Envoy Medical®, Inc. (“Envoy Medical”) (NASDAQ: “COCH”), a
revolutionary hearing health company focused on fully implanted
hearing systems, today announced the closing of up to a $10
million, five-year lending facility provided by existing investor
and billionaire entrepreneur Glen Taylor. The facility is unsecured
and does not provide for conversion into equity. Envoy Medical drew
$5 million on the facility at its origination.
“This new financing will support the launch of our upcoming
US-based pivotal clinical trial for our innovative investigational
fully implanted Acclaim® cochlear implant,” said Envoy Medical CEO
Brent Lucas. “The terms, which we believe are friendly and
favorable to the company, of this financing also demonstrate the
continued commitment of our largest investor to step up and make
sure we are well positioned to move forward.”
Funds will be available as needed and bear interest at 8% over
the term of the loan. Please see Form 8-K filed today for
additional discussion of terms and conditions of the
investment.
Lucas continued, “Glen remains a dedicated believer in and
partner to our innovative approach toward advancing the hearing
health market with innovative products. Our revolutionary design –
leveraging the natural ear to pick up sound rather than a
microphone – is an opportunity to dramatically change the landscape
for hearing health, using new, fully implantable technologies. We
believe that fully implanted devices, by virtue of their design,
come with advantages that patients may value and prefer over the
current standard of care devices. We look forward to investigating
as we proceed.”
In addition to the continued advancement of its fully implanted
Acclaim® cochlear implant, which has received Breakthrough
Designation from the FDA, Envoy Medical is also the only current
company to have a FDA-approved, fully implanted active middle ear
hearing device (different from their investigational fully
implanted cochlear implant). Approximately 1,000 Esteem® fully
implanted active middle ear implants have been installed.
Further, the Company believes that recently introduced
Congressional legislation to re-classify fully implanted active
middle ear implants properly, is long overdue. Should the bill
become law, it would provide greater patient access to important
technologies and encourage more innovation and competition within
the category. See further discussion on this with Messer’s. Lucas
and Taylor on Fox Business Network,
https://www.foxbusiness.com/video/6347858272112?playlist_id=933116626001.
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. As a U.S. company, Envoy Medical
provides jobs in Minnesota.
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 system is designed to address severe to profound
sensorineural hearing loss that is not adequately addressed by
hearing aids.
The Acclaim Cochlear Implant received the Breakthrough Device
Designation from the U.S. Food and Drug Administration (FDA) in
2019. We believe the Acclaim system 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.
About the Fully Implanted Esteem® Active Middle Ear
Hearing Device
The fully implanted Esteem® active middle ear hearing device is
the only FDA approved, completely internal hearing device designed
to improve the hearing of adults diagnosed with moderate to severe
sensorineural hearing loss.
Instead of a microphone, the Esteem device uses a novel sensor
to leverage the natural anatomy of the ear to capture sound and
convert it into electrical signals that are used by the implant to
address hearing loss.
The Esteem implant has no externally-worn components required
for daily use which allows for “invisible hearing,” the potential
for 24/7 hearing, and removing many limitations of hearing aids.
The Esteem implant is available in the U.S. through FDA PMA
approval. It is not currently covered by Medicare or Medicaid, and
is not widely covered by private insurers.
To learn more about the Esteem implant, visit
https://www.envoymedical.com/middle-ear-implants.
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 availability and benefits of future funding, the Acclaim being
the first to market fully implanted cochlear implant, the impact of
proposed legislation on the hearing health market, reimbursement
for the Esteem device, and the Envoy Medical business, and future
market conditions or economic performance, as well as 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 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 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:
Scott ArnoldCoreIR(310) 497-8817scotta@coreir.com
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