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Item 1. Financial Statements

2026-05-07 compared with 2025-11-10 · 233 added, 364 removed, 156 unchanged (79% of the section changed)

1 unchanged sentence

CONSOLIDATED FINANCIAL STATEMENTS

OF AND FOR THE QUARTER ENDED SEPTEMBER 30, 2025

OF AND FOR THE QUARTER ENDED MARCH 31, 2026

CONSOLIDATED FINANCIAL STATEMENTS (UNAUDITED):

6 unchanged sentences

dollars in thousands, except share and per share data)

September 30,

CURRENT ASSETS:

Cash and cash equivalents

Cash and cash

Marketable securities

4 unchanged sentences

Long term deposit

Property, plant and equipment, net

Operating lease right of use assets

Fund in respect of employee rights upon retirement

Property, plant and equipment,

Operating lease right of

Fund in respect of employee

rights upon retirement

TOTAL NON-CURRENT ASSETS

1 unchanged sentence

dollars in thousands other than share and per share data)

September 30,

LIABILITIES AND EQUITY

1 unchanged sentence

Accounts payable and accruals:

TOTAL CURRENT LIABILITIES

CURRENT LIABILITIES

LONG-TERM LIABILITIES-

Operating lease liabilities net of current maturities

Liability for employees’ rights upon retirement and others

TOTAL LONG-TERM LIABILITIES

TOTAL LIABILITIES

COMMITMENTS AND CONTINGENT LIABILITIES

Operating lease liabilities

net of current maturities

for employee rights upon retirement and others

LONG-TERM LIABILITIES

COMMITMENTS AND CONTINGENT

Common stock, par value $ 0.0001 per share;

150,000,000 shares authorized at September 30, 2025 and December 31, 2024;

41,919,141 and 26,611,033 shares issued and outstanding at September 30, 2025 and December 31, 2024, respectively

Preferred C shares, par value $ 0.0001 per share;

1,172,000 shares authorized at September 30, 2025 and December 31, 2024;

1,718 shares issued and outstanding at September 30, 2025 and December 31 2024, respectively

150,000,000 shares authorized at March 31, 2026 and December 31, 2025;

46,838,963 and 43,532,281 shares issued and outstanding at

March 31, 2026 and December 31, 2025, respectively

Preferred C shares, par value $ 0.0001 per

1,172,000 shares authorized at March 31, 2026 and December 31, 2025;

1,718 shares issued and outstanding at March 31, 2026

and December 31 2025

Additional paid-in capital

Accumulated deficit

Total liabilities and equity

* Represents an amount

less than $1 thousand

liabilities and equity

an amount less than $1 thousand

accompanying notes are an integral part of the condensed consolidated financial statements.

1 unchanged sentence

dollars in thousands, except share and per share data)

Three months ended

September 30,

Nine months ended

September 30,

Months Ended March 31,

COST OF REVENUES

2 unchanged sentences

Selling and marketing

General and administrative

Total operating expenses

and administrative

operating expenses

LOSS FROM OPERATIONS

FINANCIAL INCOME, net

NET LOSS PER SHARE - basic and diluted

WEIGHTED AVERAGE NUMBER OF ORDINARY SHARES USED IN COMPUTING NET LOSS PER SHARE - basic and diluted

LOSS PER SHARE - basic and diluted

AVERAGE NUMBER OF COMMON STOCK USED IN COMPUTING NET LOSS PER SHARE - basic and diluted

accompanying notes are an integral part of the condensed consolidated financial statements.

1 unchanged sentence

dollars in thousands, except share data)

Preferred C shares

Additional paid-in

BALANCE AT January 1, 2025

Exercise of pre-funded warrants

Exercise of Warrants Series H to 12,621,090 pre-funded warrants and 292,996 common stock, net of $ 1,000 issuance costs

Issuance of common shares, Included at the market offering net of $ 1 issuance costs

Share-based compensation related to stock, restricted stock,

restricted stock units and stock options award, net of forfeitures of 112,382

BALANCE AT September 30, 2024

* Represents an amount

less than $1 thousand

accompanying notes are an integral part of the condensed consolidated financial statements.

CONSOLIDATED STATEMENTS OF CHANGES IN EQUITY

dollars in thousands, except share data)

Preferred C shares

Additional paid-in

BALANCE AT July 1, 2024

Exercise of pre-funded warrants

Issuance of common shares, Included at the market offering net of $ 1 issuance costs

Share-based compensation related to stock, restricted stock,

restricted stock units and stock options award

BALANCE AT September 30, 2024

* Represents an amount

less than $1 thousand

Exercise of pre-funded

of common stock, included at the market offering net of $ 22 issuance costs

compensation related to restricted stock, restricted stock units and stock options award, net of forfeitures of 29,295 shares

BALANCE AT March 31,

an amount less than $1 thousand

accompanying notes are an integral part of the condensed consolidated financial statements.

1 unchanged sentence

dollars in thousands, except share data)

Preferred C shares

Additional paid-in

BALANCE AT January 1, 2026

Exercise of pre-funded warrants

Issuance of common stock, included at the market offering and pre-funded warrants net of $ 3,148

issuance costs

Exercise of Warrants Series I to 10,561,685 pre-funded warrants and 2,352,393 common stock, net of $ 1,000 issuance costs

Share-based compensation related to restricted stock, restricted stock units and stock options award, net of forfeitures of 322,919 shares

BALANCE AT September 30, 2025

* Represents an amount

less than $1 thousand

accompanying notes are an integral part of the condensed consolidated financial statements.

CONSOLIDATED STATEMENTS OF CHANGES IN EQUITY

dollars in thousands, except share data)

Preferred C shares

Additional paid-in

BALANCE AT July 1, 2025

Exercise of pre-funded warrants

Exercise of Warrants Series I to 10,561,685 pre-funded warrants and 943,641 common stock, net of $ 891 issuance costs

Exercise of Warrants to pre-funded warrants and common stock,

net of issuance costs

Issuance of common stock, included at the market offering and

9,764,804 pre-funded warrants net of $ 3,126

issuance costs

Issuance of common stock, included at the market offering and

pre-funded warrants net of issuance costs

Share-based compensation related to restricted stock, restricted stock units and stock options award, net of forfeitures of 34,712 shares

Share-based compensation related to stock, restricted stock,

restricted stock units and stock options award, net of forfeitures of shares

BALANCE AT September 30, 2025

* Represents an amount

less than $1 thousand

compensation related to restricted stock, restricted stock units and stock options award, net of forfeitures of 276,373 shares

compensation related to restricted stock, restricted stock units and stock options award, net of forfeitures of shares

BALANCE AT March 31,

an amount less than $1 thousand

accompanying notes are an integral part of the condensed consolidated financial statements.

1 unchanged sentence

dollars in thousands)

Nine months ended

CASH FLOWS FROM OPERATING ACTIVITIES:

Adjustments required to reconcile net loss to net cash used in operating activities:

Gain from sale of property, plant and equipment

Changes in fair value of marketable securities, net of interest received

Change in liability for employees’ rights upon retirement

Other financial income

Change in operating right of use asset and operating leasing liability

Share-based compensation expenses

Loss (gain) on amounts funded in respect of employee rights upon retirement, net

Changes in operating asset and liability items:

Decrease (increase) in prepaid expenses

Decrease (increase) in trade receivables

Decrease (increase) in other receivables

Increase in inventory

CASH FLOWS FROM OPERATING

Adjustments required to

reconcile net loss to net cash used in operating activities:

Change in fair value of

marketable securities, net of interest received

Change in liability for

employees rights upon retirement

Other financial expenses

Change in operating right

of use asset and operating leasing liability

Share-based compensation

Loss (gains) on amounts

funded in respect of employee rights upon retirement, net

Changes in operating assets

and liability items:

Decrease in prepaid expenses

Increase in trade receivables

Decrease (increase) in

other receivables

(Increase) decrease in

Increase in trade payables

Increase in other payables

Net cash used in operating activities

CASH FLOWS FROM INVESTING ACTIVITIES:

Purchase of property, plant and equipment

Proceeds from sale of property, plant and equipment

Investments in marketable securities

Proceeds from matured marketable securities

Amounts funded in respect of employee rights upon retirement

Net cash provided by investing activities

CASH FLOWS FROM FINANCING ACTIVITIES:

Proceeds from exercise of warrants, net of $ 1,000

issuance costs

Proceeds from issuance of shares and pre-funded warrants, net of $ 3,148

issuance costs, respectively

Net cash provided by financing activities

EFFECT OF EXCHANGE RATE CHANGES ON CASH AND CASH EQUIVALENTS

INCREASE IN CASH AND CASH EQUIVALENTS

BALANCE OF CASH AND CASH EQUIVALENTS AT BEGINNING OF THE PERIOD

BALANCE OF CASH AND CASH EQUIVALENTS AT END OF THE PERIOD

SUPPLEMENTAL NON-CASH INVESTING AND FINANCING ACTIVITIES:

Acquisition of right-of-use assets by means of lease liabilities

Non- cash purchase of property and equipment

in other payables

cash used in operating activities

CASH FLOWS FROM INVESTING

Purchase of property, plant

and equipment

Investments in marketable

Proceeds from matured marketable

funded in respect of employee rights upon retirement

cash provided by investing activities

CASH FLOWS FROM FINANCING

from issuance of shares

cash provided by financing activities

OF EXCHANGE RATE CHANGES ON CASH AND CASH EQUIVALENTS

INCREASE (DECREASE) IN CASH

AND CASH EQUIVALENTS

OF CASH AND CASH EQUIVALENTS AT BEGINNING OF THE PERIOD

OF CASH AND CASH EQUIVALENTS AT END OF THE PERIOD

SUPPLEMENT NON-CASH INVESTING

AND FINANCING ACTIVITIES:

Receivable on account of

share issuance

Non-cash purchase of property

and equipment

accompanying notes are an integral part of the condensed consolidated financial statements.

1 unchanged sentence

1 - DESCRIPTION OF BUSINESS

InspireMD, Inc., a Delaware corporation (the “Company”), together with its subsidiaries, is a medical device company focusing on the development and commercialization of its proprietary MicroNet™ stent platform technology for the treatment of complex vascular and coronary disease.

MicroNet, a micron mesh sleeve, is wrapped over a stent to provide embolic protection in stenting procedures.

The Company’s carotid product (CGuard™ EPS) combines MicroNet

and a self-expandable nitinol stent in a single device to treat carotid artery disease.

June 13, 2025, the Company received CE Mark approval under the European Medical Device Regulation for the CGuard Prime carotid stent

On June 23, 2025, the U.S.

Food and Drug Administration (“FDA”) granted premarket application (PMA) approval

of the CGuard Prime Carotid Stent System in the United States, and in July 2025, the Company announced the official commercial launch

of the CGuard Prime carotid stent system in the United States.

In the United States, following FDA approval of the PMA of the CGuard

Prime Carotid Stent System, the Company markets and sells its product through a direct sales organization.

In addition, the Company

also markets and sells its product through distributors in international markets, mainly in Europe.

Company has an accumulated deficit as of September 30, 2025, as well as a history of net losses and negative operating cash flows.

The Company expects to continue incurring losses and negative cash flows from operations until its product, CGuard™ EPS, reaches

commercial profitability.

As a result of these expected losses and negative cash flows from operations, along with the Company’s

current cash position, the Company does not have sufficient resources to fund operations for at least the next 12 months.

there is substantial doubt about the Company’s ability to continue as a going concern.

These financial statements have been

prepared assuming that the Company will continue as a going concern and do not include any adjustments that might result from the

outcome of this uncertainty.

plans include the continued commercialization of the Company’s product and raising capital through the sale of additional equity

securities, debt or capital inflows from strategic partnerships and exercise of warrants.

There are no assurances however, that the

Company will be successful in obtaining the level of financing needed for its operations.

If the Company is unsuccessful in commercializing

its products and raising capital, it may need to reduce activities, curtail or cease operations.

Inc., a Delaware corporation (the “Company”), together with its subsidiaries in Israel and Germany, is a medical device

company specializing in the development and commercialization of products for the treatment of carotid artery disease and other vascular

The Company’s portfolio includes two commercial products based on its proprietary CGuard™ carotid stent technology,

designed to provide market-leading embolic protection during and after stenting procedures.

A stent is an expandable scaffold-like

metallic device placed in an artery to widen the lumen and restore blood flow.

Company’s first product, the CGuard™ Carotid Embolic Prevention System (“CGuard EPS”), integrates a self-expanding

nitinol stent with a MicroNet™ mesh sleeve as a single device for carotid artery revascularization.

The Company has received

CE Mark recertification for CGuard EPS under the EU Medical Device Regulation (“MDR”).

The Company’s CGuard EPS

previously held CE Mark approval under the former Medical Device Directive (“MDD”).

CGuard EPS is marketed in over 30

countries outside the United States, mainly in Europe, through a network of distributors.

Company’s second product, the CGuard™ Prime Carotid Stent System (“CGuard

Prime”), uses the same stent and MicroNet mesh with a differentiated deployment mechanism.

CGuard Prime received premarket approval (“PMA”) by the U.S.

Food and Drug Administration

(“FDA”) on June 23, 2025, and is marketed exclusively in the United States through

the Company’s direct salesforce.

It also received MDR CE Mark approval on June 12,

to March 31, 2026, the Company announced a voluntary recall in the U.S.

for its CGuard®

Prime 135 cm carotid stent delivery system, initiated in consultation with the FDA.

The Company acted after determining during a controlled launch that the technical success

of the delivery system during carotid artery stenting procedures had not met performance

expectations.

The voluntary action pertained specifically to the CGuard Prime delivery system

and did not include the CGuard stent implant.

The action was strictly voluntary with no implications

to the safety of patients who have previously undergone the procedure to implant a CGuard

connection with the recall, the Company estimates that the reserves to be recognized are approximately

$ 700,000 for customer returns and approximately $ 650,000 for inventory impairment and remediation

Company has an accumulated deficit as of March 31, 2026, as well as a history of net losses and negative operating cash flows.

Company expects to continue incurring losses and negative cash flows from operations until the Company expands its commercial revenue

to a scale that funds its commercial resources, development activities and support functions.

As a result of these expected losses

and negative cash flows from operations, along with the Company’s current cash position, the Company does not have sufficient

resources to fund operations for at least the next 12 months.

Therefore, there is substantial doubt about the Company’s ability

to continue as a going concern.

These financial statements have been prepared assuming that the Company will continue as a going

concern and do not include any adjustments that might result from the outcome of this uncertainty.

plans include the continued commercialization of the Company’s products and raising capital through the sale of additional

equity securities, debt or capital inflows from strategic partnerships and exercises of warrants.

There are no assurances, however,

that the Company will be successful in obtaining the level of financing needed for its operations.

If the Company is unsuccessful

in commercializing its products and raising capital, it may need to reduce activities, curtail or cease operations.

Related to the Company’s Operations in Israel

October 2023, Israel was attacked by the Hamas terrorist organization and entered a state of war on several fronts.

In June 2025, following

escalating threats and intelligence reports of imminent attacks, Israel conducted preemptive strikes on military and nuclear infrastructure

Iran responded with drones and missiles attacks, some of which caused civilian casualties and infrastructure damage.

days of hostilities, a ceasefire between Israel and Iran was reached in June 2025.

As of October 9, 2025, Israel and Hamas entered into

a ceasefire agreement calling for a permanent end of the war.

However, there are no assurances that such agreements will hold.

while the ceasefire marks a potential shift towards stability in the region, the situation remains volatile, and the risk of broader

regional escalation involving additional actors persists.

As of the date of these consolidated financial statements, conflict continues

in parts of the region.

The Company’s operations, including its current production facility, are located in Israel.

At this time,

these activities remain largely unaffected.

the nine and three months ended September 30, 2025 and 2024, the impact of this war on the Company’s results of operations and

financial condition was immaterial, but such impact may increase, which could be material, as a result of the continuation, escalation

or expansion of such war.

TO THE CONDENSED CONSOLIDATED FINANCIAL STATEMENTS

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.

In addition, Iran, Hezbollah and the Houthi movement attacked military and civilian

targets in Israel, to which Israel responded, including through increased air and/or ground operations in Lebanon, Syria, Yemen and Iran.

Following years of conflict in the region, 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.

On February 28, 2026, the United States and Israel launched joint combat

operations in Iran to which Iran and Hezbollah responded with ballistic missile and drone attacks on Israel as well as other countries

military bases in the region.

On April 8, 2026, the United States and Iran agreed to a two-week ceasefire.

How long and how severe

the current conflicts in Gaza, Northern Israel, Lebanon, Iran or the broader region last and become is unknown at this time and any 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.

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.

As of the date of these consolidated financial statements,

conflict continues in parts of the region.

The Company’s current manufacturing facility, certain of its key personnel and one of

its offices are located in Israel.

At this time, these activities remain largely unaffected.

the three months ended March 31, 2026 and 2025, the impact of this war on the Company’s results of operations and financial

condition was immaterial, but such impact may increase, which could be material, as a result of the continuation, escalation or expansion

2 - BASIS OF PRESENTATION

accompanying unaudited consolidated financial statements have been prepared on the same basis as the annual consolidated financial statements.

In the opinion of the company, all adjustments considered necessary for a fair statement of the results of the interim periods reported

herein have been included (consisting only of normal recurring adjustments).

These condensed consolidated financial statements and notes

thereto are unaudited and should be read in conjunction with the Company’s audited financial statements for the year ended December

accompanying unaudited condensed consolidated financial statements have been prepared on the same basis as the annual consolidated financial

In the opinion of the Company, the financial statements reflect all adjustments, which include only normal recurring adjustments,

necessary for a fair statement of its financial position as of March 31, 2026, and its results of operations, changes in equity and cash

flows for the three months ended March 31, 2026, and 2025.

These unaudited condensed consolidated financial statements and notes thereto

are unaudited and should be read in conjunction with the Company’s audited financial statements for the year ended December 31,

2025, as found in the Company’s Annual Report on Form 10-K, filed with the Securities and Exchange Commission on March 18, 2026.

The results of operations for the nine and three months ended September 30, 2025 are not necessarily indicative of results that

could be expected for the entire fiscal year.

The results of operations for the three months ended March 31, 2026, are not necessarily indicative of results that could be expected

for the entire fiscal year.

3 - RECENTLY ADOPTED AND ISSUED ACCOUNTING PRONOUNCEMENTS

issued accounting pronouncement, not yet adopted

December 2023, the Financial Accounting Standards Board (“FASB”) issued Accounting Standards Update (“ASU”)

2023-09 “Income Taxes (Topic 740):

Improvements to Income Tax Disclosures”.

This guidance is intended to enhance the

transparency and decision-usefulness of income tax disclosures.

The amendments in ASU 2023-09 address investor requests for enhanced

income tax information primarily through changes to disclosure regarding rate reconciliation and income taxes paid both in the U.S.

and in foreign jurisdictions.

ASU 2023-09 is effective for fiscal years beginning after December 15, 2024 on a prospective basis,

with the option to apply the standard retrospectively.

Early adoption is permitted.

The Company is currently evaluating this guidance

to determine the impact it may have on its consolidated financial statements and disclosures.

November 2024, the FASB issued ASU No.

1 unchanged sentence

Disclosures (Subtopic 220-40).

The ASU improves the disclosures about a public business entity’s expenses and provides more

The ASU improves the disclosures about a public business entity’s expense and provides more

detailed information about the types of expenses in commonly presented expense captions.

7 unchanged sentences

The Company is currently evaluating this

ASU to determine its impact on the Company’s financial statements and disclosures.

In July 2025, the FASB issued Accounting Standards Update 2025-05, Financial Instruments- Credit Losses (Topic 326):

Measurement of

Credit Losses for Accounts Receivable and Contract Assets (“ASU 2025-05”).

ASU 2025-05 provides a practical expedient that

all entities can use when estimating expected credit losses for current accounts receivable and current contract assets arising from transactions

accounted for under ASC 606, Revenue from Contracts with Customers.

Under this practical expedient, an entity is allowed to assume that

the current conditions it has applied in determining credit loss allowances for current accounts receivable and current contract assets

remain unchanged for the remaining life of those assets.

ASU 2025-05 is effective for fiscal years beginning after December 15, 2025,

and interim reporting periods in those years.

Entities that elect the practical expedient and, if applicable, make the accounting policy

election are required to apply the amendments prospectively.

The Company is currently evaluating the potential impact of this guidance

on its consolidated financial statements and disclosures.

TO THE CONDENSED CONSOLIDATED FINANCIAL STATEMENTS

ASU to determine its impact on the Company’s consolidated financial statements and disclosures.

4 – FAIR VALUE MEASUREMENTS

10 unchanged sentences

The fair value hierarchy gives the lowest priority to Level

Company’s financial assets are subject to fair value measurements on a recurring basis and the level of input used in such measurements

Company’s financial assets subject to fair value measurements on a recurring basis and the level of inputs used in such measurements

were as follows:

SCHEDULE OF FINANCIAL ASSETS SUBJECT TO FAIR VALUE MEASUREMENTS

As of September 30, 2025

of March 31, 2026

in thousands)

Cash equivalents-

Money market funds

As of December 31, 2024

Marketable securities-

U.S government bonds

of December 31, 2025

in thousands)

Cash equivalents-

Money market funds

Marketable securities-

government bonds

U.S government bonds

Company’s cash equivalents and marketable securities are classified within Level 1 and Level 2 because it uses quoted market prices

or alternative pricing sources and models utilizing market observable inputs to determine their fair value.

cost of marketable securities as of December 31, 2024, is $ 15,277 thousand.

As of September 30, 2025, all marketable securities

have matured.

TO THE CONDENSED CONSOLIDATED FINANCIAL STATEMENTS

cost of marketable securities as of March 31, 2026, and December 31,2025 is $ 30,227 and $ 45,091 thousand, respectively.

5 - MARKETABLE SECURITIES

of December 31, 2024, all of the Company’s investment in marketable securities had contractual maturity of less than one

table below sets forth a summary of the changes in the fair value of the Company’s marketable securities for the nine-month period

ended September 30, 2025, and 2024:

of December 31, 2025, all of the Company’s marketable securities had contractual maturities of less than one year.

table below sets forth a summary of the changes in the fair value of the Company’s marketable securities for the three-month periods

ended March 31, 2026, and 2025:

OF CHANGES IN FAIR VALUE OF MARKETABLE SECURITIES

Nine months ended

September 30,

in thousands)

1 unchanged sentence

Interest Received

Changes in fair value during the period

Balance at end of the period

Company elected the fair value option to measure and recognize its investments in debt securities in accordance with Accounting Standards

Codification ASC 825, Financial Instruments as the Company managed and evaluated the performance on a fair value basis.

TO THE CONDENSED CONSOLIDATED FINANCIAL STATEMENTS

of September 30, 2025, there were 1,718 shares of Series C Preferred Stock outstanding, convertible into an aggregate of 7,952 shares

Changes in fair value

during the period

Balance at end of the

Capital Stock

of March 31, 2026, the Company had 155,000,000 authorized shares of capital stock, par value $ 0.0001 per share, of which 150,000,000

are shares of common stock and 5,000,000 are shares of “blank check” preferred stock.

of March 31, 2026, there were 1,718 shares of Series C preferred stock outstanding, convertible into an aggregate of 7,952 shares

of the Company’s common stock, with a total stated value of $ 10,997 .

As of September 30, 2025, there are 44,092,107 outstanding pre-funded warrants.

Prior to June 30, 2025, pre-funded warrants were exercised on a cashless basis;

from July 1, 2025 through September 30, 2025, pre-funded

warrants were exercised for cash.

of September 30, 2025, the Company has outstanding warrants to purchase an aggregate of 26,935,323 shares of common stock as follows:

of March 31, 2026, there are 43,092,107 outstanding pre-funded warrants.

of March 31, 2026, the Company has outstanding warrants to purchase an aggregate of 25,828,164 shares of common stock as follows:

SCHEDULE OF ISSUANCE OF WARRANTS TO PURCHASE COMMON STOCK

Exercise price

Expiration date

Series F Warrants

October 16, 2025

Series G Warrants

February 8, 2026

Series J Warrants

1 unchanged sentence

Total Warrants

Series J Warrants and Series K Warrants have a term of the earlier of (i) May 15, 2028 and (ii) (A) in the case of the Series J Warrants,

20 trading days following the Company’s announcement of receipt of FDA approval for the SwitchGuard and CGuard Prime 80 and

(B) in the case on the Series K Warrants, 20 trading days following the end of the fourth fiscal quarter after the fiscal quarter

in which the first commercial sales of the CGuard Carotid Stent System in the United States begins.

October 16, 2025, a total of 14,815 Series F warrants expired.

Exercise of Series I Warrant

the Company’s announcement on June 24, 2025, that the FDA approved the PMA of the CGuard Prime Carotid Stent System in the

United States, and as of September 30, 2025, an aggregate of 12,914,078

Series I Warrants were exercised into 2,352,393

shares of common stock at an exercise price of $ 1.3827

per share and 10,561,685 pre-

funded warrants at an exercise price of $ 1.3826

per pre-funded warrant, resulting in gross proceeds of approximately $ 17,855

thousand dollars.

After deducting issuance costs of $ 1,000 thousand, the net proceeds

amounted to approximately $ 16,855 thousand.

Private Placement

July 30, 2025, the Company entered into a securities purchase agreement (the “Purchase Agreement”) with investors

pursuant to which the Company issued and sold in a private placement (the “Private Placement Offering) of an aggregate of 6,791,380 shares

(the “Private Placement Shares”) of the Company’s common stock, and pre-funded warrants (the “Pre-Funded

Warrants”) to purchase up to 9,764,804 shares

of common stock, at an offering price of $ 2.42

per Private Placement Share and $ 2.4199

per Pre-Funded Warrant.

The Pre-Funded Warrants are immediately exercisable at an exercise price of $ 0.0001

per share and will not expire until exercised in full.

The Private Placement Offering resulted in gross proceeds to the Company of

approximately $ 40.1

million and closed on August 1, 2025 .

The issuance costs amounted to $ 3,084 thousand.

During the nine months ended September 30, 2025, 718,913

shares of common stock have been sold under the ATM program for total gross proceeds of approximately $ 1.8

million and total fees of approximately $ 64 thousand.

TO THE CONDENSED CONSOLIDATED FINANCIAL STATEMENTS

As of September 30, 2025, the Company had 155,000,000 authorized shares of capital stock, par value $ 0.0001 per share, of which 150,000,000

are shares of common stock and 5,000,000 are shares of “blank check” preferred stock.

the nine months ended September 30, 2025, the Company granted 3,303,618 restricted shares of the Company’s common stock to

employees and directors.

The shares to employees are subject to a three-year vesting period, with one-third of such awards vesting

The shares to directors are subject to a one-year vesting period.

* The Series J Warrants

and Series K Warrants have a term of the earlier of (i) May 15, 2028 and (ii) (A) in the case of the Series J Warrants, 20 trading days

following the Company’s announcement of receipt of FDA approval for the SwitchGuard and CGuard Prime 80 cm and (B) in the case

on the Series K Warrants, 20 trading days following the end of the fourth fiscal quarter after the fiscal quarter in which the first

commercial sales of CGuard Prime in the U.S.

Following the commencement of the first commercial sales of CGuard Prime

in the United States, which occurred during the third fiscal quarter of 2025 in July 2025, the Series K Warrants are scheduled to expire

twenty (20) trading days after the end of the fourth fiscal quarter thereafter, which is October 28, 2026.

During the three months ended March 31, 2026, a total of 1,092,344 Series G warrants expired unexercised.

the three months ended March 31, 2026, the Company granted 3,583,055 restricted shares of the Company’s common stock to employees

and directors.

The shares granted to employees are subject to a three-year vesting period, with one-third of such awards vesting

each year, subject to continued service.

The shares granted to directors are subject to a one-year vesting period, subject to continued

fair value of the above restricted shares was approximately $ 5.7 million.

the nine months ended September 30, 2025, the Company granted 558,417 restricted share units of the Company’s common stock to the

chief executive officer.

The shares are subject to a three-year vesting period, with one-third of such awards vesting each year.

the three months ended March 31, 2026, the Company granted 1,114,792 restricted stock units convertible into shares of the Company’s

common stock to the Company’s chief executive officer.

The restricted stock units are subject to a three-year vesting period,

with one-third of such awards vesting each year, subject to continued service.

fair value of the above restricted share units was approximately $ 1.8 million.

the nine months ended September 30, 2025, the Company granted to employees and directors options to purchase a total of 1,092,851 shares

of the Company’s common stock.

The options have exercise prices ranging from $ 2.24 -$ 2.79 per share, which was the fair market value

of the Company’s common stock on the respective dates of the grant.

The options to employees are subject to a three-year vesting

period, with one-third of such awards vesting each year.

The options to directors are subject to a one-year vesting period.

calculating the fair value of the above options, the Company used the following assumptions:

dividend yield of 0 % and expected term of

5.5 - 6.5 years;

expected volatility ranging from 75.74 %- 92.69 %;

and risk-free interest rate ranging from 3.89 %- 4.68 %.

fair value of the above options, using the Black-Scholes option-pricing model, was approximately $ 2.18 million.

7 – RELATED PARTIES TRANSACTIONS

the nine and three months ended September 30, 2024, and 2025, a member of the immediate family of the CEO provided certain administrative

services in connection with the Company’s expansion to the U.S.

in the amount of $ 55 and $ 25 thousand, for 2024, and $ 56 and $ 8

thousand for 2025, respectively.

In July 2025, the engagement with the related party was terminated.

the three months ended March 31, 2025, administrative services provided by a member of the chief executive officer’s immediate

family in connection with the Company’s expansion to the U.S.

amounted to $ 24 thousand.

The engagement with the related party was

terminated in July 2025.

8 - NET LOSS PER SHARE :

4 unchanged sentences

units and Series C preferred stock as the effect is anti-dilutive.

total number of shares of common stock related to outstanding options, warrants, unvested restricted stock, unvested restricted

stock units and Series C preferred stock, which were excluded from the calculations of diluted loss per share were 37,695,155

and 48,619,222 for

the nine and three-month periods ended September 30, 2025 and 2024, respectively.

This amount includes 5,385,272

and 3,979,486

of unvested restricted stock included in the number of issued and outstanding shares for the nine and three-month periods ended

September 30, 2025 and 2024, respectively.

the purpose of calculating basic net loss per share, the additional shares of common stock that are issuable upon exercise of the pre-funded

1 unchanged sentence

260-10-45-13, and have no vesting or other contingencies associated with them.

TO THE CONDENSED CONSOLIDATED FINANCIAL STATEMENTS

the nine and three months ended September 30, 2025 and 2024, the weighted average number of ordinary shares used in computing net loss

per share - basic and diluted was as follows:

total number of shares of common stock related to outstanding options, warrants, unvested restricted stock, unvested restricted stock

units and Series C preferred stock, which were excluded from the calculations of diluted loss per share were 39,285,493 shares and 52,233,293

shares for the three-month period ended March 31, 2026 and 2025, respectively.

This amount includes unvested restricted stock included

in the number of issued and outstanding shares in the amounts of 7,315,673 and 5,671,612 as of March 31, 2026, and 2025, respectively.

the three months ended March 31, 2026, and 2025, the weighted average number of common stock used in computing net loss per share - basic

and diluted was as follows:

OF WEIGHTED AVERAGE NUMBER OF SHARES

Three months ended

September 30,

Nine months ended

September 30,

Weighted average number of ordinary shares

Weighted average number of common stock

Weighted average Vested restricted stock units

Weighted average Pre-funded Warrants

Total Weighted average number of ordinary shares used in computing net loss per share - basic and diluted

9 – LEASE AGREEMENTS

May 18, 2025, the Company took possession of Suite 280 at its U.S.

headquarters in Miami, Florida, following the landlord’s

completion of construction.

This date represents the commencement of the lease for Suite 280, in accordance with the terms of the

In connection with the commencement, the Company recognized an increase of 302 thousand dollars in both operating lease

right-of-use assets and operating lease liabilities.

May 28, 2025, the Company amended the Israeli Lease, extending the lease term through December 31, 2028, and leasing additional space

within the facility.

The amendment resulted in an increase of 692 thousand dollars to the Company’s operating lease right-of-use

assets and lease liabilities to reflect the extended lease term and additional leased area.

Total Weighted average

number of common stock used in computing net loss per share - basic and diluted

9 - FINANCIAL INSTRUMENTS :

value of financial instruments

carrying amounts of financial instruments approximate their fair value either because these amounts are presented at fair value, due

to the relatively short-term maturities of certain instruments or they are measured using interest rates close to prevailing market rates.

of September 30, 2025, and December 31, 2024, allowance for expected credit loss was immaterial.

TO THE CONDENSED CONSOLIDATED FINANCIAL STATEMENTS

As of March 31, 2026, and December 31, 2025,

the carrying amounts of accounts payable, accounts receivable and other receivables approximate their fair values due to the short-term

maturities of these instruments.

The carrying amount of the long-term deposit

approximates its fair value since it is measured at its present value applying prevailing interest rates.

of March 31, 2026, and December 31, 2025, the allowance for expected credit loss was immaterial.

10 - INVENTORY :

OF INVENTORIES

September 30,

in thousands)

5 unchanged sentences

OF ACCOUNTS PAYABLE AND ACCRUALS - OTHER

September 30,

in thousands)

2 unchanged sentences

Accrued expenses

Clinical trials accrual

Clinical trial accrual

Current Operating lease liabilities

Accounts Payable and

Accruals - Other

13 - DISAGGREGATED REVENUE :

Payable and Accruals - Other

12 - DISAGGREGATED REVENUE AND ENTITY WIDE DISCLOSURES :

are attributed to geographic areas based on the location of the customers.

1 unchanged sentence

SCHEDULE OF REVENUES ATTRIBUTED TO GEOGRAPHIC AREAS

Three months ended

Nine months ended

in thousands)

individual countries do not exceed 10% in the nine and three months ended September 30, 2025 and 2024.

principal customers:

* Other countries

don’t exceed 10% in the three months ended March 31, 2026, and 2025.

principal customers (part of revenues):

OF REVENUES ATTRIBUTED TO GEOGRAPHIC AREAS BY PRINCIPAL CUSTOMERS

Three months ended

September 30,

Nine months ended

September 30,

Sales percentage

TO THE CONDENSED CONSOLIDATED FINANCIAL STATEMENTS

13 – SEGMENT INFORMATION

2 unchanged sentences

The Company’s Chief

Operating Decision Maker (“CODM”), who is the CEO evaluates the Company’s performance based on its internal reporting

which is consistent with the presentation in the Company’s consolidated financial statements.

Accordingly, our CODM uses consolidated

net income to measure segment profit or loss, allocate resources, and assess performance.

Operating Decision Maker (“CODM”), who is the chief executive officer, evaluates the Company’s performance based on

its internal reporting which is consistent with the presentation in the Company’s consolidated financial statements.

our CODM uses consolidated net loss to measure segment profit or loss, allocate resources, and assess performance.

CODM examines, within each operational function, the employee salaries including the bonus and share based compensation.

the CODM examines the clinical trials expenses within the research and development operations.

OF SEGMENT REVENUE

Three months ended

September 30,

Nine months ended

September 30,

SCHEDULE OF SEGMENT REVENUE

months ended March 31,

Cost of Revenues:

2 unchanged sentences

Total Cost of Revenues

Research and development (R&D)

Research and development

Payroll and Benefits

6 unchanged sentences

Total Selling and marketing

General and administrative (G&A)

General and administrative

Payroll and Benefits

3 unchanged sentences

Segment net Loss

15 – SUBSEQUENT EVENTS

to September 30, 2025, the Company granted an aggregate of 451,853

restricted shares of the Company’s common stock to employees, directors and consultants.

Of these, 360,185

shares of common stock granted to employees and consultants are subject to a three-year vesting period, with one-third of such

awards vesting each year, 48,000

shares of common stock granted to directors are subject to a one-year vesting period and the remaining 43,668 shares granted to a consultant are fully vested

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 1. Financial Statements