Cover
Cover - shares | 3 Months Ended | |
Mar. 31, 2023 | May 14, 2023 | |
Cover [Abstract] | ||
Document Type | 10-Q | |
Amendment Flag | false | |
Document Quarterly Report | true | |
Document Transition Report | false | |
Document Period End Date | Mar. 31, 2023 | |
Document Fiscal Period Focus | Q1 | |
Document Fiscal Year Focus | 2023 | |
Current Fiscal Year End Date | --12-31 | |
Entity File Number | 001-35731 | |
Entity Registrant Name | InspireMD, Inc. | |
Entity Central Index Key | 0001433607 | |
Entity Tax Identification Number | 26-2123838 | |
Entity Incorporation, State or Country Code | DE | |
Entity Address, Address Line One | 4 Menorat Hamaor St. | |
Entity Address, City or Town | Tel Aviv | |
Entity Address, Country | IL | |
Entity Address, Postal Zip Code | 6744832 | |
City Area Code | (888) | |
Local Phone Number | 776-6204 | |
Title of 12(b) Security | Common Stock, par value $0.0001 per share | |
Trading Symbol | NSPR | |
Security Exchange Name | NASDAQ | |
Entity Current Reporting Status | Yes | |
Entity Interactive Data Current | Yes | |
Entity Filer Category | Non-accelerated Filer | |
Entity Small Business | true | |
Entity Emerging Growth Company | false | |
Entity Shell Company | false | |
Entity Common Stock, Shares Outstanding | 8,356,394 |
Condensed Consolidated Balance
Condensed Consolidated Balance Sheets (Unaudited) - USD ($) $ in Thousands | Mar. 31, 2023 | Dec. 31, 2022 | |
CURRENT ASSETS: | |||
Cash and cash equivalents | $ 4,228 | $ 4,632 | |
Short-term bank deposits | 8,657 | 13,171 | |
Accounts receivable: | |||
Trade, net | 1,417 | 1,034 | |
Other | 310 | 213 | |
Prepaid expenses | 394 | 655 | |
Inventory | 1,697 | 1,621 | |
TOTAL CURRENT ASSETS | 16,703 | 21,326 | |
NON-CURRENT ASSETS: | |||
Property, plant and equipment, net | 887 | 917 | |
Operating lease right of use assets | 1,472 | 1,554 | |
Fund in respect of employee rights upon retirement | 859 | 856 | |
TOTAL NON-CURRENT ASSETS | 3,218 | 3,327 | |
TOTAL ASSETS | 19,921 | 24,653 | |
Accounts payable and accruals: | |||
Trade | 607 | 659 | |
Other | 3,776 | 4,411 | |
TOTAL CURRENT LIABILITIES | 4,383 | 5,070 | |
LONG-TERM LIABILITIES- | |||
Operating lease liabilities | 1,081 | 1,195 | |
Liability for employees rights upon retirement | 1,031 | 995 | |
TOTAL LONG-TERM LIABILITIES | 2,112 | 2,190 | |
COMMITMENTS AND CONTINGENT LIABILITIES | |||
TOTAL LIABILITIES | 6,495 | 7,260 | |
EQUITY: | |||
Common stock, par value $0.0001 per share; 150,000,000 shares authorized at March 31, 2023 and December 31, 2022; 8,326,648 and 8,330,918 shares issued and outstanding at March 31, 2023 and December 2022, respectively | 1 | 1 | |
Preferred C shares, par value $0.0001 per share; 1,172,000 shares authorized at March 31, 2023 and December 31, 2022; 1,718 shares issued and outstanding at March 31, 2023 and December 31 2022, respectively | [1] | ||
Additional paid-in capital | 219,266 | 218,977 | |
Accumulated deficit | (205,841) | (201,585) | |
Total equity | 13,426 | 17,393 | |
Total liabilities and equity | $ 19,921 | $ 24,653 | |
[1]Represents an amount less than $1 thousand |
Condensed Consolidated Balanc_2
Condensed Consolidated Balance Sheets (Unaudited) (Parenthetical) - $ / shares | Mar. 31, 2023 | Dec. 31, 2022 |
Common stock, par value | $ 0.0001 | $ 0.0001 |
Common stock, shares authorized | 150,000,000 | 150,000,000 |
Common stock, shares issued | 8,326,648 | 8,330,918 |
Common stock, shares outstanding | 8,326,648 | 8,330,918 |
Series C Preferred Stock [Member] | ||
Preferred stock, par value | $ 0.0001 | $ 0.0001 |
Preferred stock, shares authorized | 1,172,000 | 1,172,000 |
Preferred stock, shares issued | 1,718 | 1,718 |
Preferred stock, shares outstanding | 1,718 | 1,718 |
Condensed Consolidated Statemen
Condensed Consolidated Statements of Operations (Unaudited) - USD ($) $ in Thousands | 3 Months Ended | |
Mar. 31, 2023 | Mar. 31, 2022 | |
Income Statement [Abstract] | ||
REVENUES | $ 1,239 | $ 1,183 |
COST OF REVENUES | 866 | 1,061 |
GROSS PROFIT | 373 | 122 |
OPERATING EXPENSES: | ||
Research and development | 1,843 | 1,680 |
Selling and marketing | 788 | 746 |
General and administrative | 2,123 | 2,182 |
Total operating expenses | 4,754 | 4,608 |
LOSS FROM OPERATIONS | (4,381) | (4,486) |
FINANCIAL INCOME, net | 125 | 5 |
NET LOSS | $ (4,256) | $ (4,481) |
NET LOSS PER SHARE - basic and diluted | $ (0.53) | $ (0.57) |
WEIGHTED AVERAGE NUMBER OF ORDINARY SHARES USED IN COMPUTING NET LOSS PER SHARE - basic and diluted | 8,093,340 | 7,804,245 |
Condensed Consolidated Statem_2
Condensed Consolidated Statements of Changes in Equity (Unaudited) - USD ($) $ in Thousands | Common Stock [Member] | Preferred Stock [Member] Series C Convertible Preferred Stock [Member] | Additional Paid-in Capital [Member] | Retained Earnings [Member] | Total | |
Balance at Dec. 31, 2021 | $ 1 | [1] | $ 216,625 | $ (183,094) | $ 33,532 | |
Balance, shares at Dec. 31, 2021 | 8,296,256 | 1,718 | ||||
Net loss | (4,481) | (4,481) | ||||
Share-based compensation related to restricted stock, restricted stock units and stock options award, net of forfeitures | 653 | 653 | ||||
Share-based compensation related to restricted stock, restricted stock units and stock options award, net of forfeitures, shares | 21,620 | |||||
Balance at Mar. 31, 2022 | $ 1 | [1] | 217,278 | (187,575) | 29,704 | |
Balance, shares at Mar. 31, 2022 | 8,317,876 | 1,718 | ||||
Balance at Dec. 31, 2022 | $ 1 | [2] | 218,977 | (201,585) | 17,393 | |
Balance, shares at Dec. 31, 2022 | 8,330,918 | 1,718 | ||||
Net loss | (4,256) | (4,256) | ||||
Share-based compensation related to restricted stock, restricted stock units and stock options award, net of forfeitures | 289 | 289 | ||||
Share-based compensation related to restricted stock, restricted stock units and stock options award, net of forfeitures, shares | (4,270) | |||||
Balance at Mar. 31, 2023 | $ 1 | [2] | $ 219,266 | $ (205,841) | $ 13,426 | |
Balance, shares at Mar. 31, 2023 | 8,326,648 | 1,718 | ||||
[1]Represents an amount less than $1 thousand[2]Represents an amount less than $1 thousand |
Condensed Consolidated Statem_3
Condensed Consolidated Statements of Changes in Equity (Unaudited) (Parenthetical) - shares | 3 Months Ended | |
Mar. 31, 2023 | Mar. 31, 2022 | |
Statement of Stockholders' Equity [Abstract] | ||
Shares, restricted stock award, forfeited | 4,270 | 4,563 |
Condensed Consolidated Statem_4
Condensed Consolidated Statements of Cash Flows (Unaudited) - USD ($) $ in Thousands | 3 Months Ended | |
Mar. 31, 2023 | Mar. 31, 2022 | |
CASH FLOWS FROM OPERATING ACTIVITIES: | ||
Net loss | $ (4,256) | $ (4,481) |
Adjustments required to reconcile net loss to net cash used in operating activities: | ||
Depreciation | 55 | 41 |
Change in liability for employees rights upon retirement | 36 | 46 |
Other financial expenses | 22 | 7 |
Change in right of use asset and leasing liability | (34) | (25) |
Share-based compensation expenses | 289 | 653 |
Loss on amounts funded in respect of employee rights upon retirement, net | 23 | 18 |
Decrease (increase) in interest receivable on short term deposits | 14 | (17) |
Changes in operating asset and liability items: | ||
Decrease in prepaid expenses | 261 | 231 |
Decrease (Increase) in trade receivables | (383) | 111 |
Decrease (Increase) in other receivables | (97) | 74 |
Increase in inventory | (76) | (143) |
Increase (Decrease) in trade payables | (52) | 7 |
Decrease in other payables | (633) | (656) |
Net cash used in operating activities | (4,831) | (4,134) |
CASH FLOWS FROM INVESTING ACTIVITIES: | ||
Purchase of property, plant and equipment | (25) | (37) |
Investment in short-term bank deposits | (2,500) | (6,000) |
Withdrawal from short-term bank deposits | 7,000 | 6,000 |
Amounts funded in respect of employee rights upon retirement | (26) | (28) |
Net cash provided by (used in) investing activities | 4,449 | (65) |
CASH FLOWS FROM FINANCING ACTIVITIES: | ||
Net cash provided by (used in) financing activities | ||
EFFECT OF EXCHANGE RATE CHANGES ON CASH AND CASH EQUIVALENTS | (22) | (7) |
DECREASE IN CASH AND CASH EQUIVALENTS | (404) | (4,206) |
BALANCE OF CASH AND CASH EQUIVALENTS AT BEGINNING OF THE PERIOD | 4,632 | 12,004 |
BALANCE OF CASH AND CASH EQUIVALENTS AT END OF THE PERIOD | $ 4,228 | $ 7,798 |
DESCRIPTION OF BUSINESS
DESCRIPTION OF BUSINESS | 3 Months Ended |
Mar. 31, 2023 | |
Organization, Consolidation and Presentation of Financial Statements [Abstract] | |
DESCRIPTION OF BUSINESS | NOTE 1 - DESCRIPTION OF BUSINESS a. General InspireMD, Inc., a Delaware corporation (the “Company”), together with its subsidiaries, is a medical device company focusing on the development and commercialization of its proprietary MicroNet™ stent platform technology for the treatment of complex vascular and coronary disease. MicroNet, a micron mesh sleeve, is wrapped over a stent to provide embolic protection in stenting procedures. The Company’s carotid product (CGuard™ EPS) combines MicroNet and a self-expandable nitinol stent in a single device to treat carotid artery disease. The Company’s MGuard™ Prime™ embolic protection system (“MGuard Prime EPS”) was marketed for use in patients with acute coronary syndromes, notably acute myocardial infarction (heart attack) and saphenous vein graft coronary interventions, or bypass surgery. MGuard Prime EPS combines MicroNet with a bare-metal cobalt-chromium based stent. MGuard Prime EPS received CE mark approval in the European Union in October 2010 for improving luminal diameter and providing embolic protection. Over the past years, there has been a shift in industry preferences away from bare-metal stents, such as MGuard Prime EPS in ST-Elevation Myocardial Infarction (“STEMI”) patients. As a result of declining sales of the MGuard Prime EPS, which the Company believes is largely driven by the predominant industry preferences favoring drug-eluting, or drug-coated, stents, during the second quarter of 2022, the Company ceased sales of the Company’s MGuard Prime EPS following a phase out period. The Company markets its products through distributors in international markets, mainly in Europe. b. Liquidity The Company has an accumulated deficit as of March 31, 2023, as well as a history of net losses and negative operating cash flows in recent years. The Company expects to continue incurring losses and negative cash flows from operations until its product, CGuard™ EPS, reaches commercial profitability. As a result of these expected losses and negative cash flows from operations, along with the Company’s current cash position, the Company has sufficient resources to fund operations until the end of September 2023. Therefore, there is substantial doubt about the Company’s ability to continue as a going concern. These financial statements have been prepared assuming that the Company will continue as a going concern and do not include any adjustments that might result from the outcome of this uncertainty. Management’s plans include the continued commercialization of the Company’s product and raising capital through the sale of additional equity securities, debt or capital inflows from strategic partnerships. There are no assurances however, that the Company will be successful in obtaining the level of financing needed for its operations. If the Company is unsuccessful in commercializing its products and raising capital, it may need to reduce activities, curtail or cease operations. On May 12, 2023, the Company entered into a securities purchase agreement for the issuance and sale of Company securities in a private placement. Aggregate gross proceeds to the Company in respect of the private placement is expected to be approximately $ 42.2 c. Failure to satisfy regulatory requirements of the new European Medical Device Regulation could prevent the Company from marketing CGuard EPS in countries requiring the CE Mark. For the European Union nations, medical devices must obtain a CE mark before they may be placed on the market. In order to obtain and maintain the CE mark, the Company must Company with EU law on medical devices, which, until May 26, 2021 was governed by the MDD, by presenting comprehensive technical files for the Company’s products demonstrating safety and efficacy of the product to be placed on the market and passing initial and annual quality management system audit as per ISO 13485 standard by a European Notified Body. The company has obtained ISO 13485 quality system certification and CGuard EPS that the Company currently distribute into the European Union, displays the required CE mark. In order to maintain certification, the Company is required to pass an annual surveillance audit conducted by Notified Body auditors. The European Union replaced the MDD with the new MDR regulations. The MDR entered into force after a transitional period of three years and a one year extension of that transition period due to the COVID-19 pandemic on May 26, 2021 and which changes several aspects of the regulatory framework in the European Union. Manufacturers had the duration of the transition period to update their technical documentation and processes to meet the new requirements in order to obtain a CE Mark. In the Company’s specific case, the Company’s CE mark for CGuard EPS under the MDD expired on November 12, 2022, and the Company is in the final stages of technical documentation review by the Notified Body auditor to meet the MDR requirements for recertification. In the meantime, on February 14, 2023, the Company received a derogation per Article 97 paragraph 1 of Regulation 2017/745 from the Agency for Medicines and Health Products (FAMHP) allowing the Company to continue marketing CGuard EPS in the EU until August 15, 2023, subject to certain procedural requirements. Subsequently, on March 20, 2023 Regulation (EU) 2023/607 was published allowing the Company to continue marketing CGuard EPS in EU countries under the MDD directive until December 31, 2027. As a result of the foregoing, the Company may market and sell CGuard EPS in the EU and certain other jurisdictions subject to certain procedural requirements while the Company’s MDR CE recertification is pending. d. Risks Related to the Geopolitical and Military Tensions Between Russia and Ukraine in Europe In February 2022, Russia launched a military invasion into Ukraine. The Company derived approximately 12.1% of total sales in Russia and Belarus in 2022 while during the three months ended March 31, 2023 and March 31,2022, The Company’s sales to Russia and Belarus were 7.9% and 1.5% respectively. The escalation of geopolitical instability in Russia and Ukraine as well as currency fluctuations in the Russian Ruble could negatively impact the Company’s operations, sales, and future growth prospects in that region. As a result of the crisis in Ukraine, the United States and the EU have implemented sanctions against certain Russian individuals and entities and have made it more difficult for the Company to collect on outstanding accounts receivable from customers in this region. The Company’s global operations expose the Company to risks that could adversely affect the Company’s business, financial condition, results of operations, cash flows or the market price of the Company’s securities, including the potential for increased tensions between the United States and Russia resulting from the current situation involving Russia and Ukraine, tariffs, economic sanctions and import-export restrictions imposed by either nation, and retaliatory actions by the other nation, as well as the potential negative impact on the Company’s business and sales in Russia, and Belarus. Current geopolitical instability in Russia and Ukraine and related sanctions by the U.S. government against certain companies and individuals may hinder the Company’s ability to conduct business with potential or existing customers and vendors in these countries. The U.S. government has imposed sanctions through several executive orders restricting U.S. companies from conducting business with specified Russian individuals and companies. While the Company believes that the executive orders currently do not preclude the Company from conducting business with the Company’s current customers or vendors in Russia, and Belarus, the sanctions imposed by the U.S. government may be expanded in the future to restrict the Company from engaging with them. If the Company is unable to conduct business with new or existing customers or vendors or pursue business opportunities in Russia, or Belarus, the Company’s business, including revenue, profitability and cash flows, and operations could be adversely affected. The Company cannot provide assurance that current sanctions or potential future changes in sanctions will not have a material impact on the Company’s operations in Russia, and Belarus or on the Company’s financial results. |
BASIS OF PRESENTATION
BASIS OF PRESENTATION | 3 Months Ended |
Mar. 31, 2023 | |
Organization, Consolidation and Presentation of Financial Statements [Abstract] | |
BASIS OF PRESENTATION | NOTE 2 - BASIS OF PRESENTATION The accompanying unaudited consolidated financial statements have been prepared on the same basis as the annual consolidated financial statements. In the opinion of the Company, the financial statements reflect all adjustments, which include only normal recurring adjustments, necessary for a fair statement of its financial position as of March 31, 2023 and its results of operations, changes in equity and cash flows for the three months ended March 31, 2023 and 2022. These consolidated financial statements and notes thereto are unaudited and should be read in conjunction with the Company’s audited financial statements for the year ended December 31, 2022, as found in the Company’s Annual Report on Form 10-K, filed with the Securities and Exchange Commission on March 30, 2023. The results of operations for the three months ended March 31, 2023 are not necessarily indicative of results that could be expected for the entire fiscal year. |
RECENTLY ADOPTED AND ISSUED ACC
RECENTLY ADOPTED AND ISSUED ACCOUNTING PRONOUNCEMENTS | 3 Months Ended |
Mar. 31, 2023 | |
Accounting Changes and Error Corrections [Abstract] | |
RECENTLY ADOPTED AND ISSUED ACCOUNTING PRONOUNCEMENTS | NOTE 3 - RECENTLY ADOPTED AND ISSUED ACCOUNTING PRONOUNCEMENTS Newly issued accounting pronouncements Financial Instruments - Credit Losses In June 2016, the FASB issued ASU 2016-13, Financial Instruments-Credit Losses (Topic 326)-Measurement of Credit Losses on Financial Instruments. This guidance replaces the current incurred loss impairment methodology. Under the new guidance, on initial recognition and at each reporting period, an entity is required to recognize an allowance that reflects its current estimate of credit losses expected to be incurred over the life of the financial instrument based on historical experience, current conditions and reasonable and supportable forecasts. In November 2019, the FASB issued ASU No. 2019-10, Financial Instruments - Credit Losses (Topic 326), Derivatives and Hedging (Topic 815), and Leases (Topic 842): Effective Dates (“ASU 2019-10”). The purpose of this amendment is to create a two-tier rollout of major updates, staggering the effective dates between larger public companies and all other entities. This granted certain classes of companies, including Smaller Reporting Companies (“SRCs”), additional time to implement major FASB standards, including ASU 2016-13. Larger public companies had an effective date for fiscal years beginning after December 15, 2019, including interim periods within those fiscal years. All other entities are permitted to defer adoption of ASU 2016-13, and its related amendments, until the earlier of fiscal periods beginning after December 15, 2022. Under the current SEC definitions, the Company met the definition of an SRC and adopted the deferral period for ASU 2016-13. The guidance requires a modified retrospective transition approach through a cumulative-effect adjustment to retained earnings as of the beginning of the period of adoption. The Company adopted the provisions of this update as of January 1, 2023 with no material impact on its consolidated financial statements. |
EQUITY
EQUITY | 3 Months Ended |
Mar. 31, 2023 | |
Equity [Abstract] | |
EQUITY | NOTE 4 - EQUITY a. As of March 31, 2023, there were 1,718 2,280 As of March 31, 2023, the Company has outstanding warrants to purchase an aggregate of 1,793,504 SCHEDULE OF ISSUANCE OF WARRANTS TO PURCHASE COMMON STOCK Number of Weighted Series E Warrants 198,159 $ 27.000 Series F Warrants 433,878 $ 7.425 Series G Warrants 1,092,344 $ 10.230 Underwriter Warrants 17,966 $ 7.425 Other warrants 51,157 225 and above Total Warrants 1,793,504 $ As of March 31, 2023, the Company had 155,000,000 0.0001 150,000,000 5,000,000 b. 50,000 1.15 45,000 three 20,000 15,000 10,000 5,000 In calculating the fair value of the above options, the Company used the following assumptions: dividend yield of 0 5.5 6.5 124.58 125.61 3.65 3.68 The fair value of the above options, using the Black-Scholes option-pricing model, was approximately $ 50,658 |
RELATED PARTIES TRANSACTIONS
RELATED PARTIES TRANSACTIONS | 3 Months Ended |
Mar. 31, 2023 | |
Related Party Transactions [Abstract] | |
RELATED PARTIES TRANSACTIONS | NOTE 5 – RELATED PARTIES TRANSACTIONS During the three months ended March 31, 2022, a consulting company whose founder and CEO is our board member provided certain marketing services in the amount of $ 6,276 |
NET LOSS PER SHARE
NET LOSS PER SHARE | 3 Months Ended |
Mar. 31, 2023 | |
Earnings Per Share [Abstract] | |
NET LOSS PER SHARE | NOTE 6 - NET LOSS PER SHARE Basic and diluted net loss per share is computed by dividing the net loss for the period by the weighted average number of shares of common stock outstanding during the period. The calculation of diluted net loss per share excludes potential share issuances of common stock upon the exercise of share options, warrants, and unvested restricted stocks and unvested restricted stock units as the effect is anti-dilutive. The total number of shares of common stock related to outstanding options, warrants, restricted stock, restricted stock units, Series C Preferred Stock excluded from the calculations of diluted loss per share were 2,773,675 342,766 The total number of shares of common stock related to outstanding options, warrants, restricted stock, restricted stock units, Series C Preferred Stock excluded from the calculations of diluted loss per share were 2,903,634 547,383 |
FINANCIAL INSTRUMENTS
FINANCIAL INSTRUMENTS | 3 Months Ended |
Mar. 31, 2023 | |
Investments, All Other Investments [Abstract] | |
FINANCIAL INSTRUMENTS | NOTE 7 - FINANCIAL INSTRUMENTS a. Fair value of financial instruments The carrying amounts of financial instruments included in working capital approximate their fair value due to the relatively short-term maturities of such instruments. b. As of March 31, 2023, and December 31, 2022, allowance for expected credit loss was immaterial. |
INVENTORY
INVENTORY | 3 Months Ended |
Mar. 31, 2023 | |
Inventory Disclosure [Abstract] | |
INVENTORY | NOTE 8 - INVENTORY SCHEDULE OF INVENTORY March 31, December 31, 2023 2022 ($ in thousands) Finished goods $ 138 $ 179 Work in process 690 510 Raw materials and supplies 869 932 Total inventory $ 1,697 $ 1,621 |
ACCOUNTS PAYABLE AND ACCRUALS -
ACCOUNTS PAYABLE AND ACCRUALS - OTHER | 3 Months Ended |
Mar. 31, 2023 | |
Payables and Accruals [Abstract] | |
ACCOUNTS PAYABLE AND ACCRUALS - OTHER | NOTE 9 - ACCOUNTS PAYABLE AND ACCRUALS - OTHER SCHEDULE OF ACCOUNTS PAYABLE AND ACCRUALS - OTHER March 31, December 31, 2023 2022 ($ in thousands) Employees and employee institutions 970 1,853 Accrued vacation and recreation pay 240 197 Accrued expenses 933 554 Clinical trial accrual 1,046 1,258 Current Operating lease liabilities 417 419 Other 170 130 Accounts payable and accruals-other $ 3,776 $ 4,411 |
DISAGGREGATED REVENUE AND ENTIT
DISAGGREGATED REVENUE AND ENTITY WIDE DISCLOSURES | 3 Months Ended |
Mar. 31, 2023 | |
Segment Reporting [Abstract] | |
DISAGGREGATED REVENUE AND ENTITY WIDE DISCLOSURES | NOTE 10 - DISAGGREGATED REVENUE AND ENTITY WIDE DISCLOSURES Revenues are attributed to geographic areas based on the location of the customers. The following is a summary of revenues: SCHEDULE OF REVENUES ATTRIBUTED TO GEOGRAPHIC AREAS Three months ended 2023 2022 ($ in thousands) Italy $ 267 $ 243 Germany 214 249 Other 758 691 $ 1,239 $ 1,183 By product: SCHEDULE OF REVENUES ATTRIBUTED TO GEOGRAPHIC AREAS BY PRODUCT Three months ended 2023 2022 ($ in thousands) CGuard $ 1,239 $ 1,161 MGuard - 22 $ 1,239 $ 1,183 By principal customers: SCHEDULE OF REVENUES ATTRIBUTED TO GEOGRAPHIC AREAS BY PRINCIPAL CUSTOMERS Three months ended 2023 2022 Customer A 17 % 21 % Customer B 13 % 11 % All tangible long lived assets are located in Israel. |
SUBSEQUENT EVENTS
SUBSEQUENT EVENTS | 3 Months Ended |
Mar. 31, 2023 | |
Subsequent Events [Abstract] | |
SUBSEQUENT EVENTS | NOTE 11 – SUBSEQUENT EVENTS On May 12, 2023, the Company entered into a securities purchase agreement (the “Purchase Agreement”) pursuant to which the Company agreed to sell and issue in a private placement (the “Private Placement Offering) an aggregate of 10,266,270 15,561,894 51,656,328 12,914,086 12,914,078 12,914,086 12,914,086 1.6327 1.6326 The Pre-Funded Warrants will be immediately exercisable at an exercise price of $ 0.0001 1.3827 In connection with the Purchase Agreement, the Company entered into a registration rights agreement (the “Registration Rights Agreement”). Pursuant to the Registration Rights Agreement, the Company is required to file a resale registration statement (the “Registration Statement”) with the SEC to register for resale the Private Placement Shares and the shares of common stock issuable upon exercise of the Pre-Funded Warrants and Warrants, within 20 days of the signing date of the Purchase Agreement (the “Signing Date”), and to have such Registration Statement declared effective within 45 days after the Signing Date in the event the Registration Statement is not reviewed by the SEC, or 90 days of the Signing Date in the event the Registration Statement is reviewed by the SEC. The Company will be obligated to pay certain liquidated damages if the Company fails to file the Registration Statement when required, fails to cause the Registration Statement to be declared effective by the SEC when required, of if the Company fails to maintain the effectiveness of the Registration Statement. Aggregate gross proceeds to the Company in respect of the Private Placement Offering are expected to be approximately $ 42.2 4.6 71.4 |
EQUITY (Tables)
EQUITY (Tables) | 3 Months Ended |
Mar. 31, 2023 | |
Equity [Abstract] | |
SCHEDULE OF ISSUANCE OF WARRANTS TO PURCHASE COMMON STOCK | As of March 31, 2023, the Company has outstanding warrants to purchase an aggregate of 1,793,504 SCHEDULE OF ISSUANCE OF WARRANTS TO PURCHASE COMMON STOCK Number of Weighted Series E Warrants 198,159 $ 27.000 Series F Warrants 433,878 $ 7.425 Series G Warrants 1,092,344 $ 10.230 Underwriter Warrants 17,966 $ 7.425 Other warrants 51,157 225 and above Total Warrants 1,793,504 $ |
INVENTORY (Tables)
INVENTORY (Tables) | 3 Months Ended |
Mar. 31, 2023 | |
Inventory Disclosure [Abstract] | |
SCHEDULE OF INVENTORY | SCHEDULE OF INVENTORY March 31, December 31, 2023 2022 ($ in thousands) Finished goods $ 138 $ 179 Work in process 690 510 Raw materials and supplies 869 932 Total inventory $ 1,697 $ 1,621 |
ACCOUNTS PAYABLE AND ACCRUALS_2
ACCOUNTS PAYABLE AND ACCRUALS - OTHER (Tables) | 3 Months Ended |
Mar. 31, 2023 | |
Payables and Accruals [Abstract] | |
SCHEDULE OF ACCOUNTS PAYABLE AND ACCRUALS - OTHER | SCHEDULE OF ACCOUNTS PAYABLE AND ACCRUALS - OTHER March 31, December 31, 2023 2022 ($ in thousands) Employees and employee institutions 970 1,853 Accrued vacation and recreation pay 240 197 Accrued expenses 933 554 Clinical trial accrual 1,046 1,258 Current Operating lease liabilities 417 419 Other 170 130 Accounts payable and accruals-other $ 3,776 $ 4,411 |
DISAGGREGATED REVENUE AND ENT_2
DISAGGREGATED REVENUE AND ENTITY WIDE DISCLOSURES (Tables) | 3 Months Ended |
Mar. 31, 2023 | |
Segment Reporting [Abstract] | |
SCHEDULE OF REVENUES ATTRIBUTED TO GEOGRAPHIC AREAS | Revenues are attributed to geographic areas based on the location of the customers. The following is a summary of revenues: SCHEDULE OF REVENUES ATTRIBUTED TO GEOGRAPHIC AREAS Three months ended 2023 2022 ($ in thousands) Italy $ 267 $ 243 Germany 214 249 Other 758 691 $ 1,239 $ 1,183 |
SCHEDULE OF REVENUES ATTRIBUTED TO GEOGRAPHIC AREAS BY PRODUCT | By product: SCHEDULE OF REVENUES ATTRIBUTED TO GEOGRAPHIC AREAS BY PRODUCT Three months ended 2023 2022 ($ in thousands) CGuard $ 1,239 $ 1,161 MGuard - 22 $ 1,239 $ 1,183 |
SCHEDULE OF REVENUES ATTRIBUTED TO GEOGRAPHIC AREAS BY PRINCIPAL CUSTOMERS | By principal customers: SCHEDULE OF REVENUES ATTRIBUTED TO GEOGRAPHIC AREAS BY PRINCIPAL CUSTOMERS Three months ended 2023 2022 Customer A 17 % 21 % Customer B 13 % 11 % |
DESCRIPTION OF BUSINESS (Detail
DESCRIPTION OF BUSINESS (Details Narrative) $ in Millions | May 12, 2023 USD ($) |
Securities Purchase Agreement [Member] | Subsequent Event [Member] | |
Collaborative Arrangement and Arrangement Other than Collaborative [Line Items] | |
Private placement | $ 42.2 |
SCHEDULE OF ISSUANCE OF WARRANT
SCHEDULE OF ISSUANCE OF WARRANTS TO PURCHASE COMMON STOCK (Details) shares in Thousands | 3 Months Ended |
Mar. 31, 2023 $ / shares shares | |
Class of Stock [Line Items] | |
Total Warrants | 1,793,504 |
Series E Warrants [Member] | |
Class of Stock [Line Items] | |
Total Warrants | 198,159 |
Weighted average exercise price | $ / shares | $ 27 |
Series F Warrants [Member] | |
Class of Stock [Line Items] | |
Total Warrants | 433,878 |
Weighted average exercise price | $ / shares | $ 7.425 |
Series G Warrants [Member] | |
Class of Stock [Line Items] | |
Total Warrants | 1,092,344 |
Weighted average exercise price | $ / shares | $ 10.230 |
Underwriter Warrants [Member] | |
Class of Stock [Line Items] | |
Total Warrants | 17,966 |
Weighted average exercise price | $ / shares | $ 7.425 |
Other Warrants [Member] | |
Class of Stock [Line Items] | |
Total Warrants | 51,157 |
Weighted average exercise price, description | 225 and above |
EQUITY (Details Narrative)
EQUITY (Details Narrative) - USD ($) | 3 Months Ended | |
Mar. 31, 2023 | Dec. 31, 2022 | |
Class of Stock [Line Items] | ||
Common stock, shares outstanding | 8,326,648 | 8,330,918 |
Capital stock shares authorized | 155,000,000 | |
Capital stock par value | $ 0.0001 | |
Common stock shares authorized | 150,000,000 | 150,000,000 |
Stock option description | 45,000 options are subject to a three-year vesting period (of which 20,000 options are vesting in the first year, 15,000 options are vesting in the second year and 10,000 options are vesting in the third year) and 5,000 options with performance conditions related to marketing activities. | |
Expected dividend rate | 0% | |
Expected volatility, minimum | 124.58% | |
Expected volatility, maximum | 125.61% | |
Risk-free interest rate, minimum | 3.65% | |
Risk-free interest rate, maximum | 3.68% | |
Minimum [Member] | ||
Class of Stock [Line Items] | ||
Expected term | 5 years 6 months | |
Maximum [Member] | ||
Class of Stock [Line Items] | ||
Expected term | 6 years 6 months | |
Three Year Vesting Period [Member] | ||
Class of Stock [Line Items] | ||
Stock option grants in period | 45,000 | |
First Year Vesting Period [Member] | ||
Class of Stock [Line Items] | ||
Stock option grants in period | 20,000 | |
Second Year Vesting Period [Member] | ||
Class of Stock [Line Items] | ||
Stock option grants in period | 15,000 | |
Third Year Vesting Period [Member] | ||
Class of Stock [Line Items] | ||
Stock option grants in period | 10,000 | |
Performance Conditions [Member] | ||
Class of Stock [Line Items] | ||
Stock option grants in period | 5,000 | |
Share-Based Payment Arrangement, Option [Member] | ||
Class of Stock [Line Items] | ||
Stock option grants in period | 50,000 | |
Stock option exercise price | $ 1.15 | |
Vesting period | 3 years | |
Fair value stock option price | $ 50,658 | |
Preferred Stock Blank Check [Member] | ||
Class of Stock [Line Items] | ||
Preferred stock shares authorized | 5,000,000 | |
At The Market Offering [Member] | Warrant [Member] | ||
Class of Stock [Line Items] | ||
Purchase of warrants | 1,793,504 | |
Series C Convertible Preferred Stock [Member] | ||
Class of Stock [Line Items] | ||
Common stock, shares outstanding | 1,718 | |
Conversion of Series C Convertible Preferred Stock to common shares, shares | 2,280 |
RELATED PARTIES TRANSACTIONS (D
RELATED PARTIES TRANSACTIONS (Details Narrative) | 3 Months Ended |
Mar. 31, 2022 USD ($) | |
New Director [Member] | |
Deferred Compensation Arrangement with Individual, Excluding Share-Based Payments and Postretirement Benefits [Line Items] | |
Marketing services expense | $ 6,276 |
NET LOSS PER SHARE (Details Nar
NET LOSS PER SHARE (Details Narrative) - shares | 3 Months Ended | |
Mar. 31, 2023 | Mar. 31, 2022 | |
Antidilutive Securities Excluded from Computation of Earnings Per Share [Line Items] | ||
Diluted loss per share | 2,773,675 | 2,903,634 |
Restricted Stock [Member] | ||
Antidilutive Securities Excluded from Computation of Earnings Per Share [Line Items] | ||
Diluted loss per share | 342,766 | 547,383 |
SCHEDULE OF INVENTORY (Details)
SCHEDULE OF INVENTORY (Details) - USD ($) $ in Thousands | Mar. 31, 2023 | Dec. 31, 2022 |
Inventory Disclosure [Abstract] | ||
Finished goods | $ 138 | $ 179 |
Work in process | 690 | 510 |
Raw materials and supplies | 869 | 932 |
Total inventory | $ 1,697 | $ 1,621 |
SCHEDULE OF ACCOUNTS PAYABLE AN
SCHEDULE OF ACCOUNTS PAYABLE AND ACCRUALS - OTHER (Details) - USD ($) $ in Thousands | Mar. 31, 2023 | Dec. 31, 2022 |
Payables and Accruals [Abstract] | ||
Employees and employee institutions | $ 970 | $ 1,853 |
Accrued vacation and recreation pay | 240 | 197 |
Accrued expenses | 933 | 554 |
Clinical trial accrual | 1,046 | 1,258 |
Current Operating lease liabilities | 417 | 419 |
Other | 170 | 130 |
Accounts payable and accruals-other | $ 3,776 | $ 4,411 |
SCHEDULE OF REVENUES ATTRIBUTED
SCHEDULE OF REVENUES ATTRIBUTED TO GEOGRAPHIC AREAS (Details) - USD ($) $ in Thousands | 3 Months Ended | |
Mar. 31, 2023 | Mar. 31, 2022 | |
Revenues from External Customers and Long-Lived Assets [Line Items] | ||
Revenues | $ 1,239 | $ 1,183 |
ITALY | ||
Revenues from External Customers and Long-Lived Assets [Line Items] | ||
Revenues | 267 | 243 |
GERMANY | ||
Revenues from External Customers and Long-Lived Assets [Line Items] | ||
Revenues | 214 | 249 |
Other Countries [Member] | ||
Revenues from External Customers and Long-Lived Assets [Line Items] | ||
Revenues | $ 758 | $ 691 |
SCHEDULE OF REVENUES ATTRIBUT_2
SCHEDULE OF REVENUES ATTRIBUTED TO GEOGRAPHIC AREAS BY PRODUCT (Details) - USD ($) $ in Thousands | 3 Months Ended | |
Mar. 31, 2023 | Mar. 31, 2022 | |
Revenue from External Customer [Line Items] | ||
Revenue | $ 1,239 | $ 1,183 |
CGuard EPS [Member] | ||
Revenue from External Customer [Line Items] | ||
Revenue | 1,239 | 1,161 |
MGuard Prime EPS [Member] | ||
Revenue from External Customer [Line Items] | ||
Revenue | $ 22 |
SCHEDULE OF REVENUES ATTRIBUT_3
SCHEDULE OF REVENUES ATTRIBUTED TO GEOGRAPHIC AREAS BY PRINCIPAL CUSTOMERS (Details) - Sales [Member] - Customer Concentration Risk [Member] | 3 Months Ended | |
Mar. 31, 2023 | Mar. 31, 2022 | |
Customer A [Member] | ||
Revenue, Major Customer [Line Items] | ||
Percentage of revenues per major customer | 17% | 21% |
Customer B [Member] | ||
Revenue, Major Customer [Line Items] | ||
Percentage of revenues per major customer | 13% | 11% |
SUBSEQUENT EVENTS (Details Narr
SUBSEQUENT EVENTS (Details Narrative) - Subsequent Event [Member] $ / shares in Units, $ in Millions | May 12, 2023 USD ($) $ / shares shares |
Subsequent Event [Line Items] | |
Warrant exercise price | $ / shares | $ 1.3827 |
Securities Purchase Agreement [Member] | |
Subsequent Event [Line Items] | |
Private placement | $ | $ 42.2 |
Offering expenses | $ | 4.6 |
Warrant exercises | $ | $ 71.4 |
Warrant [Member] | |
Subsequent Event [Line Items] | |
Offering price | $ / shares | $ 1.6326 |
Warrant exercise price | $ / shares | $ 0.0001 |
Private Placement [Member] | |
Subsequent Event [Line Items] | |
Number of stock issued | 10,266,270 |
Private Placement [Member] | Warrant [Member] | |
Subsequent Event [Line Items] | |
Number of warrants or rights outstanding | 15,561,894 |
Offering price | $ / shares | $ 1.6327 |
Private Placement [Member] | Common Stock [Member] | |
Subsequent Event [Line Items] | |
Number of warrants or rights outstanding | 51,656,328 |
Private Placement [Member] | Series H Warrants [Member] | |
Subsequent Event [Line Items] | |
Number of warrants or rights outstanding | 12,914,086 |
Private Placement [Member] | Series I Warrants [Member] | |
Subsequent Event [Line Items] | |
Number of warrants or rights outstanding | 12,914,078 |
Private Placement [Member] | Series J Warrants [Member] | |
Subsequent Event [Line Items] | |
Number of warrants or rights outstanding | 12,914,086 |
Private Placement [Member] | Series K Warrants [Member] | |
Subsequent Event [Line Items] | |
Number of warrants or rights outstanding | 12,914,086 |