Envoy Medical Secures $10 Million in Funding to Advance Pivotal Clinical Trial of Breakthrough Hearing Device
Envoy Medical (NASDAQ: COCH) has secured a $10 million financing facility from its largest shareholder, billionaire Glen Taylor, to advance its pivotal clinical trial for the fully implanted Acclaim® cochlear implant. The five-year, unsecured lending facility features deferred interest for the first two years at an 8% rate.
CEO Brent Lucas reported strong enrollment progress in the trial's first stage, with investigational sites noting significant interest in their fully internal cochlear implant design. The funding will support both the clinical trial progression and other operational needs during what the company anticipates to be a transformative year with several important milestones.
Envoy Medical (NASDAQ: COCH) ha ottenuto un finanziamento di 10 milioni di dollari dal suo maggiore azionista, il miliardario Glen Taylor, per avanzare nel suo trial clinico fondamentale per l'impianto cocleare Acclaim® completamente impiantato. La linea di credito di cinque anni, non garantita, prevede interessi differiti per i primi due anni a un tasso dell'8%.
Il CEO Brent Lucas ha riportato un forte progresso nell'arruolamento della prima fase del trial, con i siti di ricerca che hanno notato un significativo interesse per il design del loro impianto cocleare completamente interno. Il finanziamento supporterà sia il progresso del trial clinico che altre esigenze operative durante quello che l'azienda prevede essere un anno trasformativo con diversi traguardi importanti.
Envoy Medical (NASDAQ: COCH) ha obtenido una línea de financiamiento de 10 millones de dólares de su mayor accionista, el multimillonario Glen Taylor, para avanzar en su ensayo clínico pivotal para el implante coclear Acclaim® completamente implantado. La línea de crédito de cinco años, no garantizada, presenta intereses diferidos durante los primeros dos años a una tasa del 8%.
El CEO Brent Lucas informó sobre un fuerte progreso en la inscripción en la primera etapa del ensayo, con los sitios de investigación señalando un interés significativo en su diseño de implante coclear completamente interno. La financiación apoyará tanto el progreso del ensayo clínico como otras necesidades operativas durante lo que la empresa anticipa será un año transformador con varios hitos importantes.
Envoy Medical (NASDAQ: COCH)는 억만장자인 최대 주주 글렌 테일러로부터 1천만 달러의 자금 조달을 확보하여 완전 이식형 Acclaim® 인공와우의 주요 임상 시험을 진행합니다. 5년 만기 무담보 대출 시설은 처음 2년 동안 8%의 이자율로 이자를 유예합니다.
CEO 브렌트 루카스는 임상 시험의 첫 단계에서 강력한 등록 진행 상황을 보고했으며, 연구 장소에서 완전 내부형 인공와우 설계에 대한 상당한 관심을 보였습니다. 이 자금은 임상 시험 진행과 회사가 여러 중요한 이정표가 예상되는 변혁의 해 동안의 기타 운영 필요를 지원할 것입니다.
Envoy Medical (NASDAQ: COCH) a sécurisé un financement de 10 millions de dollars de son plus grand actionnaire, le milliardaire Glen Taylor, pour faire avancer son essai clinique décisif pour l'implant cochléaire Acclaim® entièrement implanté. Ce prêt non garanti sur cinq ans prévoit des intérêts différés pendant les deux premières années à un taux de 8%.
Le PDG Brent Lucas a rapporté un fort progrès dans l'inscription à la première étape de l'essai, les sites d'investigation notant un intérêt significatif pour leur conception d'implant cochléaire entièrement interne. Le financement soutiendra à la fois la progression de l'essai clinique et d'autres besoins opérationnels durant ce que l'entreprise anticipe comme une année transformative avec plusieurs jalons importants.
Envoy Medical (NASDAQ: COCH) hat eine Finanzierung in Höhe von 10 Millionen Dollar von seinem größten Aktionär, dem Milliardär Glen Taylor, gesichert, um seine entscheidende klinische Studie für das vollständig implantierte Acclaim®-Cochlea-Implantat voranzutreiben. Die fünfjährige, ungesicherte Kreditlinie sieht in den ersten zwei Jahren einen aufgeschobenen Zinssatz von 8% vor.
CEO Brent Lucas berichtete von einem starken Fortschritt bei der Rekrutierung in der ersten Phase der Studie, wobei die Prüfstellen ein erhebliches Interesse an ihrem vollständig internen Cochlea-Implantat-Design verzeichneten. Die Finanzierung wird sowohl den Fortschritt der klinischen Studie als auch andere betriebliche Bedürfnisse unterstützen, während das Unternehmen ein transformierendes Jahr mit mehreren wichtigen Meilensteinen erwartet.
- Secured $10 million in additional funding
- Strong enrollment progress in pivotal clinical trial
- High interest reported from investigational sites
- Favorable loan terms with 2-year interest deferral
- 8% interest rate on the loan facility
- Company requires additional funding for operations
Billionaire Entrepreneur Glen Taylor, the Company's Largest Shareholder, Continues to Invest Significant Capital into the Company Furthering Its Progress
White Bear Lake, Minnesota--(Newsfile Corp. - March 12, 2025) - Envoy Medical®, Inc. (NASDAQ: COCH) ("Envoy Medical"), a revolutionary hearing health company focused on fully implanted hearing devices, today announced securing
"We are very happy with the enrollment progress in the first stage of our pivotal clinical trial," said Envoy Medical CEO Brent Lucas, "Investigational sites are reporting a tremendous amount of interest in our fully implanted cochlear implant. We believe that interest will only grow as awareness is increased and further progress is made. We are bullish on the reported desire of many cochlear implant candidates to have a device that is designed to be completely internal."
The
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 ability to obtain additional patents and develop future products or product improvements, the Acclaim CI being the first to market fully implanted cochlear implant, 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; 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; 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.
###
Investor Relations:
Envoy Medical Investor Relations
InvestorRelations@envoymedical.com
Media Contact:
Media@envoymedical.com
To view the source version of this press release, please visit https://www.newsfilecorp.com/release/244265
FAQ
What are the terms of Envoy Medical's (COCH) new $10 million financing?
How will Envoy Medical (COCH) use the $10 million in funding?
What is the current status of Envoy Medical's (COCH) Acclaim cochlear implant trial?
Who provided the $10 million financing to Envoy Medical (COCH)?
