Summary:
Envoy Medical has received FDA approval to expand its pivotal clinical trial for the fully implanted Acclaim cochlear implant, accelerating its path to commercialization after promising early results from the first 10 patients.
Key Takeaways:
- The FDA expansion approval shortens Envoy Medical’s commercialization timeline by three to six months and reduces projected capital needs by $10 million–$15 million.
- Early trial data from 10 patients showed no serious adverse events and confirmed the device’s effectiveness for its intended use.
- The fully implanted Acclaim aims to remove barriers to adoption by eliminating external hardware, addressing a major reason most eligible adults do not receive cochlear implants.
Envoy Medical Inc., a hearing health company pioneering fully implanted hearing solutions, has received approval from the U.S. Food and Drug Administration (FDA) to expand the Company’s pivotal clinical trial for the fully implanted Acclaim cochlear implant to the final stage based on promising three-month data from the first 10 patients.
The FDA’s approval of the expansion request removes a previously uncertain timing variable and allows the Company to solidify its path toward regulatory approval. As a result, the Company has shortened its estimated timeline by three to six months. The updated timeline to commercialization and other improved efficiencies has allowed management to cut its anticipated capital needs by $10-$15 million.
“The FDA’s granting of our expansion request is a significant and game changing milestone for Envoy Medical and our fully implanted Acclaim cochlear implant,” says Brent Lucas, chief executive officer of Envoy Medical. “We believe it is a great sign that we were able to demonstrate to the FDA that our trial data is trending in the right direction and that approving the expansion of the trial to full enrollment was warranted. With the timing of expansion now clear and earlier than originally expected, along with the anticipated rapid enrollment of the remaining participants, we are able to shorten our estimated timeline by at least one full quarter, potentially two. This means we will need less capital as we march toward our goal of changing the hearing industry by redefining the standard of care in cochlear implants.”
The first stage consisted of 10 participants at five clinical trial sites in the United States. All 10 patients successfully completed their three-month milestone with no serious adverse events (SAEs) or unanticipated device effects (UADEs) reported. In addition, the preliminary clinical data effectively characterized that the investigational Acclaim cochlear implant can achieve effectiveness for its proposed intended use, which was a required condition of expanded trial enrollment being approved by the FDA. The fully implanted Acclaim cochlear implant was tested in these participants at the three-month visit in the “cochlear implant only” condition and without the use of a hearing aid.
The second and final stage of the clinical trial will consist of an additional 46 participants at seven clinical trial sites within the United States. The clinical trial sites have noted a high level of interest from patients interested in an investigational fully implanted cochlear implant. As a result, the Company believes enrollment will proceed rapidly within the next few months.
Envoy Medical believes its investigational fully implanted cochlear implant has the potential to address a massive, underpenetrated market opportunity. Of the estimated 2.8 million U.S. adults eligible for cochlear implants, it has been estimated that fewer than 5% currently receive them. In other words, this data indicates that approximately 95% of the adults in the United States who could benefit from a cochlear implant have not received one. Envoy Medical believes one of the primary reasons for this is that most people would prefer not to have a bulky medical device attached to their head telegraphing their hearing disability, which is the case with current partially implanted cochlear implants. By eliminating external wearable hardware, the Acclaim is designed to overcome practical adoption barriers that have long plagued market penetration in the cochlear implant industry.
“Prior to joining Envoy Medical, I spent 19 years in a clinic as a cochlear implant audiologist,” says Caroline Arnedt, director of audiology of Envoy Medical. “During my prior employment at the clinic, we often saw candidates pass on getting a cochlear implant because they did not want the bulky external hardware on the side of their head. It is a practical reality that some portion of candidates avoid cochlear implants because of the external wearable component. I firmly believe more candidates will get a cochlear implant once there is a fully implanted option, and that will mean we are helping more people hear by designing a device that patients want.”
For more information about Envoy Medical’s innovation pipeline and intellectual property portfolio, visit www.envoymedical.com.
Featured image: Dreamstime
