Full Press Release Details
Envoy Medical Reports Full Year 2025 Financial
Received FDA approval to expand fully implanted
Acclaim Cochlear Implant Pivotal Clinical Trial to final stage
Strengthened balance sheet by extinguishing
Subsequent to year-end, closed on transformational
capital raise led by established institutional healthcare investors and completed enrollment of Pivotal Clinical Trial for first-of-its-kind
fully implanted cochlear implant
White Bear Lake, Minnesota - March 23, 2026 - 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 full year ended December 31, 2025, as well as
other subsequent events.
Corporate and Financial Highlights for 2025:
Highlights Subsequent to 2025 Year End:
Brent Lucas, CEO of Envoy Medical, commented: "We
are extremely proud of the significant progress we made as a company in 2025, which included the FDA approval to expand our pivotal clinical
trial to its final stage.
We were also, on the financial side,
able to extinguish over $32 million in debt to create a much stronger balance sheet. In addition, we continued to further expand our global
patent portfolio as a leading fully implanted hearing technology company.
The momentum from 2025 has set the
stage for an exceptional start to 2026. In February, we closed a transformational capital raise that included established institutional
healthcare investors and existing shareholders. In March, we announced complete enrollment of our pivotal clinical trial for investigational
fully implanted Acclaim cochlear implant. We are now in a strengthened position as we continue to gather data and look forward to submitting
our PMA application to the FDA.
The future is bright for Envoy Medical
as we aim to revolutionize hearing health by providing fully implanted solutions to address the unmet needs of millions of individuals
worldwide. We hope you join us on this meaningful and exciting journey."
Financial Results for the Year Ended December 31, 2025 (dollars
Net Revenue was $241 as of December 31, 2025 compared to $225 for year
ended December 31, 2024. The increase of $16 was primarily driven by the sales of the Esteem FI-AMEI implant and related replacement
Cost of goods sold increased $132 compared to the year ended December
31, 2024. The increase is primarily due to an increase in scrap and non-recurring expenses of $190, which was partially offset by lower
fees for third-parties performing work related to our products of $77.
R&D expenses, which include expenses related to the Acclaim pivotal
clinical trial, increased by $2,307 for the year ended December 31, 2025 compared to the year ended December 31, 2024. This increase mainly
reflects additional clinical trial expense during enrollment.
Sales and marketing expenses of December 31, 2025 were $1,220 compared
to $1,734 for the year ended December 31, 2024 a decrease of $514. The decrease is primarily due to a reduction of legal fees associated
with reimbursement work for the Esteem FI-AMEI product.
General and administrative expenses increased $1,105 to $7,931 for
the year ended December 31, 2025 compared to $6,826 for the year ended December 31, 2024. The increase was primarily due to severance
costs associated with the former Chief Financial Officer and increased consulting expenses.
As of December 31, 2025, cash was approximately $3.7 million.
The Acclaim cochlear implant received Breakthrough Device Designation
from the FDA in 2019 and is currently under investigation as part of a U.S. based pivotal clinical trial. For more information on the
trial, visit www.envoymedical.com/acclaim-pivotal.
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
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
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.
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.
Forward-Looking Statements
This press release includes "forward-looking
statements" within the meaning of the "safe harbor" provisions of the United States Private Securities Litigation Reform
Act of 1995. Forward-Looking statements may be identified by the use of words such as "estimate," "plan," "project,"
"forecast," "intend," "will," "expect," "anticipate," "believe," "seek,"
"target" or other similar expressions that predict or indicate future events or trends or that are not statements of historical
matters, but the absence of these words does not mean that a statement is not forward-looking. Such statements may include, but are not
limited to, statements regarding the expectations of Envoy Medical concerning the outlook for its business, productivity, plans and goals
for future operations; the ability to obtain additional patents and develop future products or product improvements; the ability to maintain
compliance with Nasdaq rules and requirements; the timing and future outcome of its FDA pivotal trial; the ability to raise capital and
the amount of capital required to complete the FDA pivotal trial and early commercialization; the Acclaim CI being the first to market
fully implanted cochlear implant; the timing and results of activations, enrollments, follow-up visits, data, and clinical trials of
the Acclaim CI; and the participation or any changes or delays in participation of any subjects, institutions, or healthcare professionals
in such trials; the safety, performance, and market acceptance of the Acclaim CI; the timing and results of the Acclaim CI's PMA submission
to the FDA; the size of Envoy Medical's addressable market, operational performance, future market conditions or economic performance
and developments in the capital and credit markets; and any information concerning possible or assumed future operations of Envoy Medical.
The forward-looking statements contained in this press release reflect Envoy Medical's current views about future events and are subject
to numerous known and unknown risks, uncertainties, assumptions and changes in circumstances that may cause its actual results to differ
significantly from those expressed in any forward-looking statement. Envoy Medical does not guarantee that the events described will
happen as described (or that they will happen at all). These forward-looking statements are subject to a number of risks and uncertainties,
including, but not limited to changes in the market price of shares of Envoy Medical's Class A Common Stock; changes in or removal of
Envoy Medical's shares inclusion in any index; Envoy Medical's success in retaining or recruiting, or changes required in, its officers,
key employees or directors; unpredictability in the medical device industry, the regulatory process to approve medical devices, and the
clinical development process of Envoy Medical products; the ability to engage competition in the medical device industry, and the failure
to introduce new products and services in a timely manner or at competitive prices to compete successfully against competitors; disruptions
in relationships with Envoy Medical's suppliers, or disruptions in Envoy Medical's own production capabilities for some of the key components