Envoy Medical (NASDAQ:COCH) today reported its financial and operational results for the fiscal year ended December 31, 2025, marking a year of significant regulatory progress and balance sheet restructuring.
The company reached a critical clinical milestone with FDA approval to expand the pivotal trial for its Acclaim® Fully Implanted Cochlear Implant (FICI) to its final stage.
This development follows the successful completion of enrollment for its 56-patient U.S. pivotal study, positioning the company to gather the final data necessary for a formal Premarket Approval (PMA) submission.
The Acclaim system represents a potential shift in the hearing health sector as the first cochlear implant designed to be completely internal, eliminating the need for external processors or microphones.
Beyond the clinical advancements, Envoy Medical executed a major financial overhaul in 2025, successfully extinguishing over $32 million of debt.
This restructuring significantly cleans up the company’s capital stack as it prepares for potential commercialization.
Financial results for 2025 show a company in high-intensity research and development mode.
Net revenue for the year was approximately $241,000, primarily derived from the company’s existing Esteem® hearing implant.
Research and development and general administrative expenses increased as the company scaled its clinical infrastructure and regulatory capabilities.
While Envoy ended the calendar year with approximately $3.7 million in cash, its liquidity position was drastically bolstered post-year-end by a capital raise of up to $78 million, of which $30 million has already been received.