Envoy Medical Inc. (NASDAQ:COCH) announced on Tuesday that it has received U.S. Food and Drug Administration (FDA) approval to expand its 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 and expects to complete full enrollment by the early first quarter of 2026.
The updated timeline to commercialization and other improved efficiencies has allowed management to cut its anticipated capital needs by $10-$15 million.
The first stage consisted of 10 participants at five clinical trial sites in the United States.
All 10 patients completed their three-month milestone without reported serious adverse events (SAEs) or unanticipated device effects (UADEs).
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 using 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 U.S.
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.
Price Action: COCH stock closed at $0.79 on Monday.
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