InspireMD Inc 2024年度报告

FORM10-K (Mark One) ANNUAL REPORT PURSUANT TO SECTION 13 OR 15(d) OF THE SECURITIES EXCHANGE ACT OF 1934 ☒ For the fiscal year endedDecember 31,2024 OR ☐TRANSITION REPORT PURSUANT TO SECTION 13 OR 15(d) OF THE SECURITIES EXCHANGE ACT OF 1934 COMMISSION FILE NUMBER:001-35731 InspireMD, Inc.(Exact name of registrant as specified in its charter) 6303 Waterford District DriveSuite 215Miami,Florida33126(Address of principal executive offices)(Zip Code) Registrant’s telephone number, including area code:(888)776-6804 Securities registered pursuant to Section 12(b) of the Act: Name of each exchange on which registeredNasdaqCapital Market Securities registered pursuant to Section 12(g) of the Act: none Indicate by check mark if the registrant is a well-known seasoned issuer, as defined in Rule 405 of the Securities Act. Yes☐No☒ Indicate by check mark if the registrant is not required to file reports pursuant to Section 13 or Section 15(d) of the Act. Yes☐No☒ Indicate by check mark whether the registrant (1) has filed all reports required to be filed by Section 13 or 15(d) of the Securities Exchange Act of1934 during the preceding 12 months (or for such shorter period that the registrant was required to file such reports), and (2) has been subject to suchfiling requirements for the past 90 days.Yes☒No☐ Indicate by check mark whether the registrant has submitted electronically every Interactive Data File required to be submitted pursuant to Rule 405of Regulation S-T (§ 232.405 of this chapter) during the preceding 12 months (or for such shorter period that the registrant was required to submit suchfiles).Yes☒No☐ Indicate by check mark whether the registrant is a large accelerated filer, an accelerated filer, a non-accelerated filer, a smaller reporting company,or an emerging growth company. See the definitions of “large accelerated filer,” “accelerated filer,” “smaller reporting company,” and “emerging growthcompany” in Rule 12b-2 of the Exchange Act. Accelerated filer☐Smaller reporting company☒Emerging growth company☐ Large accelerated filer☐ Non-accelerated filer☒ If an emerging growth company, indicate by check mark if the registrant has elected not to use the extended transition period for complying withany new or revised financial accounting standards provided pursuant to Section 13(a) of the Exchange Act.☐ Indicate by check mark whether the registrant has filed a report on and attestation to its management’s assessment of the effectiveness of its internalcontrol over financial reporting under Section 404(b) of the Sarbanes-Oxley Act (15 U.S.C. 7262(b)) by the registered public accounting firm thatprepared or issued its audit report.☐ If securities are registered pursuant to Section 12(b) of the Act, indicate by check mark whether the financial statements of the registrant included inthe filing reflect the correction of an error to previously issued financial statements.☐ Indicate by check mark whether any of those error corrections are restatements that required a recovery analysis of incentive-based compensationreceived by any of the registrant’s executive officers during the relevant recovery period pursuant to §240.10D-1(b).☐ Indicate by check mark whether the registrant is a shell company (as defined in Rule 12b-2 of the Act) Yes☐No☒ The aggregate market value of the voting and non-voting stock held by non-affiliates of the registrant as of June 30, 2024, based on the price atwhich the common equity was last sold on such date, was $52,421,148. For purposes of this computation only, all officers, directors and 10% or greaterstockholders of the registrant are deemed to be affiliates. Indicate the number of shares outstanding of each of the registrant’s classes of common stock as of the latest practicable date. Portions of the Registrant’s definitive proxy statement for its 2025 Annual Meeting of Stockholders, which the Registrant intends to file pursuant toRegulation 14A with the Securities and Exchange Commission not later than 120 days after December 31, 2024, are incorporated by reference into PartIII of this Annual Report on Form 10-K. TABLE OF CONTENTS PageCautionary Note Regarding Forward-Looking StatementsPART I5Item 1.Business.5Item 1A.Risk Factors.31Item 1B.Unresolved Staff Comments.61Item 1C.Cybersecurity.61Item 2.Properties.62Item 3.Legal Proceedings.62Item 4.Mine Safety Disclosures.62PART II63Item 5.Market for Registrant’s Common Equity, Related Stockholder Matters and Issuer Purchases of Equity Securities.63Item 6.[Reserved]63Item 7.Management’s Discussion and Analysis of Financial Condition63Item 7A.Quantitative and Qualitative Disclosures About Market Risk.68Item 8.Financial Statements and Supplementary Data.69Item 9.Changes in and Disagreements With Accountants on Accounting and Financial Disclosure.69Item 9A.Controls and Procedures.69Item 9B.Other Information.69Item 9C.Disclosure Regarding Foreign Jurisdictions that Prevent Inspections70PART III70Item 10.Directo