Nuwellis 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 001-35312 NUWELLIS, INC. (Exact name of registrant as specified in its charter) Delaware68-0533453(State or other jurisdiction of incorporation or organization)(I.R.S. Employer Identification No.) 12988 Valley View RoadEden Prairie, Minnesota 55344(Address of principal executive offices including zip code) (952) 345-4200(Registrant’s telephone number, including area code) Securities registered pursuant to Section 12(b) of the Act: Title of each classTrading Symbol(s)Name of each exchange on which registeredThe Nasdaq Stock Market LLC (Nasdaq Capital Market) Common Stock, par value $0.0001 per shareNUWE 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 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 theSecurities Exchange Act of 1934 during the preceding 12 months (or for such shorter period that the registrant was required to filesuch reports), and (2) has been 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 besubmitted pursuant to Rule 405 of Regulation S-T (§232.405 of this chapter) during the preceding 12 months (or for such shorterperiod 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 smallerreporting company, or emerging growth company. See the definitions of “large accelerated filer,” “accelerated filer,” “smallerreporting company,” and “emerging growth company” in Rule 12b-2 of the Exchange Act. Large accelerated filer☐ 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 periodfor complying 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 theeffectiveness of its internal control over financial reporting under Section 404(b) of the Sarbanes-Oxley Act (15 U.S.C. 7262(b)) by theregistered public accounting 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 theregistrant included 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-based compensation 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 Act). Yes☐No☒ As of June 30, 2025, the last business day of the registrant’s most recently completed second fiscal quarter, the aggregatemarket value of shares of the registrant’s common stock held by non-affiliates of the registrant (based upon the June 30, 2025 closingsale price of $9.2566 per share) was approximately$4.6 million. The number of shares of the registrant’s common stock, par value $0.0001 per share, outstanding as of March 6, 2026 was2,310,477 shares. DOCUMENTS INCORPORATED BY REFERENCE: Portions of the proxy statement for the 2026 annual meeting of stockholders are incorporated by reference into Part III of this report tothe extent described herein. NUWELLIS, INC.ANNUAL REPORT ON FORM 10-KTable of Contents Cautionary note regarding forward looking statements3Summary of Risk Factors4PART I.7Item 1.Business7Item 1A.Risk Factors25Item 1B.Unresolved Staff Comments48Item 1C.Cybersecurity49Item 2.Properties50Item 3.Legal Proceedings50Item 4.Mine Safety Disclosures50PART II50Item 5.Market for Registrant’s Common Equity, Related Stockholder Matters and Issuer Purchases of Equity Securities50Item 6.[Reserved]51Item 7.Management’s Discussion and Analysis of Financial Condition and Results of Operations51Item 7A.Quantitative and Qualitative Disclosures About Market Risk63Item 8.Financial Statements and Supplementary Data63Item 9.Changes in and Disagreements With Accountants on Accounting and Financial Disclosure89Item 9A.Controls and Procedures89Item