Cover
Cover - USD ($) | 12 Months Ended | ||
Dec. 31, 2023 | Mar. 05, 2024 | Jun. 30, 2023 | |
Cover [Abstract] | |||
Document Type | 10-K | ||
Amendment Flag | false | ||
Document Annual Report | true | ||
Document Transition Report | false | ||
Document Period End Date | Dec. 31, 2023 | ||
Document Fiscal Period Focus | FY | ||
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 | 776-6804 | ||
Title of 12(b) Security | Common Stock, par value $0.0001 per share | ||
Trading Symbol | NSPR | ||
Security Exchange Name | NASDAQ | ||
Entity Well-known Seasoned Issuer | No | ||
Entity Voluntary Filers | No | ||
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 Public Float | $ 46,130,594 | ||
Entity Common Stock, Shares Outstanding | 23,456,590 | ||
Documents Incorporated by Reference [Text Block] | Portions of the Registrant’s definitive proxy statement for its 2024 Annual Meeting of Stockholders, which the Registrant intends to file pursuant to Regulation 14A with the Securities and Exchange Commission not later than 120 days after December 31, 2023, are incorporated by reference into Part III of this Annual Report on Form 10-K | ||
ICFR Auditor Attestation Flag | false | ||
Document Financial Statement Error Correction [Flag] | false | ||
Auditor Firm ID | 1309 | ||
Auditor Name | Kesselman & Kesselman | ||
Auditor Location | Tel-Aviv, Israel |
Consolidated Balance Sheets
Consolidated Balance Sheets - USD ($) $ in Thousands | Dec. 31, 2023 | Dec. 31, 2022 | |
CURRENT ASSETS: | |||
Cash and cash equivalents | $ 9,640 | $ 4,632 | |
Short-term bank deposits | 13,171 | ||
Marketable securities | 29,383 | ||
Accounts receivable: | |||
Trade, net | 1,804 | 1,034 | |
Other | 648 | 213 | |
Prepaid expenses | 578 | 655 | |
Inventory | 2,106 | 1,621 | |
TOTAL CURRENT ASSETS | 44,159 | 21,326 | |
NON-CURRENT ASSETS: | |||
Property, plant and equipment, net | 1,060 | 917 | |
Operating lease right of use assets | 1,473 | 1,554 | |
Fund in respect of employee rights upon retirement | 951 | 856 | |
TOTAL NON-CURRENT ASSETS | 3,484 | 3,327 | |
TOTAL ASSETS | 47,643 | 24,653 | |
Accounts payable and accruals: | |||
Trade | 939 | 659 | |
Other | 5,081 | 4,411 | |
TOTAL CURRENT LIABILITIES | 6,020 | 5,070 | |
LONG-TERM LIABILITIES: | |||
Operating lease liabilities | 1,038 | 1,195 | |
Liability for employee rights upon retirement | 1,084 | 995 | |
TOTAL LONG-TERM LIABILITIES | 2,122 | 2,190 | |
TOTAL LIABILITIES | 8,142 | 7,260 | |
EQUITY: | |||
Common stock, par value $0.0001 per share; 150,000,000 shares authorized at December 31, 2023 and 2022; 21,841,215 and 8,330,918 shares issued and outstanding at December 31, 2023 and 2022, respectively | 2 | 1 | |
Preferred C shares, par value $0.0001 per share; 1,172,000 shares authorized at December 31, 2023 and 2022; 1,718 shares issued and outstanding at December 31, 2023 and 2022; | [1] | ||
Additional paid-in capital | 261,000 | 218,977 | |
Accumulated deficit | (221,501) | (201,585) | |
Total equity | 39,501 | 17,393 | |
Total liabilities and equity | $ 47,643 | $ 24,653 | |
[1]Represents an amount less than $1 |
Consolidated Balance Sheets (Pa
Consolidated Balance Sheets (Parenthetical) - $ / shares | Dec. 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 | 21,841,215 | 8,330,918 |
Common stock, shares outstanding | 21,841,215 | 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 |
Consolidated Statements of Oper
Consolidated Statements of Operations - USD ($) $ in Thousands | 12 Months Ended | |
Dec. 31, 2023 | Dec. 31, 2022 | |
Income Statement [Abstract] | ||
REVENUES | $ 6,205 | $ 5,171 |
COST OF REVENUES | 4,398 | 4,054 |
GROSS PROFIT | 1,807 | 1,117 |
OPERATING EXPENSES: | ||
Research and development | 7,981 | 7,810 |
Selling and marketing | 3,865 | 3,664 |
General and administrative | 11,104 | 8,356 |
Total operating expenses | 22,950 | 19,830 |
LOSS FROM OPERATIONS | (21,143) | (18,713) |
FINANCIAL INCOME , net: | 1,292 | 250 |
LOSS BEFORE TAX EXPENSES | (19,851) | (18,463) |
TAX EXPENSES | 65 | 28 |
NET LOSS | $ (19,916) | $ (18,491) |
NET LOSS PER SHARE - basic | $ (0.82) | $ (2.35) |
NET LOSS PER SHARE - diluted | $ (0.82) | $ (2.35) |
WEIGHTED AVERAGE NUMBER OF SHARES OF COMMON STOCK USED IN COMPUTING NET LOSS PER SHARE - basic | 24,268,181 | 7,871,814 |
WEIGHTED AVERAGE NUMBER OF SHARES OF COMMON STOCK USED IN COMPUTING NET LOSS PER SHARE - diluted | 24,268,181 | 7,871,814 |
Consolidated Statements of Chan
Consolidated Statements of Changes in Equity - USD ($) $ in Thousands | Common Stock [Member] | Preferred Stock [Member] Series C Convertible Preferred Stock [Member] | Additional Paid-in Capital [Member] | Retained Earnings [Member] | Total | ||
Beginning balance, value 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 | (18,491) | (18,491) | |||||
Share-based compensation related to stock, restricted stock, restricted stock units and stock options award, net of forfeitures | 2,352 | 2,352 | |||||
Share-based compensation related to stock, restricted stock, restricted stock units and stock options award, net of forfeitures, shares | 34,662 | ||||||
Ending balance, value 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 | (19,916) | (19,916) | |||||
Share-based compensation related to stock, restricted stock, restricted stock units and stock options award, net of forfeitures | [2] | 4,490 | 4,490 | ||||
Share-based compensation related to stock, restricted stock, restricted stock units and stock options award, net of forfeitures, shares | 2,936,767 | ||||||
Exercise of pre-funded warrants | [2] | ||||||
Exercise of pre-funded warrants, shares | 307,260 | 307,260 | |||||
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 | 7,731,618 | |||||
Ending balance, value at Dec. 31, 2023 | $ 2 | [2] | $ 261,000 | $ (221,501) | $ 39,501 | ||
Balance, shares at Dec. 31, 2023 | 21,841,215 | 1,718 | |||||
[1]Represents an amount less than $1[2]Represents an amount less than $1 |
Consolidated Statements of Ch_2
Consolidated Statements of Changes in Equity (Parenthetical) - USD ($) $ in Thousands | 12 Months Ended | |
Dec. 31, 2023 | Dec. 31, 2022 | |
Statement of Stockholders' Equity [Abstract] | ||
Shares, restricted stock award, forfeited | 29,695 | 10,832 |
Payments of stock issuance costs | $ 4,635 |
Consolidated Statements of Cash
Consolidated Statements of Cash Flows - USD ($) $ in Thousands | 12 Months Ended | |
Dec. 31, 2023 | Dec. 31, 2022 | |
CASH FLOWS FROM OPERATING ACTIVITIES: | ||
Net loss | $ (19,916) | $ (18,491) |
Adjustments required to reconcile net loss to net cash used in operating activities: | ||
Depreciation and amortization | 232 | 188 |
Gain from sale of property, plant and equipment | (6) | |
Change in fair value of markable securities, net of interest received | (739) | |
Change in liability for employees rights upon retirement | 89 | (57) |
Other financial expense | 58 | 131 |
Change in operating right of use asset and operating leasing liability | 62 | (60) |
Share-based compensation expenses | 4,490 | 2,352 |
Decrease (increase) in interest receivable on short term deposits | 171 | (135) |
Loss (gain) on amounts funded in respect of employee rights upon retirement, net | (16) | 135 |
Changes in operating asset and liability items: | ||
Decrease in prepaid expenses | 77 | 7 |
Decrease (increase) in trade receivables | (770) | 190 |
Increase in other receivables | (435) | (48) |
Increase in inventory | (485) | (478) |
Increase (decrease) in trade payables | 280 | (234) |
Increase in other payables | 532 | 958 |
Net cash used in operating activities | (16,376) | (15,542) |
CASH FLOWS FROM INVESTING ACTIVITIES: | ||
Purchase of property, plant and equipment | (381) | (473) |
Proceeds from sale of property, plant and equipment | 12 | |
Investment in short-term bank deposits | (5,500) | (19,000) |
Investments in marketable securities | (34,644) | |
Proceeds from matured marketable securities | 6,000 | |
Amounts funded in respect of employee rights upon retirement | (79) | (86) |
Withdrawal from short-term bank deposits | 18,500 | 28,000 |
Net cash provided by (used in) investing activities | (16,092) | 8,441 |
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 | (58) | (131) |
INCREASE (DECREASE) IN CASH AND CASH EQUIVALENTS | 5,008 | (7,372) |
BALANCE OF CASH AND CASH EQUIVALENTS AT BEGINNING OF YEAR | 4,632 | 12,004 |
BALANCE OF CASH AND CASH EQUIVALENTS AT END OF YEAR | 9,640 | 4,632 |
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 |
Consolidated Statements of Ca_2
Consolidated Statements of Cash Flows (Parenthetical) $ in Thousands | 12 Months Ended |
Dec. 31, 2023 USD ($) | |
Statement of Cash Flows [Abstract] | |
Payments of stock issuance costs | $ 4,635 |
DESCRIPTION OF BUSINESS
DESCRIPTION OF BUSINESS | 12 Months Ended |
Dec. 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 ceased sales of the Company’s MGuard Prime EPS in the beginning of 2022. The Company market 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. Status of European Medical Device Regulation for 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. 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. 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. In January 2024, the Company received CE mark recertification for the CGuard™ EPS under the EU’s Medical Device Regulation regulatory framework and can market Cguard permanently in EU countries as long as the Company is able to maintain its regulatory approvals. 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, Israel was attacked by a terrorist organization and entered a state of war. As of the date of these consolidated financial statements, the war in Israel is ongoing and continues to evolve. The Company operations including the production facility are located in Israel. Currently, such activities in Israel remain largely unaffected. During the year ended December 31, 2023, the impact of this war on the Company’s results of operations and financial condition was immaterial, but such impact may increase, which could be material, as a result of the continuation, escalation or expansion of such war. d. Risks Related to the Geopolitical and Military Tensions Between Russia and Ukraine in Europe The Company derived approximately 13.5 12.1 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 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. INSPIREMD, INC. NOTES TO THE CONSOLIDATED FINANCIAL STATEMENTS (continued) |
SIGNIFICANT ACCOUNTING POLICIES
SIGNIFICANT ACCOUNTING POLICIES | 12 Months Ended |
Dec. 31, 2023 | |
Accounting Policies [Abstract] | |
SIGNIFICANT ACCOUNTING POLICIES | NOTE 2 - SIGNIFICANT ACCOUNTING POLICIES a. Use of estimates The preparation of financial statements in conformity with U.S. GAAP requires management to make estimates using assumptions that affect the reported amounts of assets and liabilities, the disclosure of contingent liabilities at the date of the financial statements and the reported amounts of revenues and expenses during the reporting periods. Actual results could differ from those estimates. As applicable to these consolidated financial statements, the most significant estimates and assumptions relate to inventory valuations and assessing the likelihood of exercise of options to extend the lease term. b. Functional currency The currency of the primary economic environment in which the operations of the Company and its subsidiaries are conducted is the U.S. dollar (“$” or “dollar”). Accordingly, the functional currency of the Company and its subsidiaries is the U.S. dollar. The dollar figures are determined as follows: transactions and balances originally denominated in dollars are presented in their original amounts. Balances in foreign currencies are translated into dollars using historical and current exchange rates for non-monetary and monetary balances, respectively. The resulting translation gains or losses are recorded as financial income or expense, as appropriate. For transactions reflected in the statements of operations in foreign currencies, the exchange rates at transaction dates are used. Depreciation and changes in inventories and other changes deriving from non-monetary items are based on historical exchange rates. c. Principles of consolidation The consolidated financial statements include the accounts of the Company and of its subsidiaries. Intercompany transactions and balances have been eliminated upon consolidation. d. 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 December 31, 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. e. 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. Marketable securities are classified under current assets in the consolidated balance sheet as they represent the investment of funds available for the Company’s current operations. INSPIREMD, INC. NOTES TO THE CONSOLIDATED FINANCIAL STATEMENTS (continued) NOTE 2 - SIGNIFICANT ACCOUNTING POLICIES f. Short-term bank deposits Bank deposits with original maturities of more than three months but less than one year are presented as part of short-term bank deposits. Deposits are presented at their cost which approximates market values including accrued interest. Interest on deposits is recorded as financial income. g. Concentration of credit risk and allowance for doubtful accounts Financial instruments that may potentially subject the Company to a concentration of credit risk consist of cash and cash equivalents and short-term bank deposits, which are deposited in major financially sound institutions in the U.S, Israel and Germany, and trade accounts receivable and other receivables. The Company’s trade accounts receivable is derived from revenues earned from customers from various countries. The Company performs ongoing credit evaluations of its customers’ financial condition and, requires no collateral from its customers. The Company also has a credit insurance policy for some of its customers. The Company maintains the allowance for estimated losses resulting from the inability of the Company’s customers to make required payments. The allowance represents the current estimate of lifetime expected credit losses over the remaining duration of existing accounts receivable considering current market conditions and supportable forecasts when appropriate. The estimate is a result of the Company’s ongoing evaluation of collectability, customer creditworthiness, historical levels of credit losses, and future expectations. The allowance for expected credit losses was immaterial during the periods presented. h. Inventory Inventories are stated at the lower of cost (cost is determined on a “first-in, first-out” basis) or net realizable value. The Company’s inventories generally have a limited shelf life and are subject to impairment as they approach their expiration dates. The Company regularly evaluates the carrying value of its inventory and when, based on such evaluation, factors indicate that impairment has occurred, the Company impairs the inventories’ carrying value. i. Leases Operating leases are included in operating lease right-of-use (“ROU”) assets. Short-term balances regarding lease liabilities are included in accounts payable and accruals - Other and long-term balances regarding lease liabilities are included in operating lease liabilities. ROU assets represent Company’s right to use an underlying asset for the lease term and lease liabilities represent obligation to make lease payments arising from the lease. Operating lease ROU assets and liabilities are recognized at the lease commencement date based on the present value of lease payments over the lease term. In determining the present value of lease payments, the Company uses the incremental borrowing rate based on the information available at the lease commencement date as the rate implicit in the lease is not readily determinable. The determination of the incremental borrowing rate requires management judgment based on information available at lease commencement. The lease terms may include periods covered by options to extend the lease when it is reasonably certain that the Company will exercise such options, and periods covered by options to terminate the lease when it is reasonably certain that the Company will not exercise such options. Operating lease cost is recognized on a straight-line basis over the lease term. Lease agreements that include lease and non-lease components are accounted for as a single lease component. The Company elected the short-term lease recognition exemption for leases with a lease term of 12 months or less. j. Property, plant and equipment Property, plant and equipment are stated at cost, net of accumulated depreciation and amortization. Depreciation is calculated using the straight-line method over the estimated useful lives of the related assets: over three years for computers and other electronic equipment, and seven to fifteen years for office furniture and equipment and machinery and equipment (mainly seven years). Leasehold improvements are amortized on a straight-line basis over the term of the lease, which is shorter than the estimated life of the improvements. k. Impairment in value of long-lived assets The Company tests long-lived tangible assets for impairment whenever events or circumstances present an indication of impairment. If the sum of expected future cash flows (undiscounted and without interest charges) of the long-lived assets is less than the carrying amount of such assets, an impairment would be recognized, and the assets would be written down to their estimated fair values, based on expected future discounted cash flows. INSPIREMD, INC. NOTES TO THE CONSOLIDATED FINANCIAL STATEMENTS (continued) NOTE 2 - SIGNIFICANT ACCOUNTING POLICIES l. Revenue recognition A contract with a customer exists only when: 1) the parties to the contract have approved it and are committed to perform their respective obligations, 2) the Company can identify each party’s rights regarding the distinct goods or services to be transferred (“Performance Obligations”), 3) the Company can determine the transaction price for the goods or services to be transferred, 4) the contract has commercial substance and 5) it is probable that the Company will collect the consideration to which it will be entitled in exchange for the goods or services that will be transferred to the customer. Revenues are recorded in the amount of consideration to which the Company expects to be entitled in exchange for Performance Obligations upon transfer of control to the customer, excluding sales taxes. Revenue from sales of goods, including sales to distributors, is recognized when the customer obtains control of the product, once the Company has a present right to payment and the customer has legal title, and risk and rewards of ownership are obtained by the customer. Generally, this occurs when products are shipped. In few cases when products are directly sold to medical centers on consignment basis, revenue is recognized when the product is consumed. The Company recognizes the incremental costs of obtaining contracts as an expense since the amortization period of the assets that the Company otherwise would have recognized is one year or less. The costs are recorded under selling and marketing expenses. Disaggregated revenue is disclosed in Note 13. The Company recognizes revenue net of value added tax (VAT). m. Research and development costs Research and development costs, including the costs of the Company’s US based clinical trial costs were approximately $ 3,300,000 and $ 4,468,000 for the years ended December 31, 2023 and 2022, respectively, and charged to the statement of operations as incurred. n. Share-based compensation The Company has equity incentive plans under which the Company grants equity awards, including stock options, restricted stock and restricted stock units (“RSUs”) to employees, directors and service providers. Employee and service providers equity awards are accounted for using the grant-date fair value method. The Company determines compensation expense associated with restricted stock and RSUs based on the fair value of our common stock on the date of grant. The fair value of option awards is estimated using the Black-Scholes valuation model and expensed over the requisite service period. The Company elected to account for forfeitures as they occur. The Company elected to recognize compensation expenses for awards to employees with only service conditions that have graded vesting schedules using the accelerated multiple option approach. The attribution for nonemployee awards is in the same manner as if the Company had paid cash for the goods or services. In addition, certain of our share-based awards to service providers are performance based, i.e., the vesting of these awards depends upon achieving certain goals. The company recognizes compensation expenses for awards with performance conditions when the company concludes that it is probable that the performance condition will be achieved. o. Uncertain tax positions The Company follows a two-step approach to recognizing and measuring uncertain tax positions. The first step is to evaluate the tax position for recognition by determining if the weight of available evidence indicates that it is more likely than not that the position will be sustained on audit. If under the first step a tax position is assessed to be more likely than not of being sustained on audit, the second step is performed, under which the tax benefit is measured as the largest amount that is more than 50% likely to be realized upon ultimate settlement. Such liabilities are classified as long-term, unless the liability is expected to be resolved within twelve months from the balance sheet date. The Company’s policy is to include interest related to unrecognized tax benefits within “Financial expenses - net”. INSPIREMD, INC. NOTES TO THE CONSOLIDATED FINANCIAL STATEMENTS (continued) NOTE 2 - SIGNIFICANT ACCOUNTING POLICIES p. Deferred income taxes Deferred taxes are determined utilizing the “asset and liability” method based on the estimated future tax effects of differences between the financial accounting and tax bases of assets and liabilities under the applicable tax laws, and on tax rates anticipated to be in effect when the deferred taxes are expected to be paid or realized. The Company assesses realization of deferred income tax assets and, based on all available evidence, concludes whether it is more likely than not that the net deferred income tax assets will be realized. A valuation allowance is provided for the amount of deferred income tax assets not considered to be realizable. The Company may incur an additional tax liability in the event of intercompany dividend distributions by its subsidiaries. Such additional tax liability in respect of these foreign subsidiaries has not been provided for in these financial statements as it is the Company’s policy to permanently reinvest the subsidiaries’ earnings and to consider distributing dividends only in connection with a specific tax opportunity that may arise. Taxes that would apply in the event of disposal of investments in a foreign subsidiary have not been taken into account in computing the deferred taxes, as it is the Company’s intention to hold, and not to realize, these investments. q. Advertising Costs related to advertising and promotion of products are charged to sales and marketing expense as incurred. Advertising expenses were approximately $ 426,000 and $ 359,000 for the years ended December 31, 2023 and 2022, respectively. r. Net loss per share Basic and diluted net loss per share is computed by dividing the net loss for the period by the weighted average number of shares of common stock, pre-funded warrants and fully vested restricted stock units outstanding during the period. The calculation of diluted net loss per share excludes the effect of potential dilution of share options, warrants, and unvested restricted stocks, unvested restricted stock units and Series C preferred stock as the effect is anti-dilutive. For the purpose of calculating basic net loss per share, the additional shares of common stock that are issuable upon exercise of the Pre-funded Warrants have been included since the shares are issuable for a negligible consideration, as determined by the Company according to ASC 260-10-45-13, and have no vesting or other contingencies associated with them. For the year ended December 31, 2023, we had weighted average Pre-funded Warrants to purchase 9,612,502 share of common stock, which was used in the computation of net loss per share for the year. The total number of shares of common stock related to outstanding options, warrants, unvested restricted stock, unvested restricted stock units and Series C Preferred Stock, which were excluded from the calculations of diluted loss per share were 74,978,006 and 2,741,355 for the years ended December 31, 2023 and 2022, respectively. This amount includes 3,054,086 and 355,951 of unvested restricted stock included in the number of issued and outstanding shares as of December 31, 2023 and 2022, respectively. s. Segment reporting The Company has one operating and reportable segment. t. Fair value measurement The Company measures fair value and discloses fair value measurements for financial assets and liabilities. Fair value is based on the price that would be received to sell an asset or paid to transfer a liability in an orderly transaction between market participants at the measurement date. The accounting standard establishes a fair value hierarchy that prioritizes observable and unobservable inputs used to measure fair value into three broad levels, which are described below: 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. In determining fair value, the Company utilizes valuation techniques that maximize the use of observable inputs and minimize the use of unobservable inputs to the extent possible and considers counterparty credit risk in its assessment of fair value. INSPIREMD, INC. NOTES TO THE CONSOLIDATED FINANCIAL STATEMENTS (continued) NOTE 2 - SIGNIFICANT ACCOUNTING POLICIES u. Recently adopted accounting pronouncement v. Recently issued accounting pronouncement, not yet adopted 1) In November 2023, the FASB issued ASU 2023-07 “Segment Reporting: Improvements to Reportable Segment Disclosures”. This guidance expands public entities segment disclosures primarily by requiring disclosure of significant segment expenses that are regularly provided to the chief operating decision maker and included within each reported measure of segment profit or loss, an amount and description of its composition for other segment items, and interim disclosures of a reportable segment’s profit or loss and assets. Public entities with a single reportable segment are required to provide the new disclosures and all the disclosures required under ASC 280. The guidance is effective for fiscal years beginning after December 15, 2023, and interim periods within fiscal years beginning after December 15, 2024, with early adoption permitted. The amendments are required to be applied retrospectively to all prior periods presented in an entity’s financial statements. The Company is currently evaluating this guidance to determine the impact it may have on its consolidated financial statements related disclosures. 2) In December 2023, the FASB issued ASU 2023-09 “Income Taxes (Topic 740): Improvements to Income Tax Disclosures”. This guidance is intended to enhance the transparency and decision-usefulness of income tax disclosures. The amendments in ASU 2023-09 address investor requests for enhanced income tax information primarily through changes to disclosure regarding rate reconciliation and income taxes paid both in the U.S. and in foreign jurisdictions. ASU 2023-09 is effective for fiscal years beginning after December 15, 2024 on a prospective basis, with the option to apply the standard retrospectively. Early adoption is permitted. The Company is currently evaluating this guidance to determine the impact it may have on its consolidated financial statements disclosures. 3) 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 initial adoption of ASU 2020-06 is not expected to have a material impact on the Company’s consolidated financial statements. INSPIREMD, INC. NOTES TO THE CONSOLIDATED FINANCIAL STATEMENTS (continued) |
FAIR VALUE MEASUREMENTS
FAIR VALUE MEASUREMENTS | 12 Months Ended |
Dec. 31, 2023 | |
Fair Value Disclosures [Abstract] | |
FAIR VALUE MEASUREMENTS | NOTE 3 – FAIR VALUE MEASUREMENTS As of December 31, 2023, the carrying amounts of accounts payable, accounts receivable and other receivable approximate their fair values due to the short-term maturities of these instruments. 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 December 31, 2023 ($ in thousands) Total Level 1 Level 2 Level 3 Assets: Cash equivalents- Money market funds $ 7,094 $ 7,094 $ - $ - Cash equivalents $ 7,094 $ 7,094 $ - $ - Marketable securities- U.S government bonds $ 29,383 $ - $ 29,383 $ - Marketable securities $ 29,383 $ - $ 29,383 $ - The Company’s debt securities are classified within Level 2 because it uses quoted market prices or alternative pricing sources and models utilizing market observable inputs to determine their fair value. The cost of Marketable securities as of December 31, 2023 is $ 28,727,000 |
MARKETABLE SECURITIES
MARKETABLE SECURITIES | 12 Months Ended |
Dec. 31, 2023 | |
Investments, Debt and Equity Securities [Abstract] | |
MARKETABLE SECURITIES | NOTE 4 - MARKETABLE SECURITIES The following table sets forth the Company’s marketable securities for the indicated period: SCHEDULE OF MARKETABLE SECURITIES December 31, 2023 ($ in thousands) U.S government bonds $ 29,383 Marketable securities $ 29,383 The following table summarizes the fair value of the Company’s marketable securities classified by maturity as of December 31, 2023: SCHEDULE OF FAIR VALUE OF MARKETABLE SECURITIES CLASSIFIED BY MATURITY December 31, 2023 ($ in thousands) Amounts maturing within one year $ 24,523 Amounts maturing after one year through two years 4,860 $ 29,383 The table below sets forth a summary of the changes in the fair value of the Company’s marketable securities for the year ended December 31, 2023: SCHEDULE OF CHANGES IN FAIR VALUE OF MARKETABLE SECURITIES Year ended 2023 ($ in thousands) Balance at beginning of the period $ - Additions 34,644 Sale or maturity (6,000 ) Interest Received (38 ) Changes in fair value 777 Balance at end of the period 29,383 INSPIREMD, INC. NOTES TO THE CONSOLIDATED FINANCIAL STATEMENTS (continued) |
PROPERTY, PLANT AND EQUIPMENT
PROPERTY, PLANT AND EQUIPMENT | 12 Months Ended |
Dec. 31, 2023 | |
Property, Plant and Equipment [Abstract] | |
PROPERTY, PLANT AND EQUIPMENT | NOTE 5 - PROPERTY, PLANT AND EQUIPMENT a. Composition of assets, grouped by major classifications, is as follows: SCHEDULE OF PROPERTY PLANT AND EQUIPMENT 2023 2022 December 31, 2023 2022 ($ in thousands) Cost: Computer equipment $ 425 $ 396 Office furniture and equipment 249 231 Machinery and equipment 1,702 1,704 Leasehold improvements 724 494 Property plant and equipment, gross 3,100 2,825 Less - accumulated depreciation and amortization (2,040 ) (1,908 ) Net carrying amount $ 1,060 $ 917 b. Depreciation and amortization expenses totaled approximately $ 232,000 188,000 |
LIABILITY FOR EMPLOYEES RIGHT U
LIABILITY FOR EMPLOYEES RIGHT UPON RETIREMENT | 12 Months Ended |
Dec. 31, 2023 | |
Retirement Benefits [Abstract] | |
LIABILITY FOR EMPLOYEES RIGHT UPON RETIREMENT | NOTE 6 - LIABILITY FOR EMPLOYEES RIGHT UPON RETIREMENT Israeli labor law generally requires payment of severance pay upon dismissal of an employee or upon termination of employment in certain other circumstances. Pursuant to section 14 of the Israeli Severance Compensation Act, 1963, most of the Company’s employees are entitled to have monthly deposits, at a rate of 8.33 256,000 241,000 The severance pay liability of the Company for the rest of its Israeli employees, which reflects the undiscounted amount of the liability, is based upon the number of years of service and the latest monthly salary. The severance pay liability is partly covered by insurance policies and by regular deposits with recognized severance payment funds. The Company may only withdraw funds previously deposited for savings in connection with the payment of severance. The severance pay expenses for such employees were approximately $ 116,000 68,000 INSPIREMD, INC. NOTES TO THE CONSOLIDATED FINANCIAL STATEMENTS (continued) |
LEASE AGREEMENTS
LEASE AGREEMENTS | 12 Months Ended |
Dec. 31, 2023 | |
Lease Agreements | |
LEASE AGREEMENTS | NOTE 7 – LEASE AGREEMENTS 1) The Company’s Israeli subsidiary had a lease agreement for a facility in Israel, which expired on December 31, 2022 with an option to extend the agreement for two additional years until December 31, 2024. On May 25, 2022 the Company amended the agreement mentioned above and extended it until December 31, 2026 as well as leasing of additional space in the facility. 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. The 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 years ended December 31, 2023 and 2022 was $ 433,000 442,000 Supplemental information related to leases are as follows: SCHEDULE OF SUPPLEMENTAL INFORMATION RELATED TO LEASES 2023 2022 December 31, 2023 2022 ($ in thousands) Operating lease right-of-use assets 1,473 1,554 Current Operating lease liabilities (557 ) (419 ) Non-current operating lease liabilities (1,038 ) (1,195 ) Other information: Operating cash flows from operating leases (cash paid in thousands) (429 ) (436 ) Weighted Average Remaining Lease Term 3 4 Weighted Average Discount Rate 9.73 % 8.69 % Maturities of lease liabilities are as follows: SCHEDULE OF MATURITIES OF LEASE LIABILITIES Amount ($ in thousands) 2024 579 2025 584 2026 653 Total lease payments 1,816 Less imputed interest (221 ) Total 1,595 INSPIREMD, INC. NOTES TO THE CONSOLIDATED FINANCIAL STATEMENTS (continued) |
COMMITMENTS AND CONTINGENT LIAB
COMMITMENTS AND CONTINGENT LIABILITIES | 12 Months Ended |
Dec. 31, 2023 | |
Commitments and Contingencies Disclosure [Abstract] | |
COMMITMENTS AND CONTINGENT LIABILITIES | NOTE 8 - COMMITMENTS AND CONTINGENT LIABILITIES Distribution Agreement with Chinese Partner On February 3, 2021, the Company entered into a distribution agreement (the “Distribution Agreement”) with three China-based partners, pursuant to which the Chinese partners will be responsible for conducting the necessary registration trials for commercial approval of the Company’s products in China, followed by an eight-year exclusive distribution right to sell the Company’s products in China with the term of the agreement continuing on a year-to-year basis unless terminated. Under the Distribution Agreement, the China-based partners will be subject to minimum purchase obligations. The Distribution Agreement may be terminated for cause upon failure to meet minimum purchase obligations, failure to obtain regulatory approvals or for other material breaches. In addition, the agreement stipulates that if the Distributor fails to obtain the Regulatory Approvals by the time stipulated in the agreement due to the failure of the clinical trials, and this Agreement was terminated as a result of such failure to obtain Regulatory Approvals, InspireMD shall reimburse Distributor in an amount which is 50 1,000,000 50 |
EQUITY
EQUITY | 12 Months Ended |
Dec. 31, 2023 | |
Equity [Abstract] | |
EQUITY | NOTE 9 - EQUITY a. Share capital The Company’s common stock are listed on the Nasdaq Capital Market. 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 INSPIREMD, INC. NOTES TO THE CONSOLIDATED FINANCIAL STATEMENTS (continued) NOTE 9 – EQUITY The Pre-Funded Warrants are immediately exercisable at an exercise price of $ 0.0001 1.3827 The Company issued a total of 307,260 307,271 15,254,623 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 December 31, 2023 and 2022, there were 1,718 7,952 2,284 10,997 As of December 31, 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 underlying Common stock 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 December 31, 2023, the Company has 155,000,000 0.0001 150,000,000 5,000,000 INSPIREMD, INC. NOTES TO THE CONSOLIDATED FINANCIAL STATEMENTS (continued) NOTE 9 – EQUITY b. Share-Based Compensation 1) On September 30, 2021, at our 2021 annual meeting of stockholders, our stockholders approved our 2021 Equity Incentive Plan. The Company’s. 2021 Equity Incentive Plan provides for the granting of incentive stock options, nonqualified stock options, stock appreciation rights, restricted stock, restricted stock units, performance awards, dividend equivalent rights, and other awards, which may be granted singly, in combination, or in tandem. As of December 31, 2023, we had 7,731,618 5) The following table summarizes information about stock options granted to employees: SCHEDULE OF STOCK OPTIONS GRANTED Year ended December 31 2023 2022 Number of options Weighted average exercise price Number of options Weighted average exercise price Outstanding - beginning of period 294,712 5.21 289,408 $ 5.29 Granted 1,097,250 1.89 7,841 2.61 Forfeited (12,266 ) 4.00 (2,537 ) 5.70 Outstanding- end of period 1,379,696 2.58 294,712 $ 5.21 Exercisable at the end of the period 215,709 5.38 123,115 5.51 6) The following table summarizes information about stock options granted to non-employees: Year ended December 31 2023 2022 Number of options Weighted average exercise price Number of options Weighted average exercise price Outstanding - beginning of period 166,669 3.37 20,002 6.90 Granted 625,000 1.71 146,667 2.89 Outstanding - end of period 791,669 2.06 166,669 3.37 Exercisable at the end of the period 84,667 3.42 35,667 3.61 7) The following table summarizes information about restricted stock granted to employees: SCHEDULE OF RESTRICTED STOCK GRANTED TO EMPLOYEES Year ended December 31 2023 2022 Number of restricted stock Outstanding - beginning of period 355,951 527,668 Granted 2,914,340 45,494 Forfeited (29,695 ) (10,832 ) Vested (186,510 ) (206,379 ) Outstanding - end of period 3,054,086 355,951 INSPIREMD, INC. NOTES TO THE CONSOLIDATED FINANCIAL STATEMENTS (continued) NOTE 9 – EQUITY 8) The following table summarizes information about RSUs granted to employees: SCHEDULE OF RESTRICTED STOCK UNIT GRANTED TO EMPLOYEES Year ended December 31 2023 2022 Number of RSUs Outstanding - beginning of period 237,078 237,078 Granted 1,045,150 - Outstanding - end of period 1,282,228 237,078 9) The following table provides additional information about all options outstanding and exercisable: SCHEDULE OF ADDITIONAL INFORMATION ABOUT ALL OPTIONS OUTSTANDING AND EXERCISABLE Outstanding as of December 31, 2023 Exercise price Options outstanding Weighted average remaining contractual life (years) Options exercisable $ 1.15 2.97 1,786,211 9.28 73,946 $ 3.30 4.12 227,932 8.53 95,075 $ 4.95 10.05 153,169 7.00 127,303 $ 16.50 4,053 6.01 4,053 2,171,365 9.03 300,376 The weighted average of the remaining contractual life of total vested and exercisable options as of December 31, 2023 was 7.54 The aggregate intrinsic value of the total exercisable options as of December 31, 2023 was approximately $ 10,983 The weighted average fair value of options granted to employees was $ 1.65 2.33 The weighted average fair value of options granted to consultants was $ 1.50 2.57 The weighted average fair value of restricted stock granted was $ 1.95 2.42 The weighted average fair value of RSU granted was $ 1.76 The vesting period for outstanding stock options, restricted stock, and RSUs is typically three years, with one-third of the awards vesting annually. Additionally, some of our share-based awards to service providers are performance-based, vesting upon the achievement of specified performance criteria related to clinical or marketing activities. INSPIREMD, INC. NOTES TO THE CONSOLIDATED FINANCIAL STATEMENTS (continued) NOTE 9 – EQUITY 10) The following table sets forth the assumptions that were used in determining the fair value of options granted to employees for the year December 31, 2023 and 2022: SCHEDULE OF FAIR VALUE OF OPTIONS GRANTED TO EMPLOYEES Year ended December 31 2023 2022 Expected life 5.125 6.5 5.125 6.5 Risk-free interest rates 3.58 4.73 1.79 2.88 Volatility 109.62 125.61 127.43 130.93 Dividend yield - - The Company does not have sufficient historical exercise data to provide a reasonable basis upon which to estimate expected term. Accordingly, as to ordinary course options granted, the expected term was determined using the simplified method, which takes into consideration the option’s contractual life and the vesting periods (for non-employees, the expected term is equal to the option’s contractual life). The annual risk-free rates are based on the yield rates of zero coupon non-index linked U.S. Federal Reserve treasury bonds as both the exercise price and the share price are in dollar terms. The Company’s expected volatility is derived from its historical data. 11) As of December 31, 2023, the total unrecognized compensation cost on employee and non-employee stock options, restricted stock and RSUs, related to unvested stock-based compensation, amounted to approximately $ 7.18 0.97 12) The following table summarizes the allocation of total share-based compensation expense in the consolidated statements of operations: SCHEDULE OF ALLOCATION OF TOTAL SHARE-BASED COMPENSATION EXPENSE Year ended December 31 2023 2022 ($ in thousands) Cost of revenues $ 93 $ 72 Research and development 649 582 Sales and marketing 416 318 General and administrative 3,332 1,380 $ 4,490 $ 2,352 INSPIREMD, INC. NOTES TO THE CONSOLIDATED FINANCIAL STATEMENTS (continued) |
RELATED PARTIES TRANSACTIONS
RELATED PARTIES TRANSACTIONS | 12 Months Ended |
Dec. 31, 2023 | |
Related Party Transactions [Abstract] | |
RELATED PARTIES TRANSACTIONS | NOTE 10 – RELATED PARTIES TRANSACTIONS 1) During the twelve months ended December 31, 2023 and 2022, a consulting company whose founder and CEO is our board member provided certain marketing services in the amount of $ 788 9,645 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 year ended December 31, 2023, were $ 11,440 3) Election to Receive Shares of Common Stock in lieu of Cash Compensation For the year 2023, certain non-employee directors elected 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. For a director that made that election, a stock award under the 2021 Equity Incentive Plan was paid quarterly on the first day of each next quarter (“Issuance Dates”) and became fully vested on the Issuance Dates. The stock award was 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. During the years ended December 31, 2023 the Company issued 52,129 As of December 31, 2023, there was an accrual for $ 55,000 22,875 32,125 11,854 |
TAXES ON INCOME_
TAXES ON INCOME: | 12 Months Ended |
Dec. 31, 2023 | |
Income Tax Disclosure [Abstract] | |
TAXES ON INCOME: | NOTE 11 - TAXES ON INCOME: a. Tax laws applicable to the Company and its subsidiaries Taxation in the United States InspireMD, Inc. is taxed under U.S. tax laws. Accordingly, the applicable federal corporate tax rate in 2023 is 21 Taxation in Israel InspiredMD, Ltd is taxed under Israeli tax laws. Accordingly, the applicable corporate tax rate in 2023 is 23 Taxation in Germany InspireMD GmbH is taxed according to the tax laws in Germany. Accordingly, the applicable tax rates are corporate tax rate of 15.825 17.15 INSPIREMD, INC. NOTES TO THE CONSOLIDATED FINANCIAL STATEMENTS (continued) NOTE 11 - TAXES ON INCOME: b. Tax benefits under the Law for the Encouragement of Capital Investments, 1959 (the “Law”): On December 29, 2016, the Investment Law was amended (“73 Amendment”), which includes, inter alia, two new tax incentive opportunities. These are the Preferred Technological Enterprise (“PTE”) and Special Preferred Technological Enterprise (“SPTE”). In order to benefit from either of these options, a Company must meet certain qualifications and receive formal approval from the Israel Innovation Authority (“IIA”) which allows the Company to use the reduced corporate tax rate of 12 6 Furthermore, according to the provisions regarding “preferred technology enterprise” and “special preferred technology enterprise” in the Law and the regulations thereunder, and to the extent the income is attributable to manufacturing, this income is classified as “preferred income” and is taxed at 7.5 16 Additionally, when income of a company originating from “preferred technology income” is distributed as dividend to a foreign-resident corporation, tax withholding from the dividend is 4 90 c. Carry forward tax losses As of December 31, 2023, the Company had a net carry forward tax loss of approximately $ 54 35 expires until 2038 19 80 Under the U.S. tax laws, for net operating losses (NOLs) arising after December 31, 2017, the Tax Cuts and Jobs Act enacted on December 22, 2017 (the “2017 Act”) limits a taxpayer’s ability to utilize NOL carryforwards to 80% of taxable income. In addition, NOLs arising after 2017 can be carried forward indefinitely, but carryback is generally prohibited. NOLs generated in tax years beginning before January 1, 2018, will not be subject to the foregoing taxable income limitation and will continue to have a two-year carryback and twenty-year carryforward period. As of December 31, 2023, InspireMD Ltd., an Israeli subsidiary, had a net carry forward tax loss of approximately $ 107 The Israeli subsidiary is taxed in the New Israeli Shekel (“NIS”), which is different from its functional currency (U.S. Dollar). The change in the Israeli subsidiary NOL’s for tax purposes is partly resulted by such rate differences. d. Loss before income taxes The components of loss before income taxes are as follows: SCHEDULE OF COMPONENTS OF LOSS BEFORE INCOME TAXES Year ended December 31 2023 2022 ($ in thousands) Loss before taxes on income: InspireMD, Inc. $ (5,772 ) $ (4,773 ) Subsidiaries (14,079 ) (13,690 ) $ (19,851 ) $ (18,463 ) INSPIREMD, INC. NOTES TO THE CONSOLIDATED FINANCIAL STATEMENTS (continued) NOTE 11 - TAXES ON INCOME e. Current taxes on income The main reconciling item between the statutory tax rate of the Company and the effective tax rate is the change in valuation allowance in respect of tax benefits from carried forward tax losses due to uncertainty of the realization of such tax benefits. The changes in the valuation allowance for the year ended December 31, 2023 and 2022 were as follows: SCHEDULE OF CHANGES IN VALUATION ALLOWANCE Year ended December 31 2023 2022 ($ in thousands) Balance at the beginning of the year $ 40,071 $ 39,212 Changes during the year: Losses during the year (including foreign exchange rate effect) 2,580 859 Balance at the end of the year $ 42,651 $ 40,071 f. Accounting for Uncertain Tax position The following is a reconciliation of the total amounts of the Company’s uncertain tax positions during the year ended December 31, 2023 and 2022 were as follows: SCHEDULE OF RECONCILIATION OF UNCERTAIN TAX POSITIONS Year ended December 31, 2023 2022 ($ in thousands) Balance at beginning of period $ 106 $ 89 Increase in uncertain tax positions because of tax positions taken during the year 62 17 Balance at end of period $ 168 $ 106 A summary of open tax years by major jurisdiction is presented below: SCHEDULE OF OPEN TAX YEARS BY MAJOR JURISDICTION Jurisdiction Years U.S. 2020 2023 Israel 2019 2023 Germany 2020 2023 g. Deferred income tax: SCHEDULE OF DEFERRED INCOME TAX 2023 2022 December 31, 2023 2022 ($ in thousands) Provision for vacation and recreation pay 68 45 R&D expenses 1,691 1,452 Operating lease right of use assets (339 ) (357 ) Operating lease liabilities 367 371 Share-based compensation 3,492 3,021 Carry forward tax losses 37,342 35,507 Accrued severance pay, net 30 32 Deferred tax assets noncurrent 42,651 40,071 Less-valuation allowance (42,651 ) (40,071 ) Deferred tax assets - - INSPIREMD, INC. NOTES TO THE CONSOLIDATED FINANCIAL STATEMENTS (continued) |
SUPPLEMENTARY FINANCIAL STATEME
SUPPLEMENTARY FINANCIAL STATEMENT INFORMATION | 12 Months Ended |
Dec. 31, 2023 | |
Organization, Consolidation and Presentation of Financial Statements [Abstract] | |
SUPPLEMENTARY FINANCIAL STATEMENT INFORMATION | NOTE 12 - SUPPLEMENTARY FINANCIAL STATEMENT INFORMATION Balance sheets: Inventory: SCHEDULE OF INVENTORIES 2023 2022 December 31, 2023 2022 ($ in thousands) Finished goods $ 210 $ 179 Work in process 562 510 Raw materials and supplies 1,334 932 Total inventory $ 2,106 $ 1,621 SCHEDULE OF ACCOUNTS PAYABLE AND ACCRUALS - OTHER a. Accounts payable and accruals-other: 2023 2022 December 31, 2023 2022 ($ in thousands) Employees and employee institutions $ 2,188 $ 1,853 Accrued vacation and recreation pay 287 197 Accrued expenses 1,115 554 Clinical trial accrual 744 1,258 Current Operating lease liabilities 557 419 Other 190 130 Accounts Payable and Accruals - Other $ 5,081 $ 4,411 |
DISAGGREGATED REVENUE AND ENTIT
DISAGGREGATED REVENUE AND ENTITY WIDE DISCLOSURES | 12 Months Ended |
Dec. 31, 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 Year ended December 31, 2023 2022 ($ in thousands) Italy $ 1,195 $ 970 Germany 896 866 Russia 738 381 Other 3,376 2,954 $ 6,205 $ 5,171 By product: SCHEDULE OF REVENUES ATTRIBUTED TO GEOGRAPHIC AREAS BY PRODUCT Year ended December 31, 2023 2022 ($ in thousands) CGuard™ EPS $ 6,205 $ 5,123 MGuard Prime™ EPS - 48 $ 6,205 $ 5,171 By principal customers: SCHEDULE OF REVENUES ATTRIBUTED TO GEOGRAPHIC AREAS BY PRINCIPAL CUSTOMERS Year ended December 31, 2023 2022 Customer A 14 % 17 % Customer B 12 % 7 % All tangible long lived assets are located in Israel. |
SUBSEQUENT EVENTS
SUBSEQUENT EVENTS | 12 Months Ended |
Dec. 31, 2023 | |
Subsequent Events [Abstract] | |
SUBSEQUENT EVENTS | NOTE 14 - SUBSEQUENT EVENTS On January 23, 2024, the Company granted 1,528,316 restricted shares of the Company’s common stock to employees and directors. The shares to employees are subject to a three-year vesting period, with one-third of such awards vesting each year. The shares to directors are subject to a one-year vesting period. On January 23, 2024, the Company granted 563,499 restricted share units of the Company’s common stock to the chief executive officer. The shares are subject to a three-year vesting period, with one-third of such awards vesting each year. On January 23, 2024, the Company granted to employees and directors options to purchase a total of 669,464 shares of the Company’s common stock. The options have an exercise prices of $3.14 per share, which was the fair market value of the Company’s common stock on the date of the grant. The options to employees are subject to a three-year vesting period, with one-third of such awards vesting each year. The options to directors are subject to a one-year vesting period. |
SIGNIFICANT ACCOUNTING POLICI_2
SIGNIFICANT ACCOUNTING POLICIES (Policies) | 12 Months Ended |
Dec. 31, 2023 | |
Accounting Policies [Abstract] | |
Use of estimates | a. Use of estimates The preparation of financial statements in conformity with U.S. GAAP requires management to make estimates using assumptions that affect the reported amounts of assets and liabilities, the disclosure of contingent liabilities at the date of the financial statements and the reported amounts of revenues and expenses during the reporting periods. Actual results could differ from those estimates. As applicable to these consolidated financial statements, the most significant estimates and assumptions relate to inventory valuations and assessing the likelihood of exercise of options to extend the lease term. |
Functional currency | b. Functional currency The currency of the primary economic environment in which the operations of the Company and its subsidiaries are conducted is the U.S. dollar (“$” or “dollar”). Accordingly, the functional currency of the Company and its subsidiaries is the U.S. dollar. The dollar figures are determined as follows: transactions and balances originally denominated in dollars are presented in their original amounts. Balances in foreign currencies are translated into dollars using historical and current exchange rates for non-monetary and monetary balances, respectively. The resulting translation gains or losses are recorded as financial income or expense, as appropriate. For transactions reflected in the statements of operations in foreign currencies, the exchange rates at transaction dates are used. Depreciation and changes in inventories and other changes deriving from non-monetary items are based on historical exchange rates. |
Principles of consolidation | c. Principles of consolidation The consolidated financial statements include the accounts of the Company and of its subsidiaries. Intercompany transactions and balances have been eliminated upon consolidation. |
Cash and cash equivalents | d. 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 December 31, 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 | e. 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. Marketable securities are classified under current assets in the consolidated balance sheet as they represent the investment of funds available for the Company’s current operations. INSPIREMD, INC. NOTES TO THE CONSOLIDATED FINANCIAL STATEMENTS (continued) NOTE 2 - SIGNIFICANT ACCOUNTING POLICIES |
Short-term bank deposits | f. Short-term bank deposits Bank deposits with original maturities of more than three months but less than one year are presented as part of short-term bank deposits. Deposits are presented at their cost which approximates market values including accrued interest. Interest on deposits is recorded as financial income. |
Concentration of credit risk and allowance for doubtful accounts | g. Concentration of credit risk and allowance for doubtful accounts Financial instruments that may potentially subject the Company to a concentration of credit risk consist of cash and cash equivalents and short-term bank deposits, which are deposited in major financially sound institutions in the U.S, Israel and Germany, and trade accounts receivable and other receivables. The Company’s trade accounts receivable is derived from revenues earned from customers from various countries. The Company performs ongoing credit evaluations of its customers’ financial condition and, requires no collateral from its customers. The Company also has a credit insurance policy for some of its customers. The Company maintains the allowance for estimated losses resulting from the inability of the Company’s customers to make required payments. The allowance represents the current estimate of lifetime expected credit losses over the remaining duration of existing accounts receivable considering current market conditions and supportable forecasts when appropriate. The estimate is a result of the Company’s ongoing evaluation of collectability, customer creditworthiness, historical levels of credit losses, and future expectations. The allowance for expected credit losses was immaterial during the periods presented. |
Inventory | h. Inventory Inventories are stated at the lower of cost (cost is determined on a “first-in, first-out” basis) or net realizable value. The Company’s inventories generally have a limited shelf life and are subject to impairment as they approach their expiration dates. The Company regularly evaluates the carrying value of its inventory and when, based on such evaluation, factors indicate that impairment has occurred, the Company impairs the inventories’ carrying value. |
Leases | i. Leases Operating leases are included in operating lease right-of-use (“ROU”) assets. Short-term balances regarding lease liabilities are included in accounts payable and accruals - Other and long-term balances regarding lease liabilities are included in operating lease liabilities. ROU assets represent Company’s right to use an underlying asset for the lease term and lease liabilities represent obligation to make lease payments arising from the lease. Operating lease ROU assets and liabilities are recognized at the lease commencement date based on the present value of lease payments over the lease term. In determining the present value of lease payments, the Company uses the incremental borrowing rate based on the information available at the lease commencement date as the rate implicit in the lease is not readily determinable. The determination of the incremental borrowing rate requires management judgment based on information available at lease commencement. The lease terms may include periods covered by options to extend the lease when it is reasonably certain that the Company will exercise such options, and periods covered by options to terminate the lease when it is reasonably certain that the Company will not exercise such options. Operating lease cost is recognized on a straight-line basis over the lease term. Lease agreements that include lease and non-lease components are accounted for as a single lease component. The Company elected the short-term lease recognition exemption for leases with a lease term of 12 months or less. |
Property, plant and equipment | j. Property, plant and equipment Property, plant and equipment are stated at cost, net of accumulated depreciation and amortization. Depreciation is calculated using the straight-line method over the estimated useful lives of the related assets: over three years for computers and other electronic equipment, and seven to fifteen years for office furniture and equipment and machinery and equipment (mainly seven years). Leasehold improvements are amortized on a straight-line basis over the term of the lease, which is shorter than the estimated life of the improvements. |
Impairment in value of long-lived assets | k. Impairment in value of long-lived assets The Company tests long-lived tangible assets for impairment whenever events or circumstances present an indication of impairment. If the sum of expected future cash flows (undiscounted and without interest charges) of the long-lived assets is less than the carrying amount of such assets, an impairment would be recognized, and the assets would be written down to their estimated fair values, based on expected future discounted cash flows. INSPIREMD, INC. NOTES TO THE CONSOLIDATED FINANCIAL STATEMENTS (continued) NOTE 2 - SIGNIFICANT ACCOUNTING POLICIES |
Revenue recognition | l. Revenue recognition A contract with a customer exists only when: 1) the parties to the contract have approved it and are committed to perform their respective obligations, 2) the Company can identify each party’s rights regarding the distinct goods or services to be transferred (“Performance Obligations”), 3) the Company can determine the transaction price for the goods or services to be transferred, 4) the contract has commercial substance and 5) it is probable that the Company will collect the consideration to which it will be entitled in exchange for the goods or services that will be transferred to the customer. Revenues are recorded in the amount of consideration to which the Company expects to be entitled in exchange for Performance Obligations upon transfer of control to the customer, excluding sales taxes. Revenue from sales of goods, including sales to distributors, is recognized when the customer obtains control of the product, once the Company has a present right to payment and the customer has legal title, and risk and rewards of ownership are obtained by the customer. Generally, this occurs when products are shipped. In few cases when products are directly sold to medical centers on consignment basis, revenue is recognized when the product is consumed. The Company recognizes the incremental costs of obtaining contracts as an expense since the amortization period of the assets that the Company otherwise would have recognized is one year or less. The costs are recorded under selling and marketing expenses. Disaggregated revenue is disclosed in Note 13. The Company recognizes revenue net of value added tax (VAT). |
Research and development costs | m. Research and development costs Research and development costs, including the costs of the Company’s US based clinical trial costs were approximately $ 3,300,000 and $ 4,468,000 for the years ended December 31, 2023 and 2022, respectively, and charged to the statement of operations as incurred. |
Share-based compensation | n. Share-based compensation The Company has equity incentive plans under which the Company grants equity awards, including stock options, restricted stock and restricted stock units (“RSUs”) to employees, directors and service providers. Employee and service providers equity awards are accounted for using the grant-date fair value method. The Company determines compensation expense associated with restricted stock and RSUs based on the fair value of our common stock on the date of grant. The fair value of option awards is estimated using the Black-Scholes valuation model and expensed over the requisite service period. The Company elected to account for forfeitures as they occur. The Company elected to recognize compensation expenses for awards to employees with only service conditions that have graded vesting schedules using the accelerated multiple option approach. The attribution for nonemployee awards is in the same manner as if the Company had paid cash for the goods or services. In addition, certain of our share-based awards to service providers are performance based, i.e., the vesting of these awards depends upon achieving certain goals. The company recognizes compensation expenses for awards with performance conditions when the company concludes that it is probable that the performance condition will be achieved. |
Deferred income taxes | o. Uncertain tax positions The Company follows a two-step approach to recognizing and measuring uncertain tax positions. The first step is to evaluate the tax position for recognition by determining if the weight of available evidence indicates that it is more likely than not that the position will be sustained on audit. If under the first step a tax position is assessed to be more likely than not of being sustained on audit, the second step is performed, under which the tax benefit is measured as the largest amount that is more than 50% likely to be realized upon ultimate settlement. Such liabilities are classified as long-term, unless the liability is expected to be resolved within twelve months from the balance sheet date. The Company’s policy is to include interest related to unrecognized tax benefits within “Financial expenses - net”. INSPIREMD, INC. NOTES TO THE CONSOLIDATED FINANCIAL STATEMENTS (continued) NOTE 2 - SIGNIFICANT ACCOUNTING POLICIES p. Deferred income taxes Deferred taxes are determined utilizing the “asset and liability” method based on the estimated future tax effects of differences between the financial accounting and tax bases of assets and liabilities under the applicable tax laws, and on tax rates anticipated to be in effect when the deferred taxes are expected to be paid or realized. The Company assesses realization of deferred income tax assets and, based on all available evidence, concludes whether it is more likely than not that the net deferred income tax assets will be realized. A valuation allowance is provided for the amount of deferred income tax assets not considered to be realizable. The Company may incur an additional tax liability in the event of intercompany dividend distributions by its subsidiaries. Such additional tax liability in respect of these foreign subsidiaries has not been provided for in these financial statements as it is the Company’s policy to permanently reinvest the subsidiaries’ earnings and to consider distributing dividends only in connection with a specific tax opportunity that may arise. Taxes that would apply in the event of disposal of investments in a foreign subsidiary have not been taken into account in computing the deferred taxes, as it is the Company’s intention to hold, and not to realize, these investments. |
Advertising | q. Advertising Costs related to advertising and promotion of products are charged to sales and marketing expense as incurred. Advertising expenses were approximately $ 426,000 and $ 359,000 for the years ended December 31, 2023 and 2022, respectively. |
Net loss per share | r. Net loss per share Basic and diluted net loss per share is computed by dividing the net loss for the period by the weighted average number of shares of common stock, pre-funded warrants and fully vested restricted stock units outstanding during the period. The calculation of diluted net loss per share excludes the effect of potential dilution of share options, warrants, and unvested restricted stocks, unvested restricted stock units and Series C preferred stock as the effect is anti-dilutive. For the purpose of calculating basic net loss per share, the additional shares of common stock that are issuable upon exercise of the Pre-funded Warrants have been included since the shares are issuable for a negligible consideration, as determined by the Company according to ASC 260-10-45-13, and have no vesting or other contingencies associated with them. For the year ended December 31, 2023, we had weighted average Pre-funded Warrants to purchase 9,612,502 share of common stock, which was used in the computation of net loss per share for the year. The total number of shares of common stock related to outstanding options, warrants, unvested restricted stock, unvested restricted stock units and Series C Preferred Stock, which were excluded from the calculations of diluted loss per share were 74,978,006 and 2,741,355 for the years ended December 31, 2023 and 2022, respectively. This amount includes 3,054,086 and 355,951 of unvested restricted stock included in the number of issued and outstanding shares as of December 31, 2023 and 2022, respectively. |
Segment reporting | s. Segment reporting The Company has one operating and reportable segment. |
Fair value measurement | t. Fair value measurement The Company measures fair value and discloses fair value measurements for financial assets and liabilities. Fair value is based on the price that would be received to sell an asset or paid to transfer a liability in an orderly transaction between market participants at the measurement date. The accounting standard establishes a fair value hierarchy that prioritizes observable and unobservable inputs used to measure fair value into three broad levels, which are described below: 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. In determining fair value, the Company utilizes valuation techniques that maximize the use of observable inputs and minimize the use of unobservable inputs to the extent possible and considers counterparty credit risk in its assessment of fair value. INSPIREMD, INC. NOTES TO THE CONSOLIDATED FINANCIAL STATEMENTS (continued) NOTE 2 - SIGNIFICANT ACCOUNTING POLICIES |
Recently adopted accounting pronouncement | u. Recently adopted accounting pronouncement |
Recently issued accounting pronouncement, not yet adopted | v. Recently issued accounting pronouncement, not yet adopted 1) In November 2023, the FASB issued ASU 2023-07 “Segment Reporting: Improvements to Reportable Segment Disclosures”. This guidance expands public entities segment disclosures primarily by requiring disclosure of significant segment expenses that are regularly provided to the chief operating decision maker and included within each reported measure of segment profit or loss, an amount and description of its composition for other segment items, and interim disclosures of a reportable segment’s profit or loss and assets. Public entities with a single reportable segment are required to provide the new disclosures and all the disclosures required under ASC 280. The guidance is effective for fiscal years beginning after December 15, 2023, and interim periods within fiscal years beginning after December 15, 2024, with early adoption permitted. The amendments are required to be applied retrospectively to all prior periods presented in an entity’s financial statements. The Company is currently evaluating this guidance to determine the impact it may have on its consolidated financial statements related disclosures. 2) In December 2023, the FASB issued ASU 2023-09 “Income Taxes (Topic 740): Improvements to Income Tax Disclosures”. This guidance is intended to enhance the transparency and decision-usefulness of income tax disclosures. The amendments in ASU 2023-09 address investor requests for enhanced income tax information primarily through changes to disclosure regarding rate reconciliation and income taxes paid both in the U.S. and in foreign jurisdictions. ASU 2023-09 is effective for fiscal years beginning after December 15, 2024 on a prospective basis, with the option to apply the standard retrospectively. Early adoption is permitted. The Company is currently evaluating this guidance to determine the impact it may have on its consolidated financial statements disclosures. 3) 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 initial adoption of ASU 2020-06 is not expected to have a material impact on the Company’s consolidated financial statements. |
FAIR VALUE MEASUREMENTS (Tables
FAIR VALUE MEASUREMENTS (Tables) | 12 Months Ended |
Dec. 31, 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 December 31, 2023 ($ in thousands) Total Level 1 Level 2 Level 3 Assets: Cash equivalents- Money market funds $ 7,094 $ 7,094 $ - $ - Cash equivalents $ 7,094 $ 7,094 $ - $ - Marketable securities- U.S government bonds $ 29,383 $ - $ 29,383 $ - Marketable securities $ 29,383 $ - $ 29,383 $ - |
MARKETABLE SECURITIES (Tables)
MARKETABLE SECURITIES (Tables) | 12 Months Ended |
Dec. 31, 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 December 31, 2023 ($ in thousands) U.S government bonds $ 29,383 Marketable securities $ 29,383 |
SCHEDULE OF FAIR VALUE OF MARKETABLE SECURITIES CLASSIFIED BY MATURITY | The following table summarizes the fair value of the Company’s marketable securities classified by maturity as of December 31, 2023: SCHEDULE OF FAIR VALUE OF MARKETABLE SECURITIES CLASSIFIED BY MATURITY December 31, 2023 ($ in thousands) Amounts maturing within one year $ 24,523 Amounts maturing after one year through two years 4,860 $ 29,383 |
SCHEDULE OF CHANGES IN FAIR VALUE OF MARKETABLE SECURITIES | The table below sets forth a summary of the changes in the fair value of the Company’s marketable securities for the year ended December 31, 2023: SCHEDULE OF CHANGES IN FAIR VALUE OF MARKETABLE SECURITIES Year ended 2023 ($ in thousands) Balance at beginning of the period $ - Additions 34,644 Sale or maturity (6,000 ) Interest Received (38 ) Changes in fair value 777 Balance at end of the period 29,383 INSPIREMD, INC. NOTES TO THE CONSOLIDATED FINANCIAL STATEMENTS (continued) |
PROPERTY, PLANT AND EQUIPMENT (
PROPERTY, PLANT AND EQUIPMENT (Tables) | 12 Months Ended |
Dec. 31, 2023 | |
Property, Plant and Equipment [Abstract] | |
SCHEDULE OF PROPERTY PLANT AND EQUIPMENT | SCHEDULE OF PROPERTY PLANT AND EQUIPMENT 2023 2022 December 31, 2023 2022 ($ in thousands) Cost: Computer equipment $ 425 $ 396 Office furniture and equipment 249 231 Machinery and equipment 1,702 1,704 Leasehold improvements 724 494 Property plant and equipment, gross 3,100 2,825 Less - accumulated depreciation and amortization (2,040 ) (1,908 ) Net carrying amount $ 1,060 $ 917 b. Depreciation and amortization expenses totaled approximately $ 232,000 188,000 |
LEASE AGREEMENTS (Tables)
LEASE AGREEMENTS (Tables) | 12 Months Ended |
Dec. 31, 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 2023 2022 December 31, 2023 2022 ($ in thousands) Operating lease right-of-use assets 1,473 1,554 Current Operating lease liabilities (557 ) (419 ) Non-current operating lease liabilities (1,038 ) (1,195 ) Other information: Operating cash flows from operating leases (cash paid in thousands) (429 ) (436 ) Weighted Average Remaining Lease Term 3 4 Weighted Average Discount Rate 9.73 % 8.69 % |
SCHEDULE OF MATURITIES OF LEASE LIABILITIES | Maturities of lease liabilities are as follows: SCHEDULE OF MATURITIES OF LEASE LIABILITIES Amount ($ in thousands) 2024 579 2025 584 2026 653 Total lease payments 1,816 Less imputed interest (221 ) Total 1,595 |
EQUITY (Tables)
EQUITY (Tables) | 12 Months Ended |
Dec. 31, 2023 | |
Equity [Abstract] | |
SCHEDULE OF ISSUANCE OF WARRANTS TO PURCHASE COMMON STOCK | SCHEDULE OF ISSUANCE OF WARRANTS TO PURCHASE COMMON STOCK Number of underlying Common stock 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 $ |
SCHEDULE OF STOCK OPTIONS GRANTED | SCHEDULE OF STOCK OPTIONS GRANTED Year ended December 31 2023 2022 Number of options Weighted average exercise price Number of options Weighted average exercise price Outstanding - beginning of period 294,712 5.21 289,408 $ 5.29 Granted 1,097,250 1.89 7,841 2.61 Forfeited (12,266 ) 4.00 (2,537 ) 5.70 Outstanding- end of period 1,379,696 2.58 294,712 $ 5.21 Exercisable at the end of the period 215,709 5.38 123,115 5.51 6) The following table summarizes information about stock options granted to non-employees: Year ended December 31 2023 2022 Number of options Weighted average exercise price Number of options Weighted average exercise price Outstanding - beginning of period 166,669 3.37 20,002 6.90 Granted 625,000 1.71 146,667 2.89 Outstanding - end of period 791,669 2.06 166,669 3.37 Exercisable at the end of the period 84,667 3.42 35,667 3.61 |
SCHEDULE OF RESTRICTED STOCK GRANTED TO EMPLOYEES | SCHEDULE OF RESTRICTED STOCK GRANTED TO EMPLOYEES Year ended December 31 2023 2022 Number of restricted stock Outstanding - beginning of period 355,951 527,668 Granted 2,914,340 45,494 Forfeited (29,695 ) (10,832 ) Vested (186,510 ) (206,379 ) Outstanding - end of period 3,054,086 355,951 |
SCHEDULE OF RESTRICTED STOCK UNIT GRANTED TO EMPLOYEES | SCHEDULE OF RESTRICTED STOCK UNIT GRANTED TO EMPLOYEES Year ended December 31 2023 2022 Number of RSUs Outstanding - beginning of period 237,078 237,078 Granted 1,045,150 - Outstanding - end of period 1,282,228 237,078 |
SCHEDULE OF ADDITIONAL INFORMATION ABOUT ALL OPTIONS OUTSTANDING AND EXERCISABLE | SCHEDULE OF ADDITIONAL INFORMATION ABOUT ALL OPTIONS OUTSTANDING AND EXERCISABLE Outstanding as of December 31, 2023 Exercise price Options outstanding Weighted average remaining contractual life (years) Options exercisable $ 1.15 2.97 1,786,211 9.28 73,946 $ 3.30 4.12 227,932 8.53 95,075 $ 4.95 10.05 153,169 7.00 127,303 $ 16.50 4,053 6.01 4,053 2,171,365 9.03 300,376 |
SCHEDULE OF FAIR VALUE OF OPTIONS GRANTED TO EMPLOYEES | SCHEDULE OF FAIR VALUE OF OPTIONS GRANTED TO EMPLOYEES Year ended December 31 2023 2022 Expected life 5.125 6.5 5.125 6.5 Risk-free interest rates 3.58 4.73 1.79 2.88 Volatility 109.62 125.61 127.43 130.93 Dividend yield - - |
SCHEDULE OF ALLOCATION OF TOTAL SHARE-BASED COMPENSATION EXPENSE | SCHEDULE OF ALLOCATION OF TOTAL SHARE-BASED COMPENSATION EXPENSE Year ended December 31 2023 2022 ($ in thousands) Cost of revenues $ 93 $ 72 Research and development 649 582 Sales and marketing 416 318 General and administrative 3,332 1,380 $ 4,490 $ 2,352 |
TAXES ON INCOME_ (Tables)
TAXES ON INCOME: (Tables) | 12 Months Ended |
Dec. 31, 2023 | |
Income Tax Disclosure [Abstract] | |
SCHEDULE OF COMPONENTS OF LOSS BEFORE INCOME TAXES | The components of loss before income taxes are as follows: SCHEDULE OF COMPONENTS OF LOSS BEFORE INCOME TAXES Year ended December 31 2023 2022 ($ in thousands) Loss before taxes on income: InspireMD, Inc. $ (5,772 ) $ (4,773 ) Subsidiaries (14,079 ) (13,690 ) $ (19,851 ) $ (18,463 ) |
SCHEDULE OF CHANGES IN VALUATION ALLOWANCE | The changes in the valuation allowance for the year ended December 31, 2023 and 2022 were as follows: SCHEDULE OF CHANGES IN VALUATION ALLOWANCE Year ended December 31 2023 2022 ($ in thousands) Balance at the beginning of the year $ 40,071 $ 39,212 Changes during the year: Losses during the year (including foreign exchange rate effect) 2,580 859 Balance at the end of the year $ 42,651 $ 40,071 f. Accounting for Uncertain Tax position |
SCHEDULE OF RECONCILIATION OF UNCERTAIN TAX POSITIONS | The following is a reconciliation of the total amounts of the Company’s uncertain tax positions during the year ended December 31, 2023 and 2022 were as follows: SCHEDULE OF RECONCILIATION OF UNCERTAIN TAX POSITIONS Year ended December 31, 2023 2022 ($ in thousands) Balance at beginning of period $ 106 $ 89 Increase in uncertain tax positions because of tax positions taken during the year 62 17 Balance at end of period $ 168 $ 106 |
SCHEDULE OF OPEN TAX YEARS BY MAJOR JURISDICTION | A summary of open tax years by major jurisdiction is presented below: SCHEDULE OF OPEN TAX YEARS BY MAJOR JURISDICTION Jurisdiction Years U.S. 2020 2023 Israel 2019 2023 Germany 2020 2023 |
SCHEDULE OF DEFERRED INCOME TAX | SCHEDULE OF DEFERRED INCOME TAX 2023 2022 December 31, 2023 2022 ($ in thousands) Provision for vacation and recreation pay 68 45 R&D expenses 1,691 1,452 Operating lease right of use assets (339 ) (357 ) Operating lease liabilities 367 371 Share-based compensation 3,492 3,021 Carry forward tax losses 37,342 35,507 Accrued severance pay, net 30 32 Deferred tax assets noncurrent 42,651 40,071 Less-valuation allowance (42,651 ) (40,071 ) Deferred tax assets - - |
SUPPLEMENTARY FINANCIAL STATE_2
SUPPLEMENTARY FINANCIAL STATEMENT INFORMATION (Tables) | 12 Months Ended |
Dec. 31, 2023 | |
Organization, Consolidation and Presentation of Financial Statements [Abstract] | |
SCHEDULE OF INVENTORIES | SCHEDULE OF INVENTORIES 2023 2022 December 31, 2023 2022 ($ in thousands) Finished goods $ 210 $ 179 Work in process 562 510 Raw materials and supplies 1,334 932 Total inventory $ 2,106 $ 1,621 |
SCHEDULE OF ACCOUNTS PAYABLE AND ACCRUALS - OTHER | SCHEDULE OF ACCOUNTS PAYABLE AND ACCRUALS - OTHER a. Accounts payable and accruals-other: 2023 2022 December 31, 2023 2022 ($ in thousands) Employees and employee institutions $ 2,188 $ 1,853 Accrued vacation and recreation pay 287 197 Accrued expenses 1,115 554 Clinical trial accrual 744 1,258 Current Operating lease liabilities 557 419 Other 190 130 Accounts Payable and Accruals - Other $ 5,081 $ 4,411 |
DISAGGREGATED REVENUE AND ENT_2
DISAGGREGATED REVENUE AND ENTITY WIDE DISCLOSURES (Tables) | 12 Months Ended |
Dec. 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 Year ended December 31, 2023 2022 ($ in thousands) Italy $ 1,195 $ 970 Germany 896 866 Russia 738 381 Other 3,376 2,954 $ 6,205 $ 5,171 |
SCHEDULE OF REVENUES ATTRIBUTED TO GEOGRAPHIC AREAS BY PRODUCT | By product: SCHEDULE OF REVENUES ATTRIBUTED TO GEOGRAPHIC AREAS BY PRODUCT Year ended December 31, 2023 2022 ($ in thousands) CGuard™ EPS $ 6,205 $ 5,123 MGuard Prime™ EPS - 48 $ 6,205 $ 5,171 |
SCHEDULE OF REVENUES ATTRIBUTED TO GEOGRAPHIC AREAS BY PRINCIPAL CUSTOMERS | By principal customers: SCHEDULE OF REVENUES ATTRIBUTED TO GEOGRAPHIC AREAS BY PRINCIPAL CUSTOMERS Year ended December 31, 2023 2022 Customer A 14 % 17 % Customer B 12 % 7 % |
DESCRIPTION OF BUSINESS (Detail
DESCRIPTION OF BUSINESS (Details Narrative) | 12 Months Ended | |
Dec. 31, 2023 | Dec. 31, 2022 | |
Russia and Belarus [Member] | Sales [Member] | Geographic Concentration Risk [Member] | ||
Product Information [Line Items] | ||
Sales percentage | 13.50% | 12.10% |
SIGNIFICANT ACCOUNTING POLICI_3
SIGNIFICANT ACCOUNTING POLICIES (Details Narrative) | 12 Months Ended | |
Dec. 31, 2023 USD ($) segment shares | Dec. 31, 2022 USD ($) shares | |
[custom:ResearchAndDevelopmentExpenseIncludingUSBasedClinicalTrialCost] | $ | $ 3,300,000 | $ 4,468,000 |
Significant Change in Unrecognized Tax Benefits, Nature of Event | the tax benefit is measured as the largest amount that is more than 50% likely to be realized upon ultimate settlement. | |
Advertising Expense | $ | $ 426,000 | $ 359,000 |
Weighted Average Number of Shares Outstanding, Diluted, Adjustment | 9,612,502 | |
Share-Based Compensation Arrangement by Share-Based Payment Award, Equity Instruments Other than Options, Nonvested, Number | 3,054,086 | 355,951 |
Number of Operating Segments | segment | 1 | |
Series C Preferred Stock [Member] | ||
Antidilutive Securities Excluded from Computation of Earnings Per Share, Amount | 74,978,006 | 2,741,355 |
SCHEDULE OF FINANCIAL ASSETS SU
SCHEDULE OF FINANCIAL ASSETS SUBJECT TO FAIR VALUE MEASUREMENTS (Details) | Dec. 31, 2023 USD ($) |
Fair Value, Assets and Liabilities Measured on Recurring and Nonrecurring Basis [Line Items] | |
Marketable securities | $ 28,727,000 |
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 | 29,383,000 |
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 | 29,383,000 |
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 | 7,094,000 |
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 | 7,094,000 |
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) | Dec. 31, 2023 USD ($) |
Fair Value Disclosures [Abstract] | |
Cost of marketable securities | $ 28,727,000 |
SCHEDULE OF MARKETABLE SECURITI
SCHEDULE OF MARKETABLE SECURITIES (Details) - USD ($) $ in Thousands | Dec. 31, 2023 | Dec. 31, 2022 |
Marketable Securities [Line Items] | ||
Marketable securities | $ 29,383 | |
US Government Agencies Debt Securities [Member] | ||
Marketable Securities [Line Items] | ||
Marketable securities | $ 29,383 |
SCHEDULE OF FAIR VALUE OF MARKE
SCHEDULE OF FAIR VALUE OF MARKETABLE SECURITIES CLASSIFIED BY MATURITY (Details) - USD ($) $ in Thousands | Dec. 31, 2023 | Dec. 31, 2022 |
Investments, Debt and Equity Securities [Abstract] | ||
Amounts maturing within one year | $ 24,523 | |
Amounts maturing after one year through two years | 4,860 | |
Marketable securities | $ 29,383 |
SCHEDULE OF CHANGES IN FAIR VAL
SCHEDULE OF CHANGES IN FAIR VALUE OF MARKETABLE SECURITIES (Details) - USD ($) $ in Thousands | 12 Months Ended | |
Dec. 31, 2023 | Dec. 31, 2022 | |
Investments, Debt and Equity Securities [Abstract] | ||
Balance at beginning of the period | ||
Additions | 34,644 | |
Sale or maturity | (6,000) | |
Interest Received | (38) | |
Changes in fair value | 777 | |
Balance at end of the period | $ 29,383 |
SCHEDULE OF PROPERTY PLANT AND
SCHEDULE OF PROPERTY PLANT AND EQUIPMENT (Details) - USD ($) $ in Thousands | 12 Months Ended | |
Dec. 31, 2023 | Dec. 31, 2022 | |
Property, Plant and Equipment [Line Items] | ||
Property plant and equipment, gross | $ 3,100 | $ 2,825 |
Less - accumulated depreciation and amortization | (2,040) | (1,908) |
Net carrying amount | 1,060 | 917 |
Depreciation and amortization expenses | 232,000 | 188,000 |
Computer Equipment [Member] | ||
Property, Plant and Equipment [Line Items] | ||
Property plant and equipment, gross | 425 | 396 |
Office Furniture And Equipment [Member] | ||
Property, Plant and Equipment [Line Items] | ||
Property plant and equipment, gross | 249 | 231 |
Machinery and Equipment [Member] | ||
Property, Plant and Equipment [Line Items] | ||
Property plant and equipment, gross | 1,702 | 1,704 |
Leasehold Improvements [Member] | ||
Property, Plant and Equipment [Line Items] | ||
Property plant and equipment, gross | $ 724 | $ 494 |
LIABILITY FOR EMPLOYEES RIGHT_2
LIABILITY FOR EMPLOYEES RIGHT UPON RETIREMENT (Details Narrative) - USD ($) | 12 Months Ended | |
Dec. 31, 2023 | Dec. 31, 2022 | |
Restructuring Cost and Reserve [Line Items] | ||
Percentage of monthly deposits on salary | 8.33% | |
Severance Type One [Member] | ||
Restructuring Cost and Reserve [Line Items] | ||
Severance expenses | $ 256,000 | $ 241,000 |
Severance Type Two [Member] | ||
Restructuring Cost and Reserve [Line Items] | ||
Severance expenses | $ 116,000 | $ 68,000 |
SCHEDULE OF SUPPLEMENTAL INFORM
SCHEDULE OF SUPPLEMENTAL INFORMATION RELATED TO LEASES (Details) - USD ($) $ in Thousands | 12 Months Ended | |
Dec. 31, 2023 | Dec. 31, 2022 | |
Lease Agreements | ||
Operating lease right-of-use assets | $ 1,473 | $ 1,554 |
Current Operating lease liabilities | $ (557) | $ (419) |
Operating Lease, Liability, Current, Statement of Financial Position [Extensible Enumeration] | Accounts Payable, Other, Current | Accounts Payable, Other, Current |
Non-current operating lease liabilities | $ (1,038) | $ (1,195) |
Operating cash flows from operating leases (cash paid in thousands) | $ (429) | $ (436) |
Weighted average remaining lease | 3 years | 4 years |
Weighted average discount rate | 9.73% | 8.69% |
SCHEDULE OF MATURITIES OF LEASE
SCHEDULE OF MATURITIES OF LEASE LIABILITIES (Details) $ in Thousands | Dec. 31, 2023 USD ($) |
Lease Agreements | |
2024 | $ 579 |
2025 | 584 |
2026 | 653 |
Total lease payments | 1,816 |
Less imputed interest | (221) |
Total | $ 1,595 |
LEASE AGREEMENTS (Details Narra
LEASE AGREEMENTS (Details Narrative) - USD ($) $ in Thousands | 12 Months Ended | |
Dec. 31, 2023 | Dec. 31, 2022 | |
Lease Agreements | ||
Operating lease expense | $ 433,000 | $ 442,000 |
COMMITMENTS AND CONTINGENT LI_2
COMMITMENTS AND CONTINGENT LIABILITIES (Details Narrative) - USD ($) | Feb. 03, 2021 | Dec. 31, 2023 |
Commitments and Contingencies Disclosure [Abstract] | ||
Distribution cost rate | 50% | 50% |
Distribution reimbursement | $ 1,000,000 |
SCHEDULE OF ISSUANCE OF WARRANT
SCHEDULE OF ISSUANCE OF WARRANTS TO PURCHASE COMMON STOCK (Details) | Dec. 31, 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 |
SCHEDULE OF STOCK OPTIONS GRANT
SCHEDULE OF STOCK OPTIONS GRANTED (Details) - $ / shares | 12 Months Ended | |
Dec. 31, 2023 | Dec. 31, 2022 | |
Employee [Member] | ||
Deferred Compensation Arrangement with Individual, Excluding Share-Based Payments and Postretirement Benefits [Line Items] | ||
Number of options Outstanding - beginning of period | 294,712,000 | 289,408,000 |
Weighted average exercise price Outstanding - beginning of period | $ 5.21 | $ 5.29 |
Number of options Outstanding, Granted | 1,097,250 | 7,841 |
Weighted average exercise price, Granted | $ 1.89 | $ 2.61 |
Number of options Outstanding, Forfeited | (12,266) | (2,537) |
Weighted average exercise price, Forfeited | $ 4 | $ 5.70 |
Number of options Outstanding, Outstanding -end of period | 1,379,696,000 | 294,712,000 |
Weighted average exercise price, Outstanding -end of period | $ 2.58 | $ 5.21 |
Number of options Outstanding, Exercisable at the end of the period | 215,709,000 | 123,115,000 |
Weighted average exercise price, Exercisable at the end of the period | $ 5.38 | $ 5.51 |
Non Employee [Member] | ||
Deferred Compensation Arrangement with Individual, Excluding Share-Based Payments and Postretirement Benefits [Line Items] | ||
Number of options Outstanding - beginning of period | 166,669,000 | 20,002,000 |
Weighted average exercise price Outstanding - beginning of period | $ 3.37 | $ 6.90 |
Number of options Outstanding, Granted | 625,000 | 146,667 |
Weighted average exercise price, Granted | $ 1.71 | $ 2.89 |
Number of options Outstanding, Outstanding -end of period | 791,669,000 | 166,669,000 |
Weighted average exercise price, Outstanding -end of period | $ 2.06 | $ 3.37 |
Number of options Outstanding, Exercisable at the end of the period | 84,667,000 | 35,667,000 |
Weighted average exercise price, Exercisable at the end of the period | $ 3.42 | $ 3.61 |
SCHEDULE OF RESTRICTED STOCK GR
SCHEDULE OF RESTRICTED STOCK GRANTED TO EMPLOYEES (Details) - shares | 12 Months Ended | |
Dec. 31, 2023 | Dec. 31, 2022 | |
Deferred Compensation Arrangement with Individual, Excluding Share-Based Payments and Postretirement Benefits [Line Items] | ||
Number of restricted stock, Outstanding - beginning of period | 355,951 | |
Number of restricted stock, Outstanding - end of period | 3,054,086 | 355,951 |
Employee [Member] | Restricted Stock [Member] | ||
Deferred Compensation Arrangement with Individual, Excluding Share-Based Payments and Postretirement Benefits [Line Items] | ||
Number of restricted stock, Outstanding - beginning of period | 355,951 | 527,668 |
Number of restricted stock, Granted | 2,914,340 | 45,494 |
Number of restricted stock, Forfeited | (29,695) | (10,832) |
Number of restricted stock, Vested | (186,510) | (206,379) |
Number of restricted stock, Outstanding - end of period | 3,054,086 | 355,951 |
SCHEDULE OF RESTRICTED STOCK UN
SCHEDULE OF RESTRICTED STOCK UNIT GRANTED TO EMPLOYEES (Details) - shares | 12 Months Ended | |
Dec. 31, 2023 | Dec. 31, 2022 | |
Deferred Compensation Arrangement with Individual, Excluding Share-Based Payments and Postretirement Benefits [Line Items] | ||
Number of restricted stock, Outstanding - beginning of period | 355,951 | |
Number of restricted stock, Outstanding - end of period | 3,054,086 | 355,951 |
Employee [Member] | Restricted Stock Units (RSUs) [Member] | ||
Deferred Compensation Arrangement with Individual, Excluding Share-Based Payments and Postretirement Benefits [Line Items] | ||
Number of restricted stock, Outstanding - beginning of period | 237,078 | 237,078 |
Number of restricted stock, Granted | 1,045,150 | |
Number of restricted stock, Outstanding - end of period | 1,282,228 | 237,078 |
SCHEDULE OF ADDITIONAL INFORMAT
SCHEDULE OF ADDITIONAL INFORMATION ABOUT ALL OPTIONS OUTSTANDING AND EXERCISABLE (Details) | 12 Months Ended |
Dec. 31, 2023 $ / shares shares | |
Share-Based Payment Arrangement, Option, Exercise Price Range [Line Items] | |
Options outstanding | 2,171,365 |
Weighted average remaining contractual life (years) | 9 years 10 days |
Options exercisable | 300,376 |
Exercise Price One [Member] | |
Share-Based Payment Arrangement, Option, Exercise Price Range [Line Items] | |
Exercise price lower range | $ / shares | $ 1.15 |
Exercise price | $ / shares | $ 2.97 |
Options outstanding | 1,786,211 |
Weighted average remaining contractual life (years) | 9 years 3 months 10 days |
Options exercisable | 73,946 |
Exercise Price Two [Member] | |
Share-Based Payment Arrangement, Option, Exercise Price Range [Line Items] | |
Exercise price lower range | $ / shares | $ 3.30 |
Exercise price | $ / shares | $ 4.12 |
Options outstanding | 227,932 |
Weighted average remaining contractual life (years) | 8 years 6 months 10 days |
Options exercisable | 95,075 |
Exercise Price Three [Member] | |
Share-Based Payment Arrangement, Option, Exercise Price Range [Line Items] | |
Exercise price lower range | $ / shares | $ 4.95 |
Exercise price | $ / shares | $ 10.05 |
Options outstanding | 153,169 |
Weighted average remaining contractual life (years) | 7 years |
Options exercisable | 127,303 |
Exercise Price Four [Member] | |
Share-Based Payment Arrangement, Option, Exercise Price Range [Line Items] | |
Exercise price | $ / shares | $ 16.50 |
Options outstanding | 4,053,000 |
Weighted average remaining contractual life (years) | 6 years 3 days |
Options exercisable | 4,053 |
SCHEDULE OF FAIR VALUE OF OPTIO
SCHEDULE OF FAIR VALUE OF OPTIONS GRANTED TO EMPLOYEES (Details) | 12 Months Ended | |
Dec. 31, 2023 | Dec. 31, 2022 | |
Risk-free interest rate, minimum | 3.58% | 1.79% |
Risk-free interest rate, maximum | 4.73% | 2.88% |
Volatility, minimum | 109.62% | 127.43% |
Volatility, maximum | 125.61% | 130.93% |
Dividend yield | ||
Minimum [Member] | ||
Expected life | 5 years 1 month 15 days | 5 years 1 month 15 days |
Maximum [Member] | ||
Expected life | 6 years 6 months | 6 years 6 months |
SCHEDULE OF ALLOCATION OF TOTAL
SCHEDULE OF ALLOCATION OF TOTAL SHARE-BASED COMPENSATION EXPENSE (Details) - USD ($) $ in Thousands | 12 Months Ended | |
Dec. 31, 2023 | Dec. 31, 2022 | |
Total share-based compensation expense | $ 4,490 | $ 2,352 |
Cost of Sales [Member] | ||
Total share-based compensation expense | 93 | 72 |
Research and Development Expense [Member] | ||
Total share-based compensation expense | 649 | 582 |
Selling and Marketing Expense [Member] | ||
Total share-based compensation expense | 416 | 318 |
General and Administrative Expense [Member] | ||
Total share-based compensation expense | $ 3,332 | $ 1,380 |
EQUITY (Details Narrative)
EQUITY (Details Narrative) - USD ($) | 12 Months Ended | ||||
May 12, 2023 | Dec. 31, 2023 | Dec. 31, 2022 | May 16, 2023 | ||
Subsidiary, Sale of Stock [Line Items] | |||||
Issuance of shares | 7,731,618 | ||||
Warrants to purchase common stock | 53,396,008 | ||||
Exercise of prefunded warrants | 307,260 | ||||
Preferred stock stated value | [1] | ||||
Capital stock shares authorized | 155,000,000 | ||||
Capital stock par value | $ 0.0001 | ||||
Common stock shares authorized | 150,000,000 | 150,000,000 | |||
Restricted Stock [Member] | |||||
Subsidiary, Sale of Stock [Line Items] | |||||
Weighted average of the remaining contractual life of vested and exercisable options | 7 years 6 months 14 days | ||||
Aggregate intrinsic value of exercisable options | $ 10,983 | ||||
Restricted Stock [Member] | Consultants [Member] | |||||
Subsidiary, Sale of Stock [Line Items] | |||||
Stock option exercise price | $ 1.95 | $ 2.42 | |||
Share-Based Payment Arrangement, Option [Member] | Employees and Directors [Member] | |||||
Subsidiary, Sale of Stock [Line Items] | |||||
Stock option exercise price | 1.65 | 2.33 | |||
Share-Based Payment Arrangement, Option [Member] | Consultants [Member] | |||||
Subsidiary, Sale of Stock [Line Items] | |||||
Stock option exercise price | 1.50 | $ 2.57 | |||
Restricted Stock Units (RSUs) [Member] | Consultants [Member] | |||||
Subsidiary, Sale of Stock [Line Items] | |||||
Stock option exercise price | $ 1.76 | ||||
Employee And Non Employee Stock Option [Member] | |||||
Subsidiary, Sale of Stock [Line Items] | |||||
Unvested stock-based compensation | $ 7,180,000 | ||||
Unvested stock-based compensation weighted-average period for recognition | 11 months 19 days | ||||
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 | 2,284 | ||
Preferred stock outstanding | 1,718 | 1,718 | 1,718 | ||
Preferred stock stated value | $ 10,997 | $ 10,997 | |||
Preferred stock shares authorized | 1,172,000 | 1,172,000 | |||
Pre-Funded Warrants [Member] | |||||
Subsidiary, Sale of Stock [Line Items] | |||||
Warrant exercise price | $ 0.0001 | ||||
Warrants outstanding | 15,254,623 | ||||
Warrant [Member] | |||||
Subsidiary, Sale of Stock [Line Items] | |||||
Warrants to purchase common stock | 307,271 | ||||
Warrant exercise price | $ 1.3827 | ||||
Preferred Stock Blank Check [Member] | |||||
Subsidiary, Sale of Stock [Line Items] | |||||
Preferred stock shares authorized | 5,000,000 | ||||
Private Placement [Member] | |||||
Subsidiary, Sale of Stock [Line Items] | |||||
Issuance of shares | 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 | ||||
[1]Represents an amount less than $1 |
RELATED PARTIES TRANSACTIONS (D
RELATED PARTIES TRANSACTIONS (Details Narrative) - USD ($) | 12 Months Ended | |||
Jan. 01, 2024 | Sep. 15, 2023 | Dec. 31, 2023 | Dec. 31, 2022 | |
Related Party Transaction [Line Items] | ||||
Issuance of shares | 7,731,618 | |||
Accrued fees | $ 55,000 | |||
Subsequent Event [Member] | ||||
Related Party Transaction [Line Items] | ||||
Issuance of shares | 11,854 | |||
2021 Equity Incentive Plan [Member] | ||||
Related Party Transaction [Line Items] | ||||
Issuance of shares | 32,125 | |||
Cash paid | $ 22,875 | |||
Related Party [Member] | ||||
Related Party Transaction [Line Items] | ||||
Consulting expenses | 11,440 | |||
Consultancy Agreement [Member] | ||||
Related Party Transaction [Line Items] | ||||
Fixed hourly consulting fee | $ 50,000 | |||
Director [Member] | ||||
Related Party Transaction [Line Items] | ||||
Marketing services from related party | $ 788,000 | $ 9,645,000 | ||
Non Employee Directors [Member] | ||||
Related Party Transaction [Line Items] | ||||
Issuance of shares | 52,129 |
SCHEDULE OF COMPONENTS OF LOSS
SCHEDULE OF COMPONENTS OF LOSS BEFORE INCOME TAXES (Details) - USD ($) $ in Thousands | 12 Months Ended | |
Dec. 31, 2023 | Dec. 31, 2022 | |
Loss before taxes on income | $ (19,851) | $ (18,463) |
Parent Company [Member] | ||
Loss before taxes on income | (5,772) | (4,773) |
Subsidiaries [Member] | ||
Loss before taxes on income | $ (14,079) | $ (13,690) |
SCHEDULE OF CHANGES IN VALUATIO
SCHEDULE OF CHANGES IN VALUATION ALLOWANCE (Details) - USD ($) $ in Thousands | 12 Months Ended | |
Dec. 31, 2023 | Dec. 31, 2022 | |
Income Tax Disclosure [Abstract] | ||
Balance at the beginning of the year | $ 40,071 | $ 39,212 |
Changes during the year: Losses during the year (including foreign exchange rate effect) | 2,580 | 859 |
Balance at the end of the year | $ 42,651 | $ 40,071 |
SCHEDULE OF RECONCILIATION OF U
SCHEDULE OF RECONCILIATION OF UNCERTAIN TAX POSITIONS (Details) - USD ($) $ in Thousands | 12 Months Ended | |
Dec. 31, 2023 | Dec. 31, 2022 | |
Income Tax Disclosure [Abstract] | ||
Uncertain tax positions balance at beginning of period | $ 106 | $ 89 |
Increase in uncertain tax positions because of tax positions taken during the year | 62 | 17 |
Uncertain tax positions balance at end of period | $ 168 | $ 106 |
SCHEDULE OF OPEN TAX YEARS BY M
SCHEDULE OF OPEN TAX YEARS BY MAJOR JURISDICTION (Details) | 12 Months Ended |
Dec. 31, 2023 | |
UNITED STATES | Earliest Tax Year [Member] | |
Operating Loss Carryforwards [Line Items] | |
Open Tax Year | 2020 |
UNITED STATES | Latest Tax Year [Member] | |
Operating Loss Carryforwards [Line Items] | |
Open Tax Year | 2023 |
ISRAEL | Earliest Tax Year [Member] | |
Operating Loss Carryforwards [Line Items] | |
Open Tax Year | 2019 |
ISRAEL | Latest Tax Year [Member] | |
Operating Loss Carryforwards [Line Items] | |
Open Tax Year | 2023 |
GERMANY | Earliest Tax Year [Member] | |
Operating Loss Carryforwards [Line Items] | |
Open Tax Year | 2020 |
GERMANY | Latest Tax Year [Member] | |
Operating Loss Carryforwards [Line Items] | |
Open Tax Year | 2023 |
SCHEDULE OF DEFERRED INCOME TAX
SCHEDULE OF DEFERRED INCOME TAX (Details) - USD ($) $ in Thousands | Dec. 31, 2023 | Dec. 31, 2022 | Dec. 31, 2021 |
Income Tax Disclosure [Abstract] | |||
Provision for vacation and recreation pay | $ 68 | $ 45 | |
R&D expenses | 1,691 | 1,452 | |
Operating lease right of use assets | (339) | (357) | |
Operating lease liabilities | 367 | 371 | |
Share-based compensation | 3,492 | 3,021 | |
Carry forward tax losses | 37,342 | 35,507 | |
Accrued severance pay, net | 30 | 32 | |
Deferred tax assets noncurrent | 42,651 | 40,071 | |
Less-valuation allowance | (42,651) | (40,071) | $ (39,212) |
Deferred tax assets |
TAXES ON INCOME_ (Details Narra
TAXES ON INCOME: (Details Narrative) - USD ($) $ in Millions | 12 Months Ended | ||
Dec. 29, 2016 | Dec. 31, 2023 | Dec. 31, 2017 | |
Operating Loss Carryforwards [Line Items] | |||
Federal corporate tax rate | 21% | ||
Revised tax rate on income of preferred enterprises | 12% | ||
Tax rate on income of beneficiary enterprises | 6% | 4% | |
Tax rate on income of beneficiary enterprises | 90% | ||
Net carry forward tax loss | $ 54 | $ 35 | |
Net loss carryforwards percentage | 80% | ||
Arising Before January One 2018 [Member] | |||
Operating Loss Carryforwards [Line Items] | |||
Operating loss carryforwards expiration description | expires until 2038 | ||
Limited [Member] | |||
Operating Loss Carryforwards [Line Items] | |||
Net carry forward tax loss | $ 19 | ||
Minimum [Member] | |||
Operating Loss Carryforwards [Line Items] | |||
Corporate trade tax rate | 7.50% | ||
Maximum [Member] | |||
Operating Loss Carryforwards [Line Items] | |||
Corporate trade tax rate | 16% | ||
Israel Tax Authority [Member] | |||
Operating Loss Carryforwards [Line Items] | |||
Federal corporate tax rate | 23% | ||
Net carry forward tax loss | $ 107 | ||
Germany [Member] | |||
Operating Loss Carryforwards [Line Items] | |||
Federal corporate tax rate | 15.825% | ||
Corporate trade tax rate | 17.15% |
SCHEDULE OF INVENTORIES (Detail
SCHEDULE OF INVENTORIES (Details) - USD ($) $ in Thousands | Dec. 31, 2023 | Dec. 31, 2022 |
Organization, Consolidation and Presentation of Financial Statements [Abstract] | ||
Finished goods | $ 210 | $ 179 |
Work in process | 562 | 510 |
Raw materials and supplies | 1,334 | 932 |
Total inventory | $ 2,106 | $ 1,621 |
SCHEDULE OF ACCOUNTS PAYABLE AN
SCHEDULE OF ACCOUNTS PAYABLE AND ACCRUALS - OTHER (Details) - USD ($) $ in Thousands | Dec. 31, 2023 | Dec. 31, 2022 |
Organization, Consolidation and Presentation of Financial Statements [Abstract] | ||
Employees and employee institutions | $ 2,188 | $ 1,853 |
Accrued vacation and recreation pay | 287 | 197 |
Accrued expenses | 1,115 | 554 |
Clinical trial accrual | 744 | 1,258 |
Current Operating lease liabilities | 557 | 419 |
Other | 190 | 130 |
Accounts Payable and Accruals - Other | $ 5,081 | $ 4,411 |
SCHEDULE OF REVENUES ATTRIBUTED
SCHEDULE OF REVENUES ATTRIBUTED TO GEOGRAPHIC AREAS (Details) - USD ($) $ in Thousands | 12 Months Ended | |
Dec. 31, 2023 | Dec. 31, 2022 | |
Revenues from External Customers and Long-Lived Assets [Line Items] | ||
Revenues | $ 6,205 | $ 5,171 |
ITALY | ||
Revenues from External Customers and Long-Lived Assets [Line Items] | ||
Revenues | 1,195 | 970 |
GERMANY | ||
Revenues from External Customers and Long-Lived Assets [Line Items] | ||
Revenues | 896 | 866 |
RUSSIAN FEDERATION | ||
Revenues from External Customers and Long-Lived Assets [Line Items] | ||
Revenues | 738 | 381 |
Other Countries [Member] | ||
Revenues from External Customers and Long-Lived Assets [Line Items] | ||
Revenues | $ 3,376 | $ 2,954 |
SCHEDULE OF REVENUES ATTRIBUT_2
SCHEDULE OF REVENUES ATTRIBUTED TO GEOGRAPHIC AREAS BY PRODUCT (Details) - USD ($) $ in Thousands | 12 Months Ended | |
Dec. 31, 2023 | Dec. 31, 2022 | |
Revenue from External Customer [Line Items] | ||
Revenue | $ 6,205 | $ 5,171 |
C Guard E P S [Member] | ||
Revenue from External Customer [Line Items] | ||
Revenue | 6,205 | 5,123 |
M Guard Prime E P S [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] | 12 Months Ended | |
Dec. 31, 2023 | Dec. 31, 2022 | |
Customer A [Member] | ||
Revenue, Major Customer [Line Items] | ||
Percentage of revenues per major customer | 14% | 17% |
Customer B [Member] | ||
Revenue, Major Customer [Line Items] | ||
Percentage of revenues per major customer | 12% | 7% |