Aug. 28 at 9:29 AM
$COCH What could send COCH higher? 🚀
Envoy Medical is developing the Acclaim®, a first-of-its-kind fully implanted cochlear implant with no external processor.
The pivotal U.S. trial has completed enrollment with 56 patients, and early data showed improved speech recognition with no serious adverse events reported.
The biggest catalyst is now FDA PMA approval. Envoy has already submitted the first module of its PMA application and continues collecting 12-month data.
Key catalysts: 🦻 FDA approval + 📊 12-month data + 💰 commercialization + 🌎 market expansion.
High risk, but if Acclaim succeeds, Envoy could potentially disrupt the cochlear implant market.
