Full Press Release Details
Envoy Medical Reports Landmark Accomplishments,
FDA Approval of First-Of-Its-Kind Fully Implanted Cochlear Implant
Company Completes Historic Trial Enrollment,
Secures Transformational Financing, and
Sees Promising Early Clinical Data Presented at Industry Conferences
White Bear Lake, Minnesota - May 11,
2026 - Envoy Medical Inc. (NASDAQ: COCH) ("Envoy Medical" or the "Company"), a hearing
health company pioneering fully implanted hearing solutions, today reported first quarter 2026 results and landmark achievements that
advance the Company another step closer toward commercialization of its investigational Acclaim cochlear implant.
first quarter of 2026 marked a transformative period for Envoy Medical, highlighted by the completion of enrollment in our pivotal clinical
trial and the successful execution of a significant financing," said Brent Lucas, Chief Executive Officer of Envoy Medical.
"Achieving full enrollment in our pivotal clinical
study represents a critical step. We continue to be encouraged by the trial's progress and remain focused on advancing toward PMA
submission and, ultimately, commercialization. With a substantially strengthened balance sheet and the support of leading healthcare investors,
we believe we are well positioned to execute on our strategic objectives and deliver on the roadmap ahead."
Corporate and Financial Highlights for Q1 2026:
In a defining milestone for the hearing health sector, Envoy
Medical became the first cochlear implant company to achieve full enrollment of a U.S. pivotal clinical trial evaluating a fully implanted
cochlear implant seeking FDA approval. The 56th and final patient was successfully implanted on March 11, 2026, completing enrollment
across U.S. sites. The Company is now collecting 12-month follow-up data from all participants, with a Premarket Approval (PMA) submission
to the FDA to follow.
Envoy Medical closed an upsized public offering for up to
$78.0 million, including $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. The financing was led by Nantahala Capital and included healthcare-dedicated
funds such as Broadfin Holdings, as well as existing shareholders including members of the Board and management team.
As of February 20, 2026, Envoy Medical has expanded its global
IP portfolio to 47 patents across North America, Europe, Asia, and Australia. In February alone, the Company secured three new patents
strengthening its competitive position in the fully implanted hearing space.
Highlights Subsequent to Q1 2026:
Interim six-month clinical data from the first 10 patients
in the pivotal study showed no study-defined serious adverse events, mean CNC word recognition improved from 15.2% to 39.2%, median daily
device wear time of 24 hours, and improvements in quality-of-life and tinnitus scores. Initial safety and performance data for these 10
patients were presented at the American Academy of Audiology Annual Conference and the Combined Otolaryngology Spring Meetings.
Following the completion of enrollment, Envoy Medical confirmed
that all 56 patients implanted in the pivotal clinical trial have been activated. This milestone validates that the full patient cohort
is progressing through the study protocol on schedule, keeping the Company on track to collect the 12-month endpoint data required for
its planned PMA submission to the FDA.
Envoy Medical appointed medical device veteran Chas McKhann
to its Board of Directors in April 2026, further enhancing the Company's expertise as it prepares to conclude its pivotal clinical
study and prepare for commercial launch.
The first three patients implanted in the pivotal trial successfully
completed their 12-month endpoint visit, marking a key milestone in the study's progress. The primary endpoints for the trial are tied
to 12-month data, and achieving this critical milestone on schedule underscores the Company's continued execution as it steadily marches
toward PMA submission and commercialization.
Financial Results for the Quarter Ended March 31, 2026 (dollars
Net Revenue was $39 for the three months ended March 31, 2026.
Cost of goods sold for the three months ended March 31, 2026, were
$313, compared to $226. The $87 increase is primarily due to higher scrap and materials usage as well as increased fees for third-parties
performing work related to our products.
R&D expenses for the three months ended March 31, 2026, were $3,642
compared to $2,748 for the three months ended March 31, 2025. This increase of $894 mainly reflects additional clinical trial activity
and related personnel costs during enrollment.
Sales and marketing expenses for the three months ended March 31, 2026,
were $164 compared to $358 for the three months ended March 31, 2025. The decrease of $194 is primarily due to the reallocation of resources
to research and development activities in support of the clinical trial.
General and administrative expenses are $1,879 for the three months
ended March 31, 2026, compared to $1,821 for the three months ended March 31, 2025. The increase of $58 was primarily due to higher investor
relations and legal expenses.
As of March 31, 2026, cash was approximately $25,251.
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 (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.
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