Full Press Release Details
Envoy Medical Reports on Second Quarter 2025
White Bear Lake, Minnesota - (July 31,
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 second quarter ended June 30,
2025, as well as other subsequent events.
Financial and Corporate Highlights for Second Quarter and to date:
Brent Lucas, CEO of Envoy Medical commented: "This
quarter was another win for Envoy Medical as we continue to successfully execute our strategy. We continued to make significant strides
with our clinical study as all 10 study participants in the Acclaim trial were successfully activated and completed their one-month
follow-up visits with zero reported serious adverse events or unanticipated device events. We are confident that, once approved, our fully
implanted Acclaim cochlear implant will enjoy substantial patient interest, allowing us a rare opportunity to disrupt an established
market and grow into a significant market participant relatively quickly. We believe our investigational fully implanted Acclaim
cochlear implant is well-positioned to be able to capture market share as the industry moves towards fully implanted cochlear implants
and away from bulky externals.
As it relates to the Esteem fully implanted
active middle ear implant, which already has FDA approval, we are excited to see the potential for renewed opportunity and possibility.
Meaningful changes to reimbursement around this class of hearing devices would provide Envoy Medical with a viable pathway for a product
that already has FDA approval, is currently one-of-a-kind in the marketplace, and has demonstrated patient demand. We continue to see
wisdom in strategic investments around this product, as a shift in policy or reimbursement could rapidly change Envoy Medical's
position in the market.
As we continue to execute our strategy and drive
shareholder value, we remain steadfast in our belief that Envoy Medical will be a significant player in the hearing device industry in
Financial Results for the Quarter Ended June 30, 2025
Net revenues increased $10 thousand for the three
months ended June 30, 2025, compared to the three months ended June 30, 2024.
R&D expenses decreased $0.1 million to $2.485
million for the three months ended June 30, 2025, compared to the three months ended June 30, 2024. R&D product costs decreased
$0.5 million from the prior period as we moved from the development phase into the clinical trials phase. Personnel costs and other R&D
costs increased $0.3 million and $0.1 million, respectively, from the prior period to support the clinical trials with additional headcount
and equipment, respectively.
Sales and marketing expenses decreased $0.1 million
to for the three months ended June 30, 2025, compared to the three months ended June 30, 2024.
General and administrative expenses increased
$0.5 million for the three months ended June 30, 2025, compared to the three months ended June 30, 2024. The increase is primarily due
to a $0.3 million severance accrual for the three months ended June 30, 2025.
As of June 30, 2025, cash was approximately $5.3
For more information about Envoy Medical's innovation
pipeline and intellectual property portfolio, visit www.envoymedical.com.
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
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.
** Category III CPT codes are temporary codes
for emerging technologies, services, and procedures. The inclusion of a descriptor and its associated code number in the CPT code set
does not represent endorsement by the American Medical Association of any particular diagnostic or therapeutic procedure/service. Inclusion
or exclusion of a procedure/service does not imply any health insurance coverage or reimbursement policy.
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 ability to obtain additional patents and develop future products or product
improvements, the Acclaim CI being the first to market fully implanted cochlear implant, the timing and results of approvals, site documents,
logistics, activations, enrollments, follow-up visits, data, and clinical trials of the Acclaim CI, and the participation or any changes
in participation of any subjects, institutions, or healthcare professionals in such trials; the safety, performance, and market acceptance
of the Acclaim CI; the impact of CPT codes for active middle ear hearing devices, changes in reimbursement for the Esteem FI-AMEI device
or other changes in reimbursement policies or coverage decisions, changes in the hearing health market, and further development of the
Esteem FI-AMEI device; 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; 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