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.

• Lead product is the Acclaim CI, a fully implanted cochlear implant targeting severe to profound sensorineural hearing loss in adults.

• Esteem FI-AMEI, the first FDA-approved fully implanted active middle ear device, failed to gain commercial traction due to lack of reimbursement.

• Business model aims to disrupt the cochlear implant market, which has established reimbursement pathways.

Financial performance and metrics

• Net loss of $17.2 million for the nine months ended September 30, 2025, and $16.2 million for the same period in 2024.

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

• Revenue remains limited, primarily from legacy Esteem FI-AMEI device and replacement components.

• R&D expenses increased due to clinical trial activities and headcount growth.

• Cash balance of $3.6 million as of September 30, 2025; recent financings include $2.5 million (September 2025) and $4.0 million (October 2025) offerings.

Use of proceeds and capital allocation

• Estimated net proceeds from the offering are $23.0 million, intended for working capital and to fund operations during the pivotal FDA clinical study.

• Management retains broad discretion over use of proceeds, with a focus on supporting clinical development and regulatory activities.