• Surgical Experience with Three Initial Acclaim® Patients Documents Innovation Efforts in the Growing Cochlear Implant Market

WHITE BEAR LAKE, Minnesota, Oct. 19, 2023 (GLOBE NEWSWIRE) -- 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:

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