Full Press Release Details
Envoy Medical Reports on First Quarter 2025
Company Provides Update on its Pivotal Clinical Study for Fully
Implanted Cochlear Implant
WHITE BEAR LAKE, Minnesota--(Newsfile Corp. - May 1, 2025) -
Envoy Medical , Inc. (Nasdaq: COCH) ("Envoy Medical"), a revolutionary hearing health company focused on fully
implanted hearing devices, today announced its corporate and financial results for the first quarter ended March 31, 2025, as well as
other subsequent events.
Financial and Corporate Highlights for First Quarter and to date:
Brent Lucas, CEO of Envoy Medical commented: "We could not be
more pleased with the positive progress of our pivotal clinical study and the reported excitement from the investigational sites. Enrollment
of the first 10 patients happened quickly and efficiently, and we believe it is yet another indication that, if given the choice, a meaningful
percentage of patients who are candidates for cochlear implants will be drawn to a fully implanted solution that uses the ear to pick
up sound instead of a microphone, does not have an implanted magnet in the head, and has multiple days of battery life with typical use.
We designed our fully implanted Acclaim cochlear implant with patient's quality of life and preferences in mind, and we are thrilled
to see anecdotal reports coming back that people want what our device is designed to offer. Personally, I'm extremely excited about
Envoy Medical's future and our position in the hearing industry."
Financial Results for the Quarter Ended March 31, 2025
Net revenues decreased $13 thousand for the three months ended March
31, 2025, compared to the three months ended March 31, 2024, primarily due to the decrease in the number of Battery replacement sales
due to supply chain limitations. Cost of goods sold increased $73 thousand for the three months ended March 31, 2025, compared to the
three months ended March 31, 2024. The increase is primarily due to an increase in headcount in preparation of production growth
of the Esteem FI-AMEI product, new supplier expenses and an adjustment to the inventory reserve.
R&D expenses increased $400 thousand for the three months ended
March 31, 2025, compared to the three months ended March 31, 2024. The increase is primarily due to an increase in headcount and
contractors in our engineering and clinical departments for the three months ended March 31, 2025, as we increased headcount across our
clinical and cochlear departments in preparation for our pivotal clinical study for the Acclaim CI. The Company incurred additional expenses
related to the pivotal clinical study in the form of initial site start-up costs, parts and supplies, and data capturing platform.
Sales and marketing expenses increased $33 thousand for the three months
ended March 31, 2025, compared to the three months ended March 31, 2024. The increase is primarily due to increased headcount, travel,
and the addition of a patient engagement program, partially offset by the reduction of legal and professional fees to secure insurance
reimbursement for the Esteem FI-AMEI product.
General and administrative expenses decreased $284 thousand for the
three months ended March 31, 2025, compared to the three months ended March 31, 2024. The decrease is primarily due to reduced legal
fees and professional service costs in 2025 compared to 2024, partially offset by an increase in headcount and miscellaneous administrative
As of March 31, 2025 cash and cash equivalents were approximately $5.3
About the Fully Implanted Acclaim
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
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 operational improvements and capital investments; the timing and results of IRB approvals, site documents,
logistics or activations, enrollments, follow-up visits, data, and clinical trials of the Acclaim CI, and the participation or any changes
in participation of any institution or healthcare professionals in such trials; the Acclaim CI being the first to market fully implanted
cochlear implant; the safety, performance, and market acceptance of the Acclaim CI; 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; 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 and materials of its products; changes
in the need for capital and the availability of financing and capital to fund these needs; changes in interest rates or rates of inflation;
legal, regulatory and other proceedings could be costly and time-consuming to defend; changes in applicable laws or regulations, or the
application thereof on Envoy Medical; a loss of any of Envoy Medical's key intellectual property rights or failure to adequately
protect intellectual property rights; the effects of catastrophic events, including war, terrorism and other international conflicts;
and other risks and uncertainties set forth in the section entitled "Risk Factors" and "Cautionary Note Regarding Forward
Looking Statements" in the Annual Report on Form 10-K filed by Envoy Medical on March 31, 2025, and in other reports Envoy
Medical files, with the SEC. If any of these risks materialize or Envoy Medical's assumptions prove incorrect, actual results could
differ materially from the results implied by these forward-looking statements. While forward-looking statements reflect Envoy Medical's
good faith beliefs, they are not guarantees of future performance. Envoy Medical disclaims any obligation to publicly update or revise
any forward-looking statement to reflect changes in underlying assumptions or factors, new information, data or methods, future events
or other changes after the date of this press release, except as required by applicable law. You should not place undue reliance on any
forward-looking statements, which are based only on information currently available to Envoy Medical.
Envoy Medical Investor Relations
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