Envoy Medical Reports Landmark Accomplishments, Advancing Toward FDA Approval of First-of-Its-Kind Fully Implanted Cochlear Implant

About this update from Envoy Medical, Inc.

[{"type":"text","content":"Company Completes Historic Trial Enrollment, Secures Transformational Financing, and Sees Promising Early Clinical Data Presented at Industry Conferences","length":153,"tagName":"p","attribs":{"class":"nfSubHeading"},"className":""},{"type":"text","content":"White Bear Lake, Minnesota--(Newsfile Corp. - May 11, 2026) - Envoy Medical® Inc. (NASDAQ: COCH) ("Envoy Medical" or the "Company"), a hearing health company pioneering fully implanted hearing solutions, today reported first quarter 2026 results and landmark achievements that advance the Company another step closer toward commercialization of its investigational Acclaim® cochlear implant.","length":411,"tagName":"p"},{"type":"text","content":""The first quarter of 2026 marked a transformative period for Envoy Medical, highlighted by the completion of enrollment in our pivotal clinical trial and the successful execution of a significant financing," said Brent Lucas, Chief Executive Officer of Envoy Medical. "Achieving full enrollment in our pivotal clinical study represents a critical step. We continue to be encouraged by the trial's progress and remain focused on advancing toward PMA submission and, ultimately, commercialization. With a substantially strengthened balance sheet and the support of leading healthcare investors, we believe we are well positioned to execute on our strategic objectives and deliver on the roadmap ahead."","length":725,"tagName":"p"},{"type":"text","content":"Corporate and Financial Highlights for Q1 2026:","length":47,"tagName":"p"},{"type":"list","items":[{"val":[{"type":"text","content":"Pivotal Trial Enrollment Complete — A First for the IndustryIn a defining milestone for the hearing health sector, Envoy Medical became the first cochlear implant company to achieve full enrollment of a U.S. pivotal clinical trial evaluating a fully implanted cochlear implant seeking FDA approval. The 56th and final patient was successfully implanted on March 11, 2026, completing enrollment across U.S. sites. The Company is now collecting 12-month follow-up data from all participants, with a Premarket Approval (PMA) submission to the FDA to follow.","length":556,"tagName":"p","attribs":{}}]},{"val":[{"type":"text","content":"Transformational Capital RaiseEnvoy Medical closed an upsized public offering for up to $78.0 mi...

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