What changed in this filing

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Item 1. Financial Statements

2023-08-07 compared with 2023-05-15 · 322 added, 172 removed, 196 unchanged (72% of the section changed)

1 unchanged sentence

CONSOLIDATED FINANCIAL STATEMENTS

OF AND FOR THE QUARTER ENDED MARCH 31, 2023

OF AND FOR THE QUARTER ENDED JUNE 30, 2023

CONDENSED CONSOLIDATED

FINANCIAL STATEMENTS:

Consolidated Balance Sheets

Consolidated Statements of Operations

Consolidated Statements of Changes in Equity

Consolidated Statements of Cash Flows

Notes to the Consolidated Financial Statements

Condensed Consolidated Balance Sheets

Condensed Consolidated Statements of Operations

Condensed Consolidated Statements of Changes in Equity

Condensed Consolidated Statements of Cash Flows

Notes to the Condensed Consolidated Financial Statements

CONSOLIDATED BALANCE SHEETS

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Short-term bank deposits

Marketable securities

Accounts receivable:

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Common stock, par value $ 0.0001 per share;

150,000,000 shares authorized at March 31, 2023 and December 31, 2022;

8,326,648 and 8,330,918 shares issued and outstanding at March 31, 2023 and December 2022, respectively

Preferred C shares, par value $ 0.0001 per share;

1,172,000 shares authorized at March 31, 2023 and December 31, 2022;

1,718 shares issued and outstanding at March 31, 2023 and December 31 2022, respectively

150,000,000 shares authorized at June 30, 2023 and December 31, 2022;

21,192,204 and 8,330,918 shares issued and outstanding at June 30, 2023 and December 31, 2022, respectively

Preferred C shares, par value $ 0.0001 per

1,172,000 shares

authorized at June 30, 2023 and December 31, 2022;

issued and outstanding at June 30, 2023 and December 31 2022, respectively

Additional paid-in capital

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dollars in thousands, except per share data)

3 Months Ended March 31,

Three months ended

Six months ended

COST OF REVENUES

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NET LOSS PER SHARE - basic and diluted

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

NET LOSS PER SHARE - basic

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

WEIGHTED AVERAGE NUMBER OF SHARES OF COMMON STOCK USED IN COMPUTING NET LOSS PER SHARE - basic

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

5 unchanged sentences

Share-based compensation related to restricted stock, restricted stock units and stock options award, net of forfeitures of 4,563 shares

BALANCE AT March 31, 2022

BALANCE AT June 30, 2022

* Represents an amount

1 unchanged sentence

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

STATEMENTS OF CHANGES IN EQUITY

CONSOLIDATED STATEMENTS OF CHANGES IN EQUITY

dollars in thousands, except share data)

1 unchanged sentence

Additional paid-in

BALANCE AT April 1, 2022

Share-based compensation related to restricted stock, restricted stock units and stock options award

BALANCE AT June 30, 2022

* Represents an amount

less than $1 thousand

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

CONSOLIDATED STATEMENTS OF CHANGES IN EQUITY

dollars in thousands, except share data)

Series C Convertible Preferred Stock

Additional paid-in

BALANCE AT January 1, 2023

Share-based compensation related to restricted stock, restricted stock units and stock options award, net of forfeitures of 4,270 shares

Share-based compensation related to

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

BALANCE AT March 31, 2023

Issuance of common shares, pre-funded warrants and warrants, net of $ 4,635 issuance costs

Share-based compensation related to stock, restricted stock, restricted stock units and stock options award, net of forfeitures of 4,270 shares

BALANCE AT June 30, 2023

* Represents an amount

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

CONSOLIDATED STATEMENTS OF CHANGES IN EQUITY

dollars in thousands, except share data)

Series C Convertible Preferred Stock

Additional paid-in

BALANCE AT April 1, 2023

Issuance of common shares, pre-funded warrants and warrants, net

issuance costs

Share-based compensation related to stock, restricted stock, restricted stock units and stock options award

BALANCE AT June 30, 2023

* Represents an amount

less than $1 thousand

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

CONSOLIDATED STATEMENTS OF CASH FLOWS

dollars in thousands)

Three months ended

Six 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

Loss on amounts funded in respect of employee rights upon retirement

Changes in fair value of marketable securities

Change in liability for employees’ rights upon retirement

Other financial expenses

Change in right of use asset and leasing liability

Change in operating right of use asset and leasing liability

Share-based compensation expenses

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

Decrease (increase) in interest receivable on short term deposits

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Decrease (increase) in trade receivables

Decrease (Increase) in other receivables

Increase in other receivables

Increase in inventory

Increase (Decrease) in trade payables

Decrease in other payables

Increase in trade payables

Increase (decrease) in other payables

Net cash used in operating activities

CASH FLOWS FROM INVESTING ACTIVITIES:

Purchase of property, plant and equipment

Investment in short-term bank deposits

Purchase of property, plant and equipment

Proceeds from sale of property, plant and equipment

Investments in marketable securities

Withdrawal from short-term bank deposits

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CASH FLOWS FROM FINANCING ACTIVITIES:

Net cash provided by (used in) financing activities

Issuance costs of At The Market offering

Proceeds from issuance of shares and warrants net of $ 4,635 issuance costs,

Net cash provided by financing activities

EFFECT OF EXCHANGE RATE CHANGES ON CASH AND CASH EQUIVALENTS

DECREASE IN CASH AND CASH EQUIVALENTS

INCREASE (DECREASE) 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

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

NOTES TO THE CONSOLIDATED FINANCIAL STATEMENTS

TO THE CONDENSED CONSOLIDATED FINANCIAL STATEMENTS

1 - DESCRIPTION OF BUSINESS

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.

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

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

Company’s carotid product (CGuard™ EPS) combines MicroNet and a self-expandable nitinol stent in a single device to treat

carotid artery disease.

Company’s MGuard™ Prime™ embolic protection system (“MGuard Prime EPS”) was marketed for use in patients

with acute coronary syndromes, notably acute myocardial infarction (heart attack) and saphenous vein graft coronary interventions,

or bypass surgery.

MGuard Prime EPS combines MicroNet with a bare-metal cobalt-chromium based stent.

MGuard Prime EPS received CE

mark approval in the European Union in October 2010 for improving luminal diameter and providing embolic protection.

Over the past

years, there has been a shift in industry preferences away from bare-metal stents, such as MGuard Prime EPS in ST-Elevation Myocardial

Infarction (“STEMI”) patients.

As a result of declining sales of the MGuard Prime EPS, which the Company believes is

largely driven by the predominant industry preferences favoring drug-eluting, or drug-coated, stents, during the second quarter of

2022, the Company ceased sales of the Company’s MGuard Prime EPS following a phase out period.

Company markets its products through distributors in international markets, mainly in Europe.

Company has an accumulated deficit as of March 31, 2023, as well as a history of net losses and negative operating cash flows in

recent years.

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

The Company’s carotid

product (CGuard™ EPS) combines MicroNet and a self-expandable nitinol stent in a single device to treat carotid artery disease.

The Company’s MGuard™

Prime™ embolic protection system (“MGuard Prime EPS”) was marketed for use in patients with acute coronary syndromes,

notably acute myocardial infarction (heart attack) and saphenous vein graft coronary interventions, or bypass surgery.

EPS combines MicroNet with a bare-metal cobalt-chromium based stent.

MGuard Prime EPS received CE mark approval in the European Union

in October 2010 for improving luminal diameter and providing embolic protection.

Over the past years, there has been a shift in industry

preferences away from bare-metal stents, such as MGuard Prime EPS in ST-Elevation Myocardial Infarction (“STEMI”) patients.

As a result of declining sales of the MGuard Prime EPS, which the Company believes is largely driven by the predominant industry

preferences favoring drug-eluting, or drug-coated, stents, during the second quarter of 2022, the Company ceased sales of the Company’s

MGuard Prime EPS following a phase out period.

The Company markets its

products through distributors in international markets, mainly in Europe.

As of the date of issuance

of the consolidated financial statements, the Company has the ability to fund its planned operations for at least the next 12 months.

However, 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 has sufficient resources to fund operations until the end of September 2023.

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.

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.

On May 12, 2023, the Company entered into a securities purchase agreement for the issuance and sale of Company securities

in a private placement.

Aggregate gross proceeds to the Company

in respect of the private placement is expected to be approximately $ 42.2 million, before deducting fees payable to the placement agent

and other offering expenses payable by the Company and before exercising any warrants.

The offering is expected to close on or about May

15, 2023, subject to the satisfaction of customary closing conditions.

Therefore, in order to fund the Company’s operations until such time that the Company

can generate substantial revenues, the Company may need to raise additional funds.

to satisfy regulatory requirements of the new European Medical Device Regulation could prevent the Company from marketing CGuard

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requirements while the Company’s MDR CE recertification is pending.

Related to the Geopolitical and Military Tensions Between Russia and Ukraine in Europe

Risks Related to the Geopolitical and Military Tensions Between Russia and Ukraine in Europe

February 2022, Russia launched a military invasion into Ukraine.

The Company derived approximately 12.1% of total sales in Russia

and Belarus in 2022 while during the three months ended March 31, 2023 and March 31,2022, The Company’s sales to Russia and

Belarus were 7.9% and 1.5% respectively.

The escalation of geopolitical instability in Russia and Ukraine as well as currency fluctuations

in the Russian Ruble could negatively impact the Company’s operations, sales, and future growth prospects in that region.

and Belarus in 2022 while during the six and three months ended June 30, 2023, the Company’s sales to Russia and Belarus were

10.0% and 11.6%, compared to 6.8% and 10.9% in the six and three months ended June 30, 2022, respectively.

The escalation of geopolitical

instability in Russia and Ukraine as well as currency fluctuations in the Russian Ruble could negatively impact the Company’s

operations, sales, and future growth prospects in that region.

a result of the crisis in Ukraine, the United States and the EU have implemented sanctions against certain Russian individuals and

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negative impact on the Company’s business and sales in Russia and Belarus.

Current geopolitical instability in Russia and

Ukraine and related sanctions by the U.S.

government against certain companies and individuals may hinder the Company’s ability

to conduct business with potential or existing customers and vendors in these countries.

Current geopolitical instability in Russia and Ukraine

and related sanctions by the U.S.

government against certain companies and individuals may hinder the Company’s ability to

conduct business with potential or existing customers and vendors in these countries.

government has imposed sanctions through several executive orders restricting U.S.

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

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, 2023 and its results of operations, changes in equity and cash flows for

the three months ended March 31, 2023 and 2022.

These 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, 2022, as found in the Company’s

Annual Report on Form 10-K, filed with the Securities and Exchange Commission on March 30, 2023.

The results of operations for the three

months ended March 31, 2023 are not necessarily indicative of results that could be expected for the entire fiscal year.

3 - RECENTLY ADOPTED AND ISSUED ACCOUNTING PRONOUNCEMENTS

issued accounting pronouncements

Instruments - Credit Losses

for the year ended December 31, 2022.

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 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, 2022, as found in the Company’s Annual Report on Form 10-K, filed with the Securities and Exchange

Commission on March 30, 2023.

The results of operations for the three and six months ended June 30, 2023, are not necessarily indicative

of results that could be expected for the entire fiscal year.

and Cash Equivalents

Company considers all highly liquid investments purchased with original maturities of three months or less from the purchase date to

be cash equivalents.

As of June 30, 2023, cash and cash equivalents consisted of cash, short-term deposits (up to three months from the

date of deposit) and money market funds.

As of December 31, 2022, this balance consisted solely of cash.

securities consist of debt securities.

The Company elected the fair value option to measure and recognize its investments in debt securities

in accordance with ASC 825, Financial Instruments as the Company manages its portfolio and evaluates the performance on a fair value

Changes in fair value, realized gains and losses on sales of marketable securities, are reflected in the statements of operation

as finance expense (income), net.

3 - NEW ACCOUNTING PRONOUNCEMENT

adopted accounting pronouncement

June 2016, the FASB issued ASU 2016-13, Financial Instruments-Credit Losses (Topic 326)-Measurement of Credit Losses on Financial

This guidance replaces the current incurred loss impairment methodology.

Under the new guidance, on initial recognition

and at each reporting period, an entity is required to recognize an allowance that reflects its current estimate of credit losses

expected to be incurred over the life of the financial instrument based on historical experience, current conditions and reasonable

and supportable forecasts.

This guidance replaces the incurred loss impairment methodology.

Under the new guidance, on initial recognition and

at each reporting period, an entity is required to recognize an allowance that reflects its current estimate of credit losses expected

to be incurred over the life of the financial instrument based on historical experience, current conditions and reasonable and supportable

In November 2019, the FASB issued ASU No.

2019-10, Financial Instruments - Credit Losses (Topic 326),

Derivatives and Hedging (Topic 815), and Leases (Topic 842):

2019-10, Financial Instruments - Credit Losses (Topic 326), Derivatives and

Hedging (Topic 815), and Leases (Topic 842):

Effective Dates (“ASU 2019-10”).

The purpose of this amendment

is to create a two-tier rollout of major updates, staggering the effective dates between larger public companies and all other entities.

This granted certain classes of companies, including Smaller Reporting Companies (“SRCs”), additional time to implement

major FASB standards, including ASU 2016-13.

The purpose of this amendment is to create

a two-tier rollout of major updates, staggering the effective dates between larger public companies and all other entities.

granted certain classes of companies, including Smaller Reporting Companies (“SRCs”), additional time to implement major

FASB standards, including ASU 2016-13.

Larger public companies had an effective date for fiscal years beginning after December 15,

2019, including interim periods within those fiscal years.

All other entities are permitted to defer adoption of ASU 2016-13,

and its related amendments, until the earlier of fiscal periods beginning after December 15, 2022.

All other entities are permitted to defer adoption of ASU 2016-13, and

its related amendments, until the earlier of fiscal periods beginning after December 15, 2022.

Under the current SEC definitions,

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Company adopted the provisions of this update as of January 1, 2023 with no material impact on its consolidated financial statements.

of March 31, 2023, there were 1,718 shares of Series C Preferred Stock outstanding, convertible into an aggregate of 2,280 shares

of our common stock.

of March 31, 2023, the Company has outstanding warrants to purchase an aggregate of 1,793,504 shares of common stock as follows:

issued accounting pronouncement, not yet adopted

August 2020, the FASB issued ASU 2020-06 “Debt – Debt with Conversion and Other Options (Subtopic 470-20) and Derivatives

and Hedging – Contracts in Entity’s Own Equity (Subtopic 815 – 40).” This guidance simplifies the accounting

for certain financial instruments with characteristics of liabilities and equity, including convertible instruments and contracts

on an entity’s own equity.

This ASU is effective for the Company for fiscal years beginning after December 15, 2023, and interim

periods within those fiscal years.

The Company is currently evaluating the impact of the adoption of ASU 2020-06 on the Company’s

consolidated financial statements.

4 – FAIR VALUE MEASUREMENTS

value is based on the price that would be received from the sale of an asset or that would be paid to transfer a liability in an orderly

transaction between market participants at the measurement date.

In order to increase consistency and comparability in fair value measurements,

the guidance establishes a fair value hierarchy that prioritizes observable and unobservable inputs used to measure fair value into three

broad levels, which are described as follows:

Quoted prices (unadjusted) in active markets that are accessible at the measurement date for assets or liabilities.

The fair value

hierarchy gives the highest priority to Level 1 inputs.

Observable prices that are based on inputs not quoted on active markets but corroborated by market data.

Unobservable inputs are used when little or no market data is available.

The fair value hierarchy gives the lowest priority to Level

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:

OF FINANCIAL ASSETS SUBJECT TO FAIR VALUE MEASUREMENTS

As of June 30, 2023

($ in thousands)

Cash equivalents-

Money market funds

Cash equivalents

Marketable securities-

U.S government bonds

Marketable securities

The Company’s debt securities are classified within Level 2 because

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

The cost of marketable securities as of June 30, 2023 is $ 28,838 thousand.

5 - MARKETABLE SECURITIES

following table sets forth the Company’s marketable securities for the indicated period:

OF MARKETABLE SECURITIES

($ in thousands)

U.S government bonds

Marketable securities

following table summarizes the fair value of the Company’s marketable securities classified by maturity as of June 30, 2023, and

December 31, 2022:

SCHEDULE OF FAIR VALUE OF

MARKETABLE SECURITIES CLASSIFIED BY MATURITY

($ in thousands)

Amounts maturing within one year

Amounts maturing after one year through two years

table below sets forth a summary of the changes in the fair value of the Company’s marketable securities for the six months period

ended June 30, 2023:

OF CHANGES IN FAIR VALUE OF MARKETABLE SECURITIES

Six months ended

($ in thousands)

Balance at beginning of the period

Sale or maturity

Changes in fair value during the period

Balance at end of the period

Balance at end of the

May 12, 2023, the Company entered into a securities purchase agreement (the “Purchase Agreement”) pursuant to which the Company

agreed to sell and issue in a private placement (the “Private Placement Offering) an aggregate of 10,266,270 shares (the “Private

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

up to 15,561,894 shares of common stock and warrants to purchase up to an aggregate of 51,656,328 shares of common stock, consisting

of Series H warrants to purchase up to 12,914,086 shares of common stock (the “Series H Warrants”), Series I warrants to

purchase up to 12,914,078 shares of common stock (the “Series I Warrants”), Series J warrants to purchase up to 12,914,086

shares of Common Stock (the “Series J Warrants”) and Series K warrants to purchase up to 12,914,078 shares of common stock

(the “Series K Warrants” and together with the Series H Warrants, Series I Warrants and Series J Warrants, the “Warrants”),

at an offering price of $ 1.6327 per Private Placement Share and associated Warrants and an offering price of $ 1.6326 per Pre-Funded Warrant

and associated Warrants.

The Private Placement Offering closed on May 16, 2023.

gross proceeds to the Company in respect of the Private Placement Offering were $ 42.2 million, before deducting fees payable to the placement

agent and other offering expenses payable by the Company which amounted to approximately $ 4.6 million.

If the Warrants are exercised

in cash in full this would result in an additional $ 71.4 million of gross proceeds.

Pre-Funded Warrants are immediately exercisable at an exercise price of $ 0.0001 per share and will not expire until exercised in full.

The Warrants are immediately exercisable upon issuance at an exercise price of $ 1.3827 per share.

The Warrants have a term of the earlier

of (i) five years from the date of issuance and (ii) (A) in the case of the Series H Warrants, 20 trading days following the Company’s

public release of primary and secondary end points related to one year follow up study results from the Company’s C-Guardians pivotal

trial, (B) in the case of the Series I Warrants, 20 trading days following the Company’s announcement of receipt of Premarket Approval

(PMA) from the Food and Drug Administration, or FDA, for the CGuard Prime Carotid Stent System (135 cm), (C) in the case of the Series

J Warrants, 20 trading days following the Company’s announcement of receipt of FDA approval for the SwitchGuard transcarotid system

and CGuard Prime 80 cm and (D) 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 begin.

The Warrants may

be exercised on a cashless basis if there is no effective registration statement registering the shares underlying the warrants.

of June 30, 2023, there are 15,561,894 outstanding Pre-Funded Warrants.

to the full ratchet anti-dilution adjustment provisions in the respective certificate of designation for the Company’s Series C

Preferred Stock, the conversion price of the outstanding shares of the Series C Preferred Stock was reduced to $ 1.3827 per share, effective

as of the date of the securities purchase agreement entered for the Offering, and the number of shares of common stock issuable upon

conversion of the Series Series C Preferred Stock increased by 5,668 additional shares of common stock upon conversion of the Series

C Preferred Stock, based on 1,718 shares of Series C Preferred Stock outstanding as of May 16, 2023.

of June 30, 2023, 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.

of June 30, 2023, the Company has outstanding warrants to purchase an aggregate of 53,449,832

shares of common stock as follows:

SCHEDULE OF ISSUANCE OF WARRANTS TO PURCHASE COMMON STOCK

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Series G Warrants

Series H Warrants

Series I Warrants

Series J Warrants

Series K Warrants

Underwriter Warrants

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Total Warrants

of March 31, 2023, 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.

During the three months ended March 31, 2023, the Company granted to a consultant options to purchase a total of 50,000 shares of

the Company’s common stock.

The options have an exercise price of $ 1.15 per share, which was the fair market value of the Company’s

common stock on the date of the grant.

45,000 options are subject to a three -year vesting period (of which 20,000 options are vesting

in the first year, 15,000 options are vesting in the second year and 10,000 options are vesting in the third year) and 5,000 options

with performance conditions related to marketing activities.

of June 30, 2023, 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 six months ended June 30, 2023, the Company granted 2,569,540 restricted shares of the

Company’s common stock to employees and directors.

The shares are subject to a three-year

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

fair value of the above restricted shares was approximately $ 4.52 million.

the six months ended June 30, 2023, the Company granted 1,045,150 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.

fair value of the above restricted share units was approximately $ 1,839 thousand.

January 6, 2023, the Company granted to a consultant options to purchase a total of 50,000

shares of the Company’s common stock.

The options have an exercise price of $ 1.15 per

share, which was the fair market value of the Company’s common stock on the date of

45,000 options are subject to a three-year vesting period (of which 20,000 options

are vesting in the first year, 15,000 options are vesting in the second year and 10,000 options

are vesting in the third year) and 5,000 options with performance conditions related to marketing

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

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fair value of the above options, using the Black-Scholes option-pricing model, was approximately $ 50,658 .

May 17, 2023, the Company granted to employees and directors options to purchase a total of 1,011,930 shares of the Company’s common

The options have an exercise prices of $ 1.76 per share, which was the fair market value of the Company’s common stock on

the date of the grant.

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

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 of 116.76 %- 123.30 %;

and risk-free interest rate of 3.58 %.

fair value of the above options, using the Black-Scholes option-pricing model, was approximately $ 1.56 million.

May 17, 2023, the Company granted to consultants options to purchase a total of 575,000 shares of the Company’s common stock.

options have an exercise price of $ 1.76 per share, which was the fair market value of the Company’s common stock on the date of

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

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 of 116.76 %- 123.30 %;

and risk-free interest rate of 3.58 %.

fair value of the above options, using the Black-Scholes option-pricing model, was approximately $ 885 thousand.

to Receive Shares of Common Stock in lieu of Cash Compensation

on January 1, 2023, non-employee directors may elect to receive all or a portion of their cash retainer amount in shares of the

Company’s common stock under the 2021 Equity Incentive Plan.

If a director makes that election, a stock award under the 2021

Equity Incentive Plan will be paid quarterly on the first day of each next quarter (“Issuance Dates”) and will become

fully vested on the Issuance Dates.

The stock award will be determined by dividing (x) the product of the cash retainer amount and

percentage of the cash retainer amount elected to be taken in shares by (y) the “Fair Market Value” (as defined in the

2021 Equity Incentive Plan) of a share on the Issuance Dates.

If a director’s service on the board terminates for any reasons

prior to an Issuance Date, he/she will receive a pro rata portion of shares or cash based on the number of days served on the board

during the relevant quarter.

On April 1, 2023, the Company issued 29,746

shares of common stock to non-employee directors who elected to receive all or a portion of their cash retainer amount for the three

months ended March 31, 2023 in shares of the Company’s common stock under the 2021 Equity Incentive Plan.

As of June 30, 2023,

there was an accrual for $ 55,000

for director’s fees for the three months ended June 30, 2023.

Out of this an amount of $ 22,875

will be paid in cash and $ 32,125

will be issued in shares of the Company’s common stock under the 2021 Equity Incentive Plan and accordingly on July 1, 2023

the Company issued 12,648

share of common stock.

7 – RELATED PARTIES TRANSACTIONS

the three months ended March 31, 2022, a consulting company whose founder and CEO is our board member provided certain marketing services

in the amount of $ 6,276 .

the six and three months ended June 30, 2022, a consulting company whose founder and CEO is a member of the company’s board of

directors, provided certain marketing services in the amount of $ 8,776 and $ 2,500 , respectively.

During the six and three months ended

June 30, 2023, no marketing services were provided.

8 - NET LOSS PER SHARE :

and diluted net loss per share is computed by dividing the net loss for the period by the weighted average number of shares of common

stock outstanding during the period.

The calculation of diluted net loss per share excludes potential share issuances of common stock

upon the exercise of share options, warrants, and unvested restricted stocks and unvested restricted stock units as the effect is anti-dilutive.

total number of shares of common stock related to outstanding options, warrants, restricted stock, restricted stock units, Series C Preferred

Stock excluded from the calculations of diluted loss per share were 2,773,675 .

This amount includes 342,766 of unvested restricted stock

included in the number of issued and outstanding shares as of March 31, 2023.

total number of shares of common stock related to outstanding options, warrants, restricted stock, restricted stock units, Series C Preferred

Stock excluded from the calculations of diluted loss per share were 2,903,634 .

This amount includes 547,383 of unvested restricted stock

included in the number of issued and outstanding shares as of March 31, 2022.

stock, fully vested pre-funded warrants and fully vested restricted stock units outstanding during the period.

The calculation of diluted

net loss per share excludes potential share issuances of common stock upon the exercise of share options, warrants, and unvested restricted

stocks, unvested restricted stock units and Series C preferred stock as the effect is anti-dilutive.

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

Warrants have been included since the shares are issuable for a negligible consideration, as determined by the Company according to ASC

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

For the six and three-month periods ended June 30, 2023,

we had weighted average Pre-funded Warrants of 3,954,956

and 7,866,452 ,

respectively, which were used in the computations of net loss per share for the six and three-month periods.

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

units and Series C Preferred Stock excluded from the calculations of diluted loss per share were 75,186,979 for the six and three-month

periods ended June 30, 2023.

This amount includes 2,905,615 of unvested restricted stock included in the number of issued and outstanding

shares as of June 30, 2023.

total number of shares of common stock related to outstanding options, warrants, restricted stock, restricted stock units and Series

C Preferred Stock excluded from the calculations of diluted loss per share were 3,010,707 for the six and three month periods ended June

This amount includes 547,792 of unvested restricted stock included in the number of issued and outstanding shares as of June

9 - FINANCIAL INSTRUMENTS :

value of financial instruments

carrying amounts of financial instruments included in working capital approximate their fair value due to the relatively short-term maturities

of such instruments.

of March 31, 2023, and December 31, 2022, allowance for expected credit loss was immaterial.

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

to the relatively short-term maturities of such instruments.

of June 30, 2023, and December 31, 2022, allowance for expected credit loss was immaterial.

10- INVENTORY :

SCHEDULE OF INVENTORY

OF INVENTORIES

($ in thousands)

3 unchanged sentences

11 - ACCOUNTS PAYABLE AND ACCRUALS - OTHER :

SCHEDULE OF ACCOUNTS PAYABLE AND ACCRUALS - OTHER

OF ACCOUNTS PAYABLE AND ACCRUALS - OTHER

($ in thousands)

11 unchanged sentences

Three months ended

Six months ended

($ in thousands)

1 unchanged sentence

Three months ended

Six months ended

($ in thousands)

2 unchanged sentences

Three months ended

Six months ended

tangible long lived assets are located in Israel.

11 – SUBSEQUENT EVENTS

May 12, 2023, the Company entered into a securities purchase agreement (the “Purchase Agreement”) pursuant to which the Company

agreed to sell and issue in a private placement (the “Private Placement Offering) an aggregate of 10,266,270 shares (the “Private

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

up to 15,561,894 shares of common stock and warrants to purchase up to an aggregate of 51,656,328 shares of common stock, consisting

of Series H warrants to purchase up to 12,914,086 shares of common stock (the “Series H Warrants”), Series I warrants to

purchase up to 12,914,078 shares of common stock (the “Series I Warrants”), Series J warrants to purchase up to 12,914,086

shares of Common Stock (the “Series J Warrants”) and Series K warrants to purchase up to 12,914,086 shares of common stock

(the “Series K Warrants” and together with the Series H Warrants, Series I Warrants and Series J Warrants, the “Warrants”),

at an offering price of $ 1.6327 per Private Placement Share and associated Warrants and an offering price of $ 1.6326 per Pre-Funded Warrant

and associated Warrants.

Pre-Funded Warrants will be immediately exercisable at an exercise price of $ 0.0001 per share and will not expire until exercised in

The Warrants will be immediately exercisable upon issuance at an exercise price of $ 1.3827 per share, subject to adjustment

as set forth therein.

The Warrants have a term of the earlier of (i) five years from the date of issuance and (ii) (A) in the case of

the Series H Warrants, 20 trading days following the Company’s public release of primary and secondary end points related to one

year follow up study results from the Company’s C-Guardians pivotal trial, (B) in the case of the Series I Warrants, 20 trading

days following the Company’s announcement of receipt of Premarket Approval from the Food and Drug Administration (“FDA”)

for the CGuard Prime Carotid Stent System (135 cm), (C) 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 (D) 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.

The Warrants may be exercised on a cashless basis if there is no effective registration statement

registering the shares underlying the warrants.

connection with the Purchase Agreement, the Company entered into a registration rights agreement (the “Registration Rights Agreement”).

Pursuant to the Registration Rights Agreement, the Company is required to file a resale registration statement (the “Registration

Statement”) with the SEC to register for resale the Private Placement Shares and the shares of common stock issuable upon exercise

of the Pre-Funded Warrants and Warrants, within 20 days of the signing date of the Purchase Agreement (the “Signing Date”),

and to have such Registration Statement declared effective within 45 days after the Signing Date in the event the Registration Statement

is not reviewed by the SEC, or 90 days of the Signing Date in the event the Registration Statement is reviewed by the SEC.

will be obligated to pay certain liquidated damages if the Company fails to file the Registration Statement when required, fails to cause

the Registration Statement to be declared effective by the SEC when required, of if the Company fails to maintain the effectiveness of

the Registration Statement.

gross proceeds to the Company in respect of the Private Placement Offering are expected to be approximately $ 42.2

million, before deducting fees payable to the placement agent and other offering expenses payable by the Company which are expected

to amount to approximately $ 4.6

If the Warrants are exercised in cash in full this would result in an additional $ 71.4

million of proceeds.

The Private Placement Offering is expected to close on or about May 15, 2023, subject to satisfaction of

customary closing conditions.

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