What changed in this filing

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Item 1A. Risk Factors

2025-03-12 compared with 2024-03-05 · 466 added, 296 removed, 1084 unchanged (41% of the section changed)

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

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

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

continue as a going concern;

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

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

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

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

Failure to maintain compliance with IDE

regulations could have a material adverse effect on our business;

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

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

Failure to maintain compliance with IDE regulations could

have a material adverse effect on our business;

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

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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.

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

with respect to the market value of publicly-held-shares, market value of listed shares, minimum bid price per share, and minimum

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

Related to Our Financial Condition

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

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

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

obtaining new financing on reasonable terms or at all.

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

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

Accordingly, the report of Kesselman & Kesselman, our

independent registered public accounting firm, with respect to our financial statements for the year ended December 31, 2024, includes

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

The doubts regarding our potential ability to

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

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

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accomplish the following:

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

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

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

capital improvements to improve our infrastructure;

and retaining qualified management and key employees;

to competitive pressures;

with regulatory requirements such as licensing and registration;

compliance with applicable laws.

● commercialization

efforts in the United States following anticipated FDA approval of CGuard™ Prime;

of manufacturing and operational capabilities, including scaling up production to meet expected

demand and establishing necessary infrastructure in the United States;

● development

of our current and future products, including potential enhancements to CGuard™ Prime

and advancing SwitchGuard™ NPS;

growth opportunities, such as expanding commercial activities in key international markets

and strengthening regional distribution networks;

commercial organization, including hiring and retaining qualified personnel to support

sales, marketing, and operations;

to competitive pressures and evolving market dynamics, including potential reimbursement

challenges and pricing pressures;

regulatory and compliance obligations, including post-market surveillance, product registrations,

and adherence to evolving regulatory frameworks;

● maintaining

compliance with applicable laws and corporate governance requirements.

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

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

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

exercised in cash in full.

In July 2024, we received gross proceeds of approximately $17.9 million following the exercise of the Series H Warrants in

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

in cash in full.

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

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

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

product sales for the foreseeable future.

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

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

others, that:

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

sales for the foreseeable future.

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

on a mass scale and face a number of challenges with respect to our commercialization efforts, including, among others, that:

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

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

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

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

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

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

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

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

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

condition and results of operations.

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

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

or any other product we develop could be limited, which in turn could have a material adverse effect on our business, financial condition

and results of operations.

we met the primary endpoint in our C-GUARDIANS trial of the CGuard Carotid Stent System, the results may not be sufficient to support FDA approval.

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

We anticipate reporting primary endpoint results from the C-GUARDIANS

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

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

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

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

Clinical failure can occur at any stage of clinical development.

Our clinical trials have been conducted under differing protocols,

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

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

unanticipated complications.

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

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

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

in the analysis of the clinical trials results.

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

If CGuard EPS,

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

may not be widely adopted by healthcare providers and patients.

In November 2023, we announced positive 30-day follow up results from

the C-GUARDIANS trial in which stenting with the CGuard Carotid Stent System in patients with carotid artery stenosis.

we announced positive one-year follow up results from the C-GUARDIANS trial, with a rate of 30-day DSMI and ipsilateral stroke

between 31 and 365 days of 1.95%.

These data were used to support the PMA submission in September 2024 with a view to potential FDA

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

There can be no assurance that the primary endpoint

results will be sufficient to support FDA approval.

In addition, our clinical

trials have been conducted under differing protocols, while using specific inclusion criteria and we cannot assure you that its

actual clinical performances will be satisfactory to support proposed indications and regulatory approvals and clinical acceptance

and adoption, or that its use will not result in unanticipated complications.

Furthermore, the results of our clinical trials are

subject to human analyses and interpretation of the data accumulated, which could be affected by various errors due to, among

others, lack of sufficient clinical experience with CGuard EPS, SwitchGuard or any other product we develop, assumptions used in the

statistical analysis of results, and interpretation errors in the analysis of the clinical trials results.

Failure can occur at any

time during the clinical trial process.

If CGuard EPS, SwitchGuard or any other product we develop does not function as expected

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

if we obtain regulatory approvals, our products will be subject to ongoing regulatory review and if we fail to comply with continuing

and applicable foreign regulations, we could lose those approvals and our business would be seriously harmed.

if products we develop receive regulatory approval or clearance, we will be subject to ongoing reporting obligations, and the products

and the manufacturing operations will be subject to continuing regulatory review, including FDA inspections.

The outcome of this ongoing

review may result in the withdrawal of a product from the market, the interruption of the manufacturing operations and/or the imposition

of labeling and/or marketing limitations.

Since many more patients are exposed to drugs and medical devices following their marketing

approval, serious but infrequent adverse reactions that were not observed in clinical trials may be observed during the commercial marketing

of the product.

In addition, the manufacturer and the manufacturing facilities we will use to produce any product will be subject to

periodic review and inspection by the FDA and other, similar foreign regulators.

Later discovery of previously unknown problems with

any product, manufacturer or manufacturing process, or failure to comply with regulatory requirements, may result in actions such as:

● restrictions

on such product, manufacturer or manufacturing process;

letters from the FDA or other regulatory authorities;

of the product from the market;

or withdrawal of regulatory approvals;

to approve pending applications or supplements to approved applications that we submit;

or mandatory recall;

to permit the import or export of our products;

seizure or detentions;

● injunctions

or the imposition of civil or criminal penalties;

we, or supplier, third-party contractor, partner or clinical investigator is slow to adapt, or are unable to adapt, to changes in existing

regulatory requirements or the adoption of new regulatory requirements or policies, we may lose marketing approval for any of our products,

if any of our products are approved, resulting in decreased.

failure of third parties to meet their contractual, regulatory, and other obligations could adversely affect our business.

have engaged Aptyx, a contract manufacturer, to transfer the manufacturing of CGuard Prime finished goods to full-scale production at

their ISO Class 7 cleanroom facility in North Carolina.

Using a third party poses a number of risks,

(i) they may not perform to our standards or legal requirements;

(ii) they may not produce reliable results;

(iii) they may

not perform in a timely manner;

(iv) they may not maintain confidentiality of our proprietary information;

(v) disputes may arise with

respect to ownership of rights to technology developed with our partners;

and (vi) disagreements could cause delays in, or termination

of, the research, development or commercialization of our products or result in litigation or arbitration.

Moreover, some third parties

are located in markets subject to political and social risk, corruption, violence, infrastructure problems and natural disasters, in

addition to country-specific privacy and data security risk given current legal and regulatory environments.

Failure of third parties

to meet their contractual, regulatory, and other obligations may materially affect our business.

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

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

As part of our plan, we intend to build out

manufacturing, sales, marketing and distribution capabilities.

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

or distributing products in the U.S.

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

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

third parties to perform these services.

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

We must commit significant

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

As part of our plan, we are building out

a sales, marketing and distribution capabilities and engaged with a contract manufacturer.

Historically we have not had experience in

manufacturing, selling, marketing or distributing products in the U.S.

To be able to commercialize CGuard Prime upon approval, if at

all, we must either develop manufacturing, sales, marketing and distribution capabilities, which is expensive and time-consuming, or

enter into arrangements with third parties to perform these services.

October 2024, we established our global headquarters in Miami, Florida to support the anticipated U.S.

launch and commercialization of

the CGuard Prime carotid stent system.

During 2024, we started the build-out of the infrastructure for commercial operations in the U.S.

designed to support the anticipated commercialization of the CGuard Prime carotid stent system.

In addition, to support our anticipated

production growth following the anticipated commercialization of the CGuard Prime carotid stent system, we have engaged Aptyx, a contract

manufacturer, to transfer the manufacturing of CGuard Prime finished goods to full-scale production at their ISO Class 7 cleanroom facility

in North Carolina.

are risks involved with establishing our own sales, marketing and distribution capabilities and partnering with a third party manufacturer.

We must commit significant financial and managerial resources to develop a marketing and sales force with technical expertise and with

supporting distribution capabilities.

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will be published.

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

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

If there were a disruption to our existing manufacturing facility,

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

facility or develop alternative manufacturing facilities.

If we were unable to produce sufficient quantities of CGuard,

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

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

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

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

In addition, the development

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

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

We may not successfully complete any required

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

Additionally,

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

significantly impair our ability to produce CGuard.

face manufacturing risks that could adversely affect our ability to manufacture products, reduce our gross margins and negatively affect

our business and operating results.

business strategy following the anticipated commercialization

of the CGuard Prime carotid stent system depends on our ability to manufacture, and our contract

manufacturers’ ability to manufacture, our current and future products in sufficient quantities and on a timely basis to meet customer

demand, while adhering to product quality standards, complying with regulatory quality system requirements and managing manufacturing

We currently manufacture our CGuard EPS and our CGuard Prime at our own facility in Israel where we handle the entire assembly

process for CGuard EPS and CGuard Prime, including knitting and securing the sleeve to the stent

and the crimping of the sleeved stent into a delivery catheter.

In addition, to support our anticipated production growth following the

anticipated commercialization of the CGuard Prime carotid stent system, we have engaged Aptyx, a contract manufacturer, to transfer the

manufacturing of CGuard Prime finished goods to full-scale production at their ISO Class 7 cleanroom facility in North Carolina.

or our manufacturing partners’ facilities suffers damage, or a force majeure event, this could materially impact our ability to

are also subject to numerous other risks relating to our manufacturing capabilities, including:

and reliability of components, sub-assemblies and materials that we source from third-party

suppliers, who are required to meet our quality specifications, the majority of which are

our single-source suppliers for the products they supply;

or our manufacturing partners’ inability to secure components, sub-assemblies and materials

in a timely manner, in sufficient quantities or on commercially reasonable terms;

or our manufacturing partners’ inability to maintain compliance with quality system

requirements or pass regulatory quality inspections;

or our manufacturing partners’ failure to develop products in a timely manner or to

required specifications or to increase production capacity or volumes to meet demand;

or our manufacturing partners’ inability to design or modify production processes to

enable us to produce future products efficiently or implement changes in current products

in response to design or regulatory requirements;

identifying and qualifying, and obtaining new regulatory approvals, for alternative suppliers

for components in a timely manner.

demand for our products increases, we will have to invest additional resources to purchase components, sub-assemblies and materials,

hire and train employees, and enhance our manufacturing processes.

If we or our manufacturing partners fail to increase our production

capacity efficiently, we may not be able to fill customer orders on a timely basis, our sales may not increase in line with our expectations,

and our operating margins could fluctuate or decline.

In addition, although we expect some of our products in development to share product

features, components, sub-assemblies and materials with our existing products, the manufacture of these products may require modification

of our or our manufacturing partners’ current production processes or unique production processes, the hiring of specialized employees,

the identification of new suppliers for specific components, sub-assemblies and materials or the development of new manufacturing technologies.

It may not be possible for us or our manufacturing partners to manufacture these products at a cost or in quantities sufficient to make

these products commercially viable or to maintain current gross margins, all of which could have a material adverse effect on our business,

financial condition and results of operations.

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

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percentage of defective products in a lot.

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

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

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

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

If we or our third party manufacturer 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.

and Switch Guard are complex medical devices that requires training for qualified personal.

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

Although our distributors

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

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

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

financial condition and results of operations.

will be required to ensure that CGuard and SwitchGuard is prescribed only by trained clinicians, the potential for misuse of CGuard and

SwitchGuard still exists due to its complexity.

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

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

condition and results of operations.

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

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

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

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

Most of our current and potential competitors, including but

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

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

There can be no assurance

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

The worldwide

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

For example, during the

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

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

Current or future

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

what we or any potential licensee develop.

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

and licensing revenue would decrease.

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

system SwitchGuard and continue to seek greater market share for CGuard, we expect to compete with Silk Road Medical, which was acquired

by Boston Scientific Corporation, in the total carotid artery revascularization market that comprises CAS, TCAR and CEA.

current and potential competitors, including but not limited to those listed above, have, and will continue to have, substantially greater

financial, technological, research and development, regulatory and clinical, manufacturing, marketing and sales, distribution and personnel

resources than we do.

There can be no assurance that we will have sufficient resources to successfully commercialize our products, if

and when they are approved for sale.

The worldwide market for stent products is characterized by intensive development efforts and rapidly

advancing technology.

For example, during the second quarter of 2022 we ceased sales of our MGuard Prime EPS following a phase out period

due to a shift in industry preferences.

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

developments and advances.

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

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

If our technologies or products become obsolete

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

This would have a material adverse effect on our business,

financial condition and results of operations.

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

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

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

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

We are currently

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

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

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

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

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

current PET resin.

Therefore we purchased inventory which should be sufficient to support our production needs until the end of 2027.

We are currently testing a different source of PET showing equivalent mechanical properties and biocompatibility of the original raw

However there can be no assurance that the alternative source will result in successful validation and if we are unable to

timely source an alternative supplier this could result regulatory delays and the interruption of our manufacturing and delivery of stents

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

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

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may cause delays or disruptions in our manufacturing process.

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

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

If there is a renewed

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

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

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

clinical trial plans and timelines, including:

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

clinical trials;

or difficulties in enrolling patients in our clinical trials;

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

in clinical sites receiving the supplies and materials needed to conduct our clinical trials, including interruptions in global shipping

that may affect the transport of clinical trial materials;

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 employees;

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 any future outbreak of COVID-19 will impact our results will depend on future developments, which are highly uncertain

and cannot be predicted, including new information which may emerge concerning the severity of the virus.

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

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Related to our Clinical Trials and Regulatory Matters

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

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

Failure to maintain compliance with IDE regulations

could have a material adverse effect on our business.

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

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

Failure to maintain compliance with IDE regulations could have

a material adverse effect on our business.

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

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

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

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

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

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

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

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

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

any study activities.

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

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

the C-GUARDIANS and C-GUARDIANS II trials and any others that we are conducting or may conduct in the future, must be conducted in accordance

with the FDA’s IDE regulations, which, among other things, establish requirements for investigational device labeling, prohibit

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

and study investigators.

may not be able to obtain IRB approval to undertake clinical trials in the United States for any products we intend to market in the

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condition and results of operations.

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

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

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

financial costs and reduced revenue.

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

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

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

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

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

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

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

and such uncertainty could preclude or delay regulatory approvals and commercialization, resulting in significant financial costs and

reduced revenue.

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

significant delays attributable to various causes, including, but not limited to, scheduling conflicts with participating clinicians

and clinical institutions, difficulties in identifying and enrolling patients who meet trial eligibility criteria, failure of patients

to complete the clinical trial, delay in or failure to meet regulatory and/or IRB requirements to conduct a clinical trial at a one or

more prospective sites, and shortages of supply in the investigational device.

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

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

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

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

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

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

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

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

Patient enrollment in clinical

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clinical trials;

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

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

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

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

including with the product;

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

with the product;

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

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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.

substantiated (when required), and include adequate directions for use and any warnings that may be required in the use of the device.

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,

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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 can be modified through the

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

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

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

Uncertainties remain regarding what

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

and the healthcare industry in general.

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

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

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

physician and hospital payments).

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

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

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

private payors.

environment for health care policy generally may be changed with the new President.

President Trump has begun to reduce the numbers of

employees that work at the Department of Health and Human Services, that includes the FDA and CMS.

In addition, there are evaluations

of laws, like the Affordable Care Act, may be subject to modifications under the current leadership.

With a reduction of employees at

FDA, this would likely slow down the reviews and approvals of products.

In addition, the reduction of employees from CMS may also slow

down the payment for those individuals who have coverage under Medicare, Medicaid and the Affordable Care Act.

It is difficult to assess

what may occur.

Uncertainties remain regarding what negative unintended consequences these provisions will have on patient access to

new technologies, pricing and the market for our products.

If Medicare, Medicaid and the Affordable Care Act, any significant reductions

in coverage or payment for services may impact those beneficiaries who can’t get access to certain FDA approved products.

lower reimbursement by government programs may shift costs to employees who have coverage from their employee or private payors.

there are some uncertainties regarding the U.S.

coverage and payment for medical devices, the strength of the health care providers and

payors are likely to work to mitigate some adverse issues that may impact the health care system.

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

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

directives (93/42/EEC).

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

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

period was further extended on March 20.

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

under the The MDR imposes

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

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

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

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

Any new regulations or revisions or reinterpretations of existing

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

directives (93/42/EEC) and (90/385/EEC).

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

The MDR provided a transitional

period for placing on the market or putting into service of medical devices, which period was further extended on March 20.

such transitional provisions are not relevant to our products where already certified under the MDR.

The MDR (as amended on January 10,

2025) imposes stricter requirements on medical device manufacturers and strengthens the supervising competences of the competent authorities

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

If we fail to comply with the modified regulation

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

Any new regulations or revisions or reinterpretations

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

Factors Related to Our Intellectual Property

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public domain or to third parties could allow competitors to learn our trade secrets and use the information in competition against us.

failure to obtain or maintain patents, licensing agreements and other intellectual property rights that are sufficiently broad and protective

could impact our ability to compete effectively.

compete effectively, we need to develop and maintain a proprietary position with regard to our own technologies, intellectual property,

licensing agreements, product candidates and business.

Legal standards relating to the validity and scope of patent claims in the US

and other countries tend to be uncertain and changeable.

Therefore, the degree of future protection for our proprietary rights in our

core technologies and any products that might be made using these technologies is also uncertain.

The risks and uncertainties that we

face with respect to our patents and other proprietary rights include the following:

some of our patents have been issued, the pending patent applications we have filed may not

result in issued patents or may take longer than we expect to result in issued patents;

third party may initiate an inter parties review, or IPR, proceedings in the U.S.;

may be subject to interference proceedings in the U.S.;

third party may initiate opposition proceedings in foreign countries;

patents that are issued may not provide meaningful protection;

may not be able to develop additional proprietary technologies that are patentable;

companies may challenge patents licensed or issued to us;

companies may develop new and alternative technologies that do not fall within the scope

of our patents;

companies may design around patents we have developed;

● enforcement

of patents is complex, uncertain and expensive.

patent rights covering our products and methods are not sufficiently broad or not issued at all by the United States Patent and Trademark

Office (the “USPTO”) or by foreign patent offices, we may not have adequate protection against competitors with similar products and

technologies.

Furthermore, if the USPTO or foreign patent offices issue patents to us or our licensors, others may challenge the patents

or design around the patents, or the patent office or the courts may invalidate the patents.

Thus, any patents we own or license from

third parties may not provide any protection against our competitors.

cannot be certain that patents will be issued as a result of any pending applications, and we cannot be certain that any of our issued

patents will give us adequate protection from competing products.

For example, issued patents may be circumvented or challenged, declared

invalid or unenforceable, or narrowed in scope.

In addition, since publication of discoveries in the scientific or patent literature

often lags behind actual discoveries, we cannot be certain that we were the first to make our inventions or to file patent applications

covering those inventions.

is also possible that others may obtain issued patents that could prevent us from commercializing our products or require us to obtain

licenses requiring the payment of significant fees or royalties in order to enable us to conduct our business.

addition to patents and patent applications, we depend upon trade secrets and proprietary know-how to protect our proprietary technology.

We require our employees, consultants, advisors and collaborators to enter into confidentiality agreements that prohibit the disclosure

of confidential information to any other parties.

We require our employees and consultants to disclose and assign to us their ideas,

developments, discoveries and inventions.

These agreements may not, however, provide adequate protection for our trade secrets, know-how

or other proprietary information in the event of any unauthorized use or disclosure.

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

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

Our competitive

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

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

or uses relevant to our development plans.

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

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

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

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

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

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

No assurances can be given that a license

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

Our competitive position

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

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

our development plans.

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

pursue litigation to nullify or invalidate the third-party intellectual property right concerned or enter into a license agreement with

the intellectual property right holder, if available on commercially reasonable terms.

There may also be pending patent applications

that if they result in issued patents, could be alleged to be infringed by our new products or services.

If such an infringement claim

should be brought and be successful, we may be required to pay substantial damages, be forced to abandon our new products or services

or seek a license from any patent holders.

No assurances can be given that a license will be available on commercially reasonable terms,

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

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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.

withheld relevant information from the USPTO or made a misleading statement, during prosecution.

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

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results to be negative, it could have a material adverse effect on the price of our shares of common stock.

may not be able to protect our intellectual property rights throughout the world.

company may attempt to commercialize competing products utilizing our proprietary design, trademarks or tradenames in foreign countries

where we do not have sufficient patent protection and where legal recourse may be limited.

This may have a significant commercial impact

on our foreign business operations.

prosecuting and defending patents or trademarks on our current and future products in all countries throughout the world would be prohibitively

The requirements for patentability and trademarking may differ in certain countries, particularly developing countries.

laws of some foreign countries do not protect intellectual property rights to the same extent as laws in the United States.

Consequently,

we may not be able to prevent third parties from utilizing our inventions and trademarks in all countries outside the United States.

Competitors may use our technologies or trademarks in jurisdictions where we have not obtained patent or trademark protection to develop

or market their own products and further, may export otherwise infringing products to territories where we have patent and trademark

protection, but enforcement on infringing activities is inadequate.

These products or trademarks may compete with our products or trademarks,

and our patents, trademarks or other intellectual property rights may not be effective or sufficient to prevent them from competing.

companies have encountered significant problems in protecting and defending intellectual property rights in foreign jurisdictions.

legal systems of certain countries, particularly certain developing countries, do not favor the enforcement of patents, trademarks and

other intellectual property protection, which could make it difficult for us to stop the infringement of our patents and trademarks or

marketing of competing products in violation of our proprietary rights generally.

Proceedings to enforce our patent and trademarks rights

in foreign jurisdictions could result in substantial costs and divert our efforts and attention from other aspects of our business, could

put our patents and trademarks at risk of being invalidated or interpreted narrowly and our patent or trademark applications at risk,

and could provoke third parties to assert claims against us.

We may not prevail in any lawsuits that we initiate and the damages or other

remedies awarded, if any, may not be commercially meaningful.

In addition, certain countries in Europe and certain developing countries,

including India and China, have compulsory licensing laws under which a patent owner may be compelled to grant licenses to third parties.

In those countries, we may have limited remedies if our patents are infringed or if we are compelled to grant a license to our patents

to a third party, which could materially diminish the value of those patents.

This could limit our potential revenue opportunities.

our efforts to enforce our intellectual property rights around the world may be inadequate to obtain a significant commercial advantage

from the intellectual property that we own or license.

Finally, our ability to protect and enforce our intellectual property rights may

be adversely affected by unforeseen changes in foreign intellectual property laws.

Related to Our Business Operations

face risks associated with litigation and claims.

have in the past and may, in the future, be involved in one or more lawsuits, claims or other proceedings.

These suits could concern

issues including contract disputes, employment actions, employee benefits, taxes, environmental, health and safety, fraud and abuse,

personal injury and product liability matters.

have in the past and may, in the future, be involved in one or more lawsuits, claims or other proceedings arising in or outside the ordinary

course of business that could negatively affect our business operations and financial condition.

These suits could concern issues including

contract disputes, employment actions, employee benefits, taxes, environmental, health and safety, fraud and abuse, personal injury,

product liability matters and securities class actions, which are typically expensive to defend.

Such claims and litigation proceedings

may be brought by third parties, including our competitors, advisors, service providers, partners or collaborators, employees, and governmental

or regulatory bodies.

Any claims and lawsuits, and the disposition of such claims and lawsuits, could be time-consuming and expensive

to resolve, divert management attention and resources, and lead to attempts on the part of other parties to pursue similar claims.

may not be able to determine the amount of any potential losses and other costs we may incur due to the inherent uncertainties of litigation

and settlement negotiations.

In the event we are required or decide to pay amounts in connection with any claims or lawsuits, such amounts

could be significant and could have a material adverse impact on our liquidity, business, financial condition and results of operations.

In addition, depending on the nature and timing of any such dispute, a resolution of a legal matter could materially affect our future

operating results, our cash flows or both.

Additionally, we may be unable to maintain our existing directors’ and officers’

liability insurance in the future at satisfactory rates or adequate coverage amounts and may incur significant increases in insurance

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

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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 shareholders’ evolving expectations and standards

for responsible corporate citizenship in areas including environmental stewardship, support for local communities, board of director

and employee diversity, human capital management, employee health and safety practices, product quality, supply chain management, corporate

governance and transparency, our reputation, brand and employee retention may be negatively impacted, and our customers and suppliers

may be unwilling to continue to do business with us.

consumers, investors and other shareholders are increasingly focusing on environmental issues, including climate change, energy and water

use, plastic waste and other sustainability concerns.

Concern over climate change may result in new or increased legal and regulatory

requirements to reduce or mitigate impacts to the environment.

Changing customer and consumer preferences or increased regulatory requirements

may result in increased demands or requirements regarding plastics and packaging materials, including single-use and non-recyclable plastic

products and packaging, other components of our products and their environmental impact on sustainability, or increased customer and

consumer concerns or perceptions (whether accurate or inaccurate) regarding the effects of substances present in certain of our products.

Complying with these demands or requirements could cause us to incur additional manufacturing, operating or product development costs.

we do not adapt to or comply with new regulations, including the SEC’s published proposed rules that would require companies to

provide significantly expanded climate-related disclosures in their periodic reporting, which may require us to incur significant additional

costs to comply and impose increased oversight obligations on our management and board of directors, or fail to meet evolving investor,

industry or stakeholder expectations and concerns regarding ESG issues, investors may reconsider their capital investment in our Company,

we may become subject to penalties, and customers and consumers may choose to stop purchasing our products, if approved for commercialization,

which could have a material adverse effect on our reputation, business or financial condition.

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

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If the conditions in the global economies remain uncertain or continue

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

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

materially adversely affected.

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

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

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

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

to be volatile, or if they deteriorate, including as a result of the impact of military conflict, such as the security situation in Israel

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

adversely affected.

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

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

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

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

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

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Additionally, increases

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

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

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

A failure to adequately respond to these

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

in inflation, geopolitical developments and global supply chain disruptions, have caused, and may in the future cause, global economic

uncertainty and uncertainty about the interest rate environment, which may make it more difficult, costly or dilutive for us to secure

additional financing.

A failure to adequately respond to these risks could have a material adverse impact on our financial condition,

results of operations or cash flows.

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

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

of sustainability and environmental, social, and governance (“ESG”) initiatives could increase our costs or otherwise adversely impact

our business.

companies have recently faced scrutiny related to ESG practices and disclosures from certain investors, capital providers, shareholder

advocacy groups, other market participants and other stakeholder groups.

Such scrutiny may result in increased costs, enhanced compliance

or disclosure obligations, or other adverse impacts on our business, financial condition or results of operations.

If our ESG practices

and reporting do not meet investor or other stakeholder expectations, we may be subject to investor or regulator engagement regarding

such matters.

Our failure to comply with any applicable ESG rules or regulations could lead to penalties and adversely impact our reputation,

access to capital and employee retention.

Such ESG matters may also impact our third-party contract manufacturers and other third parties

on which we rely, which may augment or cause additional impacts on our business, financial condition, or results of operations.

Related to Operating in Israel

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in Euros and U.S.

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

dollars, while a significant portion of our expenses will be incurred in New Israeli Shekels (“NIS”).

expect a substantial portion of our revenues will be generated in U.S.

dollars and Euros, while a significant portion of our expenses,

principally salaries and related personnel expenses, is paid in New Israeli Shekels, or NIS.

principally salaries and related personnel expenses, is paid in NIS.

As a result, we are exposed to the risk

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adverse effect on our business relationships and profitability.

executive office, sole manufacturing facility and certain of our key personnel are located in Israel.

current manufacturing facility, certain of our key personnel and one of our offices are located in Israel.

Our business is directly affected

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

In addition, since the commencement

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

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

It is possible that hostilities with Hezbollah in Lebanon

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

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

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

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

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

five full time employees in Israel of ours.

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

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

other borders.

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

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

As of the date hereof, we currently

have 56 full-time employees located in Israel.

On January 19, 2025, a temporary ceasefire

went into effect, the result of which is uncertain.

addition, since the commencement of these events, there have been continued hostilities along Israel’s northern border with Lebanon

(with the Hezbollah terror organization) and on other fronts from various extremist groups in region, such as the Houthis in Yemen and

various rebel militia groups in Syria and Iraq.

In October 2024, Israel began limited ground operations against Hezbollah in Lebanon,

and in November 2024, a ceasefire was brokered between Israel and Hezbollah.

In addition, Iran recently launched direct attacks on Israel

involving hundreds of drones and missiles and has threatened to continue to attack Israel and is widely believed to be developing nuclear

Iran is also believed to have a strong influence among extremist groups in the region, such as Hamas in Gaza, Hezbollah in Lebanon,

the Houthi movement in Yemen and various rebel militia groups in Syria and Iraq.

These situations may potentially escalate in the future

to more violent events which may affect Israel and us.

Additionally, Yemeni rebel group, the Houthis, launched series of attacks on global

shipping routes in the Red Sea, causing disruptions of supply chain.

Such clashes may escalate in the future into a greater regional

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

several hundred thousand Israeli military reservists were drafted to perform immediate military service, including five full time employees

in Israel of ours.

Although many of such military reservists have since been released, including all our employees, they may be called

up for additional reserve duty, depending on developments in the war in Gaza and along Israel’s other borders.

Military service

call ups that result in absences of personnel from us for an extended period of time may materially and adversely affect our business,

prospects, financial condition and results of operations.

As of the date hereof, we currently have 67 full-time employees located in

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

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If there were a disruption to our existing manufacturing

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

manufacturing facilities and distribution capabilities.

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

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

If the war extends for a long period

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

facility or our ability to procure raw materials and ship our products, we would have no other means of manufacturing and distributing

CGuard until we were able to restore the manufacturing and distribution capability at our facility or develop alternative manufacturing

facilities and distribution capabilities.

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

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

If the ceasefires declared collapse or a new

war commences or hostilities expand to other fronts, our operations may be adversely affected.

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

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debate and unrest.

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

Actual or perceived political instability in Israel

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

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

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

have non-competition agreements with most of our employees, many of which are governed by Israeli law.

These agreements generally prohibit

our employees from competing with us or working for our competitors for a specified period following termination of their employment.

However, Israeli courts are reluctant to enforce non-compete undertakings of former employees and tend, if at all, to enforce those provisions

for relatively brief periods of time in restricted geographical areas and only when the employee has unique value specific to that employer’s

business and not just regarding the professional development of the employee.

Any such inability to enforce non-compete covenants may

cause us to lose any competitive advantage resulting from advantages provided to us by such confidential information.

Actual or perceived political instability in Israel or any negative changes in the political environment, may individually

or in the aggregate adversely affect the Israeli economy and, in turn, our business, financial condition, results of operations and growth

applicable U.S.

and Israeli law, we may not be able to enforce covenants not to compete and therefore may be unable to prevent our competitors

from benefiting from the expertise of some of our former employees.

In addition, employees may be entitled to seek compensation for their

inventions irrespective of their agreements with us, which in turn could impact our future profitability.

generally enter into non-competition agreements with our employees and certain key consultants, or our employment and consulting agreements

contain non-competition provisions.

These agreements, to the extent they are in place and in effect, prohibit our employees and certain

key consultants, if they cease working for us, from competing directly with us or working for our competitors or clients for a limited

period of time.

We may be unable to enforce these agreements under the laws of the jurisdictions in which our employees work and it may

be difficult for us to restrict our competitors from benefitting from the expertise our former employees or consultants developed while

working for us.

For example, Israeli courts have required employers seeking to enforce non-compete undertakings of a former employee

to demonstrate that the competitive activities of the former employee will harm one of a limited number of material interests of the

employer which have been recognized by the courts, such as the secrecy of a company’s confidential commercial information or the

protection of its intellectual property.

If we cannot demonstrate that such interests will be harmed, we may be unable to prevent our

competitors from benefiting from the expertise of our former employees or consultants and our ability to remain competitive may be diminished.

may become subject to claims for remuneration or royalties for assigned service invention rights by our employees, which could result

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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