Cover
Cover - shares | 9 Months Ended | |
Sep. 30, 2023 | Nov. 07, 2023 | |
Cover [Abstract] | ||
Document Type | 10-Q | |
Amendment Flag | false | |
Document Quarterly Report | true | |
Document Transition Report | false | |
Document Period End Date | Sep. 30, 2023 | |
Document Fiscal Period Focus | Q3 | |
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 $0.0001 per share | |
Trading Symbol | NSPR | |
Security Exchange Name | NASDAQ | |
Entity Current Reporting Status | Yes | |
Entity Interactive Data Current | Yes | |
Entity Filer Category | Non-accelerated Filer | |
Entity Small Business | true | |
Entity Emerging Growth Company | false | |
Entity Shell Company | false | |
Entity Common Stock, Shares Outstanding | 21,549,639 |
Condensed Consolidated Balance
Condensed Consolidated Balance Sheets (Unaudited) - USD ($) $ in Thousands | Sep. 30, 2023 | Dec. 31, 2022 | |
CURRENT ASSETS: | |||
Cash and cash equivalents | $ 13,839 | $ 4,632 | |
Short-term bank deposits | 13,171 | ||
Marketable securities | 29,159 | ||
Accounts receivable: | |||
Trade, net | 1,045 | 1,034 | |
Other | 363 | 213 | |
Prepaid expenses | 476 | 655 | |
Inventory | 1,846 | 1,621 | |
TOTAL CURRENT ASSETS | 46,728 | 21,326 | |
NON-CURRENT ASSETS: | |||
Property, plant and equipment, net | 907 | 917 | |
Operating lease right of use assets | 1,538 | 1,554 | |
Fund in respect of employee rights upon retirement | 847 | 856 | |
TOTAL NON-CURRENT ASSETS | 3,292 | 3,327 | |
TOTAL ASSETS | 50,020 | 24,653 | |
Accounts payable and accruals: | |||
Trade | 600 | 659 | |
Other | 4,090 | 4,411 | |
TOTAL CURRENT LIABILITIES | 4,690 | 5,070 | |
LONG-TERM LIABILITIES- | |||
Operating lease liabilities | 1,062 | 1,195 | |
Liability for employees’ rights upon retirement | 1,011 | 995 | |
TOTAL LONG-TERM LIABILITIES | 2,073 | 2,190 | |
COMMITMENTS AND CONTINGENT LIABILITIES | |||
TOTAL LIABILITIES | 6,763 | 7,260 | |
EQUITY: | |||
Common stock, par value $0.0001 per share; 150,000,000 shares authorized at September 30, 2023 and December 31, 2022; 21,400,163 and 8,330,918 shares issued and outstanding at September 30, 2023 and December 31, 2022, respectively | 2 | 1 | |
Preferred C shares, par value $0.0001 per share; 1,172,000 shares authorized at September 30, 2023 and December 31, 2022; 1,718 shares issued and outstanding at September 30, 2023 and December 31 2022, respectively | [1] | ||
Additional paid-in capital | 259,351 | 218,977 | |
Accumulated deficit | (216,096) | (201,585) | |
Total equity | 43,257 | 17,393 | |
Total liabilities and equity | $ 50,020 | $ 24,653 | |
[1]Represents an amount less than $1 thousand |
Condensed Consolidated Balanc_2
Condensed Consolidated Balance Sheets (Unaudited) (Parenthetical) - $ / shares | Sep. 30, 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 | 21,400,163 | 8,330,918 |
Common stock, shares outstanding | 21,400,163 | 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 | 9 Months Ended | ||
Sep. 30, 2023 | Sep. 30, 2022 | Sep. 30, 2023 | Sep. 30, 2022 | |
Income Statement [Abstract] | ||||
REVENUES | $ 1,556 | $ 1,431 | $ 4,444 | $ 4,145 |
COST OF REVENUES | 1,118 | 1,065 | 3,142 | 3,226 |
GROSS PROFIT | 438 | 366 | 1,302 | 919 |
OPERATING EXPENSES: | ||||
Research and development | 2,110 | 2,061 | 5,946 | 5,797 |
Selling and marketing | 876 | 845 | 2,556 | 2,577 |
General and administrative | 3,091 | 2,070 | 8,135 | 6,322 |
Total operating expenses | 6,077 | 4,976 | 16,637 | 14,696 |
LOSS FROM OPERATIONS | (5,639) | (4,610) | (15,335) | (13,777) |
FINANCIAL INCOME, net: | 461 | 81 | 824 | 131 |
NET LOSS | $ (5,178) | $ (4,529) | $ (14,511) | $ (13,646) |
NET LOSS PER SHARE - basic | $ (0.15) | $ (0.58) | $ (0.69) | $ (1.75) |
NET LOSS PER SHARE - diluted | $ (0.15) | $ (0.58) | $ (0.69) | $ (1.75) |
WEIGHTED AVERAGE NUMBER OF SHARES OF COMMON STOCK USED IN COMPUTING NET LOSS PER SHARE - basic | 33,984,953 | 7,838,506 | 21,148,538 | 7,816,974 |
WEIGHTED AVERAGE NUMBER OF SHARES OF COMMON STOCK USED IN COMPUTING NET LOSS PER SHARE - diluted | 33,984,953 | 7,838,506 | 21,148,538 | 7,816,974 |
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 | (13,646) | (13,646) | |||||
Share-based compensation related to stock, restricted stock, restricted stock units and stock options award, net of forfeitures | 1,984 | 1,984 | |||||
Share-based compensation related to stock, restricted stock, restricted stock units and stock options award, net of forfeitures, shares | 39,350 | ||||||
Balance at Sep. 30, 2022 | $ 1 | [1] | 218,609 | (196,740) | 21,870 | ||
Balance, shares at Sep. 30, 2022 | 8,335,606 | 1,718 | |||||
Balance at Jun. 30, 2022 | $ 1 | [2] | 217,952 | (192,211) | 25,742 | ||
Balance, shares at Jun. 30, 2022 | 8,323,200 | 1,718 | |||||
Net loss | (4,529) | (4,529) | |||||
Share-based compensation related to stock, restricted stock, restricted stock units and stock options award, net of forfeitures | 657 | 657 | |||||
Share-based compensation related to stock, restricted stock, restricted stock units and stock options award, net of forfeitures, shares | 12,406 | ||||||
Balance at Sep. 30, 2022 | $ 1 | [1] | 218,609 | (196,740) | 21,870 | ||
Balance, shares at Sep. 30, 2022 | 8,335,606 | 1,718 | |||||
Balance at Dec. 31, 2022 | $ 1 | [3] | 218,977 | (201,585) | 17,393 | ||
Balance, shares at Dec. 31, 2022 | 8,330,918 | 1,718 | |||||
Net loss | (14,511) | (14,511) | |||||
Share-based compensation related to stock, restricted stock, restricted stock units and stock options award, net of forfeitures | [3] | 2,841 | 2,841 | ||||
Share-based compensation related to stock, restricted stock, restricted stock units and stock options award, net of forfeitures, shares | 2,802,975 | ||||||
Issuance of common shares, pre-funded warrants and warrants, net of $4,635 issuance costs | $ 1 | 37,533 | 37,534 | ||||
Issuance of common shares, pre-funded warrants and warrants, net of $4,635 issuance costs, shares | 10,266,270 | ||||||
Balance at Sep. 30, 2023 | $ 2 | [3] | 259,351 | (216,096) | 43,257 | ||
Balance, shares at Sep. 30, 2023 | 21,400,163 | 1,718 | |||||
Balance at Jun. 30, 2023 | $ 2 | [4] | 257,729 | (210,918) | 46,813 | ||
Balance, shares at Jun. 30, 2023 | 21,192,204 | 1,718 | |||||
Net loss | (5,178) | (5,178) | |||||
Share-based compensation related to stock, restricted stock, restricted stock units and stock options award, net of forfeitures | [4] | 1,622 | 1,622 | ||||
Share-based compensation related to stock, restricted stock, restricted stock units and stock options award, net of forfeitures, shares | 207,959 | ||||||
Balance at Sep. 30, 2023 | $ 2 | [3] | $ 259,351 | $ (216,096) | $ 43,257 | ||
Balance, shares at Sep. 30, 2023 | 21,400,163 | 1,718 | |||||
[1]Represents an amount less than $1 thousand[2]Represents an amount less than $1 thousand[3]Represents an amount less than $1 thousand[4]Represents an amount less than $1 thousand |
Condensed Consolidated Statem_3
Condensed Consolidated Statements of Changes in Equity (Unaudited) (Parenthetical) - USD ($) $ in Thousands | 3 Months Ended | 9 Months Ended | ||
Sep. 30, 2023 | Sep. 30, 2022 | Sep. 30, 2023 | Sep. 30, 2022 | |
Statement of Stockholders' Equity [Abstract] | ||||
Shares, restricted stock award, forfeited | 9,749 | 1,581 | 14,019 | 6,144 |
Payments of stock issuance costs | $ 4,635 | $ 4,635 |
Condensed Consolidated Statem_4
Condensed Consolidated Statements of Cash Flows (Unaudited) - USD ($) $ in Thousands | 9 Months Ended | |
Sep. 30, 2023 | Sep. 30, 2022 | |
CASH FLOWS FROM OPERATING ACTIVITIES: | ||
Net loss | $ (14,511) | $ (13,646) |
Adjustments required to reconcile net loss to net cash used in operating activities: | ||
Depreciation | 171 | 134 |
Gain from sale of property, plant and equipment | (4) | |
Loss on amounts funded in respect of employee rights upon retirement | 70 | 114 |
Changes in fair value of marketable securities | (321) | |
Change in liability for employees’ rights upon retirement | 16 | (83) |
Other financial expenses | 72 | 138 |
Change in operating right of use asset and leasing liability | (39) | (78) |
Share-based compensation expenses | 2,841 | 1,984 |
Decrease (increase) in interest receivable on short term deposits | 171 | (75) |
Changes in operating asset and liability items: | ||
Decrease (increase) in prepaid expenses | 179 | (198) |
Decrease (increase) in trade receivables | (11) | 58 |
Increase in other receivables | (150) | (42) |
Increase in inventory | (225) | (271) |
Decrease in trade payables | (59) | (489) |
Increase (decrease) in other payables | (399) | 107 |
Net cash used in operating activities | (12,199) | (12,347) |
CASH FLOWS FROM INVESTING ACTIVITIES: | ||
Investment in short-term bank deposits | (5,500) | (17,000) |
Purchase of property, plant and equipment | (166) | (378) |
Proceeds from sale of property, plant and equipment | 9 | |
Investments in marketable securities | (28,838) | |
Withdrawal from short-term bank deposits | 18,500 | 22,000 |
Amounts funded in respect of employee rights upon retirement | (61) | (67) |
Net cash provided by (used in) investing activities | (16,056) | 4,555 |
CASH FLOWS FROM FINANCING ACTIVITIES: | ||
Issuance costs of At The Market offering | (140) | |
Proceeds from issuance of shares and warrants net of $4,635 issuance costs, | 37,534 | |
Net cash provided by (used in) financing activities | 37,534 | (140) |
EFFECT OF EXCHANGE RATE CHANGES ON CASH AND CASH EQUIVALENTS | (72) | (138) |
INCREASE (DECREASE) IN CASH AND CASH EQUIVALENTS | 9,207 | (8,070) |
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 | 13,839 | 3,934 |
SUPPLEMENTAL NON-CASH INVESTING AND FINANCING ACTIVITIES: | ||
Acquisition of right-of-use assets by means of lease liabilities | 419 | $ 835 |
Non-cash lease incentive | 45 | |
Decrease in right-of-use assets and lease liabilities due to shortening lease term | $ 131 |
Condensed Consolidated Statem_5
Condensed Consolidated Statements of Cash Flows (Unaudited) (Parenthetical) - USD ($) $ in Thousands | 9 Months Ended | |
Sep. 30, 2023 | Sep. 30, 2022 | |
Statement of Cash Flows [Abstract] | ||
Payments of stock issuance costs | $ 4,635 | $ 4,635 |
DESCRIPTION OF BUSINESS
DESCRIPTION OF BUSINESS | 9 Months Ended |
Sep. 30, 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. 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. 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 (“EU”) 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 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 European Medical Device Regulation (MDR 2017/745) (“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 EU. 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. c. Risks Related to Our 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, Hamas terrorists infiltrated Israel’s southern border from the Gaza Strip and conducted a series of attacks on civilian and military targets. Hamas also launched extensive rocket attacks on the Israeli population and industrial centers located along Israel’s border with the Gaza Strip and in other areas within the State of Israel. These attacks resulted in thousands of deaths and injuries, and Hamas additionally kidnapped many Israeli civilians and soldiers. Following the attack, Israel’s security cabinet declared war against Hamas and commenced a military campaign against Hamas and other terrorist organizations in parallel to their continued rocket and terror attacks. The Company cannot currently predict the intensity or duration of Israel’s war against Hamas, nor can predict how this war will ultimately affect the Company’s business and operations or Israel’s economy in general. 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 13.1 19.6 11.9 21.5 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 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 | 9 Months Ended |
Sep. 30, 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 for the year ended December 31, 2022. In the opinion of the Company, all adjustments considered necessary for a fair statement of the results of the interim periods reported herein have been included (consisting only of normal recurring adjustments). These consolidated financial statements and notes thereto are unaudited and should be read in conjunction with the Company’s audited financial statements for the year ended December 31, 2022, as found in the Company’s Annual Report on Form 10-K, filed with the Securities and Exchange Commission on March 30, 2023. The results of operations for the three and nine months ended September 30, 2023, are not necessarily indicative of results that could be expected for the entire fiscal year. Cash and Cash Equivalents The Company considers all highly liquid investments purchased with original maturities of three months or less from the purchase date to be cash equivalents. As of September 30, 2023, cash and cash equivalents consisted of cash, short-term deposits (up to three months from the date of deposit) and money market funds. As of December 31, 2022, this balance consisted solely of cash. Marketable securities Marketable securities consist of debt securities. The Company elected the fair value option to measure and recognize its investments in debt securities in accordance with ASC 825, Financial Instruments as the Company manages its portfolio and evaluates the performance on a fair value basis. Changes in fair value, realized gains and losses on sales of marketable securities, are reflected in the statements of operation as finance expense (income), net. |
NEW ACCOUNTING PRONOUNCEMENT
NEW ACCOUNTING PRONOUNCEMENT | 9 Months Ended |
Sep. 30, 2023 | |
Accounting Changes and Error Corrections [Abstract] | |
NEW ACCOUNTING PRONOUNCEMENT | NOTE 3 - NEW ACCOUNTING PRONOUNCEMENT Recently adopted accounting pronouncement 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 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. Recently issued accounting pronouncement, not yet adopted In August 2020, the FASB issued ASU 2020-06 “Debt – Debt with Conversion and Other Options (Subtopic 470-20) and Derivatives and Hedging – Contracts in Entity’s Own Equity (Subtopic 815 – 40).” This guidance simplifies the accounting for certain financial instruments with characteristics of liabilities and equity, including convertible instruments and contracts on an entity’s own equity. This ASU is effective for the Company for fiscal years beginning after December 15, 2023, and interim periods within those fiscal years. The Company is currently evaluating the impact of the adoption of ASU 2020-06 on the Company’s consolidated financial statements. |
FAIR VALUE MEASUREMENTS
FAIR VALUE MEASUREMENTS | 9 Months Ended |
Sep. 30, 2023 | |
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 September 30, 2023 Total Level 1 Level 2 Level 3 Assets: Cash equivalents- Money market funds $ 7,268 $ 7,268 $ - $ - Cash equivalents $ 7,268 $ 7,268 $ - $ - Marketable securities- U.S government bonds $ 29,159 $ - $ 29,159 $ - Marketable securities $ 29,159 $ - $ 29,159 $ - 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 September 30, 2023 is $ 28,838 |
MARKETABLE SECURITIES
MARKETABLE SECURITIES | 9 Months Ended |
Sep. 30, 2023 | |
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 September 30, December 31, 2023 2022 ($ in thousands) U.S government bonds $ 29,159 $ - Marketable securities $ 29,159 $ - The following table summarizes the fair value of the Company’s marketable securities classified by maturity as of September 30, 2023, and December 31, 2022: SCHEDULE OF FAIR VALUE OF MARKETABLE SECURITIES CLASSIFIED BY MATURITY September 30, December 31, 2023 2022 ($ in thousands) Amounts maturing within one year $ 23,417 $ - Amounts maturing after one year through two years 5,742 - $ 29,159 $ - The table below sets forth a summary of the changes in the fair value of the Company’s marketable securities for the nine months period ended September 30, 2023: SCHEDULE OF CHANGES IN FAIR VALUE OF MARKETABLE SECURITIES Nine months ended September 30, 2023 ($ in thousands) Balance at beginning of the period $ - Additions 28,838 Sale or maturity - Changes in fair value during the period 321 Balance at end of the period - Balance at end of the period 29,159 |
EQUITY
EQUITY | 9 Months Ended |
Sep. 30, 2023 | |
Equity [Abstract] | |
EQUITY | NOTE 6 - EQUITY a. Private Placement 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 12,914,078 1.6327 1.6326 Aggregate gross proceeds to the Company in respect of the Private Placement Offering were $ 42.2 4.6 71.4 The Pre-Funded Warrants are immediately exercisable at an exercise price of $ 0.0001 1.3827 As of September 30, 2023, there are 15,561,894 Pursuant to the full ratchet anti-dilution adjustment provisions in the respective certificate of designation for the Company’s Series C Preferred Stock, the conversion price of the outstanding shares of the Series C Preferred Stock was reduced to $ 1.3827 5,668 1,718 As of September 30, 2023, there were 1,718 7,952 b. As of September 30, 2023, the Company has outstanding warrants to purchase an aggregate of 53,396,008 SCHEDULE OF ISSUANCE OF WARRANTS TO PURCHASE COMMON STOCK Number of Exercise price 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 September 30, 2023, the Company had 155,000,000 0.0001 150,000,000 5,000,000 c. During the nine months ended September 30, 2023, the Company granted 2,774,600 The fair value of the above restricted shares was approximately $ 5.23 d. During the nine months ended September 30, 2023, the Company granted 1,045,150 The fair value of the above restricted share units was approximately $ 1,839 e. On January 6, 2023, the Company granted to a consultant options to purchase a total of 50,000 1.15 45,000 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 5.125 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 On May 17, 2023, the Company granted to employees and directors options to purchase a total of 1,011,930 1.76 In calculating the fair value of the above options the Company used the following assumptions: dividend yield of 0 5.5 6.5 116.76 123.30 3.58 The fair value of the above options, using the Black-Scholes option-pricing model, was approximately $ 1.56 On May 17, 2023, the Company granted to consultants options to purchase a total of 575,000 1.76 In calculating the fair value of the above options the Company used the following assumptions: dividend yield of 0 5.5 6.5 116.76 123.30 3.58 The fair value of the above options, using the Black-Scholes option-pricing model, was approximately $ 885 On August 28, 2023 and September 10, 2023the Company granted to employees options to purchase a total of 38,740 3.37 3.57 In calculating the fair value of the above options the Company used the following assumptions: dividend yield of 0 5.5 6.5 114.25 123.07 4.34 4.39 The fair value of the above options, using the Black-Scholes option-pricing model, was approximately $ 120,000 f. Election to Receive Shares of Common Stock in lieu of Cash Compensation Beginning on January 1, 2023, non-employee directors may elect to receive all or a portion of their cash retainer amount in shares of the Company’s common stock under the 2021 Equity Incentive Plan. If a director makes that election, a stock award under the 2021 Equity Incentive Plan will be paid quarterly on the first day of each next quarter (“Issuance Dates”) and will become fully vested on the Issuance Dates. The stock award will be determined by dividing (x) the product of the cash retainer amount and percentage of the cash retainer amount elected to be taken in shares by (y) the “Fair Market Value” (as defined in the 2021 Equity Incentive Plan) of a share on the Issuance Dates. If a director’s service on the board terminates for any reasons prior to an Issuance Date, he/she will receive a pro rata portion of shares or cash based on the number of days served on the board during the relevant quarter. On April 1, 2023, the Company issued 29,746 On July 1, 2023, the Company issued 12,648 As of September 30, 2023, there was an accrual for $ 55,000 22,875 32,125 9,735 |
RELATED PARTIES TRANSACTIONS
RELATED PARTIES TRANSACTIONS | 9 Months Ended |
Sep. 30, 2023 | |
Related Party Transactions [Abstract] | |
RELATED PARTIES TRANSACTIONS | NOTE 7 – RELATED PARTIES TRANSACTIONS 1) During 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 $ 9,276 500 no 2) On September 15, 2023, the board approved the company’s entry into a consultancy agreement with a member of the immediate family of the CEO for certain administrative projects in connection with the Company’s expansion to the U.S. until a full-time Company employee is retained in such capacity. Pursuant to the Consultancy Agreement, the Company will pay a fixed hourly fee of $ 50 Consulting expenses for the nine and three-month periods ended September 30, 2023, were $ 4,000 |
NET LOSS PER SHARE
NET LOSS PER SHARE | 9 Months Ended |
Sep. 30, 2023 | |
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 potential share issuances of common stock upon the exercise of share options, warrants, and unvested restricted stocks, unvested restricted stock units and Series C preferred stock as the effect is anti-dilutive. 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 nine and three-month periods ended September 30, 2023, we had weighted average Pre-funded Warrants of 7,866,452 15,561,894 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 excluded from the calculations of diluted loss per share were 75,315,352 This amount includes 3,073,821 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 excluded from the calculations of diluted loss per share were 2,932,284 This amount includes 497,767 |
LEASE AGREEMENTS
LEASE AGREEMENTS | 9 Months Ended |
Sep. 30, 2023 | |
Lease Agreements | |
LEASE AGREEMENTS | NOTE 9 – LEASE AGREEMENTS 1) The Company’s Israeli subsidiary has a lease agreement for a facility in Israel, which expires on December 31, 2026. On August 24, 2023, the Company amended the lease agreement mentioned above, leasing additional space in the facility and shortened the lease term of another space in the building. he balances of right of use assets and lease liabilities increased due to the newly leased space and decreased due to the lease that was shortened. 2) Operating lease cost for the nine and three-month periods ended September 30, 2023 were $ 337,000 112,000 Supplemental information related to leases are as follows: SCHEDULE OF SUPPLEMENTAL INFORMATION RELATED TO LEASES September 30 December 31 2023 2022 ($ in thousands) ($ in thousands) Operating lease right-of-use assets 1,538 1,554 Current operating lease liabilities (497 ) (419 ) Non-current operating lease liabilities (1,062 ) (1,195 ) Weighted Average Remaining Lease Term 3.25 4 Weighted Average Discount Rate 9.73 % 8.69 % Other information: Nine months ended September 30, Twelve months ended December 31, 2023 2022 Operating cash flows from operating leases (cash paid in thousands) (307 ) (436 ) Maturities of lease liabilities are as follows: SCHEDULE OF MATURITIES OF LEASE LIABILITIES Amount ($ in thousands) 2023 113 2024 536 2025 541 2026 606 Total lease payments 1,796 Less imputed interest (237 ) Total 1,559 |
FINANCIAL INSTRUMENTS
FINANCIAL INSTRUMENTS | 9 Months Ended |
Sep. 30, 2023 | |
Investments, All Other Investments [Abstract] | |
FINANCIAL INSTRUMENTS | NOTE 10 - FINANCIAL INSTRUMENTS a. Fair value of financial instruments The carrying amounts of financial instruments approximate their fair value either because these amounts are presented at fair value or due to the relatively short-term maturities of such instruments. b. As of September 30, 2023, and December 31, 2022, allowance for expected credit loss was immaterial. |
INVENTORY
INVENTORY | 9 Months Ended |
Sep. 30, 2023 | |
Inventory Disclosure [Abstract] | |
INVENTORY | NOTE 11- INVENTORY SCHEDULE OF INVENTORIES September 30, December 31, 2023 2022 ($ in thousands) Finished goods $ 191 $ 179 Work in process 634 510 Raw materials and supplies 1,021 932 Total inventory $ 1,846 $ 1,621 |
ACCOUNTS PAYABLE AND ACCRUALS -
ACCOUNTS PAYABLE AND ACCRUALS - OTHER | 9 Months Ended |
Sep. 30, 2023 | |
Payables and Accruals [Abstract] | |
ACCOUNTS PAYABLE AND ACCRUALS - OTHER | NOTE 12 - ACCOUNTS PAYABLE AND ACCRUALS - OTHER SCHEDULE OF ACCOUNTS PAYABLE AND ACCRUALS - OTHER September 30, December 31, 2023 2022 ($ in thousands) Employees and employee institutions 1,571 1,853 Accrued vacation and recreation pay 273 197 Accrued expenses 926 554 Clinical trial accrual 708 1,258 Current Operating lease liabilities 497 419 Other 115 130 Accounts Payable and Accruals - Other 4,090 4,411 |
DISAGGREGATED REVENUE AND ENTIT
DISAGGREGATED REVENUE AND ENTITY WIDE DISCLOSURES | 9 Months Ended |
Sep. 30, 2023 | |
Segment Reporting [Abstract] | |
DISAGGREGATED REVENUE AND ENTITY WIDE DISCLOSURES | NOTE 13 - 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 Nine months ended 2023 2022 2023 2022 ($ in thousands) Italy $ 328 $ 240 $ 932 $ 713 Russia 250 250 483 381 Germany 209 191 699 866 Other 769 750 2,330 2,185 $ 1,556 $ 1,431 $ 4,444 $ 4,145 By product: SCHEDULE OF REVENUES ATTRIBUTED TO GEOGRAPHIC AREAS BY PRODUCT Three months ended Nine months ended 2023 2022 2023 2022 ($ in thousands) CGuard $ 1,556 $ 1,431 $ 4,444 $ 4,097 MGuard - - - 48 $ 1,556 $ 1,431 $ 4,444 $ 4,145 By principal customers: SCHEDULE OF REVENUES ATTRIBUTED TO GEOGRAPHIC AREAS BY PRINCIPAL CUSTOMERS Three months ended Nine months ended 2023 2022 2023 2022 Customer A 16 % 17 % 11 % 9 % Customer B 13 % 13 % 16 % 21 % Customer C 13 % 7 % 10 % 8 % Customer D 8 % 9 % 11 % 9 % All tangible long lived assets are located in Israel. |
BASIS OF PRESENTATION (Policies
BASIS OF PRESENTATION (Policies) | 9 Months Ended |
Sep. 30, 2023 | |
Organization, Consolidation and Presentation of Financial Statements [Abstract] | |
Cash and Cash Equivalents | Cash and Cash Equivalents The Company considers all highly liquid investments purchased with original maturities of three months or less from the purchase date to be cash equivalents. As of September 30, 2023, cash and cash equivalents consisted of cash, short-term deposits (up to three months from the date of deposit) and money market funds. As of December 31, 2022, this balance consisted solely of cash. |
Marketable securities | Marketable securities Marketable securities consist of debt securities. The Company elected the fair value option to measure and recognize its investments in debt securities in accordance with ASC 825, Financial Instruments as the Company manages its portfolio and evaluates the performance on a fair value basis. Changes in fair value, realized gains and losses on sales of marketable securities, are reflected in the statements of operation as finance expense (income), net. |
FAIR VALUE MEASUREMENTS (Tables
FAIR VALUE MEASUREMENTS (Tables) | 9 Months Ended |
Sep. 30, 2023 | |
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 September 30, 2023 Total Level 1 Level 2 Level 3 Assets: Cash equivalents- Money market funds $ 7,268 $ 7,268 $ - $ - Cash equivalents $ 7,268 $ 7,268 $ - $ - Marketable securities- U.S government bonds $ 29,159 $ - $ 29,159 $ - Marketable securities $ 29,159 $ - $ 29,159 $ - |
MARKETABLE SECURITIES (Tables)
MARKETABLE SECURITIES (Tables) | 9 Months Ended |
Sep. 30, 2023 | |
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 September 30, December 31, 2023 2022 ($ in thousands) U.S government bonds $ 29,159 $ - Marketable securities $ 29,159 $ - |
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 September 30, 2023, and December 31, 2022: SCHEDULE OF FAIR VALUE OF MARKETABLE SECURITIES CLASSIFIED BY MATURITY September 30, December 31, 2023 2022 ($ in thousands) Amounts maturing within one year $ 23,417 $ - Amounts maturing after one year through two years 5,742 - $ 29,159 $ - |
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 nine months period ended September 30, 2023: SCHEDULE OF CHANGES IN FAIR VALUE OF MARKETABLE SECURITIES Nine months ended September 30, 2023 ($ in thousands) Balance at beginning of the period $ - Additions 28,838 Sale or maturity - Changes in fair value during the period 321 Balance at end of the period - Balance at end of the period 29,159 |
EQUITY (Tables)
EQUITY (Tables) | 9 Months Ended |
Sep. 30, 2023 | |
Equity [Abstract] | |
SCHEDULE OF ISSUANCE OF WARRANTS TO PURCHASE COMMON STOCK | SCHEDULE OF ISSUANCE OF WARRANTS TO PURCHASE COMMON STOCK Number of Exercise price 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 $ |
LEASE AGREEMENTS (Tables)
LEASE AGREEMENTS (Tables) | 9 Months Ended |
Sep. 30, 2023 | |
Lease Agreements | |
SCHEDULE OF SUPPLEMENTAL INFORMATION RELATED TO LEASES | Supplemental information related to leases are as follows: SCHEDULE OF SUPPLEMENTAL INFORMATION RELATED TO LEASES September 30 December 31 2023 2022 ($ in thousands) ($ in thousands) Operating lease right-of-use assets 1,538 1,554 Current operating lease liabilities (497 ) (419 ) Non-current operating lease liabilities (1,062 ) (1,195 ) Weighted Average Remaining Lease Term 3.25 4 Weighted Average Discount Rate 9.73 % 8.69 % Other information: Nine months ended September 30, Twelve months ended December 31, 2023 2022 Operating cash flows from operating leases (cash paid in thousands) (307 ) (436 ) |
SCHEDULE OF MATURITIES OF LEASE LIABILITIES | Maturities of lease liabilities are as follows: SCHEDULE OF MATURITIES OF LEASE LIABILITIES Amount ($ in thousands) 2023 113 2024 536 2025 541 2026 606 Total lease payments 1,796 Less imputed interest (237 ) Total 1,559 |
INVENTORY (Tables)
INVENTORY (Tables) | 9 Months Ended |
Sep. 30, 2023 | |
Inventory Disclosure [Abstract] | |
SCHEDULE OF INVENTORIES | SCHEDULE OF INVENTORIES September 30, December 31, 2023 2022 ($ in thousands) Finished goods $ 191 $ 179 Work in process 634 510 Raw materials and supplies 1,021 932 Total inventory $ 1,846 $ 1,621 |
ACCOUNTS PAYABLE AND ACCRUALS_2
ACCOUNTS PAYABLE AND ACCRUALS - OTHER (Tables) | 9 Months Ended |
Sep. 30, 2023 | |
Payables and Accruals [Abstract] | |
SCHEDULE OF ACCOUNTS PAYABLE AND ACCRUALS - OTHER | SCHEDULE OF ACCOUNTS PAYABLE AND ACCRUALS - OTHER September 30, December 31, 2023 2022 ($ in thousands) Employees and employee institutions 1,571 1,853 Accrued vacation and recreation pay 273 197 Accrued expenses 926 554 Clinical trial accrual 708 1,258 Current Operating lease liabilities 497 419 Other 115 130 Accounts Payable and Accruals - Other 4,090 4,411 |
DISAGGREGATED REVENUE AND ENT_2
DISAGGREGATED REVENUE AND ENTITY WIDE DISCLOSURES (Tables) | 9 Months Ended |
Sep. 30, 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 Nine months ended 2023 2022 2023 2022 ($ in thousands) Italy $ 328 $ 240 $ 932 $ 713 Russia 250 250 483 381 Germany 209 191 699 866 Other 769 750 2,330 2,185 $ 1,556 $ 1,431 $ 4,444 $ 4,145 |
SCHEDULE OF REVENUES ATTRIBUTED TO GEOGRAPHIC AREAS BY PRODUCT | By product: SCHEDULE OF REVENUES ATTRIBUTED TO GEOGRAPHIC AREAS BY PRODUCT Three months ended Nine months ended 2023 2022 2023 2022 ($ in thousands) CGuard $ 1,556 $ 1,431 $ 4,444 $ 4,097 MGuard - - - 48 $ 1,556 $ 1,431 $ 4,444 $ 4,145 |
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 Nine months ended 2023 2022 2023 2022 Customer A 16 % 17 % 11 % 9 % Customer B 13 % 13 % 16 % 21 % Customer C 13 % 7 % 10 % 8 % Customer D 8 % 9 % 11 % 9 % |
DESCRIPTION OF BUSINESS (Detail
DESCRIPTION OF BUSINESS (Details Narrative) | 3 Months Ended | 9 Months Ended | 12 Months Ended | ||
Sep. 30, 2023 | Sep. 30, 2022 | Sep. 30, 2023 | Sep. 30, 2022 | Dec. 31, 2022 | |
Russia and Belarus [Member] | Sales [Member] | Geographic Concentration Risk [Member] | |||||
Product Information [Line Items] | |||||
Sales percentage | 19.60% | 21.50% | 13.10% | 11.90% | 12.10% |
SCHEDULE OF FINANCIAL ASSETS SU
SCHEDULE OF FINANCIAL ASSETS SUBJECT TO FAIR VALUE MEASUREMENTS (Details) $ in Thousands | Sep. 30, 2023 USD ($) |
Fair Value, Assets and Liabilities Measured on Recurring and Nonrecurring Basis [Line Items] | |
Marketable securities | $ 28,838 |
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 | 29,159 |
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 | 29,159 |
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 | 7,268 |
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 | 7,268 |
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 | Sep. 30, 2023 USD ($) |
Fair Value Disclosures [Abstract] | |
Cost of marketable securities | $ 28,838 |
SCHEDULE OF MARKETABLE SECURITI
SCHEDULE OF MARKETABLE SECURITIES (Details) - USD ($) $ in Thousands | Sep. 30, 2023 | Dec. 31, 2022 |
Marketable Securities [Line Items] | ||
Marketable securities | $ 29,159 | |
US Government Agencies Debt Securities [Member] | ||
Marketable Securities [Line Items] | ||
Marketable securities | $ 29,159 |
SCHEDULE OF FAIR VALUE OF MARKE
SCHEDULE OF FAIR VALUE OF MARKETABLE SECURITIES CLASSIFIED BY MATURITY (Details) - USD ($) $ in Thousands | Sep. 30, 2023 | Dec. 31, 2022 |
Investments, Debt and Equity Securities [Abstract] | ||
Amounts maturing within one year | $ 23,417 | |
Amounts maturing after one year through two years | 5,742 | |
Marketable securities | $ 29,159 |
SCHEDULE OF CHANGES IN FAIR VAL
SCHEDULE OF CHANGES IN FAIR VALUE OF MARKETABLE SECURITIES (Details) - USD ($) $ in Thousands | 9 Months Ended | |
Sep. 30, 2023 | Sep. 30, 2022 | |
Investments, Debt and Equity Securities [Abstract] | ||
Balance at beginning of the period | ||
Additions | 28,838 | |
Sale or maturity | ||
Changes in fair value during the period | 321 | |
Balance at end of the period | $ 29,159 |
SCHEDULE OF ISSUANCE OF WARRANT
SCHEDULE OF ISSUANCE OF WARRANTS TO PURCHASE COMMON STOCK (Details) | Sep. 30, 2023 $ / 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 | 9 Months Ended | ||||||||||
Oct. 01, 2023 | Sep. 10, 2023 | Aug. 28, 2023 | Jul. 01, 2023 | May 17, 2023 | May 12, 2023 | Apr. 01, 2023 | Jan. 06, 2023 | Sep. 30, 2023 | Sep. 30, 2023 | May 16, 2023 | Dec. 31, 2022 | |
Subsidiary, Sale of Stock [Line Items] | ||||||||||||
Warrants to purchase common stock | 53,396,008 | 53,396,008 | ||||||||||
Capital stock shares authorized | 155,000,000 | 155,000,000 | ||||||||||
Capital stock par value | $ 0.0001 | $ 0.0001 | ||||||||||
Common stock shares authorized | 150,000,000 | 150,000,000 | 150,000,000 | |||||||||
Non-Employee Directors [Member] | ||||||||||||
Subsidiary, Sale of Stock [Line Items] | ||||||||||||
Number of issuance of public offering | 29,746 | |||||||||||
Number of shares issued | 12,648 | |||||||||||
Director [Member] | ||||||||||||
Subsidiary, Sale of Stock [Line Items] | ||||||||||||
Accrued director fees | $ 55,000 | $ 55,000 | ||||||||||
Cash paid for fees | 22,875 | |||||||||||
Value of common shares issued | $ 32,125 | |||||||||||
Director [Member] | Subsequent Event [Member] | ||||||||||||
Subsidiary, Sale of Stock [Line Items] | ||||||||||||
Number of shares issued | 9,735 | |||||||||||
Restricted Stock [Member] | Employees and Directors [Member] | ||||||||||||
Subsidiary, Sale of Stock [Line Items] | ||||||||||||
Shares granted | 2,774,600 | |||||||||||
Fair value of shares granted | $ 5,230,000 | |||||||||||
Restricted Stock [Member] | Chief Executive Officer [Member] | ||||||||||||
Subsidiary, Sale of Stock [Line Items] | ||||||||||||
Fair value of shares granted | $ 1,839,000 | |||||||||||
Restricted Stock Units (RSUs) [Member] | Chief Executive Officer [Member] | ||||||||||||
Subsidiary, Sale of Stock [Line Items] | ||||||||||||
Shares granted | 1,045,150 | |||||||||||
Share-Based Payment Arrangement, Option [Member] | Employees and Directors [Member] | ||||||||||||
Subsidiary, Sale of Stock [Line Items] | ||||||||||||
Options to purchase common stock | 1,011,930 | |||||||||||
Stock option exercise price | $ 1.76 | |||||||||||
Dividend yield | 0% | |||||||||||
Expected volatility, minimum | 116.76% | |||||||||||
Expected volatility, maximum | 123.30% | |||||||||||
Fair value stock option price | $ 1,560,000 | |||||||||||
Risk-free interest rate | 3.58% | |||||||||||
Share-Based Payment Arrangement, Option [Member] | Employees and Directors [Member] | Minimum [Member] | ||||||||||||
Subsidiary, Sale of Stock [Line Items] | ||||||||||||
Expected term | 5 years 6 months | |||||||||||
Share-Based Payment Arrangement, Option [Member] | Employees and Directors [Member] | Maximum [Member] | ||||||||||||
Subsidiary, Sale of Stock [Line Items] | ||||||||||||
Expected term | 6 years 6 months | |||||||||||
Share-Based Payment Arrangement, Option [Member] | Consultants [Member] | ||||||||||||
Subsidiary, Sale of Stock [Line Items] | ||||||||||||
Options to purchase common stock | 575,000 | 50,000 | ||||||||||
Stock option exercise price | $ 1.76 | $ 1.15 | ||||||||||
Dividend yield | 0% | 0% | ||||||||||
Expected volatility, minimum | 116.76% | 124.58% | ||||||||||
Expected volatility, maximum | 123.30% | 125.61% | ||||||||||
Risk-free interest rate, minimum | 3.65% | |||||||||||
Risk-free interest rate, minimum | 3.68% | |||||||||||
Fair value stock option price | $ 885,000 | $ 50,658 | ||||||||||
Risk-free interest rate | 3.58% | |||||||||||
Share-Based Payment Arrangement, Option [Member] | Consultants [Member] | Minimum [Member] | ||||||||||||
Subsidiary, Sale of Stock [Line Items] | ||||||||||||
Expected term | 5 years 6 months | 5 years 1 month 15 days | ||||||||||
Share-Based Payment Arrangement, Option [Member] | Consultants [Member] | Maximum [Member] | ||||||||||||
Subsidiary, Sale of Stock [Line Items] | ||||||||||||
Expected term | 6 years 6 months | 6 years 6 months | ||||||||||
Share-Based Payment Arrangement, Option [Member] | Consultants [Member] | Three Year Vesting Period [Member] | ||||||||||||
Subsidiary, Sale of Stock [Line Items] | ||||||||||||
Options to purchase common stock | 45,000 | |||||||||||
Share-Based Payment Arrangement, Option [Member] | Consultants [Member] | Vesting in First Year [Member] | ||||||||||||
Subsidiary, Sale of Stock [Line Items] | ||||||||||||
Options to purchase common stock | 20,000 | |||||||||||
Share-Based Payment Arrangement, Option [Member] | Consultants [Member] | Vesting in Second Year [Member] | ||||||||||||
Subsidiary, Sale of Stock [Line Items] | ||||||||||||
Options to purchase common stock | 15,000 | |||||||||||
Share-Based Payment Arrangement, Option [Member] | Consultants [Member] | Vesting in Third Year [Member] | ||||||||||||
Subsidiary, Sale of Stock [Line Items] | ||||||||||||
Options to purchase common stock | 10,000 | |||||||||||
Share-Based Payment Arrangement, Option [Member] | Consultants [Member] | Performance Conditions [Member] | ||||||||||||
Subsidiary, Sale of Stock [Line Items] | ||||||||||||
Options to purchase common stock | 5,000 | |||||||||||
Share-Based Payment Arrangement, Option [Member] | Employees [Member] | ||||||||||||
Subsidiary, Sale of Stock [Line Items] | ||||||||||||
Options to purchase common stock | 38,740 | 38,740 | ||||||||||
Dividend yield | 0% | 0% | ||||||||||
Expected volatility, minimum | 114.25% | 114.25% | ||||||||||
Expected volatility, maximum | 123.07% | 123.07% | ||||||||||
Risk-free interest rate, minimum | 4.34% | 4.34% | ||||||||||
Risk-free interest rate, minimum | 4.39% | 4.39% | ||||||||||
Fair value stock option price | $ 120,000,000 | $ 120,000,000 | ||||||||||
Share-Based Payment Arrangement, Option [Member] | Employees [Member] | Minimum [Member] | ||||||||||||
Subsidiary, Sale of Stock [Line Items] | ||||||||||||
Stock option exercise price | $ 3.37 | $ 3.37 | ||||||||||
Expected term | 5 years 6 months | 5 years 6 months | ||||||||||
Share-Based Payment Arrangement, Option [Member] | Employees [Member] | Maximum [Member] | ||||||||||||
Subsidiary, Sale of Stock [Line Items] | ||||||||||||
Stock option exercise price | $ 3.57 | $ 3.57 | ||||||||||
Expected term | 6 years 6 months | 6 years 6 months | ||||||||||
Series C Preferred Stock [Member] | ||||||||||||
Subsidiary, Sale of Stock [Line Items] | ||||||||||||
Preferred stock conversion price | $ 1.3827 | |||||||||||
Preferred stock convertible shares issuable | 5,668 | 7,952 | 7,952 | |||||||||
Preferred stock outstanding | 1,718 | 1,718 | 1,718 | 1,718 | ||||||||
Preferred stock shares authorized | 1,172,000 | 1,172,000 | 1,172,000 | |||||||||
Pre-Funded Warrants [Member] | ||||||||||||
Subsidiary, Sale of Stock [Line Items] | ||||||||||||
Warrant exercise price | $ 0.0001 | |||||||||||
Warrants outstanding | 15,561,894 | 15,561,894 | ||||||||||
Warrant [Member] | ||||||||||||
Subsidiary, Sale of Stock [Line Items] | ||||||||||||
Warrant exercise price | $ 1.3827 | |||||||||||
Preferred Stock Blank Check [Member] | ||||||||||||
Subsidiary, Sale of Stock [Line Items] | ||||||||||||
Preferred stock shares authorized | 5,000,000 | 5,000,000 | ||||||||||
Private Placement [Member] | ||||||||||||
Subsidiary, Sale of Stock [Line Items] | ||||||||||||
Number of issuance of public offering | 10,266,270 | |||||||||||
Private placement | $ 42,200,000 | |||||||||||
Fees payable and other offering expenses | 4,600,000 | |||||||||||
Gross proceeds from warrant exercises | $ 71,400,000 | |||||||||||
Private Placement [Member] | Pre-Funded Warrants [Member] | ||||||||||||
Subsidiary, Sale of Stock [Line Items] | ||||||||||||
Warrants to purchase common stock | 15,561,894 | |||||||||||
Offering price per share | $ 1.6326 | |||||||||||
Private Placement [Member] | Warrant [Member] | ||||||||||||
Subsidiary, Sale of Stock [Line Items] | ||||||||||||
Warrants to purchase common stock | 51,656,328 | |||||||||||
Offering price per share | $ 1.6327 | |||||||||||
Private Placement [Member] | Series H Warrants [Member] | ||||||||||||
Subsidiary, Sale of Stock [Line Items] | ||||||||||||
Warrants to purchase common stock | 12,914,086 | |||||||||||
Private Placement [Member] | Series I Warrants [Member] | ||||||||||||
Subsidiary, Sale of Stock [Line Items] | ||||||||||||
Warrants to purchase common stock | 12,914,078 | |||||||||||
Private Placement [Member] | Series J Warrants [Member] | ||||||||||||
Subsidiary, Sale of Stock [Line Items] | ||||||||||||
Warrants to purchase common stock | 12,914,086 | |||||||||||
Private Placement [Member] | Series K Warrants [Member] | ||||||||||||
Subsidiary, Sale of Stock [Line Items] | ||||||||||||
Warrants to purchase common stock | 12,914,078 | |||||||||||
At The Market Offering [Member] | Warrant [Member] | ||||||||||||
Subsidiary, Sale of Stock [Line Items] | ||||||||||||
Warrants to purchase common stock | 53,396,008 | 53,396,008 |
RELATED PARTIES TRANSACTIONS (D
RELATED PARTIES TRANSACTIONS (Details Narrative) - USD ($) | 3 Months Ended | 9 Months Ended | |||
Sep. 15, 2023 | Sep. 30, 2023 | Sep. 30, 2022 | Sep. 30, 2023 | Sep. 30, 2022 | |
Related Party [Member] | |||||
Related Party Transaction [Line Items] | |||||
Consulting expenses | $ 4,000 | $ 4,000 | |||
Consultancy Agreement [Member] | |||||
Related Party Transaction [Line Items] | |||||
Fixed hourly consulting fee | $ 50 | ||||
Director [Member] | |||||
Related Party Transaction [Line Items] | |||||
Marketing services from related party | $ 0 | $ 500 | $ 0 | $ 9,276 |
NET LOSS PER SHARE (Details Nar
NET LOSS PER SHARE (Details Narrative) - shares | 3 Months Ended | 9 Months Ended | ||
Sep. 30, 2023 | Sep. 30, 2022 | Sep. 30, 2023 | Sep. 30, 2022 | |
Antidilutive Securities Excluded from Computation of Earnings Per Share [Line Items] | ||||
Weighted average prefunded warrants | 15,561,894 | 7,866,452 | ||
Diluted loss per share | 75,315,352 | 2,932,284 | 75,315,352 | 2,932,284 |
Restricted Stock [Member] | ||||
Antidilutive Securities Excluded from Computation of Earnings Per Share [Line Items] | ||||
Diluted loss per share | 3,073,821 | 497,767 |
SCHEDULE OF SUPPLEMENTAL INFORM
SCHEDULE OF SUPPLEMENTAL INFORMATION RELATED TO LEASES (Details) - USD ($) $ in Thousands | 9 Months Ended | 12 Months Ended |
Sep. 30, 2023 | Dec. 31, 2022 | |
Lease Agreements | ||
Operating lease right-of-use assets | $ 1,538 | $ 1,554 |
Current operating lease liabilities | (497) | (419) |
Non-current operating lease liabilities | $ (1,062) | $ (1,195) |
Weighted average remaining lease | 3 years 3 months | 4 years |
Weighted average discount rate | 973% | 869% |
Operating cash flows from operating leases (cash paid in thousands) | $ (307) | $ (436) |
SCHEDULE OF MATURITIES OF LEASE
SCHEDULE OF MATURITIES OF LEASE LIABILITIES (Details) $ in Thousands | Sep. 30, 2023 USD ($) |
Lease Agreements | |
2023 | $ 113 |
2024 | 536 |
2025 | 541 |
2026 | 606 |
Total lease payments | 1,796 |
Less imputed interest | (237) |
Total | $ 1,559 |
LEASE AGREEMENTS (Details Narra
LEASE AGREEMENTS (Details Narrative) - USD ($) | 3 Months Ended | 9 Months Ended |
Sep. 30, 2023 | Sep. 30, 2023 | |
Lease Agreements | ||
Operating lease expense | $ 112,000 | $ 337,000 |
SCHEDULE OF INVENTORIES (Detail
SCHEDULE OF INVENTORIES (Details) - USD ($) $ in Thousands | Sep. 30, 2023 | Dec. 31, 2022 |
Inventory Disclosure [Abstract] | ||
Finished goods | $ 191 | $ 179 |
Work in process | 634 | 510 |
Raw materials and supplies | 1,021 | 932 |
Total inventory | $ 1,846 | $ 1,621 |
SCHEDULE OF ACCOUNTS PAYABLE AN
SCHEDULE OF ACCOUNTS PAYABLE AND ACCRUALS - OTHER (Details) - USD ($) $ in Thousands | Sep. 30, 2023 | Dec. 31, 2022 |
Payables and Accruals [Abstract] | ||
Employees and employee institutions | $ 1,571 | $ 1,853 |
Accrued vacation and recreation pay | 273 | 197 |
Accrued expenses | 926 | 554 |
Clinical trial accrual | 708 | 1,258 |
Current Operating lease liabilities | 497 | 419 |
Other | 115 | 130 |
Accounts Payable and Accruals - Other | $ 4,090 | $ 4,411 |
SCHEDULE OF REVENUES ATTRIBUTED
SCHEDULE OF REVENUES ATTRIBUTED TO GEOGRAPHIC AREAS (Details) - USD ($) $ in Thousands | 3 Months Ended | 9 Months Ended | ||
Sep. 30, 2023 | Sep. 30, 2022 | Sep. 30, 2023 | Sep. 30, 2022 | |
Revenues from External Customers and Long-Lived Assets [Line Items] | ||||
Revenues | $ 1,556 | $ 1,431 | $ 4,444 | $ 4,145 |
ITALY | ||||
Revenues from External Customers and Long-Lived Assets [Line Items] | ||||
Revenues | 328 | 240 | 932 | 713 |
RUSSIAN FEDERATION | ||||
Revenues from External Customers and Long-Lived Assets [Line Items] | ||||
Revenues | 250 | 250 | 483 | 381 |
GERMANY | ||||
Revenues from External Customers and Long-Lived Assets [Line Items] | ||||
Revenues | 209 | 191 | 699 | 866 |
Other Countries [Member] | ||||
Revenues from External Customers and Long-Lived Assets [Line Items] | ||||
Revenues | $ 769 | $ 750 | $ 2,330 | $ 2,185 |
SCHEDULE OF REVENUES ATTRIBUT_2
SCHEDULE OF REVENUES ATTRIBUTED TO GEOGRAPHIC AREAS BY PRODUCT (Details) - USD ($) $ in Thousands | 3 Months Ended | 9 Months Ended | ||
Sep. 30, 2023 | Sep. 30, 2022 | Sep. 30, 2023 | Sep. 30, 2022 | |
Revenue from External Customer [Line Items] | ||||
Revenue | $ 1,556 | $ 1,431 | $ 4,444 | $ 4,145 |
CGuard EPS [Member] | ||||
Revenue from External Customer [Line Items] | ||||
Revenue | 1,556 | 1,431 | 4,444 | 4,097 |
MGuard Prime EPS [Member] | ||||
Revenue from External Customer [Line Items] | ||||
Revenue | $ 48 |
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 | 9 Months Ended | ||
Sep. 30, 2023 | Sep. 30, 2022 | Sep. 30, 2023 | Sep. 30, 2022 | |
Customer A [Member] | ||||
Revenue, Major Customer [Line Items] | ||||
Percentage of revenues per major customer | 16% | 17% | 11% | 9% |
Customer B [Member] | ||||
Revenue, Major Customer [Line Items] | ||||
Percentage of revenues per major customer | 13% | 13% | 16% | 21% |
Customer C [Member] | ||||
Revenue, Major Customer [Line Items] | ||||
Percentage of revenues per major customer | 13% | 7% | 10% | 8% |
Customer D [Member] | ||||
Revenue, Major Customer [Line Items] | ||||
Percentage of revenues per major customer | 8% | 9% | 11% | 9% |