Envoy Medicalは、肯定的な初期結果に基づいて、完全埋め込み型人工内耳試験を進めるためにFDAの許可を得ました。
Envoy Medical got FDA go-ahead to advance its fully implanted cochlear implant trial, based on positive early results.
Envoy Medicalは,重篤な副作用のない10人の患者からの3ヶ月の陽性データに基づいて,完全に埋め込まれたAcclaim内器インプラントに関する重要な試験を最終段階に進めることをFDAの承認を得た.
Envoy Medical received FDA approval to move its pivotal trial for the fully implanted Acclaim cochlear implant to the final stage, based on positive three-month data from 10 patients with no serious adverse events.
この承認は3~6ヶ月でタイムラインを加速させ,現在は2026年初頭に完全登録を期待している.
The approval accelerates the timeline by three to six months, with full enrollment now expected by early 2026.
同社はさらに,より速い進歩と効率の向上により,資本需要を1千5百万ドル削減し,債務を3200万ドル引き下げ,20年後にグレン・テイラーの退社を含む取締役会の変更を発表しました.
The company also reduced its capital needs by $10–15 million due to faster progress and improved efficiency, retired $32 million in debt, and announced board changes, including the departure of Glen Taylor after 20 years.