Envoy Medical Inc. (NASDAQ:COCH) on Wednesday said it has completed enrollment of its pivotal clinical trial for the investigational fully implanted Acclaim cochlear implant for hearing loss.
The company implanted the 56th and final patient.
Differentiated Ear Implant
The investigational Acclaim fully implanted cochlear implant leverages the natural ear, rather than an external microphone, to capture sound using Envoy Medical’s proprietary implanted piezoelectric sensor technology.
Unlike traditional cochlear implants, the Acclaim device does not require an externally worn component on or in the ear, representing a differentiated approach in the cochlear implant market.
Pivotal Trial Concludes Enrollment
Envoy Medical believes it is the first cochlear implant manufacturer to complete enrollment in a U.S. pivotal trial for a fully implanted cochlear implant, positioning the company at the forefront of this next generation of hearing technology.
“Completing enrollment of a pivotal clinical trial that is evaluating a breakthrough-designated medical device that has the potential to bring about generational change to an entire industry is a very big deal,” said Brent Lucas, CEO of Envoy Medical.
What’s Next For Envoy Medical
Based on current enrollment trends and follow-up timelines, Envoy Medical in February said the trial remains on track for completion and potential Premarket Approval (PMA) submission to the U.S. Food and Drug Administration (FDA) in the second quarter of 2027.
With enrollment completed, the study will now progress through scheduled follow-up visits and data collection in accordance with the trial protocol.
Once 12-month follow-up data have been collected for all patients, the data will then be analyzed and submitted to the FDA as part of a PMA application seeking FDA approval.
Subject to FDA review and approval, commercialization in the United States would follow.
The Acclaim cochlear implant received Breakthrough Device Designation from the FDA in 2019 and is currently under investigation as part of a U.S.-based pivotal clinical trial.
Reinforced Competitive Position
Envoy Medical in February announced the issuance of three new patents, with one in the United States and two in Hong Kong.
The patents further expanded its intellectual property and reinforced its competitive position in the cochlear implant industry.
Management believes that as the company progresses toward potential PMA submission and commercialization, the strength and breadth of its intellectual property portfolio will be an increasingly important asset, both strategically and competitively.
In February, Envoy Medical regained NASDAQ listing compliance.
COCH Price Action: Envoy Medical shares were up 1.55% at $0.70 during premarket trading on Wednesday, according to Benzinga Pro data.
Image via Shutterstock
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