What changed in this filing

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Item 1A. Risk Factors

2026-05-07 compared with 2025-11-10 · 247 added, 243 removed, 31 unchanged (94% of the section changed)

4 unchanged sentences

has concluded that there is substantial doubt about our ability to continue as a going concern, and our condensed financial statements

for the quarter ended September 30, 2025 includes an explanatory paragraph as to our ability to continue as a going concern, which could

for the quarter ended March 31, 2026 includes an explanatory paragraph as to our ability to continue as a going concern, which could

prevent us from obtaining new financing on reasonable terms or at all.

2 unchanged sentences

Accordingly, our condensed financial statements for the quarter

ended September 30, 2025 includes an explanatory paragraph as to our potential inability to continue as a going concern.

ended March 31, 2026 includes an explanatory paragraph as to our potential inability to continue as a going concern.

The doubts regarding

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

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

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

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

Consequently,

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

the CGuard Prime Carotid Stent System 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 the CGuard Prime carotid stent system in the United State.

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

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

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 an independent commercialization plan for CGuard Prime in the U.S.

As part of our plan, we have, and continue, to build

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

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, if at all, 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 services.

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

commercial launch 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

commercialization of the CGuard Prime carotid stent system.

In addition, to support our anticipated production growth in connection with

the commercialization of the CGuard Prime carotid stent system, we have engaged Aptyx Interventional Systems (“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 Carolina.

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

supporting distribution capabilities.

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

partners include:

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

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

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

difficulty of obtaining reimbursement from governmental and commercial payers;

lack of complementary products 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.

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

of the CGuard Prime carotid stent system.

We expect that it will take time for this team to generate significant sales momentum, if it

does so at all.

We may 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 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.

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

reputation, business and financial results.

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

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

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

Regulators may also subject approvals to restrictions

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

jeopardized if such obligations are not fulfilled.

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

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

risk even after regulatory clearances have been obtained.

The FDA and similar governmental authorities in other countries have the authority

to require the recall of commercialized products in the event of material regulatory deficiencies or defects in design or manufacture.

Medical devices may also be modified after regulatory clearance is obtained to such an extent that additional regulatory clearance is

necessary before the device can be further marketed.

In these events, we may voluntarily implement a recall or market withdrawal or may

be required to do so by a regulatory authority.

For example, in May 2026, we announced a voluntary recall in the U.S.

of CGuard Prime,

initiated in consultation with the FDA.

This decision followed our determination during controlled launch that the technical success

of the delivery system during CAS procedures had not met performance expectations Such recall, and any recalls in the future, could result

in significant current and future costs and other negative impacts associated with such recalls (including inventory write-off costs,

refunds and other remediation costs), loss of revenues, sales or customers, potential actions by regulators or other governmental entities,

potential claims and lawsuits by customers and patients (including class action product liability litigation), other operational impacts

and consequences such as business disruption, loss of personnel and distraction of management or other key employees, the restatement

of previously issued financial statements, inability to raise capital, as well as negative publicity and damage to our reputation, which

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

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,

or agency action, such as inspection or enforcement action.

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

that they will not occur in the future.

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

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

and financial results.

or failures associated with our products has led to recalls, and 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.

in May 2026, we announced a voluntary recall in the U.S.

of CGuard Prime, initiated in consultation with the FDA.

This decision followed

our determination during controlled launch that the technical success of the delivery system during CAS procedures had not met performance

expectations.

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.

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, which could harm our commercial operations.

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

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

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

safe and effective than previously believed.

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

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

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

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

clinical trials;

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

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

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

with the product;

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

effects for distribution to patients;

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

and patients may stop using our product;

reputation may suffer.

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

example, in May 2026, we announced a voluntary recall in the U.S.

of CGuard Prime, initiated in consultation with the FDA.

This decision

followed our determination during controlled launch that the technical success of the delivery system during CAS procedures had not met

performance expectations.

Such recall, and any recalls in the future, could result in significant current and future costs and other

negative impacts associated with such recalls (including inventory write-off costs, refunds and other remediation costs), loss of revenues,

sales or customers, potential actions by regulators or other governmental entities, potential claims and lawsuits by customers and patients

(including class action product liability litigation), other operational impacts and consequences such as business disruption, loss of

personnel and distraction of management or other key employees, or the restatement of previously issued financial statements, inability

to raise capital, as well as negative publicity and damage to our reputation, which could have a material adverse impact on our business,

results of operations and financial condition.

modifications to our products may require new 510(k) clearances, premarket approval, or CE Marks, or may require us to recall or cease

marketing our products until new clearances or approvals are obtained.

modifications to the intended use or technological characteristics of our products will require new 510(k) clearances, premarket approvals

(“PMA”) by the FDA or CE Marks under the EU Medical Device Regulation (“MDR”) prior to implementing the modifications,

or require us to recall or cease marketing the modified devices until these clearances or approvals are obtained.

Furthermore, changes

to our manufacturing facility or supplier of components used in our products require prior FDA approval of a PMA supplement.

requires device manufacturers to initially make and document a determination of whether or not a modification requires a new approval,

supplement or clearance;

however, the FDA can review a manufacturer’s decision.

Any modification to an FDA cleared device that

would significantly affect its safety or effectiveness or that would constitute a major change in its intended use would require a new

510(k) clearance or approval of a PMA supplement.

We may not be able to obtain additional 510(k) clearances or premarket approvals for

new products or for modifications to, or additional indications for, our products in a timely fashion, or at all.

Delays in obtaining

required future clearances would harm our ability to introduce new or enhanced products in a timely manner, which in turn would harm

our future growth.

We have made modifications to our products in the past that we believe do not require additional clearances or approvals,

and we may make additional modifications in the future.

If the FDA or an EU Notified Body disagrees and requires new clearances or approvals

for any of these modifications, we may be required to recall and to stop selling or marketing our products as modified, which could harm

our operating results and require us to redesign our products.

In these circumstances, we may be subject to significant enforcement actions.

In response to the voluntary recall in the U.S.

of CGuard Prime, initiated in consultation with the FDA in May 2026, we intend to implement

design improvements to CGuard Prime.

However, there can be no assurance that such design improvements will be sufficient to obtain FDA

approval, or that any such approval will be obtained in a timely manner, if at all.

bear the risk of warranty claims on our products.

We may not be successful in claiming recovery under any warranty or indemnity provided

to us by our suppliers or vendors in the event of a successful warranty claim against us by a customer, and any recovery from such supplier

or vendor may not be adequate.

Furthermore, we may not have any, or have an adequate, warranty provided by our supplier.

warranty claims brought by our customers related to third-party components may arise after our ability to bring corresponding warranty

claims against such suppliers expires, which could result in costs to us.

In addition, we have been, and in the future could be, subject

to costs related to product recalls, and we could incur significant costs to correct any defects, warranty claims or other problems.

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

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 operations and ability to reach 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 neighboring Arab countries, 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.

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

and military targets.

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

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

These attacks resulted in extensive deaths, injuries and kidnapping

of civilians and soldiers.

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

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

In January 2025, Israel and Hamas entered

into a ceasefire agreement, which remained in effect until March 18, 2025, when hostilities resumed.

As of October 9, 2025, Israel and

Hamas entered into a renewed ceasefire agreement calling for a permanent end of the war.

However, there are no assurances that such as

agreement will hold.

While the conflict has created heightened security concerns, disruptions to business operations, and economic instability,

the ceasefire may contribute to improved regional stability.

However, the security situation remains fluid, and any renewed military

actions, restrictions, or government-imposed measures could adversely affect our operations, supply chains, and financial condition.

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, but there are no guarantees as to whether the agreement will hold or whether further

hostilities will resume.

addition, in April 2024 and October 2024, Iran 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 weapons.

In June 2025, in light of continued nuclear threats

and intelligence assessments indicating imminent attacks, Israel launched a preemptive strike directly targeting military and nuclear

infrastructure inside Iran, aimed at disrupting Iran’s capacity to coordinate or launch further hostilities against Israel, as

well as to degrade its nuclear program.

In response, Iran launched multiple waves of drones and ballistic missiles at Israeli cities.

While most of these attacks were intercepted, several caused civilian casualties and damage to infrastructure.

While a ceasefire was

reached between Israel and Iran in June 2025 after 12 days of hostilities, the situation remains volatile.

A broader regional conflict

involving additional state and non-state actors remains a significant risk.

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

These situations may potentially escalate in the future to more violent events which may affect Israel and us.

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

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

in Israel of ours.

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

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

Military service

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

prospects, financial condition and results of operations.

As of the date hereof, we currently have 66 full-time employees located in

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

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.

the intensity and duration of the security situation in Israel have been difficult to predict, as were the economic implications on our

business and operations and on Israel’s economy in general, the ceasefire marks a potential shift towards stability in the region.

If sustained, this could reduce the risk of disruptions to our business and the Israeli economy in general.

However, if the war is renewed

or expands to other fronts, such as Lebanon, Syria and the West Bank, our operations may be harmed.

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.

While a temporary ceasefire agreed to between Iran and the U.S.

2026 as part of ongoing negotiations for a permanent ceasefire agreement, the situation remains volatile and uncertain.

ceasefire has been subject to extensions and continued diplomatic engagement, it has reportedly been characterized by tensions, alleged

violations and stalled negotiations.

We cannot predict if and to what extent this ceasefire will remain in effect or upheld or whether

hostilities may resume or further escalate.

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.

of our employees may be obligated to perform military reserve duty generally until they reach the age of 40 (or older, for officers or

other citizens who hold certain positions in the Israeli armed forces reserves) and, in the event of a military conflict, may be called

to active duty.

In response to increases in terrorist activity and military conflicts in Israel, there have been periods of significant

call-ups of military reservists.

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

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

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

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

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

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.

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.

Further, 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 sanctions).

If new tariffs are enacted 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

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.

Unregistered Sales of Equity Securities and Use of Proceeds

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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-Q

Item 1A. Risk Factors