Initial patient enrollment anticipated during first quarter of 2025
White Bear Lake, Minnesota--(Newsfile Corp. - December 19, 2024) - Envoy Medical®, Inc. (NASDAQ: COCH) ("Envoy Medical"), a hearing health company, today announces it has selected seven study sites for participation in its pivotal clinical trial to investigate its fully implanted Acclaim® cochlear implant (Acclaim CI). Initial patient enrollment is anticipated to begin during the first quarter of 2025.
The Investigational Device Exemption (IDE) application for the pivotal study of the Acclaim® Fully Implanted Cochlear Implant was approved by the U.S. Food and Drug Administration (FDA) last month. The Acclaim CI is a fully implanted cochlear implant that previously received Breakthrough Device Designation from the FDA. It is currently differentiated from other cochlear implants in that it is designed to: (1) be fully implanted with no external components attached to the side of the head, (2) leverage the natural anatomy of the ear to pick up sound rather than rely on an external or sub-dermal microphone, (3) allow for all day hearing, and (4) have a battery lasting multiple days between recharge.
Envoy Medical is working closely with each investigational site through site initiation documents and logistics. First patients will begin to be screened and enrolled after Institutional Review Boards (IRBs) have completed their review. Additional study-specific updates can be found on ClinicalTrials.gov, by directly contacting the study sites listed below, or by contacting Envoy Medical.
"We are thrilled to announce the selection of these seven cochlear implant centers for participation in our pivotal clinical trial to study the safety and effectiveness of our breakthrough fully implanted cochlear implant," said Brent Lucas, Chief Executive Officer of Envoy Medical, "Involvement of these highly-respected cochlear implant centers in our trial is, in my opinion, further validation that we have something exciting and potentially game changing in the fully implanted Acclaim® cochlear implant."
Each study site has a dedicated cochlear implant surgeon and up to two cochlear implant audiologists who have already undergone or are scheduled to complete product-specific training on the Acclaim® cochlear implant. These individuals have dedicated their professional lives to helping those who suffer from significant hearing loss.
"These are people at the top of their game," said Lucas, "We are incredibly humbled by the opportunity to work with them."
Mayo Clinic
Rochester, Minnesota
Dr. Colin Driscoll, MD
Dr. Aniket Saoji, Ph.D
Natasha Bertsch, Au.D.
Medical University of South Carolina
Charleston, South Carolina
Dr. Theodore McRackan, MD
Dr. Kara Leyzac, Ph.D.
Elizabeth Camposeo, Au.D.
University of Florida Health
Gainesville, Florida
Dr. Patrick Antonelli, MD
Melissa Hall, Au.D.
Katherine Gray, Au.D
Shohet Ear Associates
Seal Beach, California
Dr. Jach Shohet, MD
Jaqueline Bibee-Lerner, Au.D.,
Cheryl Tanita, Au.D.
Hearts for Hearing
Oklahoma City, Oklahoma
Dr. Wayne Berryhill, MD
Sara Neumann, Au.D.
Center for Neurosciences
Tucson, Arizona
Dr. Abraham Jacob
Mary Goldstien, Au.D.
Alissa Knickerbocker, Au.D.
Cleveland Clinic Foundation
Cleveland, Ohio
Dr. Marc Bassim, MD
Dr. Sarah Sydlowski, Ph.D, MBA
Molly Smeal, Au.D.
About the Fully Implanted Acclaim® Cochlear Implant
We believe 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 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 timing and results of IRB approvals, site documents, logistics or activations, enrollments, and clinical trials of the Acclaim CI, and the participation or any changes in participation of any institution or healthcare professionals in such trials; the Acclaim CI being the first to market fully implanted cochlear implant; the safety, performance, and market acceptance of the Acclaim CI; and 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 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; changes in or removal of Envoy Medical's shares inclusion in any index; 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 Annual Report on Form 10-K filed by Envoy Medical on April 1, 2024, 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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