COCH Envoy Medical Inc

Envoy Medical®, Inc. (“Envoy Medical”) (NASDAQ: “COCH”), a hearing health company focused on fully implanted hearing systems, today commemorates its one-year anniversary trading as a public company. On September 29, 2023, the formerly private Envoy Medical merged with Anzu Special Purpose Acquisition Corp I, creating the now publicly traded Envoy Medical. COCH began trading on the Nasdaq Capital Market on October 2, 2023.  

“Over the last year, we have made significant progress towards our goal of becoming one of the leading hearing implant companies in the world. We have not been shy about our belief that we are well positioned to take market share from existing market participants, and we also see a possibility where we grow the entire market segment as a whole. We operate on the investment thesis that people want fully implanted hearing devices, and we are well-positioned to capitalize on that sentiment,” said Envoy Medical CEO Brent Lucas.

“Savvy investors are beginning to pay attention to our story and as a result our stock is currently performing better than most companies going public via a SPAC since the start of 2023. In fact, if you remove the first 60 days post-deSPAC ‘washout period,’ we are one of the top performing stocks in the deSPAC peer group over that time.

“We believe our company is poised to take advantage of a trend within the cochlear implant industry to miniaturize external components. What better way to miniaturize cochlear implants than to design them to be fully implanted? We are encouraged that some of our competitors are now openly discussing their totally implanted plans, but we continue to believe we have a better solution with our sensor technology and overall architecture, since our solution is the only one we are aware of that allows patients to use the anatomy of their ear for hearing. Competition in this area validates our existence and that we are on to something potentially disruptive.

“In addition, we are making progress in our significant push to get fully implanted active middle ear implants to become coverable technologies under Medicare. Two bills have been introduced in Congress to correct a long-standing definitional issue that prevents our first device, the Esteem® device, from coverage. Should that happen, and it is admittedly unknown if it will ever happen, Envoy Medical is the only company with a currently FDA approved fully implanted active middle ear implant. It could be a very interesting opportunity for us, and another chance to disrupt the market.

“At the end of the day, hearing loss is a problem that impacts people 24 hours a day. You cannot turn off your hearing loss. It is there all day every day. Yet, you have to take off your hearing aids and cochlear implants at night or in certain situations. You want to hear the things that go ‘bump in the night’, if you will, for the safety of you and those around you. You want to hear while taking a shower. You want to be able to hear your kids cry at night. You want to be able to hear your spouse in the other room if they need help. The answer, we believe, is a fully implanted device that is with you all day, every day, and designed to give you sound awareness in your most vulnerable moments.

“Changing the status quo is not easy. Making medical devices are not easy. We have, however, built a team and a company that we believe will be able to fundamentally shift the perceptions around hearing loss. We hope you join us in our journey and look forward to the future. If we are successful, Envoy Medical will become a name synonymous with hearing care innovation. I am so proud of our team as we are making the world a better place,” concluded Mr. Lucas.

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.

About the Fully Implanted Acclaim® Cochlear Implant

We believe the fully implanted Acclaim Cochlear Implant (“Acclaim CI”) 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 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. We believe the Acclaim CI was the first hearing-focused device to receive Breakthrough Device Designation.

CAUTION The fully implanted Acclaim Cochlear Implant is an investigational device. Limited by Federal (or United States) law to investigational use.

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 future market trading performance of our Class A Common Stock; the future size of the market for our products; the performance and benefits of our products in comparison to competitor products; the benefits of intellectual property developed by Envoy; the potential for passage of legislation related to reimbursement for active middle ear hearing devices; the impact that such proposed legislation might have on the hearing health market, reimbursement for the Esteem FI-AMEI 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 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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Investor Contact: CORE IR 516-222-2560 investorrelations@envoymedical.com