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Envoy Medical Reports Third Quarter 2025 Financial and Operational Results
White Bear Lake, Minnesota--(Newsfile Corp. - November 10, 2025) - 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 third quarter ended September 30, 2025, as well as other subsequent events.
Corporate Highlights for Third Quarter 2025:
- Extinguished over $32 Million in Debt, Strengthening Balance Sheet
- Advanced Commercialization Planning as FDA Clinical Trial Remains On Track
- Expanded Patent Portfolio by Securing Additional European Patent
- Secured Four New Global Patents
- Successfully Reached Three-Month Follow-Up Milestone in Clinical Trial
- Secured an Additional Three New Patents
- Further Expanded Patent Portfolio with New Issuances in the United States
Subsequent to Third Quarter 2025 End
- Received FDA Approval to Expand Its Pivotal Clinical Trial to Final Stage Based on Submission of Promising Three-Month Data
- Announced Closing of Up to $16 Million Registered Direct Offering Priced At-the-Market Under Nasdaq Rules
- Marked three-year anniversary of first successful implantation of fully implanted cochlear implant
- Announced first three patients were enrolled in the final stage of pivotal clinical trial of the fully implanted investigational Acclaim® cochlear implant
"The third quarter was transformational for Envoy Medical as we continue to position ourselves to capitalize on the opportunity ahead of us," said Brent Lucas, Chief Executive Officer of Envoy Medical, "We extinguished $32 million in debt without the issuance of new equity, substantially improving our balance sheet and eliminating the need to satisfy or service that debt in the future. As a result, our Stockholder's Equity materially improved. We continued to make steady progress in our pivotal clinical trial and believe we are on the right track. Throughout the quarter, we received a number of additional global patents in the U.S., Europe, and Australia. We will continue to expand our position as a first mover and market leader in fully implanted hearing solutions."
Lucas concluded, "Subsequent to quarter end, we achieved a major milestone as we received the critically important approval from the FDA to expand our pivotal clinical trial to its final stage. We continue to see strong interest in our fully implanted cochlear implant trial as new patients are now rapidly enrolling in this trial. I am very proud of the progress the Envoy Medical team is making, and we intend to increase our momentum as we finish 2025."
Financial Results for the Quarter Ended September 30, 2025 (dollars in thousands)
- Third quarter net revenue was $42 for the three months ended September 30, 2025.
- R&D expenses decreased $57 to $2,700 for the three months ended September 30, 2025, compared to the three months ended September 30, 2024. R&D product costs decreased $282 from the prior period as we moved from the development phase into the clinical trial phase. Personnel costs increased $282 and other R&D costs decreased $57 from the prior period to support the clinical trials with additional headcount. Increases in other R&D costs were more than offset by lower professional services fees.
- General and administrative expenses increased $752 for the three months ended September 30, 2025, compared to the three months ended September 30, 2024. The increase is primarily due to increased public company costs of $268 and expenses directly related to the September 2025 offering of $444.
- As of September 30, 2025, cash was approximately $3,556. Additional capital was raised post quarter end.
For more information about Envoy Medical's innovation pipeline and intellectual property portfolio, visit www.envoymedical.com.
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About Envoy Medical, Inc.
Envoy Medical (NASDAQ: COCH) is a hearing health company focused on providing innovative technologies across the hearing loss spectrum. Envoy Medical has pioneered one-of-a-kind, fully implanted devices for hearing loss, including its fully implanted Esteem® active middle ear implant, commercially available in the U.S. since 2010, and the fully implanted Acclaim® cochlear implant, an investigational device. Envoy Medical is dedicated to pushing hearing technology beyond the status quo to improve access, usability, compliance, and ultimately quality of life.
About the Fully Implanted Acclaim® Cochlear Implant
We believe the fully implanted Acclaim Cochlear Implant ("Acclaim CI") is a first-of-its-kind hearing device. Envoy Medical's fully implanted technology includes a sensor designed to leverage the natural anatomy of the ear instead of a microphone to capture sound. The Acclaim CI is designed to address severe to profound sensorineural hearing loss that is not adequately addressed by hearing aids. The Acclaim CI is expected to be indicated for adults who have been deemed adequate candidates by a qualified physician.
The Acclaim Cochlear Implant received the Breakthrough Device Designation from the U.S. Food and Drug Administration (FDA) in 2019.
CAUTION The fully implanted Acclaim Cochlear Implant is an investigational device. Limited by Federal (or United States) law to investigational use.
About the Esteem® Fully Implanted Active Middle Ear Implant (FI-AMEI)
The Esteem fully implanted active middle ear implant (FI-AMEI) is the only FDA-approved, fully implanted* hearing device for adults diagnosed with moderate to severe sensorineural hearing loss allowing for 24/7 hearing capability using the ear's natural anatomy. The Esteem FI-AMEI hearing implant is invisible and requires no externally worn components and nothing is placed in the ear canal for it to function. Unlike hearing aids, you never put it on or take it off. You can't lose it. You don't clean it. The Esteem FI-AMEI hearing implant offers true 24/7 hearing.
*Once activated, the external Esteem FI-AMEI Personal Programmer is not required for daily use.
Important safety information for the Esteem FI-AMEI can be found at: https://www.envoymedical.com/safety-information.
Additional Information and Where to Find It
Copies of the documents filed by Envoy Medical with the SEC may be obtained free of charge at the SEC's website at www.sec.gov.
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