A recent clinical publication in the Journal of Clinical Medicine
(JCM) highlighted early surgical experience with Envoy Medical®,
Inc.’s (“Envoy Medical”) (NASDAQ: “COCH”) investigational Acclaim®
fully implantable cochlear implant. According to the publication,
"All three surgeries proceeded without complication, and at
activation, all three patients were hearing through their devices.
Surgery is more technically challenging compared to a standard
cochlear implant, but the skills needed can be mastered by a
dedicated otologic surgeon."
The Company currently expects to file for an investigational
device exemption (IDE) in early 2024 to commence a pivotal clinical
trial later that year.
Current cochlear implants rely on bulky external hardware that
are held in place on the head by a magnet, which can cause
discomfort and may not be suitable for all activities, including
sleeping, showering, swimming, strenuous activity and other common
daily events.
Envoy Medical’s device, the fully implanted Acclaim® cochlear
implant seeks to alleviate these limitations by being the first
fully implanted cochlear implant (sometimes referred to as a
totally implanted cochlear implant or “TICI”). By using an
implanted middle ear sensor and an implanted rechargeable power
supply, Acclaim® aims to eliminate the need for any externally worn
components.
Acclaim® was granted Breakthrough Device Designation from the
U.S. Food and Drug Administration (FDA) and is currently in an
early feasibility study at Mayo Clinic (Rochester, Minnesota).
Envoy Medical’s Acclaim® may become the first fully implanted
cochlear implant to begin a pivotal trial in the United States.
Unlike other cochlear implants, Acclaim® intends to leverage the
patient’s natural ear – rather than an external microphone – to
capture acoustic energy. The Acclaim® is designed to not require
the use of an external processor during the day or daily
recharging.
“We are excited to see the Mayo Clinic’s team publish on their
initial experience with the fully implanted Acclaim® cochlear
implant, which we believe will be a significant advancement in a
growing but underserved hearing health market,” said Brent Lucas,
Envoy Medical’s Chief Executive Officer. “By detailing actual
surgical experience, the authors provide cochlear implant
specialists an early opportunity to learn about this innovation,
the potential quality of life benefits of a fully implanted device,
and that the additional surgical steps required likely will not be
an impediment to adoption with appropriate training.”
“People often refuse to acknowledge the limitations of the
current cochlear implants on the market in public, but in private,
they do,” said Lucas, “We believe people want a fully implanted
cochlear implant, and we are excited to be pushing the industry in
that direction just as companies like Inspire Medical pushed the
sleep apnea industry towards a fully implanted solution.”
The Mayo Clinic authors note: “While it is only conjecture at
this point, one may presume that increased breadth and comfort of
use may improve quality-of-life for many recipients, particularly
those who feel their disability prevents them from taking part in
certain activities.”
The authors also highlight that this novel device is still
developing. Certain patients may not be good candidates and that
programming requires careful monitoring.
If approved by the FDA, Envoy Medical intends to target a
significantly under-penetrated adult cochlear implant market, which
it believes to be more than $80 billion in the US. The paper notes
that the success of cochlear implants has resulted in steadily
widening the criteria by which patients can qualify for a cochlear
device.
The complete study can be found under the citation: Dornhoffer,
J.R.; Lawlor, S.K.; Saoji, A.A.; Driscoll, C.L.W. Initial
Experiences with the Envoy Acclaim® Fully Implanted Cochlear
Implant. J. Clin. Med. 2023, 12, 5875.
https://doi.org/10.3390/jcm12185875
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 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 and may still be the
only hearing focused medical technology to receive the
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,
clinical testing timeline and results, the benefits of the Acclaim
device compared to existing cochlear implants, 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 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 transactions
and 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 the Business Combination;
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.
###
Investor Contact:
Matt KrepsDarrow Associates Investor Relations(214)
597-8200mkreps@darrowir.com
Envoy Medical (NASDAQ:COCH)
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