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0.00985580424333651 0.0195659562072148 -0.0823906394135068 -0.164926931106472 -0.0241297276302375 -0.111569646064961 -0.271738602709132 -0.204204495800359
Stock impact report

Envoy Medical Receives FDA Approval to Advance Its Pivotal Clinical Trial to Final Stage Based on Submission of Promising Three-Month Data [Yahoo! Finance]

Envoy Medical, Inc. - Class A (COCH) 
Company Research Source: Yahoo! Finance
White Bear Lake, Minnesota--(Newsfile Corp. - October 7, 2025) - Envoy Medical, Inc. (NASDAQ: COCH) ("Envoy Medical" or the "Company"), a hearing health company pioneering fully implanted hearing solutions, today announced that it received approval from the U.S. Food and Drug Administration (FDA) to expand the Company's pivotal clinical trial for the fully implanted Acclaim® cochlear implant to the final stage based on promising three-month data from the first 10 patients. The FDA's approval of the expansion request removes a previously uncertain timing variable and allows the Company to solidify its path toward regulatory approval. As a result, the Company has shortened its estimated timeline by three to six months. The updated timeline to commercialization and other improved efficiencies has allowed management to cut its anticipated capital needs by $10-$15 million. "The FDA's granting of our expansion request is a significant and game changing milestone for Envoy Medical and o Show less Read more
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