Envoy Medical (COCH) investor relations material

Market opportunity and industry context

• Severe to profound hearing loss affects 2.8 million adults in the U.S., representing an $84 billion total addressable market at a $30,000 ASP.

• The cochlear implant market is dominated by a few players and has seen little innovation in 40 years.

• Hearing loss is increasingly linked to cognitive decline and dementia, making effective solutions more critical.

• The company targets the underserved segment where hearing aids are no longer effective.

• Market expansion is expected as candidacy broadens and the population ages.

Product innovation and differentiation

• Developed a fully implanted cochlear implant with no external microphone or magnet, using a piezoelectric sensor on the incus to leverage natural ear anatomy.

• Battery is placed in the chest for longer life and easier replacement, unlike competitors who place smaller batteries in the head.

• Patented modular design and architecture, with strong IP and regulatory barriers to entry.

• Device enables 24/7 hearing, including during sleep and physical activities, and is marketed as "Invisible Hearing."

• First and only company with FDA Breakthrough Device Designation for a fully implanted cochlear implant.

Clinical and regulatory progress

• Pivotal clinical trial is fully enrolled with 56 patients at seven top-tier U.S. sites; all are in the data collection phase.

• Anticipates all patients will complete 12-month follow-up by end of Q1 or early Q2 next year.

• Plans to submit PMA application to FDA in Q2 next year, with potential approval by late 2027 or early 2028.

• Regular milestone updates and data readouts are expected, including interim and publication of early patient data.

• Commercialization strategy focuses on deep relationships with key implant sites rather than broad sales force expansion.