• Analyst Hosted Event to Feature Comprehensive Discussion of Envoy Medical’s Products, Interviews with Two Study Investigators and Key Opinion Leaders in Cochlear Implants

WHITE BEAR LAKE, Minnesota, Dec. 04, 2023 (GLOBE NEWSWIRE) -- Envoy Medical®, Inc. (“Envoy Medical”) (NASDAQ: “COCH”), a revolutionary hearing health company focused on fully implanted hearing systems, today announced that it will host a fireside chat event on Thursday December 7, 2023 beginning at noon Central Time. The event will be hosted by a covering research analyst and feature interactive Q&A with Brent T. Lucas, Chief Executive Officer, and David R. Wells, Chief Financial Officer.

Additionally, the Company expects to talk with Dr. Colin Driscoll and Dr. Aniket Saoji of Mayo Clinic (Rochester, MN) about their initial experience during an ongoing investigational clinical study with the fully implanted Acclaim® cochlear implant and how fully implanted cochlear implants may alter the current cochlear implant market should one of them obtain regulatory approval. In addition, the Company plans to talk with a patient who has received the Esteem® fully implanted active middle ear hearing device about what it is like hearing with a fully implanted hearing device.

A webcast link to join the live and replay event will be available on the investor relations section of the Envoy Medical website, at https://www.envoymedical.com/, by selecting “About,” “Investors,” then “Events.”

“Our third quarter results demonstrated significant progress in our development efforts, in addition to our listing as a public company on the Nasdaq. We are looking forward to offering an opportunity for investors to learn more about our business strategy and also to hear from Doctors Driscoll and Saoji on their initial Acclaim experience. The discussion will include time with one of our Esteem® patients to hear about life with a fully implanted hearing device. We hope that investors will be able to more fully understand our business, the incredible potential offered by both of our fully implanted solutions, and the unique benefits of our sensor technology leveraging the natural ear to pick up sound, rather than external or sub-dermal microphones. We expect to achieve significant progress in 2024, including the launch of our clinical program to seek FDA approval of the Envoy Acclaim, which we believe will be the first fully implantable cochlear implant of its kind, addressing a significant unmet need in the large and growing hearing industry,” said Mr. Lucas, Envoy Medical’s Chief Executive Officer.

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 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 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.

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 here.

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 ability to obtain additional patents and develop future products or product improvements, clinical testing timeline and results, the benefits of the Acclaim device compared to existing cochlear implants, the Acclaim being the first to market fully implanted cochlear implant, 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 includes statements regarding future regulatory approval of the Envoy Acclaim device, the process for regulatory approval of the Envoy Acclaim, and the success the Envoy Medical products will have once they receive regulatory approval or Medicare reimbursement. These forward-looking statements 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 Envoy Medical’s performance following its business combination transaction, which closed September 29, 2023; 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 Kreps
Darrow Associates Investor Relations
(214) 597-8200
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