COCH News & Events

Envoy Medical files to sell Class A common stock, no amount given

Reports Q3 revenue $56,000 vs. $80,000 last year. "The progress and accomplishments of late have been extremely important to Envoy Medical as they have set the stage for us to demonstrate the value of fully implanted hearing devices. First, we have received FDA's approval to start our pivotal trial of the Acclaim fully implanted cochlear implant. Second, we continue to make tremendous progress on obtaining meaningful reimbursement for our already FDA-approved Esteem FIAMEI. We continue to receive considerable support for the bipartisan bills that were introduced in both the House and the Senate this year to change the way fully implanted active middle ear hearing devices classified by CMS. In addition, the American Medical Association's CPT Editorial Panel has approved Category III CPT codes for totally implantable active middle ear hearing devices for the first time. A significant step forward for our Esteem device. Ultimately, we continue to believe that our products are important innovations for patients suffering from hearing loss and foresee a bright future for Envoy Medical," commented Brent Lucas, Envoy Medical's Chief Executive Officer. "We look forward to updating shareholders on our progress as we initiate the trial for the Acclaim(R) device and as we progress with our reimbursement strategy for the Esteem device."

Envoy Medical 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 95% of patients with significant hearing loss who could benefit from a cochlear implant have not received one. We believe the differences in our device's design provide an opportunity to pursue this important therapy in a more discrete manner and offer candidates a welcomed new option that may get more patients to embrace the potential benefits of a cochlear implant."

Envoy Medical expresses gratitude to the Independence Through Enhancement of Medicare and Medicaid Coalition and the twelve ITEM member signatories for sending a strong letter to CMS supporting a reconsideration of the benefit category for fully implanted active middle ear hearing devices. The letter states in part: "[W]e request that you please provide an explanation as to CMS' reasoning for determining that fully implanted active middle ear hearing devices do not qualify as an exception to the hearing aid exclusion under statute. In addition, we believe CMS has the authority to reconsider their decision and urge you to clarify that this technology qualifies as a prosthetic device for purposes of Medicare coverage." ITEM is a national consumer- and clinician-led coalition advocating for access to and coverage of assistive devices, technologies, and related services for people with injuries, illnesses, disabilities, and chronic conditions of all ages. Members represent individuals with a wide range of disabling conditions, as well as the providers who serve them. In the letter to CMS, ITEM referenced the profound impact that hearing loss has on quality of life of Medicare beneficiaries. The Hearing Loss Association of America and Alexander Graham Bell Association for the Deaf and Hard of Hearing were two of the twelve organizations willing to lend their voice and influence to the Medicare beneficiaries with significant hearing loss who want access to novel hearing implants. "We are grateful that the ITEM Coalition took up such a critically important issue and that twelve coalition member organizations signed the letter urging CMS to do the right thing," commented Brent Lucas, Envoy Medical CEO. "It especially hits home that the Coalition's mission is in their name -- 'Independence Through Enhancement of Medicare and Medicaid' - and we strongly believe that fully implanted hearing devices can help Medicare beneficiaries with hearing impairments significantly regain, or maintain, a level of independence that is good for them and for society as a whole."