Envoy Medical Reports $20.8 Million Net Loss for Fiscal Year 2024

Envoy Medical, Inc. reported a net loss of $20.8 million for the fiscal year ending December 31, 2024, a decrease from a net loss of $29.9 million in the previous year. The company’s accumulated deficit increased to approximately $284.7 million, up from $257.3 million in 2023. Revenue for the year was $225,000, down from $316,000 in 2023, primarily due to a decrease in battery replacement sales attributed to supply chain limitations. The cost of goods sold also decreased slightly, reflecting the decline in revenue. Operating expenses rose to $19.5 million, compared to $18.7 million in the prior year, driven by increased research and development costs as the company prepares for pivotal clinical trials for its lead product, the Acclaim CI.

The company underwent significant changes in its organizational structure following the completion of a Business Combination with Anzu Special Acquisition Corp I in September 2023. This merger resulted in the conversion of various securities, including convertible notes and preferred stock, into common stock, and the issuance of new shares. As of December 31, 2024, Envoy Medical had approximately 21.3 million shares of Class A common stock outstanding. The company’s stock began trading on Nasdaq under the symbols "COCH" and "COCHW" on October 2, 2023.

Envoy Medical is focused on the development of the Acclaim CI, a fully implanted cochlear implant designed to address severe to profound sensorineural hearing loss. The Acclaim CI received Breakthrough Device Designation from the FDA in 2019 and is currently undergoing clinical trials, with the company anticipating FDA approval in late 2027 or early 2028. The company aims to capture a significant share of the cochlear implant market, which it estimates could exceed $80 billion in the U.S. alone, based on the number of adults who could qualify for such devices.

Operationally, Envoy Medical has faced challenges, including a limited customer base and reliance on third-party suppliers for critical components. As of December 31, 2024, the company had approximately 42 employees, reflecting its focus on building a skilled workforce to support its product development and commercialization efforts. The company has also identified material weaknesses in its internal controls over financial reporting, which it is actively working to remediate.

Looking ahead, Envoy Medical expects to continue incurring significant losses as it invests in the development and commercialization of the Acclaim CI. The company plans to raise additional capital through equity offerings and other financing arrangements to support its operations. However, it acknowledges the uncertainty surrounding its ability to secure funding and achieve profitability, which raises substantial doubt about its ability to continue as a going concern.