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Envoy Med Inc Cl A (COCH0.00%) has filed its annual report on Form 10-K filing for the fiscal year ended December 31, 2024.
The filing details the company's financial performance, including a net loss of $20.8 million for the year. This represents an improvement from the previous year's net loss of $29.9 million.
Envoy Medical's primary focus is on the development of the Acclaim CI, a fully implanted cochlear implant, which is currently undergoing clinical trials. The company received FDA approval for an Investigational Device Exemption in October 2024.
Revenue for the year was reported at $225,000, a decrease from $316,000 in the prior year, primarily due to a decrease in sales of replacement components for the Esteem FI-AMEI.
Research and development expenses increased to $10.2 million from $9.0 million, reflecting the company's ongoing investment in the Acclaim CI.
The company completed a business combination with Anzu Special Acquisition Corp I in September 2023, resulting in net proceeds of $11.7 million.
Envoy Medical's cash balance as of December 31, 2024, was $5.5 million, with management expressing confidence in its ability to fund operations through future capital raises and product sales.
The company acknowledges the risks associated with its dependence on the Acclaim CI for future revenue and the uncertainties in obtaining FDA approval.
Envoy Medical also reported a material weakness in its internal control over financial reporting and is implementing remediation measures.
The company is subject to various risks, including competition in the medical device industry and potential changes in reimbursement policies that could impact sales.
This content was summarized by generative artificial intelligence using public filings retrieved from SEC.gov. The original data was derived from the Envoy Med Inc Cl A annual 10-K report dated March 31, 2025. To report an error, please email earnings@qz.com.