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Item 1A. Risk Factors

2025-05-08 compared with 2024-11-12 · 68 added, 29 removed, 56 unchanged (63% 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, 2024 includes an explanatory paragraph as to our ability to continue as a going concern, which could

for the quarter ended March 31, 2025 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.

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Accordingly, our condensed financial statements for the quarter

ended September 30, 2024 includes an explanatory paragraph as to our potential inability to continue as a going concern.

ended March 31, 2025 includes an explanatory paragraph as to our potential inability to continue as a going concern.

The doubts regarding

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adverse effect on our business relationships and profitability.

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

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

Our business is directly affected

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

In addition, since the commencement

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

and on other fronts from various extremist groups in region, such as the Houthis in Yemen and various rebel militia groups in Syria and

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 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

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 conflict.

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

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

various rebel militia groups in Syria and Iraq.

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

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

In addition, Iran recently launched direct attacks on Israel

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

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

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

These situations may potentially escalate in the future

to more violent events which may affect Israel and us.

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

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

Such clashes may escalate in the future into a greater regional

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

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

employees in Israel.

Although many of such military reservists have since been released, including the majority of 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.

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 62 full-time employees located

in Israel and 18 employees located outside of Israel.

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, and we have not experienced

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facilities and distribution capabilities.

intensity and duration of the current security situation in Israel 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, and

we continue to monitor the situation closely and examine the potential disruptions that could adversely affect our operations .

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

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

If the ceasefires declared collapse or a new

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

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

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debate and unrest.

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

Actual or perceived political instability in Israel

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

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

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

Changes 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.

manufacture, package and distribute all of our products, including the CGuard Prime carotid stent system, which is under FDA review for

commercial approval, 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 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.

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