Envoy Medical®, Inc. (“Envoy Medical”) (NASDAQ: “COCH”), a
revolutionary hearing health company focused on fully implanted
hearing systems, today announced that it will host a fireside chat
event on Thursday December 7, 2023 beginning at noon Central Time.
The event will be hosted by a covering research analyst and feature
interactive Q&A with Brent T. Lucas, Chief Executive Officer,
and David R. Wells, Chief Financial Officer.
Additionally, the Company expects to talk with Dr. Colin
Driscoll and Dr. Aniket Saoji of Mayo Clinic (Rochester, MN) about
their initial experience during an ongoing investigational clinical
study with the fully implanted Acclaim® cochlear implant and how
fully implanted cochlear implants may alter the current cochlear
implant market should one of them obtain regulatory approval. In
addition, the Company plans to talk with a patient who has received
the Esteem® fully implanted active middle ear hearing device about
what it is like hearing with a fully implanted hearing device.
A webcast link to join the live and replay event will be
available on the investor relations section of the Envoy Medical
website, at https://www.envoymedical.com/, by selecting “About,”
“Investors,” then “Events.”
“Our third quarter results demonstrated significant progress in
our development efforts, in addition to our listing as a public
company on the Nasdaq. We are looking forward to offering an
opportunity for investors to learn more about our business strategy
and also to hear from Doctors Driscoll and Saoji on their initial
Acclaim experience. The discussion will include time with one of
our Esteem® patients to hear about life with a fully implanted
hearing device. We hope that investors will be able to more fully
understand our business, the incredible potential offered by both
of our fully implanted solutions, and the unique benefits of our
sensor technology leveraging the natural ear to pick up sound,
rather than external or sub-dermal microphones. We expect to
achieve significant progress in 2024, including the launch of our
clinical program to seek FDA approval of the Envoy Acclaim, which
we believe will be the first fully implantable cochlear implant of
its kind, addressing a significant unmet need in the large and
growing hearing industry,” said Mr. Lucas, Envoy Medical’s Chief
Executive Officer.
About Envoy Medical
Envoy Medical, Inc. (NASDAQ: COCH), headquartered in White Bear
Lake, Minnesota, is a hearing health company focused on providing
innovative medical technologies.
Envoy Medical is dedicated to pushing hearing technology beyond
the status quo to provide patients with improved access, usability,
independence and quality of life.
About the Fully Implanted Acclaim® Cochlear
Implant
We believe the fully implanted Acclaim Cochlear Implant will be
a first-of-its-kind fully implanted cochlear implant. 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 is designed to address severe to profound
sensorineural hearing loss that is not adequately addressed by
hearing aids. The Acclaim 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. We believe the Acclaim was the first hearing-focused device
to receive Breakthrough Device Designation.
CAUTION The fully implanted Acclaim Cochlear Implant is
an investigational device. Limited by United States law to
investigational use.
Important safety information for the Esteem 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 operational improvements and capital investments,
the ability to obtain additional patents and develop future
products or product improvements, clinical testing timeline and
results, the benefits of the Acclaim device compared to existing
cochlear implants, the Acclaim being the first to market fully
implanted cochlear implant, the size of Envoy Medical’s addressable
market, operational performance, future market conditions or
economic performance and developments in the capital and credit
markets, as well as any information concerning possible or assumed
future operations of Envoy Medical. Forward-looking statements also
include statements regarding the expected benefits of the Nasdaq
listing. The forward-looking statements contained in this press
release includes statements regarding future regulatory approval of
the Envoy Acclaim device, the process for regulatory approval of
the Envoy Acclaim, and the success the Envoy Medical products will
have once they receive regulatory approval or Medicare
reimbursement. These forward-looking statements 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 Envoy
Medical’s performance following its business combination
transaction, which closed September 29, 2023; changes in the market
price of shares of Envoy Medical’s Class A Common Stock; 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
Registration Statement on Form S-4 (File No. 333-271920) filed
by Envoy Medical (then known as Anzu Special Acquisition
Corp I), 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.
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Investor Contact:
Matt KrepsDarrow Associates Investor Relations(214)
597-8200mkreps@darrowir.com
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