Envoy Medical (COCH) investor relations material

Market opportunity and industry context

• Hearing loss is a large, underpenetrated market, with only 5% of eligible U.S. adults having received cochlear implants.

• The total addressable market is estimated at $84 billion in the U.S., with potential for higher pricing and bilateral implants.

• The market is expected to grow due to aging populations and increased incidence of hearing loss from factors like ototoxic drugs.

• There is a strong link between untreated hearing loss and cognitive decline, increasing the value proposition for intervention.

• No major traditional medical device companies have entered this space, leaving significant white space for new entrants.

Product innovation and differentiation

• The fully implanted cochlear implant uses a unique piezoelectric sensor and places the battery in the chest, unlike competitors.

• The device leverages the natural ear for sound input, eliminating the need for an external microphone and making it truly invisible.

• The battery is larger, rechargeable, and easily replaceable, offering multi-day use and simple maintenance.

• Competing devices require external components for part of the day and have smaller, non-replaceable batteries in the head.

• The design allows compatibility with wearables and future tech, enhancing user experience.

Clinical progress and regulatory status

• The pivotal clinical study has fully enrolled 56 patients at seven top-tier U.S. sites, with data collection underway.

• The company received FDA Breakthrough Device Designation and was first to start and complete pivotal study enrollment.

• Submission for FDA premarket approval (PMA) is planned for May or June next year, with potential approval by year-end.

• The clinical trial focuses on word score improvements and quality of life, with no control arm; safety profile expected to match existing implants.

• The device is already covered by insurance under existing Medicare guidelines for cochlear implants.