

If one or more of the analysts who cover us downgrade our stock, or if our results of operations do not meet their

expectations, our stock price could decline.

This division of our board

of directors could have the effect of impeding an attempt to take over our company or change or remove management, since only one class

will be elected annually.

Thus, only approximately one-third of the existing board of directors could be replaced at any election of

a former shell company, resales of shares of our restricted common stock in reliance on Rule 144 of the Securities Act are subject to

the requirements of Rule 144(i).

previously were a “shell company” and, as such, sales of our securities pursuant to Rule 144 under the Securities Act of

1933, as amended, cannot be made unless, among other things, at the time of a proposed sale, we are subject to the reporting requirements

of Section 13 or 15(d) of the Securities Exchange Act of 1934, as amended, and have filed all reports and other materials required to

be filed by Section 13 or 15(d) of the Securities Exchange Act of 1934 as amended, as applicable, during the preceding 12 months, other

than Form 8-K reports.

Because, as a former shell company, the reporting requirements of Rule 144(i) will apply regardless of holding

period, restrictive legends on certificates for shares of our common stock cannot be removed except in connection with an actual sale

that is subject to an effective registration statement under, or an applicable exemption from the registration requirements of, the Securities

Act of 1933, as amended.

Because our unregistered securities cannot be sold pursuant to Rule 144 unless we continue to meet such requirements,

any unregistered securities we issue will have limited liquidity unless we continue to comply with such requirements.

securities and/or industry analysts fail to continue publishing research about our business, if they change their recommendations adversely

or if our results of operations do not meet their expectations, our stock price and trading volume could decline.

trading market for our common stock will be influenced by the research and reports that industry or securities analysts publish about

us or our business.

If one or more of these analysts cease coverage of our company or fail to publish reports on us regularly, we could

lose visibility in the financial markets, which in turn could cause our stock price or trading volume to decline.

In addition, it is

likely that in some future period our operating results will be below the expectations of securities analysts or investors.

more of the analysts who cover us downgrade our stock, or if our results of operations do not meet their expectations, our stock price

could decline.

of the tax treatment of the securities may be uncertain.

tax treatment of our preferred stock and our warrants is uncertain and may vary depending upon whether you are an individual or

a legal entity and whether or not you are domiciled in the United States.

tax treatment of our preferred stock and our warrants is uncertain and may vary depending upon whether you are an individual or a legal

entity and whether or not you are domiciled in the United States.

In the event you are a non-U.S.

investor, you should

consult your tax advisors as to the consequences, under the tax laws of the country where you are resident for tax purposes, of

acquiring, holding and disposing of our preferred stock and our warrants.

NOTE REGARDING FORWARD-LOOKING STATEMENTS

Annual Report on Form 10-K contains “forward-looking statements,”

which include information relating to future events,

future financial performance, strategies, expectations, competitive environment and regulation.

Words such as “may,”

“will,”

“should,”

“could,”

“would,”

“predicts,”

“potential,”

“continue,”

“expects,”

“anticipates,”

“future,”

“intends,”

“plans,”

“believes,”

“estimates,”

and similar expressions, as well as statements in future tense, identify forward-looking

Forward-looking statements should not be read as a guarantee of future performance or results and will probably not

be accurate indications of when such performance or results will be achieved.

Forward-looking statements are based on information

we have when those statements are made or our management’s good faith belief as of that time with respect to future events,

and are subject to risks and uncertainties that could cause actual performance or results to differ materially from those expressed

in or suggested by the forward-looking statements.

Important factors that could cause such differences include, but are not limited

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

difficult to obtain and could dilute out stockholders’

ownership interests;

impact of the COVID-19 pandemic on our manufacturing, sales, business plan and the global economy;

clinical trial results or lengthy product delays in key markets;

ability to maintain compliance with the NYSE American listing standards;

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

ability to adequately protect our intellectual property;

dependence on a single manufacturing facility and our ability to comply with stringent manufacturing quality standards and

to increase production as necessary;

risk that the data collected from our current and planned clinical trials may not be sufficient to demonstrate that our technology

is an attractive alternative to other procedures and products;

acceptance of our products;

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

competition in our industry, with competitors having substantially greater financial, technological, research and development,

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

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

to carry out research, development and commercialization plans;

of a key customer or supplier;

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

malfunctions;

increases for supplies and components;

economic conditions;

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

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

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

fact that we conduct business in multiple foreign jurisdictions, exposing us to foreign currency exchange rate fluctuations,

logistical and communications challenges, burdens and costs of compliance with foreign laws and political and economic instability

in each jurisdiction;

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

or retirement of key executives and research scientists.

foregoing does not represent an exhaustive list of matters that may be covered by the forward-looking statements contained herein

or risk factors that we are faced with that may cause our actual results to differ from those anticipated in our forward-looking

You should review carefully the risks and uncertainties described under the heading “Item 1A.

Risk Factors”

in this Annual Report on Form 10-K for a discussion of these and other risks that relate to our business and investing in shares

of our common stock.

The forward-looking statements contained in this Annual Report on Form 10-K are expressly qualified in their

entirety by this cautionary statement.

We do not undertake any obligation to publicly update any forward-looking statement to

reflect events or circumstances after the date on which any such statement is made or to reflect the occurrence of unanticipated

investor, you should consult your tax

advisors as to the consequences, under the tax laws of the country where you are resident for tax purposes, of acquiring, holding and

disposing of our preferred stock and our warrants.

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