What changed in this filing

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Item 1. Financial Statements

2023-05-15 compared with 2022-11-07 · 198 added, 228 removed, 170 unchanged (71% of the section changed)

1 unchanged sentence

CONSOLIDATED FINANCIAL STATEMENTS

OF AND FOR THE QUARTER ENDED SEPTEMBER 30, 2022

OF AND FOR THE QUARTER ENDED MARCH 31, 2023

FINANCIAL STATEMENTS:

6 unchanged sentences

dollars in thousands)

September 30,

CURRENT ASSETS:

11 unchanged sentences

dollars in thousands other than share and per share data)

September 30,

LIABILITIES AND EQUITY

9 unchanged sentences

Common stock, par value $ 0.0001 per share;

150,000,000 shares authorized at September 30, 2022 and December 31, 2021;

8,335,606 and 8,296,256 shares issued and outstanding at September 30, 2022 and December 31, 2021, respectively

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 September 30, 2022 and December 31, 2021;

1,718 shares issued and outstanding at September 30, 2022 and December 31, 2021

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

Additional paid-in capital

6 unchanged sentences

dollars in thousands, except per share data)

September 30,

3 Months Ended March 31,

COST OF REVENUES

5 unchanged sentences

LOSS FROM OPERATIONS

FINANCIAL INCOME (EXPENSES), net:

LOSS BEFORE TAX EXPENSES

FINANCIAL INCOME, net

NET LOSS PER SHARE - basic and diluted

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

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

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

2 unchanged sentences

Preferred Stock

Additional paid-in

BALANCE AT January 1, 2022

$ ( 168,176 )

Issuance of common stock, including at the market offering net of $ 2,024 issuance costs

Exercise of Warrants F

Exercise of Warrants G

Conversion of Series B Convertible Preferred Stock to common stock

Conversion of Series C Convertible Preferred Stock to common stock

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

Round up of shares due to reverse stock split effectuated on April 26, 2021

BALANCE AT September 30, 2021

$ ( 178,997 )

* 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 B Convertible Preferred Stock

Series C Convertible Preferred Stock

Additional paid-in

BALANCE AT July 1, 2021

$ ( 174,926 )

Share-based compensation related to restricted stock, restricted stock units and stock options award, net of forfeitures of 13,077 shares

Round up of shares due to reverse stock split effectuated on April 26, 2021

BALANCE AT September 30, 2021

$ ( 178,997 )

* 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, 2022

Share-based compensation related to restricted stock, restricted stock units and stock options award, net of forfeitures of 6,144 shares

BALANCE AT September 30, 2022

BALANCE AT March 31, 2022

* Represents an amount

1 unchanged sentence

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

CONSOLIDATED STATEMENTS OF CHANGES IN EQUITY

STATEMENTS OF CHANGES IN EQUITY

dollars in thousands, except share data)

1 unchanged sentence

Additional paid-in

BALANCE AT July 1, 2022

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 September 30, 2022

Share-based compensation related to

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

BALANCE AT March 31, 2023

* Represents an amount

3 unchanged sentences

dollars in thousands)

Nine months ended

Three months ended

CASH FLOWS FROM OPERATING ACTIVITIES:

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

Loss from sale of property, plant and equipment

Loss on amounts funded in respect of employee rights upon retirement

Change in liability for employees rights upon retirement

Other financial expense

Change in operating right of use asset and operating leasing liability

Other financial expenses

Change in right of use asset and leasing liability

Share-based compensation expenses

Increase in interest receivable on short term deposits

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

Decrease (increase) in interest receivable on short term deposits

Changes in operating asset and liability items:

Increase in prepaid expenses

Decrease in prepaid expenses

Decrease (Increase) in trade receivables

Decrease (Increase) in other receivables

Decrease (increase) in inventory

Increase in inventory

Increase (Decrease) in trade payables

Increase (decrease) in other payables

Decrease in other payables

Net cash used in operating activities

1 unchanged sentence

Purchase of property, plant and equipment

Proceeds from withdrawal of (invest in) short-term deposits

Investment in short-term bank deposits

Withdrawal from short-term bank deposits

Amounts funded in respect of employee rights upon retirement

1 unchanged sentence

CASH FLOWS FROM FINANCING ACTIVITIES:

Issuance costs of At The Market offering

Proceeds from issuance of shares and warrants and exercise of Pre-Funded Warrants and unit purchase option, net of $ 2,024 issuance costs

Net cash provided by (used in) financing activities

EFFECT OF EXCHANGE RATE CHANGES ON CASH AND CASH EQUIVALENTS

INCREASE (DECREASE) IN CASH AND CASH EQUIVALENTS

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.

TO THE CONSOLIDATED FINANCIAL STATEMENTS

NOTES TO THE 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.

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

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.

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

9 unchanged sentences

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.

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 September 30, 2022, as well as a history of net losses and negative operating cash flows

in recent years.

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™

EPS, reach commercial profitability.

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.

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.

See also note 1b regarding the new European Medical Device Regulation.

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

2 unchanged sentences

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.

to satisfy regulatory requirements of the new European Medical Device Regulation by November

12, 2022 could prevent the Company from marketing CGuard EPS in in countries requiring the

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.

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

EPS in countries requiring the CE Mark.

the European Union nations, medical devices must obtain a CE mark before they may be placed on the market.

In order to obtain and

maintain the CE mark, the Company must comply with EU law on medical devices, which, until May 26, 2021 was governed by the Medical

Device Directive 93/42/EEC (“MDD”), by presenting comprehensive technical files for its products demonstrating safety

and efficacy of the product to be placed on the market and passing initial and annual quality management system audit as per ISO

13485 standard by a European Notified Body.

Company has obtained ISO 13485 quality system certification and CGuard EPS that the Company currently distributes into the European

Union, displays the required CE mark.

maintain the CE mark, the Company must Company with EU law on medical devices, which, until May 26, 2021 was governed by the MDD,

by presenting comprehensive technical files for the Company’s products demonstrating safety and efficacy of the product to

be placed on the market and passing initial and annual quality management system audit as per ISO 13485 standard by a European Notified

The company has obtained ISO 13485 quality system certification and CGuard EPS that the Company currently distribute into the

European Union, displays the required CE mark.

In order to maintain certification, the Company is required to pass an annual surveillance

audit conducted by Notified Body auditors.

European Union replaced the MDD with the new European Medical Device Regulation, or MDR (MDR 2017/745).

The MDR entered into force

after a transitional period of three years and a one year extension of that transition period due to the COVID-19 pandemic on May

26, 2021 and which changes several aspects of the regulatory framework in the European Union.

Manufacturers had the duration of the

transition period to update their technical documentation and processes to meet the new requirements in order to obtain a CE Mark.

After May 26, 2021, medical devices can generally still be placed on the market under the provision of the MDD until May 26, 2024;

provided the CE Mark was issued prior to this date and the manufacturer continues to comply with this directive.

By May 26, 2024,

all medical devices entering the EU will need to have a CE Mark under the MDR, even if they have been on the market previously under

the Company’s’ particular case, CGuard EPS can continue to be marketed under the MDD until November 12, 2022.

Specifically,

the EU MDR requires changes in the clinical evidence required for medical devices, post-market clinical follow-up evidence, annual

reporting of safety information for Class III products, Unique Device Identification (“UDI”) for all products, submission

of core data elements to a European UDI database prior to placement of a device on the market, and multiple other labeling changes.

Currently the Company is under technical documentation review by the Notified Body auditor to meet the MDR requirements for recertification having completed the quality management system Notified Body audit in

October 2021.

Notified Body is currently experiencing chronic delays in processing MDR audits and reviews and the Company does not expect to

satisfy MDR requirements by November 12, 2022.

While the Company continues to seek to expedite the review process, if the CE mark

lapses, the Company will not be able to promote and sell CGuard EPS into countries requiring the CE mark until the Company receives

recertification.

No assurance can be provided as to the length of time it will take to obtain recertification, If the Company is unable to promote and sell CGuard EPS into countries requiring the CE mark for a prolonged period,

this is expected to have a material adverse effect on our business, financial condition, results of operations or cash

COVID-19 global pandemic has led governments and authorities around the globe to take various precautionary measures in order to

limit the spread of COVID-19, including government-imposed quarantines, lockdowns, and other public health safety measures.

experienced a significant COVID-19 related impact on the Company’s financial condition and results of operations, primarily

during the year ended December 31, 2020, which the Company primarily attribute to the postponement of CGuard EPS procedures (non-emergency

procedures), as hospitals have shifted resources to patients affected by COVID-19.

New COVID-19 variants, and potentially increasing

infection rates make the current COVID-related environment highly volatile and uncertain and the Company anticipates that the continuation

of the pandemic and related restrictions and safety measures will likely result in continued fluctuations in sales of the Company’s

products, potentially enrollments in the Company’s studies as well as potential disruptions to the Company’s

supply chain for the upcoming periods.

The European Union replaced the MDD with the new MDR regulations.

The MDR entered into

force after a transitional period of three years and a one year extension of that transition period due to the COVID-19 pandemic

on May 26, 2021 and which changes several aspects of the regulatory framework in the European Union.

Manufacturers had the duration

of the transition period to update their technical documentation and processes to meet the new requirements in order to obtain a

In the Company’s specific case, the Company’s CE mark for CGuard EPS under the MDD expired on November 12, 2022,

and the Company is in the final stages of technical documentation review by the Notified Body auditor to meet the MDR requirements

for recertification.

In the meantime, on February 14, 2023, the Company received a derogation per Article 97 paragraph 1 of Regulation

2017/745 from the Agency for Medicines and Health Products (FAMHP) allowing the Company to continue marketing CGuard EPS in the EU

until August 15, 2023, subject to certain procedural requirements.

Subsequently, on March 20, 2023 Regulation (EU) 2023/607 was published

allowing the Company to continue marketing CGuard EPS in EU countries under the MDD directive until December 31, 2027.

of the foregoing, the Company may market and sell CGuard EPS in the EU and certain other jurisdictions subject to certain procedural

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

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

10.5% of total sales in Russia, Ukraine and Belarus in 2021 while during the nine and three

months ended September 30, 2022 the Company’s sales to Russia, Ukraine and Belarus

were 12.1% and 22.2% 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 entities and have made it more difficult

for us to collect on outstanding accounts receivable from customers in this region.

The Company’s

global operations expose us to risks that could adversely affect the Company’s business,

financial condition, results of operations, cash flows or the market price of the Company’s

securities, including the potential for increased tensions between the United States and

Russia resulting from the current situation involving Russia and Ukraine, tariffs, economic

sanctions and import-export restrictions imposed by either nation, and retaliatory actions

by the other nation, as well as the potential negative impact on the Company’s business

and sales in Russia, Ukraine and Belarus.

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.

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

entities and have made it more difficult for the Company to collect on outstanding accounts receivable from customers in this region.

The Company’s global operations expose the Company to risks that could adversely affect the Company’s business, financial

condition, results of operations, cash flows or the market price of the Company’s securities, including the potential for increased

tensions between the United States and Russia resulting from the current situation involving Russia and Ukraine, tariffs, economic

sanctions and import-export restrictions imposed by either nation, and retaliatory actions by the other nation, as well as the potential

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.

government has imposed sanctions through several

executive orders restricting U.S.

companies from conducting business with specified Russian

and Ukrainian individuals and companies.

While the Company believes that the executive orders

currently do not preclude the Company from conducting business with the Company’s current

customers or vendors in Russia, Ukraine and Belarus, the sanctions imposed by the U.S.

may be expanded in the future to restrict the Company from engaging with them.

If the Company

is unable to conduct business with new or existing customers or vendors or pursue business

opportunities in Russia, Ukraine or Belarus, the Company’s business, including revenue,

profitability and cash flows, and operations could be adversely affected.

The Company cannot

provide assurance that current sanctions or potential future changes in sanctions will not

have a material impact on the Company’s operations in Russia, Ukraine and Belarus or

on the Company’s financial results.

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.

companies from conducting business with specified

Russian individuals and companies.

While the Company believes that the executive orders currently do not preclude the Company from

conducting business with the Company’s current customers or vendors in Russia, and Belarus, the sanctions imposed by the U.S.

government may be expanded in the future to restrict the Company from engaging with them.

If the Company is unable to conduct business

with new or existing customers or vendors or pursue business opportunities in Russia, or Belarus, the Company’s business, including

revenue, profitability and cash flows, and operations could be adversely affected.

The Company cannot provide assurance that current

sanctions or potential future changes in sanctions will not have a material impact on the Company’s operations in Russia, and

Belarus or on the Company’s financial results.

2 - BASIS OF PRESENTATION

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

for the year ended December 31, 2021.

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, 2021, as found in the Company’s Annual Report on Form 10-K,

filed with the Securities and Exchange Commission on March 7, 2022.

The results of operations for the three and nine months ended

September 30, 2022 are not necessarily indicative of results that could be expected for the entire fiscal year.

of September 30, 2022, there were 1,718 shares of Series C Preferred Stock outstanding, convertible into an aggregate of 2,280 shares

of the Company’s common stock.

of September 30, 2022, the Company has outstanding warrants to purchase an aggregate of 1,793,815 shares of common stock as follows:

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

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.

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):

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.

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.

Under the current SEC definitions,

the Company met the definition of an SRC and adopted the deferral period for ASU 2016-13.

The guidance requires a modified retrospective

transition approach through a cumulative-effect adjustment to retained earnings as of the beginning of the period of adoption.

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:

SCHEDULE OF ISSUANCE OF WARRANTS TO PURCHASE COMMON STOCK

7 unchanged sentences

Total Warrants

of September 30, 2022, the Company had 155,000,000 authorized shares of capital stock, par value $ 0.0001 per share, of which 150,000,000

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 nine months ended September 30, 2022, the Company granted to employees and consultants’ options to purchase a total

of 154,508 shares of the Company’s common stock.

The options have an exercise price ranging from $ 2.61 - $ 2.97 per share, which

was the fair market value of the Company’s common stock on the date of the grant.

98,838 options are subject to a three -year

vesting period, with one-third of such awards vesting each year and 55,670 options with performance conditions, mainly related to clinical

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.

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

4 unchanged sentences

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

During the nine months ended September 30, 2022, the Company granted 13,987 restricted shares of the Company’s common stock to

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 $ 25,736 .

5 – RELATED PARTIES TRANSACTIONS

the nine and three months ended September 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 $ 9,276

and $ 500 , respectively.

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 .

6 - NET LOSS PER SHARE :

2 unchanged sentences

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

upon the exercise of share options, warrants, unvested restricted stock and unvested restricted stock units 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 excluded from the calculations of diluted loss per share were 2,932,284 for the nine and three month

periods ended September 30, 2022.

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 2,163,741 for the nine and three month periods ended

September 30, 2021.

6 – LEASE AGREEMENTS

Company’s Israeli subsidiary has a lease agreement for a facility in Israel, which expires on December 31, 2022 with an option

to extend the agreement for two additional years until December 31, 2024 under the terms stipulated in the agreement., On May

25, 2022 the Company amended the agreement mentioned above and extended it until December 31, 2026 as well as leasing of additional

space in the facility, the additional space amendment was taken in consideration when calculating the operating lease right of use

assets and liabilities.

lease cost for the nine and three-month periods ended September 30, 2022 were $ 331,000 and $ 113,000 respectively.

information related to leases are as follows:

SCHEDULE OF SUPPLEMENTAL INFORMATION RELATED TO LEASES

Operating lease right-of-use assets

Current operating lease liabilities

Non-current operating lease liabilities

Operating cash flows from operating leases (cash paid in thousands)

Weighted Average Remaining Lease Term

Weighted Average Discount Rate

of lease liabilities are as follows:

SCHEDULE OF MATURITIES OF LEASE LIABILITIES

($ in thousands)

Total lease payments

Less imputed interest

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.

7 - FINANCIAL INSTRUMENTS :

value of financial instruments

carrying amounts of financial instruments included in working capital 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 September 30, 2022, and December 31, 2021, allowance for doubtful accounts was $ 0 .

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.

8 - INVENTORY :

SCHEDULE OF INVENTORY

September 30,

($ in thousands)

4 unchanged sentences

SCHEDULE OF ACCOUNTS PAYABLE AND ACCRUALS - OTHER

September 30,

($ in thousands)

2 unchanged sentences

Accrued expenses

Clinical trial accrual

Current Operating lease liabilities

6 unchanged sentences

Three months ended

September 30,

Nine months ended

September 30,

($ in thousands)

1 unchanged sentence

Three months ended

September 30,

Nine months ended

September 30,

($ in thousands)

2 unchanged sentences

Three months ended

September 30,

Nine months ended

September 30,

Concentration risk percentage

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