Acclaim 인공와우 임상시험 6개월 추적 관찰 마일스톤 달성

원문

Envoy Medical Hits Six-Month Milestone, Marks Halfway Point in Final Stage of Data Collection, and Highlights Differentiated Device Design

Company Believes It Is the First to Reach This Milestone in a U.S. Pivotal Trial of a Fully Implanted Cochlear Implant Remains on Track to Reach 12-Month Visit Milestone by Early Q2 2027 and Submit Final Clinical PMA Module by End of Q2 2027 White Bear Lake, Minnesota--(Newsfile Corp. - October 20, 2026) - Envoy Medical ® Inc. (NASDAQ: COCH) ("Envoy Medical" or the "Company"), a hearing health and neuroprosthetics company pioneering fully implanted hearing solutions, today announced that it has surpassed the six-month follow-up visit milestone for the Company's pivotal clinical trial evaluating the investigational fully implanted Acclaim® cochlear implant. This milestone signifies the halfway point in the trial's final stage of data collection as each participant is followed for a total of 12 months. To the Company's knowledge, Envoy Medical is the first company to achieve this milestone in a U.S. pivotal clinical trial of a fully implanted cochlear implant and remains the only company pursuing fully implanted cochlear implants ("FCIs") with its differentiated device design. The Company remains on track to complete 12-month visits by early Q2 2027. Envoy Medical has submitted two of the four planned modules of its Modular Premarket Approval ("PMA") application to the U.S. Food and Drug Administration ("FDA") and expects to submit the final module, containing final clinical trial data, by the end of Q2 2027. "We continue to make tangible progress in our pivotal trial and remain on track to complete data collection early next year, allowing for the potential of an FDA decision by the end of 2027 or first part of 2028," said Brent Lucas, Chief Executive Officer of Envoy Medical. "Cochlear implant candidates have wanted a fully implanted cochlear implant option for decades, and they are now within a short year or two of that being a realistic possibility here in the United States. It is an extremely exciting time for those with significant hearing loss." The design of the Company's investigational Acclaim® device is significantly differentiated from other FCIs being pursued: Requires no external device to be worn on the side of the head, not even for recharging; Has no implanted magnet to hold an external device on side of the head; Leverages the natural ear to capture sound via middle ear sensor, no implanted microphone; Allows for use of ear-worn third-party devices such as earbuds or hearing aids; Features a rechargeable battery in the chest designed to last multiple days between charges; Modular design allows for battery replacement without explanting the entire system; The fully implanted Acclaim® cochlear implant received Breakthrough Device Designation from the FDA in 2019 and is currently under investigation as part of a U.S.-based pivotal clinical trial. For more information on the trial, visit www.envoymedical.com/acclaim-pivotal . To be added to the Envoy Medical email distribution list, please email Envoy@kcsa.com with COCH in the subject line. It is important to note that approval of an Investigational Device Exemption ("IDE") application, the expansion of an IDE pivotal clinical trial, or the completion of any follow-up visit milestone does not ensure that the results of the investigation will ultimately provide a reasonable assurance of the safety and effectiveness of the device or assure a determination of approval of a premarket submission. About Envoy Medical, Inc. Envoy Medical (NASDAQ: COCH) is a hearing health and neuroprosthetics company focused on providing innovative technologies across the hearing loss spectrum. Envoy Medical has pioneered one-of-a-kind, fully implanted devices for hearing loss, including its fully implanted Esteem® active middle ear implant, commercially available in the U.S. since 2010, and the fully implanted Acclaim® cochlear implant, an investigational device. Envoy Medical is dedicated to pushing hearing technology beyond the status quo to improve access, usability, compliance, and ultimately quality of life. 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. 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 operations; the ability to obtain additional patents and develop future products or product improvements; the ability to maintain compliance with Nasdaq rules and requirements; the timing and future outcome of its FDA pivotal trial; the ability to raise capital and the amount of capital required to complete the FDA pivotal trial and early commercialization; the Acclaim CI being the first to market fully implanted cochlear implant; the timing and results of activations, enrollments, follow-up visits, data, and clinical trials of the Acclaim CI; performance of the Acclaim CI during clinical trials, including improvement of patient outcomes over time after implant; and the participation or any changes or delays in participation of any subjects, institutions, or healthcare professionals in such trials; the safety, performance, and market acceptance of the Acclaim CI; the Acclaim CI's differentiation and competitive position relative to other cochlear implants; the timing and results of the Acclaim CI's PMA submissions to the FDA, including modular submissions and related feedback; the size of Envoy Medical's addressable market, operational performance, future market conditions or economic performance and developments in the capital and credit markets; 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; the ability to engage 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 March 23, 2026, 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: Phil Carlson KCSA Strategic Communications O: 212.896.1233 E: Envoy@kcsa.com To view the source version of this press release, please visit https://www.newsfilecorp.com/release/319914