Envoy Medical Secures Lending Facility of $10M
Envoy Medical (NASDAQ: COCH), a hearing health company focused on fully implanted hearing devices, has secured a $10 million lending facility from long-time investor and majority shareholder Glen Taylor. The company has already drawn $5 million from this facility. The five-year, unsecured loan defers interest for the first two years and carries an 8% interest rate.
Envoy Medical plans to seek an Investigational Device Exemption (IDE) for its fully implanted Acclaim® cochlear implant, aiming to start a Pivotal Study in late 2024 or early 2025. The company also has the FDA-approved Esteem® device, the only fully implanted active middle ear implant on the market. Envoy Medical is working with Congress to reclassify fully implanted active middle ear implants, potentially improving patient access and encouraging innovation in the hearing implant category.
Envoy Medical (NASDAQ: COCH), un'azienda specializzata in dispositivi per l'udito completamente impiantati, ha ottenuto un prestito di 10 milioni di dollari da Glen Taylor, investitore di lunga data e azionista di maggioranza. L'azienda ha già prelevato 5 milioni di dollari da questo prestito. Si tratta di un prestito non garantito della durata di cinque anni che differisce gli interessi per i primi due anni e ha un tasso d'interesse dell'8%.
Envoy Medical intende richiedere un Investigational Device Exemption (IDE) per il suo impianto cocleare Acclaim® completamente impiantato, con l'obiettivo di avviare uno Studio Pivotal alla fine del 2024 o all'inizio del 2025. L'azienda possiede anche il dispositivo Esteem®, approvato dalla FDA, l'unico impianto attivo dell'orecchio medio completamente impiantato disponibile sul mercato. Envoy Medical sta collaborando con il Congresso per riqualificare gli impianti attivi dell'orecchio medio completamente impiantati, con l'obiettivo di migliorare l'accesso dei pazienti e incoraggiare l'innovazione nella categoria degli impianti uditivi.
Envoy Medical (NASDAQ: COCH), una empresa de salud auditiva centrada en dispositivos auditivos completamente implantados, ha asegurado un préstamo de 10 millones de dólares de Glen Taylor, un inversor de larga data y accionista mayoritario. La empresa ya ha utilizado 5 millones de dólares de esta línea de crédito. Se trata de un préstamo no garantizado a cinco años que difiere el interés durante los primeros dos años y tiene una tasa de interés del 8%.
Envoy Medical planea solicitar una Investigational Device Exemption (IDE) para su implante coclear Acclaim® completamente implantado, con el objetivo de comenzar un Estudio Pivotal a finales de 2024 o principios de 2025. La empresa también cuenta con el dispositivo Esteem®, aprobado por la FDA, que es el único implante activo del oído medio completamente implantado en el mercado. Envoy Medical está trabajando con el Congreso para reclasificar los implantes activos del oído medio completamente implantados, lo que podría mejorar el acceso de los pacientes y fomentar la innovación en la categoría de implantes auditivos.
Envoy Medical (NASDAQ: COCH)은 완전 임플란트 청각 장치에 중점을 둔 청각 건강 회사로, 오랜 투자자이자 대주주인 Glenn Taylor로부터 1천만 달러 대출 시설을 확보했습니다. 이 회사는 이미 이 시설에서 500만 달러를 인출했습니다. 이 5년 만기의 무담보 대출은 처음 2년 동안 이자를 연기하고 8% 이자율을 적용합니다.
Envoy Medical은 완전 임플란트 Acclaim® 인공 와우에 대해 Investigational Device Exemption (IDE)를 요청할 계획이며, 2024년 말 또는 2025년 초에 중요한 연구를 시작하는 것을 목표로 하고 있습니다. 이 회사는 또한 시장에서 유일한 완전 임플란트 활성 중이 임플란트인 FDA 승인 Esteem® 장치를 보유하고 있습니다. Envoy Medical은 완전 임플란트 활성 중이 임플란트를 재분류하기 위해 의회와 협력하고 있으며, 이는 환자의 접근성을 개선하고 청각 임플란트 카테고리의 혁신을 촉진할 수 있습니다.
Envoy Medical (NASDAQ: COCH), une entreprise de santé auditive axée sur les dispositifs auditifs entièrement implantés, a obtenu un financement de 10 millions de dollars de la part de Glen Taylor, un investisseur de longue date et actionnaire majoritaire. L'entreprise a déjà tiré 5 millions de dollars de ce financement. Il s'agit d'un prêt non garanti de cinq ans qui suspend les intérêts pendant les deux premières années et comporte un taux d'intérêt de 8%.
Envoy Medical prévoit de demander une Investigational Device Exemption (IDE) pour son implant cochléaire Acclaim® entièrement implanté, avec l'objectif de commencer une étude pivote à la fin de 2024 ou au début de 2025. L'entreprise dispose également du dispositif Esteem®, approuvé par la FDA, le seul implant actif de l'oreille moyenne entièrement implanté sur le marché. Envoy Medical collabore avec le Congrès pour reclassifier les implants actifs de l'oreille moyenne entièrement implantés, ce qui pourrait améliorer l'accès des patients et encourager l'innovation dans la catégorie des implants auditifs.
Envoy Medical (NASDAQ: COCH), ein Unternehmen für Hörgesundheit, das sich auf vollständig implantierbare Hörgeräte konzentriert, hat eine Darlehensvereinbarung über 10 Millionen Dollar mit dem langjährigen Investor und Mehrheitsaktionär Glen Taylor gesichert. Das Unternehmen hat bereits 5 Millionen Dollar aus dieser Vereinbarung abgerufen. Es handelt sich um ein fünf Jahre laufendes, ungesichertes Darlehen, bei dem die Zinsen in den ersten zwei Jahren aufgeschoben werden und das einen Zinssatz von 8% hat.
Envoy Medical plant, eine Investigational Device Exemption (IDE) für ihr vollständig implantiertes Acclaim® Cochlea-Implantat zu beantragen, mit dem Ziel, eine wegweisende Studie Ende 2024 oder Anfang 2025 zu starten. Das Unternehmen verfügt auch über das von der FDA genehmigte Esteem®-Gerät, das einzige vollständig implantierte aktive Mittelohr-Implantat auf dem Markt. Envoy Medical arbeitet mit dem Kongress zusammen, um vollständig implantierte aktive Mittelohr-Implantate umzuqualifizieren, um den Zugang der Patienten zu verbessern und Innovationen im Bereich der Hörimplantate zu fördern.
- Secured $10 million lending facility from major investor Glen Taylor
- Drew $5 million from the facility at origination
- Loan has favorable terms: 5-year term, unsecured, no conversion feature, 2-year interest deferral
- Plans to seek IDE for Acclaim® cochlear implant, potentially starting Pivotal Study by early 2025
- Acclaim® cochlear implant has received FDA Breakthrough Designation
- Owns FDA-approved Esteem® device, the only fully implanted active middle ear implant on market
- Loan carries 8% interest rate over the term
- Reliance on single investor for significant funding
Envoy Medical's
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Envoy Medical's progress towards an IDE for the fully implanted Acclaim® cochlear implant is a potential game-changer in hearing implant technology. The FDA's Breakthrough Designation underscores its innovative nature and potential impact. If successful, this could revolutionize treatment for severe-to-profound hearing loss, addressing a significant unmet need.
The company's dual focus on the Acclaim® cochlear implant and the FDA-approved Esteem® middle ear implant demonstrates a comprehensive approach to hearing solutions. The potential reclassification of fully implanted active middle ear implants could significantly expand market access and drive innovation in this space, potentially benefiting both patients and the industry at large.
Envoy Medical's positioning in the hearing implant market is noteworthy. With the only FDA-approved fully implanted active middle ear implant and a potentially groundbreaking cochlear implant in development, the company is well-placed to capture a significant share of this growing market. The potential for reimbursement for the Acclaim® cochlear implant, once available, could drive rapid adoption and market penetration.
The legislative efforts to reclassify fully implanted active middle ear implants could be a major catalyst for the entire sector. If successful, this could lead to increased competition and innovation, potentially expanding the overall market size. Investors should closely monitor these regulatory developments as they could significantly impact Envoy's market position and growth trajectory.
Glen Taylor, Committed Investor and Believer in Envoy Medical’s Mission to Help People with Significant Hearing Loss, Provides Significant Additional Funding as the Company Eyes Important Milestones and Seeks to Grow Hearing Implant Market with Breakthrough Device
WHITE BEAR LAKE, Minnesota, Aug. 28, 2024 (GLOBE NEWSWIRE) -- Envoy Medical®, Inc. (“Envoy Medical”) (NASDAQ: “COCH”), a revolutionary hearing health company focused on fully implanted hearing devices, today announces entry into an additional lending facility with long-time investor, majority shareholder, and billionaire entrepreneur Glen Taylor. The financing allows the Company to draw up to
“We believe that Envoy Medical is on the cusp of something great that will forever change the hearing implant landscape,” said Envoy Medical CEO Brent Lucas. “This new funding from Glen Taylor allows us to remain focused on building and growing the business without losing momentum. Mr. Taylor’s support gives us the flexibility and security to reach our next milestones securely and intelligently.”
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The Company has previously stated that it intends to seek an Investigational Device Exemption (IDE) to start a Pivotal Study of its fully implanted Acclaim® cochlear implant in the coming months. Should the IDE be granted in a timely manner, first enrollments could be expected by the end of calendar year 2024 or the first part of 2025.
“We know people both inside and outside of the hearing implant industry are excited for us to move forward with the fully implanted Acclaim® cochlear implant,” continued Lucas. “As we progress, our hope is that we can make the decades old dream of a fully implanted cochlear implant a reality. If we are successful, we anticipate substantial value from realizing that dream for millions of people with severe-to-profound levels of hearing loss.”
In addition to its investigational, fully implanted Acclaim® cochlear implant, which previously received Breakthrough Designation from the FDA, Envoy Medical also has the only FDA-approved fully implanted active middle ear implant, the Esteem® device.
Concurrently, the Company has worked closely with members of Congress to introduce bills in both the House of Representatives and the Senate to properly re-classify fully implanted active middle ear implants. Should these bills pass and become law, it would provide greater patient access to important hearing implant technologies and encourage more innovation and competition within the hearing implant category.
The investigational fully implanted Acclaim® cochlear implant is expected to have reimbursement once it becomes available, as it is a cochlear implant, and cochlear implants are classified as coverable benefits.
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.
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 availability and benefits of future funding, the Acclaim CI being the first to market fully implanted cochlear implant, the performance of the Acclaim CI and availability of insurance reimbursement of the Acclaim CI, the timing of Envoy Medical’s IDE submission, the approval of the IDE submission, and the beginning of its clinical trial, the effect of such clinical trial on the development of Envoy Medical’s business, the impact of proposed legislation 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 transactions and 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
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