Business
Envoy Medical Provides Third Quarter 2023 Financial Results and Business Update
Interim Findings from Early Feasibility Trial Provide Important Learnings and Feedback Ahead of Pivotal Clinical Trial Planned for 2024 Virtual Fireside Chat
About this update from Envoy Medical, Inc.
[{"type":"text","content":"Interim Findings from Early Feasibility Trial Provide Important Learnings and Feedback Ahead of Pivotal Clinical Trial Planned for 2024 Virtual Fireside Chat to be held December 7 WHITE BEAR LAKE, Minn., Nov. 20, 2023 (GLOBE NEWSWIRE) -- Envoy Medical, Inc. (“Envoy Medical”) (NASDAQ: COCH), a hearing health company, today is providing a business update and its financial results for the quarter ended September 30, 2023. The Company will host a virtual fireside chat event on December 7, which will cover a range of topics, including introductions to the technology, financial and clinical aspects of the business, as well as potential participation from cochlear implant key opinion leaders. Envoy Medical is a medical technology company specializing in revolutionary “fully” or “totally” implanted hearing devices. Its propriety sensor technology leverages the unique benefits of the human ear to pick up and relay sound rather than relying on external microphones. Envoy Medical currently has its sights on disrupting what it believes to be a complacent cochlear implant industry with new, fully implanted solutions designed to address well-known shortcomings in existing devices. The Company’s first product, the Esteem®, remains the only FDA approved fully implanted active middle ear implant. In fact, it is the only fully implanted active hearing device to have received FDA approval for any set of clinical indications. The Esteem® is indicated for use in adults diagnosed with moderate to severe sensorineural hearing loss who no longer benefit from their hearing aids. Envoy Medical is now leveraging its extensive understanding of fully implanted hearing devices for the development of a fully implanted Acclaim® cochlear implant, an investigational device that is currently in an early feasibility trial at Mayo Clinic in Rochester, Minnesota. The Acclaim® is expected to be the first fully implanted cochlear implant to use the natural ear to pick up sound. The Acclaim® was granted Breakthrough Device Designation from the U.S. Food and Drug Administration (FDA) and is currently considered Investigational (not yet commercially available). A pivotal clinical trial is expected to commence in 2024. Upon FDA approval of the Acclaim® cochlear implant, Envoy Medical intends to target the significantly under-penetrated adult cochlear implant market, which...