Envoy Medical Gets FDA Nod for Final Acclaim Trial Stage, Wipes Out $32M Debt
Envoy Medical secured FDA approval to expand its fully implanted Acclaim Cochlear Implant pivotal clinical trial to its final stage and extinguished $32M of debt, bolstering its balance sheet. The company closed a transformational institutional capital raise in February and completed enrollment of its pivotal Acclaim CI trial in March.
1. Clinical Trial Progress
Envoy Medical received FDA approval to expand its Acclaim Cochlear Implant pivotal clinical trial into its final stage and announced full patient enrollment in March, positioning the company to gather outcome data ahead of its planned PMA application.
2. Balance Sheet and Capital Raise
The company strengthened its balance sheet by extinguishing $32 million in debt during 2025 and secured a transformational capital raise in February led by established institutional healthcare investors, providing additional funding for continued trial execution and future commercial activities.
3. 2025 Financial Performance
Net revenue rose modestly to $241,000 in 2025 from $225,000 in 2024, driven by Esteem FI-AMEI sales, while R&D expenses increased by $2.3 million due to trial costs, and year-end cash stood at approximately $3.7 million.