Newly Published Peer-Reviewed Article Highlights Advances in Fully Implanted Cochlear Implant Technology
Envoy Medical (Nasdaq: COCH) has highlighted a peer-reviewed article in Current Otorhinolaryngology Reports discussing advancements in fully implanted cochlear implants (FICI). The article, authored by Mayo Clinic doctors, reviews the current state of FICI, including challenges and breakthroughs. It emphasizes the influence of middle ear implants (MEIs) on FICI development, particularly microphone technologies that bypass external microphones. Envoy Medical’s Esteem® device is currently the only commercially available fully implanted active middle ear implant. CEO Brent T. Lucas underscores the benefits of leveraging outer and middle ear anatomy for better integration with accessories like headphones. The article also highlights the importance of a well-designed implantable power supply, noting Envoy Medical’s choice of a larger rechargeable battery in the pectoral region for its investigational Acclaim® cochlear implant.
- Envoy Medical's Esteem® device is the only commercially available fully implanted active middle ear implant.
- The article in a peer-reviewed journal enhances credibility and visibility.
- Envoy Medical's design choice for a larger rechargeable battery aligns with patient preferences for less frequent charging.
- The company leverages extensive experience in fully implanted sensor technology, providing a competitive advantage.
- Integration with outer and middle ear anatomy allows compatibility with common electronics like headphones and earbuds.
- The article mentions challenges and limitations in the development of fully implanted cochlear implants, which could indicate ongoing technical and clinical hurdles.
- Reliance on investigational status for the Acclaim® device means it's not yet commercially available, posing a risk of delays or regulatory hurdles.
- The need for a larger rechargeable battery might raise concerns about the size and placement of the implant in the pectoral region.
Insights
Envoy Medical's emphasis on fully implanted cochlear implant technology signifies a noteworthy advancement in the field of auditory implants. The article, published in the Current Otorhinolaryngology Reports, provides a comprehensive review of these implants' current state, including the role of middle ear implants (MEIs) in their development. A key takeaway is the uniqueness of Envoy Medical’s Esteem® device as the only fully implanted active middle ear implant available commercially. This is a significant differentiator, particularly in a market where advancements in sensor technology can lead to more natural hearing experiences.
One substantial benefit mentioned is the preservation of the outer and middle ear's natural anatomy, which allows users to continue using other accessories like headphones and hearing aids. This approach could improve user convenience and overall satisfaction. Additionally, the article highlights an innovative design choice for the Acclaim® cochlear implant, opting for a larger rechargeable battery placed in the pectoral region, which could extend the time between charges—a clear advantage from the patient’s perspective.
For retail investors, understanding these technological nuances can provide insight into Envoy Medical’s strategic advantages in product development and patient-centered innovation. This could possibly translate into a stronger market position and enhanced competitive edge.
Envoy Medical's advancements in fully implanted cochlear implant technology could potentially shift market dynamics significantly. The company's expertise with the Esteem® device, which is currently the only fully implanted active middle ear implant available, provides a competitive moat that could deter new entrants and solidify its market leadership. This positioning is important for investors looking for companies with strong competitive advantages.
The article also underscores the company's strategy of leveraging patient feedback to inform design decisions, such as the choice of battery placement in the Acclaim® cochlear implant. This patient-centric approach not only enhances product usability but can also lead to higher adoption rates, translating to better market penetration and increased revenue streams.
For retail investors, this news showcases Envoy Medical’s potential for attaining sustainable growth driven by technological innovation and market differentiation. While the company's current market position seems promising, monitoring future developments and adoption rates will be key to assessing long-term investment potential.
Envoy Medical in Position to Leverage its Sensor Technology
WHITE BEAR LAKE, MN, June 05, 2024 (GLOBE NEWSWIRE) -- Envoy Medical®, Inc. (“Envoy Medical”) (Nasdaq: COCH) today highlighted a recently published article in the Current Otorhinolaryngology Reports. The article, titled, “Fully Implanted Cochlear Implants,” was authored by Dr. Eric Babajanian, Dr. James Dornhoffer, and Dr. Colin Driscoll from Mayo Clinic in Rochester, Minnesota. Authors describe it as a review of the current state of fully implanted cochlear implants, including some of the challenges, limitations and breakthroughs.
The authors discuss the important influence middle ear implants (MEIs) have had on the development of fully implanted cochlear implants (FICI): “Many of the advancements in this area have contributed to the development of a FICI, primarily with the development of various microphone technologies that bypass the need for a separate external microphone.”
The article goes on to say that Envoy Medical’s fully implanted active middle ear implant (FI-AMEI), the Esteem® device, is the only fully implanted active middle ear implant currently commercially available. Envoy Medical believes its commercial experience with the Esteem fully implanted sensor technology provides it with an important competitive advantage in the marketplace.
“Envoy Medical is a leader in fully implanted hearing devices and we owe that leadership to our many years of experience with our fully implanted sensor technology,” said Brent T. Lucas, Envoy Medical’s Chief Executive Officer, “We have always believed that leveraging the outer and middle ear anatomy makes a lot more sense than sticking a microphone under the skin somewhere behind the ear.
“One of the benefits of leveraging the outer and middle ear anatomy is that the ear can still be used for other accessories and electronics, including headphones, ear buds, and even hearing aids,” added Lucas.
The article also notes the importance of an implantable power supply for a fully implanted cochlear implant. For its investigational fully implanted Acclaim® cochlear implant, Envoy Medical chose an architecture with a larger rechargeable battery in the pectoral region, versus a smaller rechargeable battery in the head.
“When faced with design choices, we felt that patients would rather go several days between charges. Our device was designed with patient preference in mind, and I believe we are headed in the right direction,” said Lucas.
The complete article can be found under the citation: Babajanian, E.E., Dornhoffer, J.R. & Driscoll, C.L.W. Fully Implanted Cochlear Implants. Curr Otorhinolaryngol Rep (2024). https://doi.org/10.1007/s40136-024-00507-3.
Author Colin L.W. Driscoll, MD is the principal investigator and Mayo Clinic is the clinical investigation site for the Acclaim® Early Feasibility Study.
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 timing of Envoy Medical’s IDE submission and beginning of its clinical trial, 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; 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:
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FAQ
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