Envoy Medical Inc. (NASDAQ:COCH) saw its shares soar 150% in premarket trading on Tuesday after the company announced that the U.S. Food and Drug Administration (FDA) had granted approval to expand its pivotal clinical trial for the fully implanted Acclaim® cochlear implant, allowing the study to progress to its final stage.
The regulatory approval eliminates key timing uncertainties and enables Envoy Medical to accelerate its pathway toward full FDA approval, potentially shortening its timeline by three to six months. The company also revealed that, as a result of the updated commercialization schedule and improved operational efficiency, it has reduced its projected capital requirements 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,” said Brent Lucas, Chief Executive Officer of Envoy Medical.
The first stage of the study involved 10 participants across five U.S. clinical sites, all of whom successfully reached the three-month milestone without any serious adverse events or unexpected device-related effects. Early results confirmed that the Acclaim® cochlear implant can achieve the desired clinical effectiveness for its intended purpose.
The final stage will enroll 46 additional participants at seven U.S. clinical sites, with rapid enrollment expected due to strong patient interest in a fully implanted cochlear implant alternative.
Envoy emphasized that its device is designed to tap into a largely underserved market, noting that of the estimated 2.8 million adults in the U.S. eligible for cochlear implants, less than 5% have received one. The company attributes this gap in adoption partly to patient hesitation over the visible external hardware associated with traditional, partially implanted systems.
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