WHITE BEAR LAKE, Minnesota, Nov. 08, 2024 (GLOBE NEWSWIRE) --Envoy Medical®, Inc. (“Envoy Medical”) (NASDAQ: “COCH”), a hearing health company...
Envoy Medical Provides Business Update Following Transformative Financing and Positive Progress in Clinical Trial
Financing was led by new investor and top-tier healthcare fund Nantahala Capital and longtime Envoy Medical shareholder, billionaire Glen Taylor
Closing of $30 million in gross proceeds in upsized offering, with up to an additional $48 Million upon exercise of milestone warrants, provides potential funding through commercialization
Company hosting Fireside Chat with Dr. Theodore McRackan, on February 25th at 10 a.m. ET, to discuss his initial experiences as clinical trial's leading implanter
White Bear Lake, Minnesota--(Newsfile Corp. - February 19, 2026) - Envoy Medical® Inc. (NASDAQ: COCH) ("Envoy Medical" or the "Company"), a hearing health company pioneering fully implanted hearing solutions, today provided a business update highlighting its recent transformative financing led by long-term institutional investors and existing shareholders, noting further positive clinical trial progress, and announcing an upcoming fireside chat.
"Envoy Medical has had an extremely strong start to 2026, and, frankly, we are fired up about what is ahead of us as we continue to make meaningful progress across our strategic priorities," said Brent Lucas, Chief Executive Officer of Envoy Medical.
Transformative Financing
Envoy Medical recently closed an upsized public offering for up to $78.0 million. The financing included $30.0 million in gross proceeds at closing with up to an additional $48.0 million of potential aggregate gross proceeds upon the exercise in full of milestone-linked warrants. Importantly, if the milestones are reached and the warrants are fully executed, the resulting capital is expected to provide the Company with enough cash to fund its market launch and initial commercialization growth strategy. In other words, this financing has the potential to fund the Company through 2028 and into 2029.
The funding strategy is designed to position Envoy Medical to execute on its clinical and regulatory milestones to bring its breakthrough cochlear implant technology to market to create significant value and substantial impact.
"Our recently closed financing led by Nantahala Capital, a successful and well-respected institutional investor, and our long-time shareholder Glen Taylor has reshaped and significantly improved our outlook. We are thrilled that additional healthcare-dedicated funds, including Broadfin Holdings, joined as new investors while several existing shareholders, including members of the Board and management, also participated. This financing has the potential to not only fund the Company through our pivotal clinical trial and regulatory submission, but also through initial commercialization. We believe we have positioned Envoy Medical to successfully realize its short- and long-term potential. The future of the cochlear implant industry is fully implanted solutions, and we are thrilled to be on the cutting edge and leading the way."
The Company believes that the breadth of participation from both specialized healthcare investors and insiders reflects confidence in Envoy Medical's strategy and probability of success.
Positive Clinical Trial Progress
After receiving approval from the FDA to expand the Company's pivotal clinical trial for the investigational fully implanted Acclaim® cochlear implant to the second and final stage, trial enrollment has proceeded in a steady and efficient manner. The trial's protocol calls for a total of 56 implanted participants and, as of today, 47 people have been implanted.
The nine remaining participants have been identified and are waiting for surgery. Assuming the nine remaining surgeries occur as currently scheduled, the Company expects trial enrollment to be completed by the end of March 2026.
To the best of its knowledge, the Company believes that it will be the first cochlear implant manufacturer to complete enrollment of a pivotal clinical trial studying a fully implanted cochlear implant in support of a Pre-Market Approval (PMA) application.
Fireside Chat with Dr. Theodore McRackan
Brent Lucas, Envoy Medical's CEO, will host a Fireside Chat on Wednesday, February 25, 2026, at 10 a.m. ET, with Dr. Theodore McRackan, an experienced cochlear implant surgeon at the Medical University of South Carolina.
Dr. McRackan is one of the Principal Investigators involved in the Acclaim® pivotal clinical trial and has implanted 14 of the 47 currently enrolled subjects. The Medical University of South Carolina was the first site to reach 14 enrolled subjects in this pivotal clinical trial. During the discussion, Dr. McRackan is expected to share initial impressions, insights into patient selection, device design and surgical technique, and the potential impact of Envoy Medical's technology if regulatory approval is achieved.
Event: Envoy Medical Fireside Chat
Date: Wednesday, February 25, 2026
Time: 10:00 AM ET
Webinar Registration Link: https://ir.envoymedical.com/news-events/ir-calendar
To be added to the Envoy Medical email distribution list, please email Envoy@kcsa.com with COCH in the subject line.
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.
Click here for important information.
