InspireMD (NSPR) 10-Q 13 May 24 2024 Q1 Quarterly report Financial data

Cover

Cover - shares	3 Months Ended
	Mar. 31, 2024	May 13, 2024
Cover [Abstract]
Document Type	10-Q
Amendment Flag	false
Document Quarterly Report	true
Document Transition Report	false
Document Period End Date	Mar. 31, 2024
Document Fiscal Period Focus	Q1
Document Fiscal Year Focus	2024
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		24,929,825

Condensed Consolidated Balance

Condensed Consolidated Balance Sheets (Unaudited) - USD ($) $ in Thousands		Mar. 31, 2024	Dec. 31, 2023
CURRENT ASSETS:
Cash and cash equivalents		$ 9,389	$ 9,640
Marketable securities		24,561	29,383
Accounts receivable:
Trade, net		1,187	1,804
Other		483	648
Prepaid expenses		531	578
Inventory		2,360	2,106
TOTAL CURRENT ASSETS		38,511	44,159
NON-CURRENT ASSETS:
Property, plant and equipment, net		1,186	1,060
Operating lease right of use assets		1,366	1,473
Fund in respect of employee rights upon retirement		965	951
TOTAL NON-CURRENT ASSETS		3,517	3,484
TOTAL ASSETS		42,028	47,643
Accounts payable and accruals:
Trade		659	939
Other		4,218	5,081
TOTAL CURRENT LIABILITIES		4,877	6,020
LONG-TERM LIABILITIES-
Operating lease liabilities		914	1,038
Liability for employees rights upon retirement		1,150	1,084
TOTAL LONG-TERM LIABILITIES		2,064	2,122
COMMITMENTS AND CONTINGENT LIABILITIES
TOTAL LIABILITIES		6,941	8,142
EQUITY:
Common stock, par value $0.0001 per share; 150,000,000 shares authorized at March 31, 2024 and December 31, 2023; 23,412,385 and 21,841,215 shares issued and outstanding at March 31, 2024 and December 2023, respectively		2	2
Preferred C shares, par value $0.0001 per share; 1,172,000 shares authorized at March 31, 2024 and December 31, 2023; 1,718 shares issued and outstanding at March 31, 2024 and December 31 2023, respectively	[1]
Additional paid-in capital		263,618	261,000
Accumulated deficit		(228,533)	(221,501)
Total equity		35,087	39,501
Total liabilities and equity		$ 42,028	$ 47,643
[1]Represents an amount less than $1 thousand

Condensed Consolidated Balanc_2

Condensed Consolidated Balance Sheets (Unaudited) (Parenthetical) - $ / shares	Mar. 31, 2024	Dec. 31, 2023
Common stock, par value	$ 0.0001	$ 0.0001
Common stock, shares authorized	150,000,000	150,000,000
Common stock, shares issued	23,412,385	21,841,215
Common stock, shares outstanding	23,412,385	21,841,215
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, 2024	Mar. 31, 2023
Income Statement [Abstract]
REVENUES	$ 1,511	$ 1,239
COST OF REVENUES	1,219	866
GROSS PROFIT	292	373
OPERATING EXPENSES:
Research and development	2,625	1,843
Selling and marketing	1,237	788
General and administrative	3,844	2,123
Total operating expenses	7,706	4,754
LOSS FROM OPERATIONS	(7,414)	(4,381)
FINANCIAL INCOME, net	382	125
NET LOSS	$ (7,032)	$ (4,256)
NET LOSS PER SHARE - basic	$ (0.21)	$ (0.53)
NET LOSS PER SHARE - diluted	$ (0.21)	$ (0.53)
WEIGHTED AVERAGE NUMBER OF ORDINARY SHARES USED IN COMPUTING NET LOSS PER SHARE - basic	34,242,976	8,093,340
WEIGHTED AVERAGE NUMBER OF ORDINARY SHARES USED IN COMPUTING NET LOSS PER SHARE - diluted	34,242,976	8,093,340

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, 2022	$ 1		[1]	$ 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 stock, restricted stock, restricted stock units and stock options award, net of forfeitures				289		289
Share-based compensation related to stock, restricted stock, restricted stock units and stock options award, net of forfeitures, shares	(4,270)
Balance at Mar. 31, 2023	$ 1		[1]	219,266	(205,841)	13,426
Balance, shares at Mar. 31, 2023	8,326,648	1,718
Balance at Dec. 31, 2023	$ 2		[2]	261,000	(221,501)	39,501
Balance, shares at Dec. 31, 2023	21,841,215	1,718
Net loss					(7,032)	(7,032)
Share-based compensation related to stock, restricted stock, restricted stock units and stock options award, net of forfeitures				2,618		2,618
Share-based compensation related to stock, restricted stock, restricted stock units and stock options award, net of forfeitures, shares	1,571,170
Balance at Mar. 31, 2024	$ 2		[2]	$ 263,618	$ (228,533)	$ 35,087
Balance, shares at Mar. 31, 2024	23,412,385	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, 2024	Mar. 31, 2023
Statement of Stockholders' Equity [Abstract]
Shares, restricted stock award, forfeited	75,090	4,270

Condensed Consolidated Statem_4

Condensed Consolidated Statements of Cash Flows (Unaudited) - USD ($) $ in Thousands	3 Months Ended
	Mar. 31, 2024	Mar. 31, 2023
CASH FLOWS FROM OPERATING ACTIVITIES:
Net loss	$ (7,032)	$ (4,256)
Adjustments required to reconcile net loss to net cash used in operating activities:
Depreciation	69	55
Change in fair value of markable securities, net of interest received	(218)
Change in liability for employees rights upon retirement	66	36
Other financial expenses	4	22
Change in operating right of use asset and operating leasing liability	(25)	(34)
Share-based compensation expenses	2,618	289
Loss on amounts funded in respect of employee rights upon retirement, net	14	23
Decrease in interest receivable on short term deposits		14
Changes in operating asset and liability items:
Decrease in prepaid expenses	47	261
Decrease (Increase) in trade receivables	617	(383)
Decrease (Increase) in other receivables	165	(97)
Increase in inventory	(254)	(76)
Decrease in trade payables	(280)	(52)
Decrease in other payables	(855)	(633)
Net cash used in operating activities	(5,064)	(4,831)
CASH FLOWS FROM INVESTING ACTIVITIES:
Purchase of property, plant and equipment	(195)	(25)
Investment in short-term bank deposits		(2,500)
Withdrawal from short-term bank deposits		7,000
Investments in marketable securities	(1,960)
Proceeds from matured marketable securities	7,000
Amounts funded in respect of employee rights upon retirement	(28)	(26)
Net cash provided by (used in) investing activities	4,817	4,449
CASH FLOWS FROM FINANCING ACTIVITIES:
Net cash provided by (used in) financing activities
EFFECT OF EXCHANGE RATE CHANGES ON CASH AND CASH EQUIVALENTS	(4)	(22)
DECREASE IN CASH AND CASH EQUIVALENTS	(251)	(404)
BALANCE OF CASH AND CASH EQUIVALENTS AT BEGINNING OF THE PERIOD	9,640	4,632
BALANCE OF CASH AND CASH EQUIVALENTS AT END OF THE PERIOD	$ 9,389	$ 4,228

Pay vs Performance Disclosure

Pay vs Performance Disclosure - USD ($) $ in Thousands	3 Months Ended
	Mar. 31, 2024	Mar. 31, 2023
Pay vs Performance Disclosure [Table]
Net Income (Loss)	$ (7,032)	$ (4,256)

Insider Trading Arrangements

Insider Trading Arrangements	3 Months Ended
	Mar. 31, 2024
Trading Arrangements, by Individual [Table]
Rule 10b5-1 Arrangement Adopted	false
Non-Rule 10b5-1 Arrangement Adopted	false
Rule 10b5-1 Arrangement Terminated	false
Non-Rule 10b5-1 Arrangement Terminated	false

DESCRIPTION OF BUSINESS

DESCRIPTION OF BUSINESS	3 Months Ended
	Mar. 31, 2024
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 markets its product through distributors in international markets, mainly in Europe. As of the date of issuance of these 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. 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. b. Risks Related to the Company’s Operations in Israel including the recent attack by Hamas and other terrorist organizations from the Gaza Strip and Israel’s war against them. In October 2023, Israel was attacked by a terrorist organization and entered a state of war. As of the date of these consolidated financial statements, the war in Israel is ongoing and continues to evolve. The Company operations, including its production facility, are located in Israel. Currently, such activities in Israel remain largely unaffected. During the three months ended March 31, 2024, the impact of this war on the Company’s results of operations and financial condition was immaterial, but such impact may increase, which could be material, as a result of the continuation, escalation or expansion of such war.

BASIS OF PRESENTATION

BASIS OF PRESENTATION	3 Months Ended
	Mar. 31, 2024
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, 2024 and its results of operations, changes in equity and cash flows for the three months ended March 31, 2024 and 2023. 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, 2023, as found in the Company’s Annual Report on Form 10-K, filed with the Securities and Exchange Commission on March 5, 2024. The results of operations for the three months ended March 31, 2024 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, 2024
Accounting Changes and Error Corrections [Abstract]
RECENTLY ADOPTED AND ISSUED ACCOUNTING PRONOUNCEMENTS	NOTE 3 - RECENTLY ADOPTED AND ISSUED ACCOUNTING PRONOUNCEMENTS Recently adopted accounting pronouncements In August 2020, the Financial Accounting Standards Board (“FASB”) issued Accounting Standards Update (“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 adopted the provisions of this update as of January 1, 2024 with no material impact on its consolidated financial statements. Recently issued accounting pronouncement, not yet adopted 1) In November 2023, the FASB issued ASU 2023-07 “Segment Reporting: Improvements to Reportable Segment Disclosures”. This guidance expands public entities segment disclosures primarily by requiring disclosure of significant segment expenses that are regularly provided to the chief operating decision maker and included within each reported measure of segment profit or loss, an amount and description of its composition for other segment items, and interim disclosures of a reportable segment’s profit or loss and assets. Public entities with a single reportable segment are required to provide the new disclosures and all the disclosures required under Accounting Standards Codification (“ASC”) 280. The guidance is effective for fiscal years beginning after December 15, 2023, and interim periods within fiscal years beginning after December 15, 2024, with early adoption permitted. The amendments are required to be applied retrospectively to all prior periods presented in an entity’s financial statements. The Company is currently evaluating this guidance to determine the impact it may have on its consolidated financial statements related disclosures. 2) In December 2023, the FASB issued ASU 2023-09 “Income Taxes (Topic 740): Improvements to Income Tax Disclosures”. This guidance is intended to enhance the transparency and decision-usefulness of income tax disclosures. The amendments in ASU 2023-09 address investor requests for enhanced income tax information primarily through changes to disclosure regarding rate reconciliation and income taxes paid both in the U.S. and in foreign jurisdictions. ASU 2023-09 is effective for fiscal years beginning after December 15, 2024 on a prospective basis, with the option to apply the standard retrospectively. Early adoption is permitted. The Company is currently evaluating this guidance to determine the impact it may have on its consolidated financial statements disclosures.

FAIR VALUE MEASUREMENTS

FAIR VALUE MEASUREMENTS	3 Months Ended
	Mar. 31, 2024
Fair Value Disclosures [Abstract]
FAIR VALUE MEASUREMENTS	NOTE 4 – FAIR VALUE MEASUREMENTS Fair 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: Level 1: 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. Level 2: Observable prices that are based on inputs not quoted on active markets but corroborated by market data. Level 3: Unobservable inputs are used when little or no market data is available. The fair value hierarchy gives the lowest priority to Level 3 inputs. The Company’s financial assets subject to fair value measurements on a recurring basis and the level of inputs used in such measurements were as follows: SCHEDULE OF FINANCIAL ASSETS SUBJECT TO FAIR VALUE MEASUREMENTS Total Level 1 Level 2 Level 3 As of March 31, 2024 ($ in thousands) Total Level 1 Level 2 Level 3 Assets: Cash equivalents- Money market funds $ 3,745 $ 3,745 $ - $ - Marketable securities- U.S government bonds $ 24,561 $ - $ 24,561 $ - Total Level 1 Level 2 Level 3 As of December 31, 2023 ($ in thousands) Total Level 1 Level 2 Level 3 Assets: Cash equivalents- Money market funds $ 7,094 $ 7,094 $ - $ - Cash equivalents $ 7,094 $ 7,094 $ - $ - Marketable securities- U.S government bonds $ 29,383 $ - $ 29,383 $ - Marketable securities $ 29,383 $ - $ 29,383 $ - 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 March 31, 2024 is $ 23,878 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. As of March 31, 2024, and December 31, 2023, allowance for expected credit loss was immaterial.

MARKETABLE SECURITIES

MARKETABLE SECURITIES	3 Months Ended
	Mar. 31, 2024
Investments, Debt and Equity Securities [Abstract]
MARKETABLE SECURITIES	NOTE 5 - MARKETABLE SECURITIES The following table sets forth the Company’s marketable securities for the indicated period: SCHEDULE OF MARKETABLE SECURITIES March 31, 2023 December 31, 2023 ($ in thousands) U.S government bonds $ 24,561 $ 29,383 Marketable securities $ 24,561 $ 29,383 The following table summarizes the fair value of the Company’s marketable securities classified by maturity as of March 31, 2024, and December 31, 2023: SCHEDULE OF FAIR VALUE OF MARKETABLE SECURITIES CLASSIFIED BY MATURITY March 31, 2024 December 31, 2023 ($ in thousands) Amounts maturing within one year $ 23,573 $ 24,523 Amounts maturing after one year through two years 988 4,860 $ 24,561 $ 29,383 The table below sets forth a summary of the changes in the fair value of the Company’s marketable securities for the three month period ended March 31, 2024: SCHEDULE OF CHANGES IN FAIR VALUE OF MARKETABLE SECURITIES Three months ended March 31, 2024 ($ in thousands) Balance at beginning of the period $ 29,383 Additions 1,960 Maturity (7,000 ) Interest Received (75 ) Changes in fair value during the period 293 Balance at end of the period 24,561

EQUITY

EQUITY	3 Months Ended
	Mar. 31, 2024
Equity [Abstract]
EQUITY	NOTE 6 - EQUITY a. As of March 31, 2024, there were 1,718 7,952 10,997 b. As of March 31, 2024, there are 15,254,623 c. As of March 31, 2024, the Company has outstanding warrants to purchase an aggregate of 53,396,008 SCHEDULE OF ISSUANCE OF WARRANTS TO PURCHASE COMMON STOCK Number of underlying Exercise Series E Warrants 198,159 $ 27.0000 Series F Warrants 433,878 $ 7.4250 Series G Warrants 1,092,344 $ 10.2300 Series H Warrants 12,914,086 $ 1.3827 Series I Warrants 12,914,078 $ 1.3827 Series J Warrants 12,914,086 $ 1.3827 Series K Warrants 12,914,078 $ 1.3827 Underwriter Warrants 15,299 $ 7.4250 Total Warrants 53,396,008 $ As of March 31, 2024, the Company had 155,000,000 0.0001 150,000,000 5,000,000 d. During the three months ended March 31, 2024, the Company granted 1,634,403 The fair value of the above restricted shares was approximately $ 5.07 During the three months ended March 31, 2024, the Company granted 563,499 The fair value of the above restricted share units was approximately $ 1.77 During the three months ended March 31, 2024, the Company granted to employees and directors options to purchase a total of 715,614 2.71 3.14 In calculating the fair value of the above options, the Company used the following assumptions: dividend yield of 0 5.5 6.5 96.40 119.38 3.93 4.10 The fair value of the above options, using the Black-Scholes option-pricing model, was approximately $ 1.85

RELATED PARTIES TRANSACTIONS

RELATED PARTIES TRANSACTIONS	3 Months Ended
	Mar. 31, 2024
Related Party Transactions [Abstract]
RELATED PARTIES TRANSACTIONS	NOTE 7 – RELATED PARTIES TRANSACTIONS During the three months ended March 31, 2024, a member of the immediate family of the CEO provided certain administrative services in connection with the Company’s expansion to the U.S. in the amount of $ 15

NET LOSS PER SHARE

NET LOSS PER SHARE	3 Months Ended
	Mar. 31, 2024
Earnings Per Share [Abstract]
NET LOSS PER SHARE	NOTE 8 - 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, pre-funded warrants and fully vested restricted stock units outstanding during the period. The calculation of diluted net loss per share excludes the effect of potential dilution of share options, warrants, and unvested restricted stocks, unvested restricted stock units and Series C preferred stock as the effect is anti-dilutive. For 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 three month period ended March 31, 2024, the Company had weighted average pre-funded warrants to purchase 15,254,623 The total number of shares of common stock related to outstanding options, warrants, unvested restricted stock, unvested restricted stock units and Series C preferred stock, which were excluded from the calculations of diluted loss per share were 62,556,668 2,773,675 4,611,500 342,766

INVENTORY

INVENTORY	3 Months Ended
	Mar. 31, 2024
Inventory Disclosure [Abstract]
INVENTORY	NOTE 9 - INVENTORY SCHEDULE OF INVENTORIES March 31, 2024 December 31, 2023 ($ in thousands) Finished goods $ 73 $ 210 Work in process 917 562 Raw materials and supplies 1,370 1,334 Total inventory $ 2,360 $ 2,106

ACCOUNTS PAYABLE AND ACCRUALS -

ACCOUNTS PAYABLE AND ACCRUALS - OTHER	3 Months Ended
	Mar. 31, 2024
Payables and Accruals [Abstract]
ACCOUNTS PAYABLE AND ACCRUALS - OTHER	NOTE 10 - ACCOUNTS PAYABLE AND ACCRUALS - OTHER SCHEDULE OF ACCOUNTS PAYABLE AND ACCRUALS - OTHER March 31, 2024 December 31, 2023 ($ in thousands) Employees and employee institutions 1,207 2,188 Accrued vacation and recreation pay 348 287 Accrued expenses 1,101 1,115 Clinical trial accrual 826 744 Current Operating lease liabilities 549 557 Other 187 190 Accounts Payable and Accruals - Other $ 4,218 $ 5,081

DISAGGREGATED REVENUE AND ENTIT

DISAGGREGATED REVENUE AND ENTITY WIDE DISCLOSURES	3 Months Ended
	Mar. 31, 2024
Segment Reporting [Abstract]
DISAGGREGATED REVENUE AND ENTITY WIDE DISCLOSURES	NOTE 11 - 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 March 31 2024 2023 ($ in thousands) Italy $ 295 $ 267 Germany 242 214 Poland 152 119 Other 822 639 $ 1,511 $ 1,239 By principal customers: SCHEDULE OF REVENUES ATTRIBUTED TO GEOGRAPHIC AREAS BY PRINCIPAL CUSTOMERS Three months ended March 31 2024 2023 Customer A 16 % 17 % Customer B 12 % 13 % Customer C 10 % 10 % All tangible long lived assets are located in Israel.

FAIR VALUE MEASUREMENTS (Tables

FAIR VALUE MEASUREMENTS (Tables)	3 Months Ended
	Mar. 31, 2024
Fair Value Disclosures [Abstract]
SCHEDULE OF FINANCIAL ASSETS SUBJECT TO FAIR VALUE MEASUREMENTS	The Company’s financial assets subject to fair value measurements on a recurring basis and the level of inputs used in such measurements were as follows: SCHEDULE OF FINANCIAL ASSETS SUBJECT TO FAIR VALUE MEASUREMENTS Total Level 1 Level 2 Level 3 As of March 31, 2024 ($ in thousands) Total Level 1 Level 2 Level 3 Assets: Cash equivalents- Money market funds $ 3,745 $ 3,745 $ - $ - Marketable securities- U.S government bonds $ 24,561 $ - $ 24,561 $ - Total Level 1 Level 2 Level 3 As of December 31, 2023 ($ in thousands) Total Level 1 Level 2 Level 3 Assets: Cash equivalents- Money market funds $ 7,094 $ 7,094 $ - $ - Cash equivalents $ 7,094 $ 7,094 $ - $ - Marketable securities- U.S government bonds $ 29,383 $ - $ 29,383 $ - Marketable securities $ 29,383 $ - $ 29,383 $ -

MARKETABLE SECURITIES (Tables)

MARKETABLE SECURITIES (Tables)	3 Months Ended
	Mar. 31, 2024
Investments, Debt and Equity Securities [Abstract]
SCHEDULE OF MARKETABLE SECURITIES	The following table sets forth the Company’s marketable securities for the indicated period: SCHEDULE OF MARKETABLE SECURITIES March 31, 2023 December 31, 2023 ($ in thousands) U.S government bonds $ 24,561 $ 29,383 Marketable securities $ 24,561 $ 29,383
SCHEDULE OF FAIR VALUE OF MARKETABLE SECURITIES CLASSIFIED BY MATURITY	The following table summarizes the fair value of the Company’s marketable securities classified by maturity as of March 31, 2024, and December 31, 2023: SCHEDULE OF FAIR VALUE OF MARKETABLE SECURITIES CLASSIFIED BY MATURITY March 31, 2024 December 31, 2023 ($ in thousands) Amounts maturing within one year $ 23,573 $ 24,523 Amounts maturing after one year through two years 988 4,860 $ 24,561 $ 29,383
SCHEDULE OF CHANGES IN FAIR VALUE OF MARKETABLE SECURITIES	The table below sets forth a summary of the changes in the fair value of the Company’s marketable securities for the three month period ended March 31, 2024: SCHEDULE OF CHANGES IN FAIR VALUE OF MARKETABLE SECURITIES Three months ended March 31, 2024 ($ in thousands) Balance at beginning of the period $ 29,383 Additions 1,960 Maturity (7,000 ) Interest Received (75 ) Changes in fair value during the period 293 Balance at end of the period 24,561

EQUITY (Tables)

EQUITY (Tables)	3 Months Ended
	Mar. 31, 2024
Equity [Abstract]
SCHEDULE OF ISSUANCE OF WARRANTS TO PURCHASE COMMON STOCK	SCHEDULE OF ISSUANCE OF WARRANTS TO PURCHASE COMMON STOCK Number of underlying Exercise Series E Warrants 198,159 $ 27.0000 Series F Warrants 433,878 $ 7.4250 Series G Warrants 1,092,344 $ 10.2300 Series H Warrants 12,914,086 $ 1.3827 Series I Warrants 12,914,078 $ 1.3827 Series J Warrants 12,914,086 $ 1.3827 Series K Warrants 12,914,078 $ 1.3827 Underwriter Warrants 15,299 $ 7.4250 Total Warrants 53,396,008 $

INVENTORY (Tables)

INVENTORY (Tables)	3 Months Ended
	Mar. 31, 2024
Inventory Disclosure [Abstract]
SCHEDULE OF INVENTORIES	SCHEDULE OF INVENTORIES March 31, 2024 December 31, 2023 ($ in thousands) Finished goods $ 73 $ 210 Work in process 917 562 Raw materials and supplies 1,370 1,334 Total inventory $ 2,360 $ 2,106

ACCOUNTS PAYABLE AND ACCRUALS_2

ACCOUNTS PAYABLE AND ACCRUALS - OTHER (Tables)	3 Months Ended
	Mar. 31, 2024
Payables and Accruals [Abstract]
SCHEDULE OF ACCOUNTS PAYABLE AND ACCRUALS - OTHER	SCHEDULE OF ACCOUNTS PAYABLE AND ACCRUALS - OTHER March 31, 2024 December 31, 2023 ($ in thousands) Employees and employee institutions 1,207 2,188 Accrued vacation and recreation pay 348 287 Accrued expenses 1,101 1,115 Clinical trial accrual 826 744 Current Operating lease liabilities 549 557 Other 187 190 Accounts Payable and Accruals - Other $ 4,218 $ 5,081

DISAGGREGATED REVENUE AND ENT_2

DISAGGREGATED REVENUE AND ENTITY WIDE DISCLOSURES (Tables)	3 Months Ended
	Mar. 31, 2024
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 March 31 2024 2023 ($ in thousands) Italy $ 295 $ 267 Germany 242 214 Poland 152 119 Other 822 639 $ 1,511 $ 1,239
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 March 31 2024 2023 Customer A 16 % 17 % Customer B 12 % 13 % Customer C 10 % 10 %

SCHEDULE OF FINANCIAL ASSETS SU

SCHEDULE OF FINANCIAL ASSETS SUBJECT TO FAIR VALUE MEASUREMENTS (Details) - USD ($) $ in Thousands	Mar. 31, 2024	Dec. 31, 2023
Fair Value, Assets and Liabilities Measured on Recurring and Nonrecurring Basis [Line Items]
Marketable securities	$ 23,878
Fair Value, Recurring [Member] | US Government Agencies Debt Securities [Member]
Fair Value, Assets and Liabilities Measured on Recurring and Nonrecurring Basis [Line Items]
Marketable securities	24,561	$ 29,383
Fair Value, Recurring [Member] | Fair Value, Inputs, Level 1 [Member] | US Government Agencies Debt Securities [Member]
Fair Value, Assets and Liabilities Measured on Recurring and Nonrecurring Basis [Line Items]
Marketable securities
Fair Value, Recurring [Member] | Fair Value, Inputs, Level 2 [Member] | US Government Agencies Debt Securities [Member]
Fair Value, Assets and Liabilities Measured on Recurring and Nonrecurring Basis [Line Items]
Marketable securities	24,561	29,383
Fair Value, Recurring [Member] | Fair Value, Inputs, Level 3 [Member] | US Government Agencies Debt Securities [Member]
Fair Value, Assets and Liabilities Measured on Recurring and Nonrecurring Basis [Line Items]
Marketable securities
Fair Value, Recurring [Member] | Money Market Funds [Member]
Fair Value, Assets and Liabilities Measured on Recurring and Nonrecurring Basis [Line Items]
Cash equivalents	3,745	7,094
Fair Value, Recurring [Member] | Money Market Funds [Member] | Fair Value, Inputs, Level 1 [Member]
Fair Value, Assets and Liabilities Measured on Recurring and Nonrecurring Basis [Line Items]
Cash equivalents	3,745	7,094
Fair Value, Recurring [Member] | Money Market Funds [Member] | Fair Value, Inputs, Level 2 [Member]
Fair Value, Assets and Liabilities Measured on Recurring and Nonrecurring Basis [Line Items]
Cash equivalents
Fair Value, Recurring [Member] | Money Market Funds [Member] | Fair Value, Inputs, Level 3 [Member]
Fair Value, Assets and Liabilities Measured on Recurring and Nonrecurring Basis [Line Items]
Cash equivalents

FAIR VALUE MEASUREMENTS (Detail

FAIR VALUE MEASUREMENTS (Details Narrative) $ in Thousands	Mar. 31, 2024 USD ($)
Fair Value Disclosures [Abstract]
Cost of marketable securities	$ 23,878

SCHEDULE OF MARKETABLE SECURITI

SCHEDULE OF MARKETABLE SECURITIES (Details) - USD ($) $ in Thousands	Mar. 31, 2024	Dec. 31, 2023
Marketable Securities [Line Items]
Marketable securities	$ 24,561	$ 29,383
US Government Agencies Debt Securities [Member]
Marketable Securities [Line Items]
Marketable securities	$ 24,561	$ 29,383

SCHEDULE OF FAIR VALUE OF MARKE

SCHEDULE OF FAIR VALUE OF MARKETABLE SECURITIES CLASSIFIED BY MATURITY (Details) - USD ($) $ in Thousands	Mar. 31, 2024	Dec. 31, 2023
Investments, Debt and Equity Securities [Abstract]
Amounts maturing within one year	$ 23,573	$ 24,523
Amounts maturing after one year through two years	988	4,860
Marketable securities	$ 24,561	$ 29,383

SCHEDULE OF CHANGES IN FAIR VAL

SCHEDULE OF CHANGES IN FAIR VALUE OF MARKETABLE SECURITIES (Details) - USD ($) $ in Thousands	3 Months Ended
	Mar. 31, 2024	Mar. 31, 2023
Investments, Debt and Equity Securities [Abstract]
Balance at beginning of the period	$ 29,383
Additions	1,960
Maturity	(7,000)
Interest Received	(75)
Changes in fair value during the period	293
Balance at end of the period	$ 24,561

SCHEDULE OF ISSUANCE OF WARRANT

SCHEDULE OF ISSUANCE OF WARRANTS TO PURCHASE COMMON STOCK (Details)	Mar. 31, 2024 $ / shares shares
Class of Stock [Line Items]
Total Warrants	53,396,008
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	$ 7.4250
Series G Warrants [Member]
Class of Stock [Line Items]
Total Warrants	1,092,344
Weighted average exercise price | $ / shares	$ 10.2300
Series H Warrants [Member]
Class of Stock [Line Items]
Total Warrants	12,914,086
Weighted average exercise price | $ / shares	$ 1.3827
Series I Warrants [Member]
Class of Stock [Line Items]
Total Warrants	12,914,078
Weighted average exercise price | $ / shares	$ 1.3827
Series J Warrants [Member]
Class of Stock [Line Items]
Total Warrants	12,914,086
Weighted average exercise price | $ / shares	$ 1.3827
Series K Warrants [Member]
Class of Stock [Line Items]
Total Warrants	12,914,078
Weighted average exercise price | $ / shares	$ 1.3827
Underwriter Warrants [Member]
Class of Stock [Line Items]
Total Warrants	15,299
Weighted average exercise price | $ / shares	$ 7.4250

EQUITY (Details Narrative)

EQUITY (Details Narrative) - USD ($)		3 Months Ended
		Mar. 31, 2024	Dec. 31, 2023
Class of Stock [Line Items]
Preferred stock stated value	[1]
Warrants to purchase common stock		53,396,008
Capital stock shares authorized		155,000,000
Capital stock par value		$ 0.0001
Common stock shares authorized		150,000,000	150,000,000
Restricted Stock [Member] | Employees and Directors [Member]
Class of Stock [Line Items]
Shares granted		1,634,403
Fair value of shares granted		$ 5,070,000
Restricted Stock Units (RSUs) [Member] | Chief Executive Officer [Member]
Class of Stock [Line Items]
Shares granted		563,499
Fair value of shares granted		$ 1,770,000
Share-Based Payment Arrangement, Option [Member] | Employees and Directors [Member]
Class of Stock [Line Items]
Share based compensation arrangement by share based payment award options grants in period		715,614
Expected dividend rate		0%
Expected volatility, minimum		96.40%
Expected volatility, maximum		119.38%
Fair value stock option price		$ 1,850,000
Share-Based Payment Arrangement, Option [Member] | Employees and Directors [Member] | Minimum [Member]
Class of Stock [Line Items]
Stock option exercise price		$ 2.71
Expected term		5 years 6 months
Risk-free interest rate, maximum		3.93%
Share-Based Payment Arrangement, Option [Member] | Employees and Directors [Member] | Maximum [Member]
Class of Stock [Line Items]
Stock option exercise price		$ 3.14
Expected term		6 years 6 months
Risk-free interest rate, maximum		4.10%
Pre Funded Warrants [Member]
Class of Stock [Line Items]
Warrants outstanding		15,254,623
Warrant [Member] | At The Market Offering [Member]
Class of Stock [Line Items]
Warrants to purchase common stock		53,396,008
Preferred Stock Blank Check [Member]
Class of Stock [Line Items]
Preferred stock shares authorized		5,000,000
Series C Preferred Stock [Member]
Class of Stock [Line Items]
Preferred stock, shares outstanding		1,718	1,718
Preferred stock convertible shares issuable		7,952
Preferred stock stated value		$ 10,997
Preferred stock shares authorized		1,172,000	1,172,000
[1]Represents an amount less than $1 thousand

RELATED PARTIES TRANSACTIONS (D

RELATED PARTIES TRANSACTIONS (Details Narrative) $ in Thousands	3 Months Ended
	Mar. 31, 2024 USD ($)
Chief Executive Officer [Member]
Administrative services from related party	$ 15

NET LOSS PER SHARE (Details Nar

NET LOSS PER SHARE (Details Narrative) - shares	3 Months Ended
	Mar. 31, 2024	Mar. 31, 2023
Earnings Per Share, Basic, by Common Class, Including Two Class Method [Line Items]
Weighted average prefunded warrants	15,254,623
Unvested restricted stock	4,611,500	342,766
Series C Preferred Stock [Member]
Earnings Per Share, Basic, by Common Class, Including Two Class Method [Line Items]
Diluted loss per share	62,556,668	2,773,675

SCHEDULE OF INVENTORIES (Detail

SCHEDULE OF INVENTORIES (Details) - USD ($) $ in Thousands	Mar. 31, 2024	Dec. 31, 2023
Inventory Disclosure [Abstract]
Finished goods	$ 73	$ 210
Work in process	917	562
Raw materials and supplies	1,370	1,334
Total inventory	$ 2,360	$ 2,106

SCHEDULE OF ACCOUNTS PAYABLE AN

SCHEDULE OF ACCOUNTS PAYABLE AND ACCRUALS - OTHER (Details) - USD ($) $ in Thousands	Mar. 31, 2024	Dec. 31, 2023
Payables and Accruals [Abstract]
Employees and employee institutions	$ 1,207	$ 2,188
Accrued vacation and recreation pay	348	287
Accrued expenses	1,101	1,115
Clinical trial accrual	826	744
Current Operating lease liabilities	549	557
Other	187	190
Accounts Payable and Accruals - Other	$ 4,218	$ 5,081

SCHEDULE OF REVENUES ATTRIBUTED

SCHEDULE OF REVENUES ATTRIBUTED TO GEOGRAPHIC AREAS (Details) - USD ($) $ in Thousands	3 Months Ended
	Mar. 31, 2024	Mar. 31, 2023
Revenues from External Customers and Long-Lived Assets [Line Items]
Revenues	$ 1,511	$ 1,239
ITALY
Revenues from External Customers and Long-Lived Assets [Line Items]
Revenues	295	267
GERMANY
Revenues from External Customers and Long-Lived Assets [Line Items]
Revenues	242	214
POLAND
Revenues from External Customers and Long-Lived Assets [Line Items]
Revenues	152	119
Other Countries [Member]
Revenues from External Customers and Long-Lived Assets [Line Items]
Revenues	$ 822	$ 639

SCHEDULE OF REVENUES ATTRIBUT_2

SCHEDULE OF REVENUES ATTRIBUTED TO GEOGRAPHIC AREAS BY PRINCIPAL CUSTOMERS (Details) - Sales [Member] - Customer Concentration Risk [Member]	3 Months Ended
	Mar. 31, 2024	Mar. 31, 2023
Customer A [Member]
Revenue, Major Customer [Line Items]
Percentage of revenues per major customer	16%	17%
Customer B [Member]
Revenue, Major Customer [Line Items]
Percentage of revenues per major customer	12%	13%
Customer C [Member]
Revenue, Major Customer [Line Items]
Percentage of revenues per major customer	10%	10%