InspireMD Inc 2025年度报告

FORM 10-K (Mark One) ANNUAL REPORT PURSUANT TO SECTION 13 OR 15(d) OF THE SECURITIES EXCHANGE ACT OF 1934 For the fiscal year ended December 31, 2025 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) 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 whether the registrant (1) has filed all reports required to be filed by Section 13 or 15(d) of the Securities Exchange Act of 1934 duringthe preceding 12 months (or for such shorter period that the registrant was required to file such reports), and (2) has been subject to such filing requirements for thepast 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 405 ofRegulation S-T (§ 232.405 of this chapter) during the preceding 12 months (or for such shorter period that the registrant was required to submit such files). 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 anemerging growth company. See the definitions of “large accelerated filer,” “accelerated filer,” “smaller reporting company,” and “emerging growth company” in Rule12b-2 of the Exchange Act. If an emerging growth company, indicate by check mark if the registrant has elected not to use the extended transition period for complying with any new orrevised 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 internal control overfinancial reporting under Section 404(b) of the Sarbanes-Oxley Act (15 U.S.C. 7262(b)) by the registered public accounting firm that prepared or issued its auditreport.☐ If securities are registered pursuant to Section 12(b) of the Act, indicate by check mark whether the financial statements of the registrant included in the filingreflect 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 compensation received byany 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, 2025, based on the price at which thecommon equity was last sold on such date, was $60,925,742. For purposes of this computation only, all officers, directors and 10% or greater stockholders of theregistrant 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 2026 Annual Meeting of Stockholders, which the Registrant intends to file pursuant to Regulation 14Awith the Securities and Exchange Commission not later than 120 days after December 31, 2025, are incorporated by reference into Part III of this Annual Report onForm 10-K. TABLE OF CONTENTS PageCautionary Note Regarding Forward-Looking Statements3PART IItem 1.Business.5Item 1A.Risk Factors.33Item 1B.Unresolved Staff Comments.71Item 1C.Cybersecurity.71Item 2.Properties.72Item 3.Legal Proceedings.72Item 4.Mine Safety Disclosures.72PART IIItem 5.Market for Registrant’s Common Equity, Related Stockholder Matters and Issuer Purchases of Equity Securities.73Item 6.[Reserved]73Item 7.Management’s Discussion and Analysis of Financial Condition73Item 7A.Quantitative and Qualitative Disclosures About Market Risk.78Item 8.Financial Statements and Supplementary Data.79Item 9.Changes in and Disagreements With Accountants on Accounting and Financial Disclosure.79Item 9A.Controls and Procedures.79Item 9B.Other Information.79Item 9C.Disclosure Regarding Foreign Jurisdictions that Prevent Inspections79PART IIIItem 10.Directors, Executive Officers and Corporate Governance.80Item 11.Executive Compensation.80Item 12.Security Ownership of Certain Beneficial Owners and Management and Related Stockholder Matters.80Item 13.Certain Relationships and Related Transactions, and Director Independence.80Item 14.Principal Accounting Fees and Services.80PART IVItem 15.Exhibits and Financial Statement Schedules.812 INTRODUCTION “InspireMD,” the “InspireMD” logo, “CGuard,” “CGuard Prime,” “MicroNet,” “SwitchGuard,” and our other registered or common law trade names,trademarks or service marks appearing in this Annual Report on Form 10-K are our p