Envoy Medical Achieves Clinical Trial Milestone and is Optimistic About Expansion into Final Stage of Trial
Envoy Medical (NASDAQ: COCH) has reached a significant milestone in its pivotal clinical trial for the Acclaim® fully implanted cochlear implant. The company successfully completed the activation of all 10 study participants' implants in the first stage of the trial. CEO Brent Lucas expressed optimism about expanding into the second and final stage during Q4 2025.
The company reports strong interest from individuals with significant hearing loss who are specifically waiting for fully implanted cochlear implant options, suggesting substantial market demand for this innovative technology.
Envoy Medical (NASDAQ: COCH) ha raggiunto un traguardo importante nel suo studio clinico cruciale per l'impianto cocleare completamente impiantabile Acclaim®. L'azienda ha completato con successo l'attivazione degli impianti di tutti e 10 i partecipanti nella prima fase dello studio. Il CEO Brent Lucas si è detto ottimista riguardo all'espansione nella seconda e ultima fase prevista per il quarto trimestre del 2025.
L'azienda segnala un forte interesse da parte di persone con perdita uditiva significativa che attendono specificamente opzioni di impianti cocleari completamente impiantabili, indicando una domanda di mercato rilevante per questa tecnologia innovativa.
Envoy Medical (NASDAQ: COCH) ha alcanzado un hito importante en su ensayo clínico pivotal para el implante coclear totalmente implantado Acclaim®. La compañía completó con éxito la activación de los implantes de los 10 participantes en la primera fase del estudio. El CEO Brent Lucas expresó optimismo sobre la expansión hacia la segunda y última fase durante el cuarto trimestre de 2025.
La empresa reporta un gran interés por parte de personas con pérdida auditiva significativa que están esperando específicamente opciones de implantes cocleares totalmente implantados, lo que sugiere una demanda considerable en el mercado para esta tecnología innovadora.
Envoy Medical (NASDAQ: COCH)는 Acclaim® 완전 이식형 인공와우에 대한 중요한 임상 시험에서 중요한 이정표를 달성했습니다. 회사는 시험 첫 단계에서 10명의 참가자 모두의 이식 장치 활성화를 성공적으로 완료했습니다. CEO 브렌트 루카스는 2025년 4분기에 두 번째이자 마지막 단계로 확장할 것에 대해 낙관적인 입장을 밝혔습니다.
회사는 심각한 청력 손실이 있는 개인들 사이에서 완전 이식형 인공와우 옵션을 기다리는 수요가 강하다고 보고하며, 이 혁신적인 기술에 대한 시장 수요가 상당함을 시사합니다.
Envoy Medical (NASDAQ : COCH) a franchi une étape importante dans son essai clinique pivot pour l'implant cochléaire entièrement implanté Acclaim®. La société a réussi à activer les implants des 10 participants à l'étude lors de la première phase de l'essai. Le PDG Brent Lucas s'est montré optimiste quant à l'expansion vers la deuxième et dernière phase au cours du quatrième trimestre 2025.
L'entreprise rapporte un fort intérêt de la part des personnes souffrant d'une perte auditive importante, qui attendent spécifiquement des options d'implants cochléaires entièrement implantés, ce qui suggère une demande importante sur le marché pour cette technologie innovante.
Envoy Medical (NASDAQ: COCH) hat einen bedeutenden Meilenstein in seiner entscheidenden klinischen Studie für das vollständig implantierbare Cochlea-Implantat Acclaim® erreicht. Das Unternehmen hat erfolgreich die Aktivierung der Implantate aller 10 Studienteilnehmer in der ersten Phase der Studie abgeschlossen. CEO Brent Lucas zeigte sich optimistisch, im vierten Quartal 2025 in die zweite und letzte Phase überzugehen.
Das Unternehmen berichtet von großem Interesse seitens Personen mit erheblichem Hörverlust, die speziell auf vollständig implantierbare Cochlea-Implantate warten, was auf eine erhebliche Marktnachfrage nach dieser innovativen Technologie hinweist.
- Successful activation of all 10 study participants' Acclaim® cochlear implants in first trial stage
- Clinical trial progressing on track as planned
- Strong reported patient interest indicating significant pent-up market demand
- Potential expansion into final trial stage in Q4 2025
- None.
White Bear Lake, Minnesota--(Newsfile Corp. - May 13, 2025) - Envoy Medical®, Inc. (NASDAQ: COCH) ("Envoy Medical"), a revolutionary hearing health company focused on fully implanted hearing devices that leverage the ear's natural anatomy, today announces achieving the important milestone of successful activation of all 10 study participants' fully implanted Acclaim® cochlear implants in the first stage of the Company's pivotal clinical trial.
Brent Lucas, CEO of Envoy Medical commented: "We are excited to report the positive and meaningful progress of our pivotal clinical trial, which is currently on track and moving along as anticipated. We are optimistic we will be able to expand the study into the second and final stage during the fourth quarter of this year. We are also encouraged by the reported interest from people suffering from significant hearing loss who want to wait until a fully implanted cochlear implant is an option. We believe there is significant pent-up demand for fully implanted cochlear implants, and we are thrilled to be closer to meeting this unmet need."
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, follow-up visits, data, and clinical trials of the Acclaim CI, and the participation or any changes in participation of any subjects, institutions 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 March 31, 2025, 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 Relations:
Envoy Medical Investor Relations
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Media Contact:
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FAQ
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