What changed in this filing

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Item 1A. Risk Factors

2026-08-14 compared with 2026-05-07 · 147 added, 31 removed, 247 unchanged (42% of the section changed)

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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 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.

for the quarter ended June 30, 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.

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

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Accordingly, our condensed financial statements for the quarter

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

ended June 30, 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

we fail to comply with the continued listing requirements of the Nasdaq Capital Market, our common stock may be delisted and the price

of our common stock and our ability to access the capital markets could be negatively impacted.

has established certain standards for the continued listing of a security on the Nasdaq Capital Market.

The standards for continued listing

include, among other things, that the minimum bid price for the listed securities not fall below $1.00 per share for a period of 30 consecutive

trading days and that we maintain a minimum of $2,500,000 in stockholders’ equity and a market value of listed securities of at

least $5 million.

July 17, 2026, we received a notification letter, or the Notification Letter, from the Nasdaq Listing Qualifications notifying us

that we are not in compliance with the minimum bid price requirements set forth in Nasdaq Listing Rule 5550(a)(2), or the Rule, for

continued listing on The Nasdaq Capital Market.

The Notification Letter provides that we have 180 calendar days, or until

January 13, 2027, to regain compliance with the Rule.

To regain compliance, the bid price of our common stock must have a closing

bid price of at least $1.00 per share for a minimum of 10 consecutive business days.

In the event we do not regain compliance by

January 13, 2027, we may then be eligible for an additional 180 days if we meet the continued listing requirement for market value

of publicly held shares and all other initial listing standards for The Nasdaq Capital Market, with the exception of the bid price

requirement, and will need to provide written notice of our intention to cure the deficiency during the second compliance period.

we do not qualify for the second compliance period or fail to regain compliance during the second compliance period, then Nasdaq

will notify us of its determination to delist our common stock, at which point we will have an opportunity to appeal the delisting

determination to a Hearings Panel.

assurance can be given that we will be able to regain compliance with the Rule.

Failure to meet applicable Nasdaq continued listing standards

could result in a delisting of our common stock.

A delisting of our common stock from Nasdaq could materially reduce the liquidity of

our common stock and result in a corresponding material reduction in the price of our common stock.

In addition, delisting could harm

our ability to raise capital through alternative financing sources on terms acceptable to us, or at all, and may result in the potential

loss of confidence by investors, employees and fewer business development opportunities.

Our restructuring and the associated workforce

reduction may not result in anticipated savings, could result in total costs and expenses that are greater than expected and could disrupt

our business.

We have begun to implement

a restructuring plan that includes a reduction in our workforce, and we expect to continue to implement this plan.

We may incur additional

expenses not currently contemplated due to events associated with the reduction in force, and our restructuring activities may subject

us to reputational risks and litigation risks and expenses.

We may not realize, in full or in part, the anticipated benefits, savings

and improvements in our cost structure from our restructuring efforts due to unforeseen difficulties, delays or unexpected costs.

are unable to realize the expected operational efficiencies and cost savings from the restructuring, our operating results and financial

condition would be adversely affected.

In addition, to the extent we do not realize such anticipated operational efficiencies, we may

need to undertake additional workforce reductions or restructuring activities in the future.

Furthermore, our restructuring

plan may be disruptive to our operations.

For example, our workforce reductions could yield unanticipated consequences, such as attrition

beyond planned staff reductions, increased difficulties in our day-to-day operations and reduced employee morale.

The changes to our operations

and the reduction in workforce may yield unintended consequences and costs, such as the loss of institutional knowledge and expertise,

attrition beyond our intended reductions in force, and a reduction in morale among our remaining employees, all of which may have an adverse

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

If employees who were not affected by the reductions in force seek

alternative employment, this could result in our seeking contractor support at unplanned additional expense or harm our productivity.

Any employee litigation related to the headcount reduction could be costly and prevent management from fully concentrating on the business.

Our workforce reductions

could also harm our ability to attract and retain qualified management, scientific, technical, and manufacturing personnel who are critical

to our business.

For example, the workforce reduction may negatively impact our regulatory, technical operations, and commercial functions,

which would have a negative impact on our ability to successfully develop, and ultimately, commercialize our products.

We may also discover

that the reductions in workforce could make it difficult for us to pursue new opportunities and initiatives and require us to hire qualified

replacement personnel, which may require us to incur additional and unanticipated costs and expenses.

Our future financial performance

and our ability to develop our products or additional assets will depend, in part, on our ability to effectively manage any future growth

or restructuring, as the case may be.

Our failure to successfully accomplish any of the above activities and goals may have a material

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

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

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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 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), 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

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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

or failures associated with our products have led to recalls, and could lead to additional recalls, safety alerts or litigation, as well

as significant costs and negative publicity.

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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.

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.

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.

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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,

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

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

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

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 adopted, proposed and considered a variety of tariff measures and other trade restrictions affecting imports

from numerous countries, and additional changes to U.S.

trade policy remain under active consideration.

The implementation, modification,

suspension, expiration, extension or judicial review of existing or proposed tariffs and trade measures has created and may continue

to create significant uncertainty for companies engaged in international manufacturing and cross-border commerce.

In addition, new investigations

trade laws, changes to customs rules, import restrictions, sanctions or other trade-related measures could result in additional

duties, restrictions or compliance obligations affecting imported products and components.

we currently manufacture our products in Israel and remain dependent on shipments from Israel to serve the U.S.

market while we continue

efforts to expand manufacturing capacity in the United States, changes in tariffs, customs duties, import regulations or other trade

measures applicable to products imported into the United States could increase our costs, reduce our margins, disrupt our supply chain,

adversely affect customer demand or require us to modify our manufacturing, sourcing or distribution strategies.

We cannot predict the

scope, duration or outcome of current or future trade actions, related legal challenges, or any retaliatory measures by affected countries.

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

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.

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

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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.

Although the United States and Iran have announced ceasefire and de-escalation

arrangements from time to time, including a memorandum of understanding entered into on June 17, 2026 that contemplates the termination

of military operations on multiple fronts, hostilities have resumed and may continue or 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

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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