Envoy Medical (COCH) Registration filing summary

Company overview and business model

• Focuses on innovative, fully implanted hearing devices leveraging natural ear anatomy for sound capture, targeting severe to profound sensorineural hearing loss in adults.

• Lead product is the Acclaim CI, a fully implanted cochlear implant with no external components, currently in pivotal clinical trials.

• Esteem FI-AMEI, the first FDA-approved fully implanted active middle ear device, remains on the market but with limited commercial traction due to reimbursement issues.

• Business model centers on developing, obtaining regulatory approval for, and commercializing advanced hearing implants, with future plans for international expansion post-FDA approval.

Financial performance and metrics

• Reported net losses of $17.2 million for the nine months ended September 30, 2025, and $20.8 million for the year ended December 31, 2024.

• Accumulated deficit reached $305.7 million as of September 30, 2025.

• Revenue remains minimal, primarily from legacy Esteem FI-AMEI device sales and replacements.

• Operations funded mainly through equity, term loans, and convertible debt; recent offerings in September and October 2025 raised $2.5 million and $4.0 million, respectively.

• Cash balance was $3.6 million as of September 30, 2025, with substantial doubt about ability to continue as a going concern beyond Q1 2026 without additional funding.

Use of proceeds and capital allocation

• Net proceeds from the IPO are intended for working capital and general corporate purposes, primarily to fund operations during the FDA pivotal clinical study for Acclaim CI.

• Management retains broad discretion over allocation of proceeds, with priority on clinical development and regulatory milestones.