Envoy Medical Receives FDA Approval To Initiate Pivotal Clinical Study for Breakthrough Hearing Device
Envoy Medical (NASDAQ: COCH) has received FDA approval for its Investigational Device Exemption (IDE) application to begin a pivotal study of the Acclaim® Fully Implanted Cochlear Implant. The device features an implanted sensor that utilizes the ear's natural anatomy to capture sound, distinguishing it from existing cochlear implants. The FDA approved a staged clinical study, allowing preliminary data collection on a subset of patients before expanding to full enrollment. The company plans to collaborate with top U.S. cochlear implant institutions as investigational sites.
Envoy Medical (NASDAQ: COCH) ha ricevuto l'approvazione dalla FDA per la sua richiesta di Esenzione per Dispositivi Sperimentali (IDE) per avviare uno studio cruciale sull'Impianto Cocleare Acclaim® Completamente Impiantato. Il dispositivo è dotato di un sensore impiantato che utilizza l'anatomia naturale dell'orecchio per catturare il suono, distinguendosi dagli impianti cocleari esistenti. La FDA ha approvato uno studio clinico in fasi, consentendo la raccolta di dati preliminari su un sottoinsieme di pazienti prima di ampliare l'arruolamento completo. L'azienda prevede di collaborare con le principali istituzioni statunitensi nel campo degli impianti cocleari come siti di sperimentazione.
Envoy Medical (NASDAQ: COCH) ha recibido la aprobación de la FDA para su solicitud de Exención de Dispositivos Investigacionales (IDE) para comenzar un estudio pivotal del Implante Coclear Acclaim® Totalmente Implantado. El dispositivo cuenta con un sensor implantado que utiliza la anatomía natural del oído para captar el sonido, diferenciándose de los implantes cocleares existentes. La FDA aprobó un estudio clínico por etapas, permitiendo la recolección de datos preliminares sobre un subconjunto de pacientes antes de ampliar la inscripción total. La empresa planea colaborar con las principales instituciones estadounidenses de implantes cocleares como sitios de investigación.
Envoy Medical (NASDAQ: COCH)는 완전 이식형 와우 임플란트 Acclaim®의 주요 연구를 시작하기 위한 FDA 조사 기기 면제(IDE) 신청 승인을 받았습니다. 이 장치는 귀의 자연적 해부학을 사용하여 소리를 포착하는 이식된 센서를 특징으로 하며, 기존의 와우 임플란트와 구별됩니다. FDA는 단계적 임상 연구를 승인하여 전체 등록으로 확대하기 전에 환자 하위 집합에 대한 초기 데이터 수집을 허용했습니다. 이 회사는 주요 미국 와우 임플란트 기관과 협력하여 연구 사이트로 사용할 계획입니다.
Envoy Medical (NASDAQ: COCH) a reçu l'approbation de la FDA pour sa demande d'Exemption pour Dispositif d'Investigation (IDE) afin de commencer une étude clé sur l'Implant Cochléaire Acclaim® Entièrement Implanté. L'appareil dispose d'un capteur implanté qui utilise l'anatomie naturelle de l'oreille pour capturer le son, le distinguant des implants cochléaires existants. La FDA a approuvé une étude clinique par étapes, permettant la collecte de données préliminaires sur un sous-ensemble de patients avant d'élargir l'enrôlement complet. L'entreprise prévoit de collaborer avec les principales institutions américaines en matière d'implants cochléaires en tant que sites d'investigation.
Envoy Medical (NASDAQ: COCH) hat die FDA-Zulassung für seinen Antrag auf Untersuchungsgeräteausnahme (IDE) erhalten, um eine entscheidende Studie zum Vollständig Implantierten Cochlea-Implantat Acclaim® zu beginnen. Das Gerät verfügt über einen implantierten Sensor, der die natürliche Anatomie des Ohrs nutzt, um Geräusche zu erfassen, und unterscheidet sich so von bestehenden Cochlea-Implantaten. Die FDA genehmigte eine gestaffelte klinische Studie, die die vorläufige Datensammlung bei einer Untergruppe von Patienten ermöglicht, bevor die vollständige Rekrutierung erweitert wird. Das Unternehmen plant, mit führenden US-amerikanischen Einrichtungen für Cochlea-Implantate als Forschungsstandorte zusammenzuarbeiten.
- FDA approval received for pivotal study initiation
- Strong interest from top-tier cochlear implant programs for study participation
- Recent AMA approval of new CPT codes for totally implantable active middle ear implants
- Potential market opportunity with 95% of eligible patients currently not using cochlear implants
- IDE approval doesn't guarantee future FDA commercial approval
- Study requires staged approach, potentially extending development timeline
Insights
The FDA's IDE approval for Envoy Medical's Acclaim® Fully Implanted Cochlear Implant pivotal study represents a significant development in the hearing device market. The device's innovative approach using an implanted sensor that leverages natural ear anatomy differentiates it from existing solutions and could potentially address the significant market gap, where
The staged clinical study approach reduces initial risk and allows for careful data collection. Combined with the recent CPT code approval for their Esteem® device, Envoy Medical is strategically positioning itself in two distinct market segments. The strong interest from top-tier cochlear implant programs suggests potential market validation, though commercial success will ultimately depend on pivotal study outcomes.
This development could significantly impact Envoy Medical's market position in the
The dual-product strategy with Acclaim® and Esteem® demonstrates strong portfolio management and positions the company to capture different segments of the hearing loss market. However, investors should note that IDE approval is just one step in a lengthy commercialization process and success in the pivotal study is important for market entry.
The Acclaim® Fully Implanted Cochlear Implant is differentiated from existing cochlear implants and may offer new option for hearing loss patients
WHITE BEAR LAKE, Minnesota, Nov. 01, 2024 (GLOBE NEWSWIRE) -- Envoy Medical®, Inc. (“Envoy Medical”) (NASDAQ: “COCH”), a hearing health company focused on fully implanted hearing systems, today announces that its Investigational Device Exemption (IDE) application for its pivotal study of the Acclaim® Fully Implanted Cochlear Implant has been approved by the U.S. Food and Drug Administration (FDA). The Acclaim® technology includes an implanted sensor designed to leverage the natural anatomy of the ear to capture sound, making it different from existing cochlear implants on the market.
“Receiving FDA approval to initiate this pivotal study marks a significant milestone in our efforts to bring this breakthrough hearing device to more people with severe to profound hearing loss,” said Brent Lucas CEO of Envoy Medical. “Currently, it is estimated that roughly
The Company plans to select some of the top cochlear implant institutions in the U.S. as investigational sites for the study. As IRB approvals are obtained, the Company will share information on the investigational sites for interested patients.
“The excitement around the Acclaim® device is palpable, and we have been extremely humbled by the number of top-tier cochlear implant programs that want to participate in this study,” said Lucas. “While we are not able to select every site for this study, we believe that this excitement and significant interest across the country is a strong signal of our potential ability to penetrate the market should we be successful in gaining commercial approval.”
The FDA approved the IDE application as a staged clinical study. This allows preliminary clinical data to be gathered on a subset of patients prior to expanding enrollment to the full subject cohort. As with any investigational device, approval of an IDE application does not ensure that the results of the investigation will provide a reasonable assurance of the safety and effectiveness or assure a determination of approval for a premarket submission.
Lucas continued, “The last two weeks demonstrate our passionate commitment to innovation, competition, and change in the hearing industry. Last week marked the American Medical Association’s approval of new CPT codes for totally implantable active middle ear implants, which opens new opportunities for our already FDA-approved Esteem® device. This week, we are celebrating IDE approval to start a pivotal study for our investigational Acclaim® device. Two devices serving two patient populations, both moving the hearing industry forward. We are building a company that is positioning itself to be a market segment leader in the hearing industry. We are excited about what the future holds for Envoy Medical.”
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 Acclaim CI being the first to market fully implanted cochlear implant, the timing of IRB approvals, site activations, enrollment, and beginning of Envoy Medical’s clinical trial, the timing of and FDA’s position related to expanding the clinical trial to full cohort, the result of the clinical trial, the timing and results of clinical trials of the Acclaim CI, and the participation of any institution in such trials; 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 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
FAQ
What makes Envoy Medical's Acclaim cochlear implant (COCH) different from existing devices?
What is the significance of Envoy Medical's FDA IDE approval for COCH stock?
How will Envoy Medical (COCH) conduct the Acclaim pivotal study?
