UNITED STATES SECURITIES AND EXCHANGE COMMISSION Washington, D.C. 20549 FORM 10-K Commission File Number 001-40133 ENVOY MEDICAL, INC. (Exact name of registrant as specified in its charter) | Delaware | 86-1369123 | | --- | --- | | (State or other jurisdiction of | (I.R.S. Employer | | incorporation or organization) | Identification No.) | 4875 White Bear Parkway, White Bear Lake, MN 55110 (Mark One) ☒ ANNUAL REPORT PURSUANT TO SECTION 13 OR 15(d) OF THE SECURITIES EXCHANGE ACT OF 1934 For the fiscal year e ...

Core Insights - Envoy Medical has received FDA approval to expand its pivotal clinical trial for the fully implanted Acclaim® Cochlear Implant to its final stage, marking a significant milestone for the company [1][2] - The company has strengthened its balance sheet by extinguishing $32 million in debt, which positions it for future growth [3][4] - A transformational capital raise was completed in February 2026, involving established institutional healthcare investors, which will support ongoing clinical trials and future product development [4][5] Financial Performance - For the year ended December 31, 2025, net revenue increased to $241,000 from $225,000 in 2024, primarily driven by sales of the Esteem® FI-AMEI implant and related components [5][21] - Cost of goods sold rose to $874,000, up from $742,000 in 2024, largely due to increased scrap and non-recurring expenses [6][21] - Research and development expenses surged by $2,307,000 to $12,486,000, reflecting additional costs associated with the Acclaim pivotal clinical trial [7][21] - Sales and marketing expenses decreased to $1,220,000 from $1,734,000, attributed to reduced legal fees related to reimbursement work for the Esteem product [8][21] - General and administrative expenses increased by $1,105,000 to $7,931,000, mainly due to severance costs and higher consulting expenses [9][21] Balance Sheet Overview - As of December 31, 2025, total assets were approximately $8.56 million, down from $11.54 million in 2024 [19][20] - Current liabilities increased to $11.56 million from $7.54 million, reflecting higher accounts payable and accrued expenses [20] - The company's stockholders' deficit improved to $(12.16 million) from $(18.84 million) in 2024, indicating a stronger financial position [20] Future Outlook - The company aims to revolutionize hearing health with fully implanted solutions, addressing the needs of millions with severe to profound sensorineural hearing loss [4][5][12] - The Acclaim cochlear implant, which received Breakthrough Device Designation from the FDA in 2019, is expected to be a key product in the company's portfolio [10][13]

Core Insights - Envoy Medical has completed enrollment for its pivotal clinical trial of the fully implanted Acclaim® cochlear implant, marking a significant milestone as the first cochlear implant company to achieve this in the U.S. [1][4] Company Overview - Envoy Medical, listed on NASDAQ as COCH, specializes in innovative hearing health technologies, including fully implanted devices for hearing loss [6]. - The company has previously launched the Esteem® active middle ear implant, which has been commercially available since 2010 [6]. Clinical Trial Details - The pivotal trial for the Acclaim cochlear implant received Breakthrough Device Designation from the FDA in 2019 and is currently under investigation [4][8]. - The trial involved 56 participants, with the final two patients implanted by Dr. Patrick Antonelli at the University of Florida [2][3]. - Following the completion of enrollment, the study will proceed with follow-up visits and data collection, with a PMA application to be submitted to the FDA after 12 months of data collection [3]. Product Features - The Acclaim cochlear implant is designed for adults with severe to profound sensorineural hearing loss and aims to provide a fully implanted solution without the need for an external processor [7][8]. - The device utilizes a sensor that leverages the natural anatomy of the ear to capture sound, representing a significant advancement over traditional cochlear implants [7].

White Bear Lake, Minnesota--(Newsfile Corp. - February 23, 2026) - Envoy Medical® Inc. (NASDAQ: COCH) ("Envoy Medical" or the "Company"), a hearing health company pioneering fully implanted hearing solutions, today announced the issuance of three new patents with one in the United States and two in Hong Kong, further expanding its intellectual property and reinforcing its competitive position in the cochlear implant industry."We believe the future of the cochlear implant industry is fully implanted devices ...

$30.0 million upfront with up to an additional $48.0 million of potential aggregate gross proceeds upon the exercise in full of milestone-linked warrants for cashOffering led by Nantahala Capital, with participation of healthcare-dedicated funds, including Broadfin Holdings, and participation from existing shareholder, Glen Taylor, and members of the Company's board of directors and managementNet proceeds extend anticipated cash runway into second half of 2027, beyond expected PMA submission; if milestone- ...

As filed with the U.S. Securities and Exchange Commission on February 9, 2026 Registration No. 333-292260 Identification Number) 4875 White Bear Parkway White Bear Lake, MN 55110 Tel: (877) 900-3277 UNITED STATES SECURITIES AND EXCHANGE COMMISSION Washington, D.C. 20549 AMENDMENT NO. 2 TO FORM S-1 REGISTRATION STATEMENT UNDER THE SECURITIES ACT OF 1933 Envoy Medical, Inc. (Exact name of registrant as specified in its charter) Delaware 3842 86-1369123 (State or other jurisdiction of incorporation or organiza ...

As filed with the U.S. Securities and Exchange Commission on February 6, 2026 Registration No. 333-292260 UNITED STATES SECURITIES AND EXCHANGE COMMISSION Washington, D.C. 20549 AMENDMENT NO. 1 TO FORM S-1 REGISTRATION STATEMENT UNDER THE SECURITIES ACT OF 1933 Envoy Medical, Inc. (Exact name of registrant as specified in its charter) (State or other jurisdiction of incorporation or organization) (Primary Standard Industrial Delaware 3842 86-1369123 Approximate date of commencement of proposed sale to the p ...

As filed with the U.S. Securities and Exchange Commission on February 6, 2026 Registration No. 333-292260 UNITED STATES SECURITIES AND EXCHANGE COMMISSION Washington, D.C. 20549 AMENDMENT NO. 1 TO FORM S-1 REGISTRATION STATEMENT UNDER THE SECURITIES ACT OF 1933 Envoy Medical, Inc. (Exact name of registrant as specified in its charter) (State or other jurisdiction of incorporation or organization) (Primary Standard Industrial Delaware 3842 86-1369123 (IRS Employer Identification Number) 4875 White Bear Parkw ...

Core Viewpoint - Envoy Medical, a hearing health company, is set to participate in the Small Cap Growth Virtual Investor Conference on February 5, 2026, highlighting its commitment to innovation in hearing solutions [1]. Group 1: Company Overview - Envoy Medical (NASDAQ: COCH) specializes in innovative technologies for hearing loss, offering fully implanted devices such as the Esteem® active middle ear implant, available in the U.S. since 2010, and the investigational Acclaim® cochlear implant [2]. Group 2: Event Details - The Small Cap Growth Virtual Investor Conference will take place on February 5, 2026, at 10:00 A.M. ET, featuring a presentation followed by a real-time Q&A session for investors [1]. - A recording of the event will be accessible on Envoy's Investor Relations website for those unable to attend the live session [1].

As filed with the U.S. Securities and Exchange Commission on December 18, 2025. Registration No. 333- UNITED STATES SECURITIES AND EXCHANGE COMMISSION Washington, D.C. 20549 FORM S-1 REGISTRATION STATEMENT UNDER THE SECURITIES ACT OF 1933 Envoy Medical, Inc. (Exact name of registrant as specified in its charter) (State or other jurisdiction of incorporation or organization) (Primary Standard Industrial Classification Code Number) Delaware 3842 86-1369123 (IRS Employer Identification Number) 4875 White Bear ...