Envoy Medical, Inc.·Healthcare

Company Remains on Schedule for PMA Submission to FDA White Bear Lake, Minnesota--(Newsfile Corp. - April 1, 2026) - Envoy Medical®, Inc. (NASDAQ: COCH) ("Envoy Medical"), a hearing health company pioneering fully implanted hearing solutions, announced that the first three patients implanted in its pivotal clinical trial for the fully implanted Acclaim® cochlear implant have successfully completed their 12-month endpoint visit, marking a key milestone in the study's progress. The first three pivotal trial patients implanted at the start of 2025 are now the first to reach the 12-month follow-up evaluation point.

Received FDA approval to expand fully implanted Acclaim® Cochlear Implant Pivotal Clinical Trial to final stage Strengthened balance sheet by extinguishing $32 million in debt Subsequent to year-end, closed on transformational capital raise led by established institutional healthcare investors and completed enrollment of Pivotal Clinical Trial for first-of-its-kind fully implanted cochlear implant White Bear Lake, Minnesota--(Newsfile Corp. - March 23, 2026) - Envoy Medical® Inc. (NASDAQ: COCH) ("Envoy Medical" or the "Company"), a hearing health company pioneering fully implanted hearing solutions, today announced its corporate and financial results for the full year ended December 31, 2025, as well as other subsequent events. Corporate and Financial Highlights for 2025: Received FDA Approval to Expand Its Pivotal Clinical Trial to Final Stage Based on Submission of Promising Three-Month Data Extinguished over $32 Million in Debt, Strengthening Balance Sheet Completed First Set of Activations in Final Stage of Pivotal Clinical Study for its First-Of-Its-Kind Fully Implanted Acclaim(R) Cochlear Implant Achieved Six-Month Milestone with First 10 Patients in Acclaim(R) Cochlear Implant Clinical Trial Highlights Subsequent to 2025 Year End: Completed enrollment of a 56-patient U.S. pivotal trial for the fully implanted Acclaim® Cochlear Implant Strengthened balance sheet with up to $78M public offering ($30M received, $48M potential from warrants) Expanded IP portfolio to 47 patents across North America, Europe, Asia, and Australia as of Feb. 20, 2026 Brent Lucas, CEO of Envoy Medical, commented: "We are extremely proud of the significant progress we made as a company in 2025, which included the FDA approval to expand our pivotal clinical trial to its final stage.

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First Cochlear Implant Company to Announce Completed Enrollment of a U.S. Pivotal Clinical Trial for a Fully Implanted Cochlear Implant seeking FDA Approval White Bear Lake, Minnesota--(Newsfile Corp. - March 11, 2026) - Envoy Medical® Inc. (NASDAQ: COCH) ("Envoy Medical" or the "Company"), a hearing health company pioneering fully implanted hearing solutions, today announced completed enrollment of its pivotal clinical trial for the investigational fully implanted Acclaim® cochlear implant. With the successful implantation of the 56th and final patient, Envoy Medical is the first cochlear implant company to achieve full enrollment of a U.S. pivotal clinical trial to evaluate a fully implanted cochlear implant seeking FDA approval.

White Bear Lake, Minnesota--(Newsfile Corp. - February 24, 2026) - Envoy Medical® Inc. (NASDAQ: COCH) ("Envoy Medical" or the "Company"), a hearing health company pioneering fully implanted hearing solutions, today announced that it has received written notification from The Nasdaq Stock Market LLC ("Nasdaq") confirming that the Company has evidenced compliance with Nasdaq Listing Rule 5550(b)(2) through the alternatives permitted under Listing Rule 5550(b). As previously disclosed, the Company received a notice from Nasdaq on February 25, 2025, indicating that it was not in compliance with the continued listing requirement to maintain a minimum Market Value of Listed Securities (MVLS) of $35 million.

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 and that our approach is novel when compared to other designs," said Brent Lucas, Chief Executive Officer of Envoy Medical.
Envoy Medical, Inc., a hearing health company, provides medical technologies for the hearing loss spectrum. Its products include hearing aids; Esteem middle ear implants; bone conduction devices; and Acclaim cochlear implants. Envoy Medical Corporation was formerly known as St. Croix Medical, Inc. and changed its name to Envoy Medical Corporation in December 2004. The company was founded in 1995 and is based in White Bear Lake, Minnesota.
Healthcare
Medical - Devices
42
2021-04-29
2.05