What changed in this filing

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Item 1A. Risk Factors

2026-03-18 compared with 2025-03-12 · 990 added, 565 removed, 985 unchanged (61% of the section changed)

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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

clinical trials for CGuard Prime 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.

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

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;

if additional products receive FDA approval, 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;

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

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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 neighbours, it could have a material

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;

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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.

we fail to maintain compliance with the Nasdaq minimum listing requirements, our common stock will be subject to delisting.

to publicly or privately sell equity securities and the liquidity of our common stock could be adversely affected if our common stock

to trade policy, including tariff and customs regulations, or failure to comply with such regulations may have an adverse effect

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

Related to Our Financial Condition

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

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

be 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

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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

efforts in the United States following 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;

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

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

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

certain milestones specific to each series.

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

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.

May 2023, we issued four series of warrants that expire upon the earlier of (i) five years following issuance or (ii) 20 trading days

following the occurrence of certain milestones specific to each series.

If all of the four series of warrants are exercised in cash in

full, this would result in $71.4 million of gross proceeds.

In July 2024, we received gross proceeds of approximately $17.9 million following

the exercise of the Series H Warrants in full.

In July 2025, we received gross proceeds of approximately $17.9 million following the

exercise of the Series I Warrants in full.

In July 2025, we completed a private placement that generated approximately $40.1 million

in gross proceeds.

For additional information, see “Item 7.

Management’s Discussion and Analysis of Financial Condition and

Results of Operations – Recent Developments – Private Placements.” There can be no assurance that we will achieve any

of the milestones set forth in the remaining unexercised Warrants or that these 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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Related to Commercialization of Our Products

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

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

we may develop.

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

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

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

We have not received

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

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

jusrisdiction where we are seeking approvals.

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

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

as well as to demonstrate sufficient clinical evidence and manufacture

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

In addition, there

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

If we fail to generate sufficient revenues

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

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

sales for the foreseeable future.

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

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

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

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

target markets;

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

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

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

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

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

at an adequate quality or at an acceptable cost;

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

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

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

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

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

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

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

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

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

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

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

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

and results of operations.

we 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.

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.

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

or distributing products in the U.S.

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

As part of our plan, we 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.

have only recently transitioned to a commercial stage medical device company in the United States, which may make it difficult for analysts

and investors to evaluate the success of our business to date and to assess our future viability.

only recently launched CGuard Prime in the United States following FDA approval in June 2025.

Consequently, any predictions that analysts

and investors make about our future success or viability may not be as accurate as they could be if we had more experience commercializing

CGuard Prime in the United States.

To be profitable, we will need to successfully transition our focus to expand our commercialization

capabilities through our direct sales organization and build our distribution capabilities to support the commercial launch of CGuard

Prime in the United States.

Ultimately, we may not be successful in such a transition.

Prime has been commercially launched in the United States, and we have limited experience manufacturing, selling, marketing and distributing

products in the U.S.

The timing of uptake and distribution efforts are unpredictable and there is a risk that we may not achieve and

sustain commercial success for the CGuard Prime.

July 2025, we announced the official commercial launch of CGuard Prime in the U.S.

following FDA approval in June 2025, and we are currently

executing on the commercialization plan.

As part of our plan, we are building out sales, marketing and distribution capabilities and

have engaged with a contract manufacturer to supplement our internal manufacturing capacity.

Historically, prior to the commencement

of our commercialization activities in the U.S., we did not have experience in manufacturing, selling, marketing or distributing products

To be able to successfully commercialize CGuard Prime we may need to further develop our existing manufacturing, sales, marketing

and distribution capabilities, which is expensive and time-consuming, or enter into arrangements with third parties to perform these

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

commercial launch of CGuard Prime.

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

designed to support the commercialization

of CGuard Prime.

In addition, to support our anticipated production growth in connection with the commercialization of CGuard Prime,

we have engaged Aptyx a contract manufacturer that is a developer and manufacturer of complex components and devices for the life sciences,

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

are risks involved in 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

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difficulty of obtaining reimbursement from governmental and commercial payers;

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

with more extensive product lines;

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

more extensive product lines;

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

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

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

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

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

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

are continuing to expand our commercialization capabilities and to build our distribution capabilities to support the commercialization

of CGuard Prime.

We expect that it will take time for this team to generate significant sales momentum, if it does so at all.

not be successful in recruiting and retaining the manufacturing, sales and marketing personnel necessary to sell CGuard Prime, and we

may not be successful in marketing CGuard Prime, which would have a material adverse effect on our business, financial condition and

results of operations.

addition, other factors that have and may continue to inhibit our efforts to successfully commercialize CGuard Prime in the United States

include our ability to access key health care decision makers, price CGuard Prime at a sufficient price point to ensure an adequate and

attractive level of profitability, and maintain sufficient financial resources to cover the costs and expenses associated with creating

and sustaining a capable sales and marketing organization and related commercial infrastructure.

If we are not successful in setting

our marketing, pricing and reimbursement strategies, recruiting and maintaining effective sales and marketing personnel or building and

maintaining the infrastructure to support commercial operations in the United States and elsewhere, we will have difficulty successfully

commercializing CGuard Prime in the U.S.

market, which would adversely affect our business and financial condition.

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

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

If we are not successful in commercializing CGuard Prime in the United States, we may be required to collaborate or partner

with a third-party medical device or biotechnology company with existing products.

To the extent we collaborate or partner, the financial

value will be shared with another party and we will need to establish and maintain a successful collaboration arrangement, and we may

not be able to enter into these arrangements on acceptable terms or in a timely manner in order to establish CGuard Prime in the U.S.

To the extent that we enter into co-promotion or other arrangements, any revenues we receive will depend upon the efforts of

third parties, which may not be successful and are only partially in our control.

In that event, our product revenues may be lower than

if we marketed and sold our products directly with the highest priority, and we may be required to reduce or eliminate much of our commercial

infrastructure and personnel as a result of such collaboration or partnership.

Prime, or any other product candidate that may receive marketing approval in the future, may fail to achieve the degree of market acceptance

by physicians, patients, third-party payors and others in the medical community necessary for commercial success and the market opportunity

for CGuard Prime or any other product candidate may be smaller than our estimates.

Prime, or any other product candidate that may be approved in the future by the appropriate regulatory authorities for marketing and

sale, may fail to gain sufficient market acceptance by physicians, patients, third-party payors and others in the medical community.

Physicians are often reluctant to switch their patients from existing medical devices even when new and potentially more effective or

convenient products enter the market.

to educate the medical community and third-party payors on the benefits of CGuard Prime over its competition have required significant

resources and may not ultimately be successful.

If CGuard Prime, or any other product candidate that may be approved in the future for

marketing and sale in the future, does not achieve an adequate level of market acceptance, we may not generate significant revenues and

we may not become profitable.

The degree of market acceptance of CGuard Prime, or any other product candidate that may be approved in

the future, will depend on a number of factors, including:

the advantages of the product compared to competitive products;

the number of competitors approved for similar uses;

the relative promotional effort and marketing success of us as compared with our competitors;

how the product is positioned in physician treatment guidelines and pathways;

the prevalence and severity of any side effects;

the functionality and ease of use of the product;

the efficacy and safety of the product;

our ability to offer the product for sale at competitive prices;

the product’s tolerability, consistency of performance, convenience and ease of administration compared to alternative product;

the willingness of the target patient population to try, and of physicians to utilize, the product;

limitations or warnings, including use restrictions, contained in the product’s approved labeling;

the strength of sales, marketing and distribution support;

the timing of market introduction of our approved products as well as competitive products;

adverse publicity about the product or favorable publicity about competitive products;

potential product liability claims;

changes in the standard of care for the targeted indications of the product;

availability and amount of coverage and reimbursement from government payors, managed care plans and other third-party payors.

addition, the potential market opportunities for CGuard Prime and any other product are difficult to estimate precisely.

Our estimates

of the potential market opportunities are predicated on many assumptions, including industry knowledge and publications, third-party

research reports and other surveys.

While we believe that our internal assumptions are reasonable, these assumptions involve the exercise

of significant judgment on the part of our management, are inherently uncertain and the reasonableness of these assumptions has not been

assessed by an independent source.

If any of the assumptions prove to be inaccurate, the actual markets for our therapeutic candidate

could be smaller than our estimates of the potential market opportunities.

the commercial launch of CGuard Prime in the United States for which we established a direct sales organization and distribution capabilities

is not successful for any reason, we could incur substantial costs and our investment in our direct sales organization and distribution

capabilities would be lost if we cannot retain or reassign our sales, marketing, market access and medical affairs personnel.

achieve commercial success for CGuard Prime in the United States, we have expended and anticipate that we will continue to expend significant

resources to support our direct sales organization and distribution capabilities.

There are risks involved with establishing our own

sales, marketing, distribution, training and support capabilities.

For example, recruiting and training sales and marketing personnel

is expensive and time consuming and could delay our ability to focus on other priorities.

If the commercial launch of CGuard Prime in

the United States is not successful for any reason, this would be costly, and our investment would be lost if we cannot retain or reassign

our sales, marketing, market access and medical affairs personnel or terminate on favorable terms any agreements entered into with third

parties to support our commercialization efforts.

that may inhibit or limit our efforts to commercialize CGuard Prime in the United States on our own include:

inability to train and retain adequate numbers of effective sales, marketing, training and support personnel;

inability of sales personnel to obtain access to physicians, including key opinion leaders, or to educate an adequate number of physicians

of the benefits of CGuard Prime over alternative treatment options;

costs and expenses associated with establishing and maintaining an independent sales, marketing, training and support organization.

our direct sales organization and distribution capabilities fail, or are otherwise unsuccessful, it would materially adversely impact

the commercialization of CGuard Prime in the United States, impact our ability to generate revenue and harm our business.

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

profitability depends, among other things, on our abilities to successfully commercialize CGuard Prime and receive FDA approval of SwitchGuard

and other products we may develop.

If we fail to successfully commercializae CGuard Prime or obtain FDA approval for SwitchGuard or any

other products we may develop, our results of operations and the value of our business would be materially and adversely affected.

derive most of our revenue from sales of our CGuard EPS in CE marked countries and certain other select jurisdictions, and we only recently

announced the official commercial launch of CGuard Prime in July 2025.

In addition, we have not received any approvals for SwitchGuard

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

any jurisdiction where we are seeking approvals.

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

ability to successfully commercialize and manufacture commercial quantities of CGuard Prime and obtain required regulatory approvals

for SwitchGuard and any other products we may develop at an acceptable cost.

In addition, there may be insufficient demand for CGuard

Prime, SwitchGuard and any other products we commercialize or develop.

If we fail to generate sufficient revenues from these products,

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

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

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will be published.

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

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 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.

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

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

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

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

double layer metal stent.

As we develop and seek regulatory approval in the United States for our new TCAR neuroprotection system, SwitchGuard

NPS, and continue to seek greater market share for CGuard Prime, we expect to compete with Silk Road Medical, which was acquired by Boston

Scientific Corporation, in the TCAR market.

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 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 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.

or uncompetitive, our related revenue would decrease.

This would have a material adverse effect on our business, financial condition

and results of operations.

may not be able to achieve or maintain satisfactory pricing and margins for our products.

Manufacturers

of medical devices have a history of price competition, and we can give no assurance that we will be able to achieve satisfactory prices

for our products or maintain prices at the levels we have historically achieved.

Any decline in the amount that payers reimburse our

customers for CAS could make it difficult for customers to continue using, or to adopt, our products and could create additional pricing

pressure for us.

In addition, the introduction of competitive stents that could be used in CAS procedures and other products could also

put pressure on the pricing of our products.

If we are forced to lower the price we charge for our products, our gross margins will decrease,

which will adversely affect our ability to invest in and grow our business.

If we are unable to maintain our prices, or if our costs

increase and we are unable to offset such increase with an increase in our prices, our margins could erode.

We will continue to be subject

to significant pricing pressure, which could harm our business and results of operations.

Also, our use of distributors in non-U.S.

may adversely impact our gross margins.

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

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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.

As the number of competitors in the stent market grows and our commercial sales expand geographically, the possibility of

patent infringement by us or claim against us increases.

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

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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.

These raw materials or components may not always be available at our standards

or on acceptable terms, if at all, and we may be unable to locate alternative suppliers or produce necessary materials or components

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

We may have difficulty obtaining

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 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

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

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

basis or at all.

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

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

may cause delays or disruptions in our manufacturing process.

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.

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.

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

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

clinical study.

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

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

Examples may include

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

or treating disease or in preventing impairment to human health.

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

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

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

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

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

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

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

reduced revenue.

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

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

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

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

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

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

suitable patients may be difficult to identify and recruit.

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

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

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

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

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

Patient enrollment in clinical

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

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

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

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

in contemporaneous clinical trials of competitive products.

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

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

Delays in patient enrollment or failure

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

or result in the failure of the clinical trial.

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

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

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

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

product is safe and effective.

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

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

of clinical trials for CGuard Prime 80 cm in TCAR procedures (C-GUARDIANS II), SwitchGuard NPS (C-GUARDIANS III), and any other investigational

product candidates requires compliance with FDA IDE regulations, and failure to meet these requirements could materially harm our business .

recently completed patient enrollment in the C-GUARDIANS II IDE trial to evaluate the safety and efficacy of the CGuard Prime 80 cm carotid

stent system used with the ENROUTE NPS during TCAR procedures, following FDA approval of the IDE on October 3, 2024.

The study enrolled

its first patient on December 6, 2024 and we completed enrollment of 50 patients in the first quarter of 2026.

For additional information, see “Item

1 – Business – On-going and Planned Clinical Trials – C-GUARDIANS II for TCAR procedures.” In addition, FDA approved

the IDE for C-GUARDIANS III on June 6, 2025, a pivotal study evaluating the SwitchGuard NPS when used in conjunction with the CGuard

Prime 80 cm system for TCAR.

The C-GUARDIANS III study is expected to begin enrollment of patients during the second quarter of 2026.

For additional information, see “Item 1 – Business – On-going and Planned Clinical Trials – C-GUARDIANS III for

TCAR procedures using SwitchGuard NPS.”

and any future clinical studies must comply with FDA IDE regulations and Good Clinical Practice requirements, including IRB approvals,

predefined protocols, informed consent, monitoring, data integrity, and reporting obligations.

Delays in patient enrollment, site activation,

supply availability, protocol deviations, investigator performance, or regulatory compliance issues could delay or disrupt these studies.

the TCAR indication for CGuard Prime and the SwitchGuard NPS remain investigational, the results from C-GUARDIANS II, C-GUARDIANS III,

or any future clinical trials may not demonstrate safety and effectiveness to the FDA’s satisfaction.

Failure to generate acceptable

clinical data could delay or prevent FDA approval of these expanded indications or new products, limit our commercial opportunities in

the TCAR market, and materially harm our business, financial condition, and results of operations.

trials necessary to support regulatory submissions for our products, including the C-GUARDIANS II study evaluating the CGuard Prime

80 cm stent system for TCAR procedures and the C-GUARDIANS III study evaluating the SwitchGuard NPS, are often lengthy and

difficult to conduct, and delays or failures in these trials could adversely affect our business.

are currently conducting C-GUARDIANS II, an FDA-approved IDE study evaluating the safety and effectiveness of the CGuard Prime

80 cm carotid stent system when used with the ENROUTE NPS during TCAR procedures.

Although CGuard Prime received PMA approval in

June 2025 for transfemoral use, the TCAR indication remains investigational and will require a PMA supplement supported by C-GUARDIANS II

We are also conducting C-GUARDIANS III, an FDA-approved IDE study evaluating the SwitchGuard NPS, which is expected to support

a 510(k) submission for SwitchGuard as a standalone neuroprotection system for TCAR.

trials for these products may encounter delays related to patient enrollment, site activation, protocol adherence, availability of investigational

product, competing studies, and investigator engagement.

TCAR-eligible patients represent a more limited subset of the carotid stenosis

population, and suitable patients may be difficult to identify and recruit, particularly across centers with variable TCAR procedure

Patients may withdraw consent, fail to complete required follow-up, or experience unrelated adverse events that complicate interpretation

of study data.

we are unable to complete these studies successfully, or if the resulting data do not demonstrate safety and effectiveness to the FDA’s

satisfaction, we may be unable to obtain approval for the TCAR indication for CGuard Prime or clearance for the SwitchGuard NPS.

such delays or failures could materially harm our business, financial condition, results of operations, and our commercial opportunities

in the TCAR market.

results of our C-GUARDIANS II and C-GUARDIANS III trials, as well as any other clinical trials, may be insufficient to obtain regulatory

approval for our products.

will only receive regulatory approval for additional indications of CGuard Prime, SwitchGuard or any other product we develop if we can

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

that the product is safe and effective.

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

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

We face risks that:

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

results of clinical trials may not meet the level of statistical significance required by the FDA or comparable foreign regulatory

authorities for approval;

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

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patient eligibility criteria for the study.

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

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

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

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:

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;

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.

if products we develop receive marketing approval, we or others may later discover that the product is less effective than previously

believed or causes undesirable side effects that were not previously identified, which could compromise our ability or that of any collaborators

to market the product, and could cause regulatory authorities to take certain regulatory actions.

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

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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.

the European Economic Area, we must comply with the medical device vigilance system under Regulation (EU) 2017/745 on medical devices,

Under this system, manufacturers are generally required to report serious incidents involving medical devices via an electronic

system incorporated into the EU database on medical devices, called EUDAMED.

Furthermore, 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.

An 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.

FSCAs must be reported to the relevant competent authorities, even if the FSCA

was undertaken in a third country in relation to a device which is also legally made available on the Union market and the reason for

the FSCA is not limited to the device made available in the third country.

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

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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, SwitchGuard and any other product

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

Treatments may

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

Any change in accepted metrics may result

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

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

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

of only ten employees.

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

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

Treatments may exhibit a favorable

measure using one metric and an unfavorable measure using another metric.

Any change in accepted metrics may result in reconfiguration

of, and delays in, our clinical trials.

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

to gain regulatory approvals, and our clinical, regulatory and quality assurance personnel are currently composed of only ten employees.

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

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the imposition of civil penalties or criminal prosecution.

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

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 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,

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

FDA and the Federal Trade Commission (“FTC”) 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 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 or FTC 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.

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market CGuard EPS in certain international markets.

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

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

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

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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.

are 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

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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

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.

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

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.

environment for health care policy generally may change when new Presidential administrations take office.

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.

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

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

pricing and the market for our products.

Any significant reductions in coverage or payment for services under Medicare, Medicaid and

the Affordable Care Act may affect those beneficiaries who cannot get access to certain FDA approved products.

In addition, lower reimbursement

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

While 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

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

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

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

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

the remaining provisions of the Affordable Care Act are invalid.

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

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

The regulatory

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

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

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

have on our business.

The enactment of the Tax Act, on December 14, 2018, removed

penalties for not complying with the Affordable Care Act’s individual mandate to carry health insurance.

The regulatory process

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

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

We cannot predict

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

on our business.

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

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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;

Any changes in, or uncertainty with respect to, future reimbursement rates could cause an 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.

For example, CMS issued a national coverage determination on October 11, 2023, finding that Medicare coverage for percutaneous transluminal

angioplasty of the carotid artery concurrent with stenting with an FDA-approved or -cleared device to be reasonable and necessary.

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

the past, 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.

For example, the

One Big Beautiful Bill Act of 2025 (OBBBA) went into effect on July 4, 2025, and greatly modified Medicaid reimbursements and enrollment

to include work requirements and periodic eligibility determinations, all of which could reduce Medicaid enrollment.

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.

or the effect ongoing uncertainty

about these matters will have on our customers’ purchasing decisions.

payors are developing increasingly sophisticated methods of controlling healthcare costs and increasingly challenging the prices charged

for medical products and services.

Additionally, the containment of healthcare costs has become a priority of federal and state governments

and the prices of drugs have been a focus in this effort.

The United States government, state legislatures and foreign governments have

shown significant interest in implementing cost-containment programs, including price controls and transparency requirements, restrictions

on reimbursement and requirements for substitution of generic products.

For example, HHS began implementation in 2025 of “Most

Favored Nation” drug pricing by setting the Medicare price of single-source brand drugs without generic or biosimilar competition

to the lowest price available in wealthy countries with a per capita GDP of at least 60% of that in the United States.

Adoption of price

controls and cost-containment measures, and adoption of more restrictive policies in jurisdictions with existing controls and measures,

could limit our revenue and operating results.

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

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

Furthermore, we cannot predict what actions

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

However, it is possible that such initiatives could have

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

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

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

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

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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 regulation entered into full application on May 26, 2021.

The MDR (as amended on January

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.

10, 2025) imposes strict requirements on medical device manufacturers and strengthens the supervising competences of the competent authorities

of EEA member states, the notified bodies and the authorized representatives.

If we fail to comply with the MDR and applicable national

legislation on medical devices in EEA member states, 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.

January 12, 2025, Regulation (EU) 2021/2282 of the European Parliament and of the Council of December 15, 2021 on health technology assessment

and amending Directive 2011/24/EU, or the EU HTA Regulation, became applicable.

The EU HTA Regulation stipulates joint clinical assessments

at EU level for certain medical devices.

A Joint Clinical Assessment (JCA) under the EU HTA Regulation is a centralized, EU-level evaluation

of the comparative clinical effectiveness and safety of health technologies, including medical devices.

The JCA is designed to influence

pricing and reimbursement decisions of EU member states at the national level, although its result does not pre-determine national decisions

concerning reimbursement.

Within the scope of the EU HTA Regulation are, among others, medical devices classified as class IIb or III

under the MDR for which the relevant expert panels have provided a scientific opinion in the framework of the clinical evaluation consultation

The medical devices under the EU HTA Regulation are subject to selection by the European Commission at least every two years,

based on statutory criteria.

Furthermore, the EU HTA Regulation provides a framework for voluntary cooperation of member states regarding

the non-clinical assessment of health technologies and collaborative assessments on medical devices not already covered by the mandatory

joint clinical assessment.

The EU HTA Regulation may increase compliance costs and adversely affect pricing of our products.

at the FDA and other government agencies caused by funding shortages or global health concerns could hinder their ability to hire, retain

or deploy key leadership and other personnel, or otherwise prevent new or modified products from being developed, cleared or approved

or commercialized in a timely manner or at all, which could negatively impact our business.

ability of the FDA to review and clear or approve new products can be affected by a variety of factors, including government budget and

funding levels, statutory, regulatory, and policy changes, the FDA’s ability to hire and retain key personnel and accept the payment

of user fees, and other events that may otherwise affect the FDA’s ability to perform routine functions.

Average review times at

the FDA have fluctuated in recent years as a result.

In addition, government funding of other government agencies that fund research

and development activities is subject to the political process, which is inherently fluid and unpredictable.

at the FDA and other agencies may also slow the time necessary for new medical devices or modifications to cleared or approved medical

devices to be reviewed and/or approved by necessary government agencies, which would adversely affect our business.

Most recently, the

federal government was shut down for approximately 43 days from October 1 to November 12, 2025, due to a lapse in appropriations, during

which federal employees were furloughed and many agencies, including components of the HHS, operated with reduced staffing or suspended

In early 2025, following the inauguration of President Trump, the Trump Administration began terminating federal government

employees, including approximately 3,500 employees at the FDA.

Prior shutdowns, such as the 35-day shutdown beginning December 22, 2018,

similarly resulted in furloughs and delays in regulatory review activities.

Any future government shutdowns, funding lapses, continuing

resolutions, or similar events could result in reduced agency staffing, delays in regulatory reviews, interruptions to critical government

functions, or uncertainty in agency operations, each of which could materially and adversely affect our business, financial condition,

and results of operations.

Factors Related to Our Intellectual Property

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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

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

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

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from their first filing date.

Similarly, publication of discoveries in the scientific or patent literature often lags behind actual discoveries.

Similarly, publication of discoveries in 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

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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.

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

enforce proprietary rights than in the United States.

This risk may be exacerbated if we move our manufacturing to certain countries

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,

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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.

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

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

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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;

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.;

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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 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.

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

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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.

Patent 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

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withheld relevant information from the 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 and inter partes review proceedings before

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

Under the Leahy-Smith Act, the validity

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

The outcome following legal

assertions of invalidity and unenforceability is unpredictable.

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

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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.

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,

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

Related to Our Business Operations

Related to Our Business and Operations

EPS, CGuard Prime, and SwitchGuard NPS are complex medical devices that require training for qualified personnel.

EPS, CGuard Prime, and SwitchGuard NPS are complex medical devices that require training for qualified personnel, including physicians.

Although our distributors and direct salespeople will be required to ensure that CGuard EPS, CGuard Prime, and SwitchGuard NPS are prescribed

only by trained clinicians, the potential for misuse of these products still exists due to their 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.

we fail to maintain or establish reliable supply arrangements, or if we experience interruptions in the supply of key materials or components,

our ability to manufacture and commercialize our products could be adversely affected.

rely on external suppliers for certain raw materials, components, and sub-assemblies used in the manufacture of CGuard EPS, CGuard Prime,

and our products under development.

Some of these items are sourced from a single supplier.

If any supplier is unable or unwilling to

meet our quality standards, delivery schedules, or quantity requirements, or if they cease supplying us, we may not be able to obtain

suitable alternative materials or components on acceptable terms, or at all.

critical components of our products are currently provided by single-source vendors.

For example, in 2022 our mesh supplier notified

us that it would no longer be able to supply the polymer fiber used to produce our MicroNet mesh because of supply constraints affecting

its PET resin source.

We subsequently purchased sufficient inventory to support our anticipated production needs through early 2028,

and we have identified and begun validating an alternative PET resin with comparable mechanical and biocompatibility characteristics.

However, there can be no assurance that this validation will be successful, that the alternative material will receive required regulatory

approvals, or that additional or replacement PET sources will be available when needed.

If we are unable to secure timely approval of

an alternative PET resin supplier or are unable to qualify additional suppliers, we could face manufacturing delays, supply interruptions,

increased component costs, or an inability to meet commercial demand.

CGuard Prime is approved in the United States under a PMA, any change to certain suppliers, components, or raw materials, including the

PET resin used in MicroNet, requires FDA approval through a PMA supplement.

Similar approvals or notifications may be required by foreign

regulatory authorities.

These processes can be time-consuming and may delay our ability to implement supplier changes or address supply

As a result, commercial supply or clinical studies involving products under development could be adversely affected.

also depend on a third-party sterilization vendor for our finished products.

If this vendor experiences disruptions, capacity limitations,

compliance issues, or quality failures, or if we are unable to obtain timely regulatory approval to qualify an alternative sterilization

provider, we could face delays or interruptions in product release and distribution.

interruption in our supply chain, including raw materials, specialized components, or sterilization services, could impair our ability

to meet demand, maintain inventory levels, or support ongoing commercial sales and clinical activities.

This could materially harm our

business, financial condition, and results of operations.

business is dependent upon the total market opportunity for CAS and our ability to penetrate it through continued adoption of CAS by

hospitals and physicians.

future growth and profitability largely depend on the total market opportunity for CAS, the determination of which is inherently imprecise,

and our ability to penetrate it, which is largely dependent upon our ability to increase physician awareness and adoption of CAS and

on the willingness of physicians to recommend the procedure to more of their patients.

While we are confident in our estimate of the

annual total addressable market for our CAS products, especially since it is based on a number of internal and third-party estimates,

it may prove to be incorrect.

If the actual number of patients who would benefit from our products and the annual total addressable market

for our products is smaller than we have estimated, it may impair our sales growth and have an adverse impact on our business.

to our ability to penetrate this market opportunity, physicians may not use our products unless they are able to determine, based on

experience, clinical data, medical society recommendations and other analyses, that our products provide a safe and effective treatment

alternative for carotid artery disease and other vascular

Even if we are able to raise awareness and increase adoption of CAS among physicians,

physicians tend to be slow in changing their medical treatment practices and may be hesitant to select our products or CAS for recommendation

to patients for a variety of reasons, including:

● Long-standing

relationships with competing companies and distributors that sell other products;

● Competitive

response and negative selling efforts from providers of alternative carotid revascularization

liability risk generally associated with the use of new products and procedures;

or perceived lack of sufficient clinical evidence, including long-term data or a randomized

controlled trial, supporting clinical benefits;

of experience with CAS as a treatment alternative to CEA;

● Familiarity

and experience with CEA, and reluctance to change to or use new products and procedures;

commitment and skill development that may be required to gain familiarity and proficiency

with CAS and our products.

play a significant role in determining the course of a patient’s treatment for carotid artery disease and, as a result, the type

of treatment that will be recommended or provided to a patient.

We focus part of our sales, marketing and education efforts primarily

on interventional cardiologists, vascular surgeons, and neurosurgeons and aim to educate referring physicians such as internal medicine

specialties, cardiologists, radiologists, neurologists, and general practitioners regarding the patient population that would benefit

However, we cannot assure you that we will achieve broad education or market acceptance among these practitioners.

if diagnosing physicians who serve as the primary point of contact for patients are not made aware of CAS, they may not refer patients

to physicians for treatment using our products, and those patients may instead not seek treatment at all or may be treated with alternative

In addition, some physicians may choose to utilize CAS on only a subset of their total patient population or may not adopt

If a physician experiences an adverse event in one or more of their CAS patients or elects to convert CAS to CEA mid-procedure,

they may not continue offering and performing CAS at the same rate or at all.

Further, CAS may not fit into the workstreams of certain

If we are not able to effectively demonstrate that CAS is beneficial in a broad range of patients, adoption of CAS will be

limited and may not occur as rapidly as we anticipate, which would have a material adverse effect on our business, financial condition

and results of operations.

We cannot assure you that CAS or our products will achieve broad market acceptance among hospitals and physicians.

Any failure of CAS or our products to satisfy demand or to achieve meaningful market acceptance and penetration will harm our future

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

most cases, before physicians can use our products for the first time, our products must be approved for use by a hospital’s new

product or value analysis committee, or the staff of a hospital or health system.

Following such approval, we may be required to enter

into a purchase contract.

Such approvals or requirements to enter into a purchase contract could deter or delay the use of our products

by physicians.

We cannot provide assurance that our efforts to obtain such approvals, enter into purchase contracts, or generate adoption

will be successful or increase the use of our products, and if we are not successful, it could have a material adverse effect on our

business, financial condition and results of operations.

addition, if patient receptivity toward CAS becomes less favorable in the future, this shift could negatively impact market acceptance

Any negative change due to patient receptivity could also be compounded by patients reporting to physicians or other patients

through word-of-mouth or social media.

of CAS depends upon appropriate physician training, and inadequate training may lead to adverse patient outcomes, adversely affect adoption

of CAS and adversely affect our business.

success of CAS depends in part on the skill of the physician who is performing the procedure and on our customers’ adherence to

appropriate patient selection and proper techniques provided in training sessions conducted by our training faculty.

Physicians rely

on their previous medical training and experience when performing CAS, and we cannot guarantee that all such physicians will have the

necessary surgical and endovascular skills to perform the procedure.

If physicians perform CAS in a manner that is inconsistent with

its labeled indications, with components that are not our products or without adhering to or completing our training sessions, their

patient outcomes may not be consistent with the outcomes achieved in our and other clinical trials, studies or registries of CAS.

result may negatively impact the perception of patient benefit and safety and limit adoption of CAS and our products that facilitate

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

Additionally,

hospitals and physician organizations may adopt physician credentialing guidelines requiring CAS training that is more extensive than

our training program.

If physicians conclude that we do not provide adequate CAS training, they may be less likely to adopt CAS and our

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

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

have engaged Aptyx, a contract manufacturer, to expand our manufacturing capacity 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, such as:

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

(ii) they may not produce reliable results;

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.

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 commercial launch of

CGuard Prime 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 costs.

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 commercialization

of CGuard Prime, we have engaged Aptyx, a contract manufacturer, to expand our manufacturing capacity of CGuard Prime finished goods

to full-scale production at their ISO Class 7 cleanroom facility in North Carolina.

If our or our manufacturing partners’ facilities

suffers damage, or a force majeure event, this could materially affect our ability to operate.

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

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 fulfill 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

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 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.

results of operations could be materially harmed if we are unable to accurately forecast customer demand for our products and manage

our inventory.

seek to maintain sufficient levels of inventory in order to protect ourselves from supply interruptions, but keep limited components,

sub-assemblies, materials and finished products on hand.

To ensure adequate inventory supply and manage our operations with our manufacturing

partners and suppliers, we forecast anticipated materials requirements and demand for our products in order to predict inventory needs

and then place orders with our suppliers based on these predictions.

Our ability to accurately forecast demand for our products would

be negatively affected by many factors, including our rapid growth, product recalls, pandemics, failure to accurately manage our expansion

strategy, product introductions by competitors, an increase or decrease in customer demand for our products, our failure to accurately

forecast customer acceptance of new products, changes to hospital capacity, staffing, procedure and protocol changes, unanticipated changes

in general market conditions or regulatory matters, weakening of economic conditions or consumer confidence and the realization of other

risks as described in this section.

levels in excess of customer demand may result in a portion of our inventory becoming obsolete or expiring, as well as inventory write-downs

or write-offs.

Conversely, if we underestimate customer demand for our products or our own requirements for components, sub-assemblies

and materials, our manufacturing partners and suppliers may not be able to deliver components, sub-assemblies and materials to meet our

requirements.

If we do not have adequate supply of components, sub-assemblies and materials there may be interruptions, delays or cancellations

of deliveries of our products to our customers, any of which would damage our reputation, customer relationships and business.

several components, sub-assemblies and materials incorporated into our products require lengthy order lead times, and additional supplies

or materials may not be available when required on terms that are acceptable to us or our manufacturing partners, or at all, and our

manufacturing partners and suppliers may not be able to allocate sufficient capacity in order to meet our increased requirements, any

of which could have an adverse effect on our ability to meet customer demand for our products and our results of operations.

quarterly and annual results may fluctuate significantly and may not fully reflect the underlying performance of our business.

quarterly and annual results of operations, including our revenue, net income or net loss and cash flow, may vary significantly in the

future, and period-to-period comparisons of our operating results may not be meaningful.

Accordingly, the results of any one quarter

or period should not be relied upon as an indication of future performance.

Our quarterly and annual financial results may fluctuate

as a result of a variety of factors, many of which are outside our control and, as a result, may not fully reflect the underlying performance

of our business.

Fluctuations in quarterly and annual results may decrease the value of our common stock.

Because our quarterly results

may fluctuate, period-to-period comparisons may not be the best indication of the underlying results of our business and should only

be relied upon as one factor in determining how our business is performing.

or failures associated with our products could lead to additional recalls, safety alerts or litigation, as well as significant costs

and negative publicity.

business is subject to significant risks associated with the manufacture, distribution and use of medical devices that are placed inside

the human body, including the risk that patients may be severely injured by or even die from the misuse or malfunction of our products

caused by design flaws or manufacturing defects.

In addition, component failures, design defects, off-label uses or inadequate disclosure

of product-related information could also result in an unsafe condition or the injury or death of a patient.

These problems could lead

to a recall or market withdrawal of, or issuance of a safety alert relating to, our products and could result in significant costs, negative

publicity and adverse competitive pressure.

The circumstances giving rise to recalls are unpredictable, and any recalls of existing or

future products increase the probability of inspection by, or additional scrutiny from, the FDA and could have a material adverse effect

on our business, financial condition and results of operations.

medical device industry has historically been subject to extensive litigation over product liability claims.

Operating in the area of

the neck with the brain as the end organ is dangerous and presents risks of adverse events such as bleeding, arterial dissection, cranial

nerve injury, myocardial infarction, stroke and death, which subject us to a greater risk of being involved in litigation than companies

with products used in less critical areas of the body.

We may be subject to product liability claims if our products cause, or merely

appear to have caused, an injury or death, even if due to physician error.

In addition, an injury or death that is caused by the activities

of our suppliers, such as those that provide us with components and materials, or by an aspect of a treatment used in combination with

our products, such as a complementary drug or anesthesia, may be the basis for a claim against us by patients, hospitals, physicians

or others purchasing or using our products, even if our products were not the actual cause of such injury or death.

We may choose to

settle any claims to avoid fault and complication, not due to failure of our products.

An adverse outcome involving one of our products

could result in reduced market acceptance and demand for all of our products and could harm our reputation and our ability to market

our products in the future.

In some circumstances, adverse events arising from or associated with the design, manufacture or marketing

of our products could result in the suspension or delay of regulatory reviews of our premarket notifications or applications for marketing.

Any of the foregoing problems could disrupt our business and have a material adverse effect on our business, financial condition and

results of operations.

we carry product liability insurance in the United States and in other countries in which we conduct business, including for clinical

trials and product marketing, we can give no assurance that such coverage will be available or adequate to satisfy any claims.

liability insurance is expensive, subject to significant deductibles and exclusions, and may not be available on acceptable terms, if

If we are unable to obtain or maintain insurance at an acceptable cost or on acceptable terms with adequate coverage or otherwise

protect against potential product liability claims, we could be exposed to significant liabilities.

A product liability claim, recall

or other claim with respect to uninsured liabilities or for amounts in excess of insured liabilities could have a material adverse effect

on our business, financial condition and results of operations.

Defending a suit, regardless of its merit or eventual outcome, could

be costly, could divert management’s attention from our business and might result in adverse publicity, which could result in reduced

acceptance of our products in the market, product recalls or market withdrawals.

are required to file adverse event reports under MDR and regulations with the FDA, which reports are publicly available on the FDA’s

We are required to file MDRs if our products may have caused or contributed to a serious injury or death or malfunctioned in

a way that could likely cause or contribute to a serious injury or death if it were to recur.

Any such MDR that reports a significant

adverse event could result in negative publicity, which could harm our reputation and future sales.

use, misuse or off-label use of our products may result in injuries that lead to product liability suits, which could be costly to our

CGuard Prime carotid stent system has been approved by the FDA for the treatment of patients who require carotid revascularization and

meet certain treatment parameters.

If physicians expand the patient population in which they elect to use our products that is outside

of the intended use approved by the FDA, then the use, misuse, or off-label use of our products may result in outcomes and adverse events

including stroke, myocardial infarction and death, potentially leading to product liability claims.

However, we cannot prevent a physician

from using our products for off-label applications or using components or products that are not our products when performing CAS.

addition, we cannot guarantee that physicians are trained by us or their peers prior to utilizing our products.

Complications resulting

from the use of our products off-label or use by physicians who have not been trained appropriately, or at all, may expose us to product

liability claims and harm our reputation.

Moreover, if the FDA determines that our promotional materials or physician training, including

our paid consultants’ educational materials, constitutes promotion of an off-label use, it could request that we modify our training

or promotional materials or subject us to enforcement action, including warning letters, untitled letters, fines, penalties, or seizures.

If we are found to have promoted such off-label uses, we may become subject to significant liability.

The federal government has levied

large civil and criminal fines and/or other penalties against companies for alleged improper promotion and has investigated, prosecuted,

and/or enjoined several companies from engaging in off-label promotion.

addition, if our products are defectively designed, manufactured or labeled, contain defective components or are misused, we may become

subject to costly litigation initiated by physicians, hospitals or patients.

Product liability claims are especially prevalent in the

medical device industry and could harm our reputation, divert management’s attention from our core business, be expensive to defend

and may result in sizable damage awards against us.

Although we maintain product liability insurance, we may not have sufficient insurance

coverage for future product liability claims.

We may not be able to obtain insurance in amounts or scope sufficient to provide us with

adequate coverage against all potential liabilities.

Any product liability claims brought against us, with or without merit, could increase

our product liability insurance rates or prevent us from securing continuing coverage, harm our reputation, significantly increase our

expenses, and reduce product sales.

Product liability claims could cause us to incur significant legal fees and deductibles and claims

in excess of our insurance coverage would be paid out of cash reserves, harming our financial condition and operating results.

face risks associated with litigation and claims.

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Similarly, our third-party providers possess certain of our sensitive data and confidential information.

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

The securityof 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.

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clinical trials could result in delays in our regulatory approval efforts and significantly increase our costs to recover or reproduce

we are unable to manage the anticipated growth of our business, our future revenue and operating results may be harmed.

past growth has provided, and our future growth may create, challenges to our organization.

The number of our employees has increased

significantly during the past several years and in the future, we expect to hire and train new personnel as we continue to grow and expand

our operations.

Any growth that we experience in the future will require us to expand our sales, general and administrative personnel,

manufacturing and distribution operations, and facilities and information technology, or IT, and infrastructure.

In addition to the need

to scale our organization, future growth will impose significant added responsibilities on management, including the need to identify,

recruit, train and integrate additional employees.

Rapid expansion in personnel could mean that less experienced people manufacture,

market and sell our products, which could result in inefficiencies and unanticipated costs, reduced quality and disruptions to our operations.

In addition, rapid and significant growth may strain our administrative and operational infrastructure.

Our ability to manage our business

and growth will require us to continue to improve our operational, financial and management controls, reporting systems and procedures.

If we are unable to manage our growth effectively, it may be difficult for us to execute our business strategy, and our business could

demand for our products or any of our future products increases, we will need to continue to scale our capacity, expand customer service,

billing and systems processes and enhance our internal quality assurance program.

We cannot assure you that any increases in scale, related

improvements and quality assurance will be successfully implemented or that appropriate personnel will be available to facilitate the

growth of our business.

Failure to implement necessary procedures, transition to new processes or hire the necessary personnel could

result in higher costs or inability to meet increased demand.

If we encounter difficulty meeting market demand, quality standards or

physician expectations, our reputation could be harmed and our business could suffer.

loss of key members of our senior management team or our inability to attract and retain highly skilled scientists and laboratory and

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of these changes could have a material adverse effect on our reputation, business, financial condition or results of operations.

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

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

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

International

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been detected.

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

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

occur because of simple errors or mistakes.

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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.

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

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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.

Scrutiny may come

from stakeholders both supporting and opposing ESG initiatives, adding complexity to our compliance and communication efforts.

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.

Failure to comply with applicable ESG rules or regulations could lead to penalties, enforcement actions, adverse

publicity, or could negatively affect our reputation, access to capital, or employee retention.

ESG-related regulations, such as sustainability reporting requirements, supply-chain diligence obligations, and international frameworks

(including the EU Corporate Sustainability Reporting Directive (CSRD)), may also affect our contract manufacturers, suppliers, and other

third parties.

Any inability of such third parties to comply with applicable ESG standards may disrupt our supply chain or otherwise

negatively effect our business, financial condition, or results of operations.

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.

to trade policy, including tariff and customs regulations, or failure to comply with such regulations may have an adverse effect on our

reputation, business, financial condition and results of operations.

or international social, political, regulatory and economic conditions or in laws and policies governing trade, manufacturing,

development and investment in the countries where we currently conduct our business could adversely affect our business, reputation,

financial condition and results of operations.

Changes or proposed changes in U.S.

or other countries’ trade policies may result

in restrictions and economic disincentives on international trade.

currently manufacture, package and distribute all of our products, including CGuard Prime, which we commercially launched in July 2025

following FDA approval of the PMA in June 2025, at our own facility in Israel.

To support our anticipated production growth following

the commercialization of CGuard Prime, we have engaged Aptyx to expand our manufacturing capacity of CGuard Prime finished goods to full-scale

production at their ISO Class 7 cleanroom facility in North Carolina.

While we are in the process of establishing manufacturing operations

in the United States with Aptyx, this transition will take time, and until it is operational, we expect to rely entirely on product shipments

from Israel to the U.S.

government has recently imposed, or is currently considering imposing, tariffs on certain products, including medical devices, on

certain trade partners, including Israel.

On February 20, 2026, the Supreme Court ruled that the International Emergency Economic Powers

Act (“IEEPA”) does not authorize a U.S.

President to impose tariffs during peacetime national emergencies and that the challenge

to the legality of the tariffs imposed under IEEPA (the “incremental tariffs”) was within the exclusive jurisdiction of the

Court of International Trade.

In response to this ruling, the U.S.

President signed a proclamation imposing a new 10% global tariff

under Section 122 of the Trade Act of 1974, effective February 24, 2026, and subsequently increased these tariffs to 15% on February

Section 122 tariffs are subject to a 150-day statutory limit unless extended by Congress.

In addition, the Office of the U.S.

Trade Representative has announced it will initiate new Section 301 investigations into trading partners’ unfair practices, which

could result in additional tariffs.

economic sanctions and other changes in U.S.

trade policy have in the past and could in the future trigger retaliatory actions by affected

countries, and certain foreign governments have instituted or are considering imposing retaliatory measures on certain U.S.

any emerging protectionist or nationalist trends (whether regulatory- or consumer-driven) either in the United States or in other countries

could affect the trade environment.

Our business, like many other corporations, would be impacted by changes to the trade policies of

the United States and foreign countries (including governmental action related to tariffs, international trade agreements, or economic

We cannot predict whether, and to what extent, trade policies will change in the future.

If tariffs or other trade restrictions

are imposed on products manufactured in Israel while we remain dependent on Israeli manufacturing, our cost of goods sold for the U.S.

market may increase materially, which could negatively impact our gross margins and limit our pricing flexibility.

Additionally, changes

to trade agreements or customs regulations between the U.S.

and Israel could increase lead times, introduce logistical complexities,

or require modifications to our supply chain planning.

These or similar trade-related developments may have a material adverse effect

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

in tax laws could have a material adverse effect on our business, cash flow, results of operations or financial conditions.

are subject to tax laws, regulations, and policies of several taxing jurisdictions.

Changes in tax laws, as well as other factors, could

cause us to experience fluctuations in our tax obligations and effective tax rates and otherwise adversely affect our tax positions and/or

our tax liabilities.

Recently, legislation commonly known as the One Big Beautiful Bill Act (OBBBA) was signed into law in July 2025,

which enacts significant changes to U.S tax and related laws, including but not limited to current deduction of domestic research expenses,

increasing the limit of the deduction of interest expense to thirty percent of EBITDA and one hundred percent bonus depreciation on eligible

property acquired after January 19, 2025.

There were no changes to the Company’s tax expense or effective income tax rate given

the Company’s valuation allowance position.

Further, many countries, and organizations such as the Organization for Economic Cooperation

and Development have proposed implementing changes to existing tax laws.

Any of these developments or changes in federal, state, or international

tax laws or tax rulings could adversely affect our effective tax rate and our operating results.

There can be no assurance that our effective

tax rates, tax payments, or tax credits and incentives will not be adversely affected by these or other developments or changes in law.

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.

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

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

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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 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.

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.

2025, approximately 39% of our revenues were denominated in U.S.

dollars and approximately 61% in other currencies, primarily Euros.

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

dollars and Euros, particularly as U.S.

sales increase

following FDA approval of CGuard Prime, while a significant portion of our expenses, principally salaries and related personnel expenses,

is paid in NIS.

As a result, our operating results are exposed primarily to movements in the USD/NIS and EUR/NIS exchange rates.

of the NIS against the U.S.

dollar or the Euro increases the U.S.

dollar cost of our shekel-denominated expenses and may adversely impact

our net loss or net income (if any).

Based on our 2025 expense levels, a 10% appreciation of the NIS against the U.S.

dollar would have

decreased our net income by approximately $1.1 million.

exchange rates may fluctuate due to many factors, including interest-rate differentials between markets, capital flows, monetary policy

decisions, geopolitical events, global macroeconomic developments, and investor sentiment toward Israel and regional markets.

These factors

may cause the NIS to appreciate or depreciate against the U.S.

dollar or the Euro independent of local inflation levels.

If the NIS strengthens

without a corresponding increase in our foreign-currency revenues, our U.S.

dollar-measured costs will rise.

value of the NIS relative to the Euro, the U.S.

dollar, and other currencies has fluctuated significantly.

For example, the shekel appreciated

on average by 12.5% relative to the U.S.

dollar in 2025, after depreciating by 0.4% in 2024 and by 3.1% in 2023, thereby increasing,

in 2025, the U.S.

dollar cost of our shekel-denominated expenses.

The Euro also appreciated relative to the dollar in 2025 on average,

by 11.3%, thereby increasing the U.S.

dollar cost of our Euro-denominated expenses.

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

adverse effect on our business relationships and profitability.

current manufacturing facility, certain of our key personnel and one of our offices 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.

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

and military targets.

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

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

These attacks resulted in extensive deaths, injuries and kidnapping

of civilians and soldiers.

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

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

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

adverse effect on our business operations and ability to reach profitability.

we are incorporated in the State of Delaware and our headquarters are in Miami, Florida, our current manufacturing facility, certain

of our key personnel and one of our offices 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 neighboring countries and terrorist organizations active in the region, including Iran, Hamas (an Islamist terrorist

militia and political group that controls the Gaza strip), Hezbollah (an Islamist terrorist militia and political group based in Lebanon)

and other terrorist organizations active in the region.

These conflicts have involved missile strikes, hostile infiltrations and terrorism

against civilian targets in various parts of Israel, which have negatively affected business conditions in Israel.

recent years, Israel has been engaged in sporadic armed conflicts with Hamas, an Islamist terrorist group that controls the Gaza Strip,

with Hezbollah, an Islamist terrorist group that controls large portions of southern Lebanon, and with Iranian-backed military forces

In addition, Iran has threatened to attack Israel and may be developing nuclear weapons.

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.

On October 7, 2023, Hamas launched a series of attacks on civilian and military targets in Southern

Israel and Central Israel, to which the Israel Defense Forces responded.

On October 9, 2025, Israel, Hamas, the United States and other

countries in the region agreed to a framework for a ceasefire in Gaza between Israel and Hamas.

addition, both Hezbollah and the Houthi movement attacked military and civilian targets in Israel, to which Israel responded, including

through increased air and ground operations in Lebanon.

In addition, the Houthi movement attacked international shipping lanes in the

Red Sea, to which both Israel and the United States responded.

While a ceasefire was brokered between Israel and Hezbollah in November

2024, in March 2026, hostilities resumed along Israel’s northern border with Lebanon, when Hezbollah resumed its attacks as part

of a broader regional escalation.

In response, Israel resumed military operations against Hezbollah in Lebanon.

in April 2024 and October 2024, Iran launched a series of drone and missile strikes against Israel, to which Israel responded.

in response to ongoing Iranian aggression and support of proxy attacks against Israel, on June 13, 2025, Israel conducted a series of

preemptive defensive air strikes in Iran targeting Iran’s nuclear program and military commanders.

While a ceasefire was reached

in June 2025 following 12 days of hostilities, on February 28, 2026, the United States and Israel launched coordinated military strikes

against Iran, including attacks on strategic military infrastructure and leadership targets, with the stated aim of degrading Iran’s

capacity to conduct or support hostile operations against them.

In response, Iran has fired missiles and drones toward population centers

and military installations in Israel, Europe and neighboring countries in the Gulf region, and also launched counter-strikes against

forces and allied bases throughout the Gulf region.

A broader regional conflict involving additional state and non-state actors

remains a significant risk How long and how severe the conflicts in Gaza, Northern Israel, Lebanon, Iran or the broader region last and

become is unknown at this time and any renewed or continued clash among Israel, Hamas, Hezbollah, Iran or other countries or militant

groups in the region may escalate in the future into a greater regional conflict.

Continued military escalation, retaliatory actions,

or broader regional involvement may adversely affect economic conditions, disrupt markets, and create uncertainty that could negatively

impact our business, financial condition and results of operations.

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

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As of the date hereof, we currently have 66 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

disruptions to our clinical studies.

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

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

If there were a disruption to our existing manufacturing

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

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

facilities and distribution capabilities.

intensity and duration of Israel’s current war 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.

date, our operations have not been adversely affected by this situation.

Five of our full-time employees in Israel were called to reserve

duty in the Israel Defense Forces, all of whom have since been released.

We currently manufacture our CGuard EPS and CGuard Prime at

our facility in Tel Aviv, Israel.

If there were a disruption to our existing manufacturing facility or our ability to procure raw materials

and ship our products, we would have no other means of manufacturing and distributing CGuard EPS or CGuard Prime until we were able to

restore the manufacturing and distribution capability at our facility or develop alternative manufacturing facilities and distribution

capabilities.

However, the intensity and duration of the security situation in Israel have been difficult to predict, as are the economic

implications on our 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, our operations may be harmed.

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

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

political conditions within Israel may affect our operations.

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

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

debate and unrest.

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.

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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.

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

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

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These market fluctuations may also significantly affect the market prices of our common

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 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.

we fail to maintain compliance with the Nasdaq minimum listing requirements, our common stock will be subject to delisting.

to publicly or privately sell equity securities and the liquidity of our common stock could be adversely affected if our common stock

common stock is listed on the Nasdaq Capital Market.

To maintain our listing, we are required to satisfy certain continued listing requirements,

including, among other things, minimum bid price, minimum market value of publicly held shares, minimum stockholders’ equity (or

other financial metrics), corporate governance requirements, and timely filing of periodic reports with the SEC.

can be no assurance that we will be able to comply with Nasdaq’s continued listing standards in the future.

If we fail to satisfy

any of Nasdaq’s continued listing requirements, we may receive a deficiency notice from Nasdaq and, depending on the nature of

the deficiency, may be afforded a limited period of time to regain compliance.

However, certain deficiencies may not be subject to a

cure period or may result in immediate delisting.

If we do not regain compliance within any applicable cure period, or if Nasdaq determines

that we are not eligible for a compliance period, Nasdaq may determine to delist our common stock.

from the Nasdaq Capital Market may adversely affect our ability to raise additional financing through the public or private sale of equity

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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

203 could delay or prohibit mergers or other takeovers 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

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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