InspireMD (NSPR) 10-Q 15 May 23 2023 Q1 Quarterly report Financial data

Cover

Cover - shares	3 Months Ended
	Mar. 31, 2023	May 14, 2023
Cover [Abstract]
Document Type	10-Q
Amendment Flag	false
Document Quarterly Report	true
Document Transition Report	false
Document Period End Date	Mar. 31, 2023
Document Fiscal Period Focus	Q1
Document Fiscal Year Focus	2023
Current Fiscal Year End Date	--12-31
Entity File Number	001-35731
Entity Registrant Name	InspireMD, Inc.
Entity Central Index Key	0001433607
Entity Tax Identification Number	26-2123838
Entity Incorporation, State or Country Code	DE
Entity Address, Address Line One	4 Menorat Hamaor St.
Entity Address, City or Town	Tel Aviv
Entity Address, Country	IL
Entity Address, Postal Zip Code	6744832
City Area Code	(888)
Local Phone Number	776-6204
Title of 12(b) Security	Common Stock, par value $0.0001 per share
Trading Symbol	NSPR
Security Exchange Name	NASDAQ
Entity Current Reporting Status	Yes
Entity Interactive Data Current	Yes
Entity Filer Category	Non-accelerated Filer
Entity Small Business	true
Entity Emerging Growth Company	false
Entity Shell Company	false
Entity Common Stock, Shares Outstanding		8,356,394

Condensed Consolidated Balance

Condensed Consolidated Balance Sheets (Unaudited) - USD ($) $ in Thousands		Mar. 31, 2023	Dec. 31, 2022
CURRENT ASSETS:
Cash and cash equivalents		$ 4,228	$ 4,632
Short-term bank deposits		8,657	13,171
Accounts receivable:
Trade, net		1,417	1,034
Other		310	213
Prepaid expenses		394	655
Inventory		1,697	1,621
TOTAL CURRENT ASSETS		16,703	21,326
NON-CURRENT ASSETS:
Property, plant and equipment, net		887	917
Operating lease right of use assets		1,472	1,554
Fund in respect of employee rights upon retirement		859	856
TOTAL NON-CURRENT ASSETS		3,218	3,327
TOTAL ASSETS		19,921	24,653
Accounts payable and accruals:
Trade		607	659
Other		3,776	4,411
TOTAL CURRENT LIABILITIES		4,383	5,070
LONG-TERM LIABILITIES-
Operating lease liabilities		1,081	1,195
Liability for employees rights upon retirement		1,031	995
TOTAL LONG-TERM LIABILITIES		2,112	2,190
COMMITMENTS AND CONTINGENT LIABILITIES
TOTAL LIABILITIES		6,495	7,260
EQUITY:
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		1	1
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	[1]
Additional paid-in capital		219,266	218,977
Accumulated deficit		(205,841)	(201,585)
Total equity		13,426	17,393
Total liabilities and equity		$ 19,921	$ 24,653
[1]Represents an amount less than $1 thousand

Condensed Consolidated Balanc_2

Condensed Consolidated Balance Sheets (Unaudited) (Parenthetical) - $ / shares	Mar. 31, 2023	Dec. 31, 2022
Common stock, par value	$ 0.0001	$ 0.0001
Common stock, shares authorized	150,000,000	150,000,000
Common stock, shares issued	8,326,648	8,330,918
Common stock, shares outstanding	8,326,648	8,330,918
Series C Preferred Stock [Member]
Preferred stock, par value	$ 0.0001	$ 0.0001
Preferred stock, shares authorized	1,172,000	1,172,000
Preferred stock, shares issued	1,718	1,718
Preferred stock, shares outstanding	1,718	1,718

Condensed Consolidated Statemen

Condensed Consolidated Statements of Operations (Unaudited) - USD ($) $ in Thousands	3 Months Ended
	Mar. 31, 2023	Mar. 31, 2022
Income Statement [Abstract]
REVENUES	$ 1,239	$ 1,183
COST OF REVENUES	866	1,061
GROSS PROFIT	373	122
OPERATING EXPENSES:
Research and development	1,843	1,680
Selling and marketing	788	746
General and administrative	2,123	2,182
Total operating expenses	4,754	4,608
LOSS FROM OPERATIONS	(4,381)	(4,486)
FINANCIAL INCOME, net	125	5
NET LOSS	$ (4,256)	$ (4,481)
NET LOSS PER SHARE - basic and diluted	$ (0.53)	$ (0.57)
WEIGHTED AVERAGE NUMBER OF ORDINARY SHARES USED IN COMPUTING NET LOSS PER SHARE - basic and diluted	8,093,340	7,804,245

Condensed Consolidated Statem_2

Condensed Consolidated Statements of Changes in Equity (Unaudited) - USD ($) $ in Thousands	Common Stock [Member]	Preferred Stock [Member] Series C Convertible Preferred Stock [Member]		Additional Paid-in Capital [Member]	Retained Earnings [Member]	Total
Balance at Dec. 31, 2021	$ 1		[1]	$ 216,625	$ (183,094)	$ 33,532
Balance, shares at Dec. 31, 2021	8,296,256	1,718
Net loss					(4,481)	(4,481)
Share-based compensation related to restricted stock, restricted stock units and stock options award, net of forfeitures				653		653
Share-based compensation related to restricted stock, restricted stock units and stock options award, net of forfeitures, shares	21,620
Balance at Mar. 31, 2022	$ 1		[1]	217,278	(187,575)	29,704
Balance, shares at Mar. 31, 2022	8,317,876	1,718
Balance at Dec. 31, 2022	$ 1		[2]	218,977	(201,585)	17,393
Balance, shares at Dec. 31, 2022	8,330,918	1,718
Net loss					(4,256)	(4,256)
Share-based compensation related to restricted stock, restricted stock units and stock options award, net of forfeitures				289		289
Share-based compensation related to restricted stock, restricted stock units and stock options award, net of forfeitures, shares	(4,270)
Balance at Mar. 31, 2023	$ 1		[2]	$ 219,266	$ (205,841)	$ 13,426
Balance, shares at Mar. 31, 2023	8,326,648	1,718
[1]Represents an amount less than $1 thousand[2]Represents an amount less than $1 thousand

Condensed Consolidated Statem_3

Condensed Consolidated Statements of Changes in Equity (Unaudited) (Parenthetical) - shares	3 Months Ended
	Mar. 31, 2023	Mar. 31, 2022
Statement of Stockholders' Equity [Abstract]
Shares, restricted stock award, forfeited	4,270	4,563

Condensed Consolidated Statem_4

Condensed Consolidated Statements of Cash Flows (Unaudited) - USD ($) $ in Thousands	3 Months Ended
	Mar. 31, 2023	Mar. 31, 2022
CASH FLOWS FROM OPERATING ACTIVITIES:
Net loss	$ (4,256)	$ (4,481)
Adjustments required to reconcile net loss to net cash used in operating activities:
Depreciation	55	41
Change in liability for employees rights upon retirement	36	46
Other financial expenses	22	7
Change in right of use asset and leasing liability	(34)	(25)
Share-based compensation expenses	289	653
Loss on amounts funded in respect of employee rights upon retirement, net	23	18
Decrease (increase) in interest receivable on short term deposits	14	(17)
Changes in operating asset and liability items:
Decrease in prepaid expenses	261	231
Decrease (Increase) in trade receivables	(383)	111
Decrease (Increase) in other receivables	(97)	74
Increase in inventory	(76)	(143)
Increase (Decrease) in trade payables	(52)	7
Decrease in other payables	(633)	(656)
Net cash used in operating activities	(4,831)	(4,134)
CASH FLOWS FROM INVESTING ACTIVITIES:
Purchase of property, plant and equipment	(25)	(37)
Investment in short-term bank deposits	(2,500)	(6,000)
Withdrawal from short-term bank deposits	7,000	6,000
Amounts funded in respect of employee rights upon retirement	(26)	(28)
Net cash provided by (used in) investing activities	4,449	(65)
CASH FLOWS FROM FINANCING ACTIVITIES:
Net cash provided by (used in) financing activities
EFFECT OF EXCHANGE RATE CHANGES ON CASH AND CASH EQUIVALENTS	(22)	(7)
DECREASE IN CASH AND CASH EQUIVALENTS	(404)	(4,206)
BALANCE OF CASH AND CASH EQUIVALENTS AT BEGINNING OF THE PERIOD	4,632	12,004
BALANCE OF CASH AND CASH EQUIVALENTS AT END OF THE PERIOD	$ 4,228	$ 7,798

DESCRIPTION OF BUSINESS

DESCRIPTION OF BUSINESS	3 Months Ended
	Mar. 31, 2023
Organization, Consolidation and Presentation of Financial Statements [Abstract]
DESCRIPTION OF BUSINESS	NOTE 1 - DESCRIPTION OF BUSINESS a. General 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. 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. 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. The Company markets its products through distributors in international markets, mainly in Europe. b. Liquidity The 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, 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. Management’s 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 c. Failure 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. For 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 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 Body. 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. 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 CE Mark. 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. As a result 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. d. Risks Related to the Geopolitical and Military Tensions Between Russia and Ukraine in Europe In 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. As 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. The U.S. 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.

BASIS OF PRESENTATION

BASIS OF PRESENTATION	3 Months Ended
	Mar. 31, 2023
Organization, Consolidation and Presentation of Financial Statements [Abstract]
BASIS OF PRESENTATION	NOTE 2 - BASIS OF PRESENTATION The 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.

RECENTLY ADOPTED AND ISSUED ACC

RECENTLY ADOPTED AND ISSUED ACCOUNTING PRONOUNCEMENTS	3 Months Ended
	Mar. 31, 2023
Accounting Changes and Error Corrections [Abstract]
RECENTLY ADOPTED AND ISSUED ACCOUNTING PRONOUNCEMENTS	NOTE 3 - RECENTLY ADOPTED AND ISSUED ACCOUNTING PRONOUNCEMENTS Newly issued accounting pronouncements Financial Instruments - Credit Losses In June 2016, the FASB issued ASU 2016-13, Financial Instruments-Credit Losses (Topic 326)-Measurement of Credit Losses on Financial Instruments. 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. The Company adopted the provisions of this update as of January 1, 2023 with no material impact on its consolidated financial statements.

EQUITY

EQUITY	3 Months Ended
	Mar. 31, 2023
Equity [Abstract]
EQUITY	NOTE 4 - EQUITY a. As of March 31, 2023, there were 1,718 2,280 As of March 31, 2023, the Company has outstanding warrants to purchase an aggregate of 1,793,504 SCHEDULE OF ISSUANCE OF WARRANTS TO PURCHASE COMMON STOCK Number of Weighted Series E Warrants 198,159 $ 27.000 Series F Warrants 433,878 $ 7.425 Series G Warrants 1,092,344 $ 10.230 Underwriter Warrants 17,966 $ 7.425 Other warrants 51,157 225 and above Total Warrants 1,793,504 $ As of March 31, 2023, the Company had 155,000,000 0.0001 150,000,000 5,000,000 b. 50,000 1.15 45,000 three 20,000 15,000 10,000 5,000 In calculating the fair value of the above options, the Company used the following assumptions: dividend yield of 0 5.5 6.5 124.58 125.61 3.65 3.68 The fair value of the above options, using the Black-Scholes option-pricing model, was approximately $ 50,658

RELATED PARTIES TRANSACTIONS

RELATED PARTIES TRANSACTIONS	3 Months Ended
	Mar. 31, 2023
Related Party Transactions [Abstract]
RELATED PARTIES TRANSACTIONS	NOTE 5 – RELATED PARTIES TRANSACTIONS During 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

NET LOSS PER SHARE

NET LOSS PER SHARE	3 Months Ended
	Mar. 31, 2023
Earnings Per Share [Abstract]
NET LOSS PER SHARE	NOTE 6 - NET LOSS PER SHARE Basic 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. The 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 2,773,675 342,766 The 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 2,903,634 547,383

FINANCIAL INSTRUMENTS

FINANCIAL INSTRUMENTS	3 Months Ended
	Mar. 31, 2023
Investments, All Other Investments [Abstract]
FINANCIAL INSTRUMENTS	NOTE 7 - FINANCIAL INSTRUMENTS a. Fair value of financial instruments The carrying amounts of financial instruments included in working capital approximate their fair value due to the relatively short-term maturities of such instruments. b. As of March 31, 2023, and December 31, 2022, allowance for expected credit loss was immaterial.

INVENTORY

INVENTORY	3 Months Ended
	Mar. 31, 2023
Inventory Disclosure [Abstract]
INVENTORY	NOTE 8 - INVENTORY SCHEDULE OF INVENTORY March 31, December 31, 2023 2022 ($ in thousands) Finished goods $ 138 $ 179 Work in process 690 510 Raw materials and supplies 869 932 Total inventory $ 1,697 $ 1,621

ACCOUNTS PAYABLE AND ACCRUALS -

ACCOUNTS PAYABLE AND ACCRUALS - OTHER	3 Months Ended
	Mar. 31, 2023
Payables and Accruals [Abstract]
ACCOUNTS PAYABLE AND ACCRUALS - OTHER	NOTE 9 - ACCOUNTS PAYABLE AND ACCRUALS - OTHER SCHEDULE OF ACCOUNTS PAYABLE AND ACCRUALS - OTHER March 31, December 31, 2023 2022 ($ in thousands) Employees and employee institutions 970 1,853 Accrued vacation and recreation pay 240 197 Accrued expenses 933 554 Clinical trial accrual 1,046 1,258 Current Operating lease liabilities 417 419 Other 170 130 Accounts payable and accruals-other $ 3,776 $ 4,411

DISAGGREGATED REVENUE AND ENTIT

DISAGGREGATED REVENUE AND ENTITY WIDE DISCLOSURES	3 Months Ended
	Mar. 31, 2023
Segment Reporting [Abstract]
DISAGGREGATED REVENUE AND ENTITY WIDE DISCLOSURES	NOTE 10 - DISAGGREGATED REVENUE AND ENTITY WIDE DISCLOSURES Revenues are attributed to geographic areas based on the location of the customers. The following is a summary of revenues: SCHEDULE OF REVENUES ATTRIBUTED TO GEOGRAPHIC AREAS Three months ended 2023 2022 ($ in thousands) Italy $ 267 $ 243 Germany 214 249 Other 758 691 $ 1,239 $ 1,183 By product: SCHEDULE OF REVENUES ATTRIBUTED TO GEOGRAPHIC AREAS BY PRODUCT Three months ended 2023 2022 ($ in thousands) CGuard $ 1,239 $ 1,161 MGuard - 22 $ 1,239 $ 1,183 By principal customers: SCHEDULE OF REVENUES ATTRIBUTED TO GEOGRAPHIC AREAS BY PRINCIPAL CUSTOMERS Three months ended 2023 2022 Customer A 17 % 21 % Customer B 13 % 11 % All tangible long lived assets are located in Israel.

SUBSEQUENT EVENTS

SUBSEQUENT EVENTS	3 Months Ended
	Mar. 31, 2023
Subsequent Events [Abstract]
SUBSEQUENT EVENTS	NOTE 11 – SUBSEQUENT EVENTS On 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 15,561,894 51,656,328 12,914,086 12,914,078 12,914,086 12,914,086 1.6327 1.6326 The Pre-Funded Warrants will be immediately exercisable at an exercise price of $ 0.0001 1.3827 In 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. The Company 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. Aggregate gross proceeds to the Company in respect of the Private Placement Offering are expected to be approximately $ 42.2 4.6 71.4

EQUITY (Tables)

EQUITY (Tables)	3 Months Ended
	Mar. 31, 2023
Equity [Abstract]
SCHEDULE OF ISSUANCE OF WARRANTS TO PURCHASE COMMON STOCK	As of March 31, 2023, the Company has outstanding warrants to purchase an aggregate of 1,793,504 SCHEDULE OF ISSUANCE OF WARRANTS TO PURCHASE COMMON STOCK Number of Weighted Series E Warrants 198,159 $ 27.000 Series F Warrants 433,878 $ 7.425 Series G Warrants 1,092,344 $ 10.230 Underwriter Warrants 17,966 $ 7.425 Other warrants 51,157 225 and above Total Warrants 1,793,504 $

INVENTORY (Tables)

INVENTORY (Tables)	3 Months Ended
	Mar. 31, 2023
Inventory Disclosure [Abstract]
SCHEDULE OF INVENTORY	SCHEDULE OF INVENTORY March 31, December 31, 2023 2022 ($ in thousands) Finished goods $ 138 $ 179 Work in process 690 510 Raw materials and supplies 869 932 Total inventory $ 1,697 $ 1,621

ACCOUNTS PAYABLE AND ACCRUALS_2

ACCOUNTS PAYABLE AND ACCRUALS - OTHER (Tables)	3 Months Ended
	Mar. 31, 2023
Payables and Accruals [Abstract]
SCHEDULE OF ACCOUNTS PAYABLE AND ACCRUALS - OTHER	SCHEDULE OF ACCOUNTS PAYABLE AND ACCRUALS - OTHER March 31, December 31, 2023 2022 ($ in thousands) Employees and employee institutions 970 1,853 Accrued vacation and recreation pay 240 197 Accrued expenses 933 554 Clinical trial accrual 1,046 1,258 Current Operating lease liabilities 417 419 Other 170 130 Accounts payable and accruals-other $ 3,776 $ 4,411

DISAGGREGATED REVENUE AND ENT_2

DISAGGREGATED REVENUE AND ENTITY WIDE DISCLOSURES (Tables)	3 Months Ended
	Mar. 31, 2023
Segment Reporting [Abstract]
SCHEDULE OF REVENUES ATTRIBUTED TO GEOGRAPHIC AREAS	Revenues are attributed to geographic areas based on the location of the customers. The following is a summary of revenues: SCHEDULE OF REVENUES ATTRIBUTED TO GEOGRAPHIC AREAS Three months ended 2023 2022 ($ in thousands) Italy $ 267 $ 243 Germany 214 249 Other 758 691 $ 1,239 $ 1,183
SCHEDULE OF REVENUES ATTRIBUTED TO GEOGRAPHIC AREAS BY PRODUCT	By product: SCHEDULE OF REVENUES ATTRIBUTED TO GEOGRAPHIC AREAS BY PRODUCT Three months ended 2023 2022 ($ in thousands) CGuard $ 1,239 $ 1,161 MGuard - 22 $ 1,239 $ 1,183
SCHEDULE OF REVENUES ATTRIBUTED TO GEOGRAPHIC AREAS BY PRINCIPAL CUSTOMERS	By principal customers: SCHEDULE OF REVENUES ATTRIBUTED TO GEOGRAPHIC AREAS BY PRINCIPAL CUSTOMERS Three months ended 2023 2022 Customer A 17 % 21 % Customer B 13 % 11 %

DESCRIPTION OF BUSINESS (Detail

DESCRIPTION OF BUSINESS (Details Narrative) $ in Millions	May 12, 2023 USD ($)
Securities Purchase Agreement [Member] | Subsequent Event [Member]
Collaborative Arrangement and Arrangement Other than Collaborative [Line Items]
Private placement	$ 42.2

SCHEDULE OF ISSUANCE OF WARRANT

SCHEDULE OF ISSUANCE OF WARRANTS TO PURCHASE COMMON STOCK (Details) shares in Thousands	3 Months Ended
	Mar. 31, 2023 $ / shares shares
Class of Stock [Line Items]
Total Warrants	1,793,504
Series E Warrants [Member]
Class of Stock [Line Items]
Total Warrants	198,159
Weighted average exercise price | $ / shares	$ 27
Series F Warrants [Member]
Class of Stock [Line Items]
Total Warrants	433,878
Weighted average exercise price | $ / shares	$ 7.425
Series G Warrants [Member]
Class of Stock [Line Items]
Total Warrants	1,092,344
Weighted average exercise price | $ / shares	$ 10.230
Underwriter Warrants [Member]
Class of Stock [Line Items]
Total Warrants	17,966
Weighted average exercise price | $ / shares	$ 7.425
Other Warrants [Member]
Class of Stock [Line Items]
Total Warrants	51,157
Weighted average exercise price, description	225 and above

EQUITY (Details Narrative)

EQUITY (Details Narrative) - USD ($)	3 Months Ended
	Mar. 31, 2023	Dec. 31, 2022
Class of Stock [Line Items]
Common stock, shares outstanding	8,326,648	8,330,918
Capital stock shares authorized	155,000,000
Capital stock par value	$ 0.0001
Common stock shares authorized	150,000,000	150,000,000
Stock option description	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.
Expected dividend rate	0%
Expected volatility, minimum	124.58%
Expected volatility, maximum	125.61%
Risk-free interest rate, minimum	3.65%
Risk-free interest rate, maximum	3.68%
Minimum [Member]
Class of Stock [Line Items]
Expected term	5 years 6 months
Maximum [Member]
Class of Stock [Line Items]
Expected term	6 years 6 months
Three Year Vesting Period [Member]
Class of Stock [Line Items]
Stock option grants in period	45,000
First Year Vesting Period [Member]
Class of Stock [Line Items]
Stock option grants in period	20,000
Second Year Vesting Period [Member]
Class of Stock [Line Items]
Stock option grants in period	15,000
Third Year Vesting Period [Member]
Class of Stock [Line Items]
Stock option grants in period	10,000
Performance Conditions [Member]
Class of Stock [Line Items]
Stock option grants in period	5,000
Share-Based Payment Arrangement, Option [Member]
Class of Stock [Line Items]
Stock option grants in period	50,000
Stock option exercise price	$ 1.15
Vesting period	3 years
Fair value stock option price	$ 50,658
Preferred Stock Blank Check [Member]
Class of Stock [Line Items]
Preferred stock shares authorized	5,000,000
At The Market Offering [Member] | Warrant [Member]
Class of Stock [Line Items]
Purchase of warrants	1,793,504
Series C Convertible Preferred Stock [Member]
Class of Stock [Line Items]
Common stock, shares outstanding	1,718
Conversion of Series C Convertible Preferred Stock to common shares, shares	2,280

RELATED PARTIES TRANSACTIONS (D

RELATED PARTIES TRANSACTIONS (Details Narrative)	3 Months Ended
	Mar. 31, 2022 USD ($)
New Director [Member]
Deferred Compensation Arrangement with Individual, Excluding Share-Based Payments and Postretirement Benefits [Line Items]
Marketing services expense	$ 6,276

NET LOSS PER SHARE (Details Nar

NET LOSS PER SHARE (Details Narrative) - shares	3 Months Ended
	Mar. 31, 2023	Mar. 31, 2022
Antidilutive Securities Excluded from Computation of Earnings Per Share [Line Items]
Diluted loss per share	2,773,675	2,903,634
Restricted Stock [Member]
Antidilutive Securities Excluded from Computation of Earnings Per Share [Line Items]
Diluted loss per share	342,766	547,383

SCHEDULE OF INVENTORY (Details)

SCHEDULE OF INVENTORY (Details) - USD ($) $ in Thousands	Mar. 31, 2023	Dec. 31, 2022
Inventory Disclosure [Abstract]
Finished goods	$ 138	$ 179
Work in process	690	510
Raw materials and supplies	869	932
Total inventory	$ 1,697	$ 1,621

SCHEDULE OF ACCOUNTS PAYABLE AN

SCHEDULE OF ACCOUNTS PAYABLE AND ACCRUALS - OTHER (Details) - USD ($) $ in Thousands	Mar. 31, 2023	Dec. 31, 2022
Payables and Accruals [Abstract]
Employees and employee institutions	$ 970	$ 1,853
Accrued vacation and recreation pay	240	197
Accrued expenses	933	554
Clinical trial accrual	1,046	1,258
Current Operating lease liabilities	417	419
Other	170	130
Accounts payable and accruals-other	$ 3,776	$ 4,411

SCHEDULE OF REVENUES ATTRIBUTED

SCHEDULE OF REVENUES ATTRIBUTED TO GEOGRAPHIC AREAS (Details) - USD ($) $ in Thousands	3 Months Ended
	Mar. 31, 2023	Mar. 31, 2022
Revenues from External Customers and Long-Lived Assets [Line Items]
Revenues	$ 1,239	$ 1,183
ITALY
Revenues from External Customers and Long-Lived Assets [Line Items]
Revenues	267	243
GERMANY
Revenues from External Customers and Long-Lived Assets [Line Items]
Revenues	214	249
Other Countries [Member]
Revenues from External Customers and Long-Lived Assets [Line Items]
Revenues	$ 758	$ 691

SCHEDULE OF REVENUES ATTRIBUT_2

SCHEDULE OF REVENUES ATTRIBUTED TO GEOGRAPHIC AREAS BY PRODUCT (Details) - USD ($) $ in Thousands	3 Months Ended
	Mar. 31, 2023	Mar. 31, 2022
Revenue from External Customer [Line Items]
Revenue	$ 1,239	$ 1,183
CGuard EPS [Member]
Revenue from External Customer [Line Items]
Revenue	1,239	1,161
MGuard Prime EPS [Member]
Revenue from External Customer [Line Items]
Revenue		$ 22

SCHEDULE OF REVENUES ATTRIBUT_3

SCHEDULE OF REVENUES ATTRIBUTED TO GEOGRAPHIC AREAS BY PRINCIPAL CUSTOMERS (Details) - Sales [Member] - Customer Concentration Risk [Member]	3 Months Ended
	Mar. 31, 2023	Mar. 31, 2022
Customer A [Member]
Revenue, Major Customer [Line Items]
Percentage of revenues per major customer	17%	21%
Customer B [Member]
Revenue, Major Customer [Line Items]
Percentage of revenues per major customer	13%	11%

SUBSEQUENT EVENTS (Details Narr

SUBSEQUENT EVENTS (Details Narrative) - Subsequent Event [Member] $ / shares in Units, $ in Millions	May 12, 2023 USD ($) $ / shares shares
Subsequent Event [Line Items]
Warrant exercise price | $ / shares	$ 1.3827
Securities Purchase Agreement [Member]
Subsequent Event [Line Items]
Private placement | $	$ 42.2
Offering expenses | $	4.6
Warrant exercises | $	$ 71.4
Warrant [Member]
Subsequent Event [Line Items]
Offering price | $ / shares	$ 1.6326
Warrant exercise price | $ / shares	$ 0.0001
Private Placement [Member]
Subsequent Event [Line Items]
Number of stock issued	10,266,270
Private Placement [Member] | Warrant [Member]
Subsequent Event [Line Items]
Number of warrants or rights outstanding	15,561,894
Offering price | $ / shares	$ 1.6327
Private Placement [Member] | Common Stock [Member]
Subsequent Event [Line Items]
Number of warrants or rights outstanding	51,656,328
Private Placement [Member] | Series H Warrants [Member]
Subsequent Event [Line Items]
Number of warrants or rights outstanding	12,914,086
Private Placement [Member] | Series I Warrants [Member]
Subsequent Event [Line Items]
Number of warrants or rights outstanding	12,914,078
Private Placement [Member] | Series J Warrants [Member]
Subsequent Event [Line Items]
Number of warrants or rights outstanding	12,914,086
Private Placement [Member] | Series K Warrants [Member]
Subsequent Event [Line Items]
Number of warrants or rights outstanding	12,914,086