ENvue Medical Inc 2025年度报告

FORM 10-K ☒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 For the transition period fromto Commission File Number: 001-36445 ENvue Medical, Inc. (Exact name of registrant as specified in its charter) Securities registered pursuant to Section 12(b) of the Act: 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 ExchangeAct of 1934 during the preceding 12 months (or for such shorter period that the registrant was required to file such reports) and (2) hasbeen subject to such filing 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 toRule 405 of Regulation S-T (§ 232.405 of this chapter) during the preceding 12 months (or for such shorter period that the registrant wasrequired 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 reportingcompany or an emerging growth company. See the definitions of “large accelerated filer,” “accelerated filer,” “smaller reporting company,”and “emerging growth company” in Rule 12b-2 of the Exchange Act. Large accelerated filerNon-accelerated filer If an emerging growth company, indicate by check mark if the registrant has elected not to use the extended transition period forcomplying with any 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 ofits internal control over financial reporting under Section 404(b) of the Sarbanes-Oxley Act (15 U.S.C 7262(b)) by the registered publicaccounting firm that prepared 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 registrantincluded in the 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-basedcompensation received 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 Exchange Act). Yes☐No☒ The aggregate market value of voting stock held by non-affiliates as of June 30, 2025, the last business day of the registrant’s most recentlycompleted second quarter and based on the closing price of the registrant’s common stock as reported on the Nasdaq Capital Market, wasapproximately $7.3 Million. The number of shares outstanding of the registrant’s common stock as of April 15, 2026, was 3,700,908 shares. DOCUMENTS INCORPORATED BY REFERENCE None. TABLE OF CONTENTS PART I.1ITEM 1: BUSINESS1ITEM 1A: RISK FACTORS41ITEM 1B: UNRESOLVED STAFF COMMENTS75ITEM 1C: CYBERSECURITY75ITEM 2: PROPERTIES76ITEM 3: LEGAL PROCEEDINGS77ITEM 4: MINE SAFETY DISCLOSURES78PART II.79ITEM 5: MARKET FOR REGISTRANT’S COMMON EQUITY, RELATED STOCKHOLDER MATTERS, AND ISSUERPURCHASES OF EQUITY SECURITIES79ITEM 6: [RESERVED]80ITEM 7: MANAGEMENT’S DISCUSSION AND ANALYSIS OF FINANCIAL CONDITION AND RESULTS OFOPERATIONS81ITEM 7A: QUANTITATIVE AND QUALITATIVE DISCLOSURES ABOUT MARKET RISK87ITEM 8: FINANCIAL STATEMENTS AND SUPPLEMENTARY DATA87ITEM 9: CHANGES IN AND DISAGREEMENTS WITH ACCOUNTANTS ON ACCOUNTING AND FINANCIALDISCLOSURE87ITEM 9A: CONTROLS AND PROCEDURES88ITEM 9B: OTHER INFORMATION90ITEM 9C: DISCLOSURE REGARDING FOREIGN JURISDICTIONS THAT PREVENT INSPECTIONS.90PART III.91ITEM 10: DIRECTORS, EXECUTIVE OFFICERS, AND CORPORATE GOVERNANCE91ITEM 11: EXECUTIVE COMPENSATION97ITEM 12: SECURITY OWNERSHIP OF CERTAIN BENEFICIAL OWNERS AND MANAGEMENT AND RELATEDSTOCKHOLDER MATTERS111ITEM 13: CERTAIN RELATIONSHIPS AND RELATED TRANSACTIONS, AND DIRECTOR INDEPENDENCE112ITEM 14: PRINCIPAL ACCOUNTANT FEES AND SERVICES113PART IV.ITEM 15: EXHIBITS, FINANCIAL STATEMENT SCHEDULES114ITEM 16: FORM 10-K SUMMARY114SIGNATURES123i EXPLANATORY NOTE On February 14, 2025, subsequent to the end of the fiscal year ended December 31, 2024, the fiscal year to which this Annual Report onForm 10-K relates and as further described herein, pursuant to the terms of that certain Agreement and Plan of Merger, dated as ofFebruary 14, 202