Full Press Release Details
Medical Secures Up To $10 Million Term Debt Financing to Advance Upcoming Clinical Trial
Entrepreneur Glen Taylor Commits to a 5-Year Facility to Support Company's upcoming FDA Clinical Trial for the Acclaim Fully
Implanted Cochlear Implant
BEAR LAKE, Minnesota, March 04, 2024 (GLOBE NEWSWIRE) -- 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.
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."
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.
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."
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.
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
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.
Medical is dedicated to pushing hearing technology beyond the status quo to provide patients with improved access, usability, independence
and quality of life.
the Fully Implanted Acclaim Cochlear Implant
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.
Acclaim system is designed to address severe to profound sensorineural hearing loss that is not adequately addressed by hearing aids.
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.
The fully implanted Acclaim Cochlear Implant is an investigational device. Limited by United States law to investigational use.
safety information for the Esteem can be found at: https://www.envoymedical.com/safety-information.
the Fully Implanted Esteem Active Middle Ear Hearing Device
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.
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.
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.
learn more about the Esteem implant, visit https://www.envoymedical.com/middle-ear-implants.
Information and Where to Find It
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.
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.