Acclaim CI Tracker Envoy Medical · NASDAQ: COCH
Updated Aug 14, 2026
Current phase

Stage 1 primary endpoint met · Stage 2 accruing 12‑month data

1 of 4 modular PMA sections filed with FDA. Full submission targeted a few months after Stage 2 reaches its 12‑month readout, expected early Q2 2027.

$0.75 +0.13% · after hours Mkt cap $15.5M · 52-wk $0.36–$1.89
Enrollment 56/56 Complete · Mar 11, 2026
PMA modules filed 1/4 Module 1 · Jun 30, 2026
Stage 1 · 12-mo CNC score 53.2% +38.0 pts vs 15.2% baseline
Serious adverse events 0 Through 12-mo · Stage 1 (n=10)
Cash on hand $19.7M As of Jun 30, 2026

Regulatory pathway

Breakthrough Device → modular PMA → FDA decision
  1. FDA Breakthrough Device Designation 2019
  2. Early feasibility study & IDE trial expansion 2022 – 2025
  3. Pivotal trial fully enrolled (56/56) Mar 11, 2026
  4. All 56 patients activated Apr 22, 2026
  5. PMA Module 1 of 4 submitted Jun 30, 2026
  6. Stage 1 (n=10) 12-month primary endpoint met Jul 14, 2026
  7. Stage 2 full cohort → 12-month data collection In progress · target early Q2 2027
  8. PMA Module 4 (final clinical data) submitted Target Q2 2027
  9. FDA completes PMA review No timeline disclosed
  10. FDA decision — approval or rejection Not yet determined

Speech-perception gains (Stage 1, n=10)

Mean CNC word-recognition score
9 of 10 responders: 59.1% at 12 months (+42.2 pts). 1 potential non‑responder under review. Source

Milestones to watch

  • Stage 2 completes 12-month follow-upTarget: early Q2 2027
  • PMA Module 4 (final clinical data) filedTarget: Q2 2027
  • FDA feedback on Modules 2 & 3Rolling · no fixed date
  • Full PMA submission completeEst. few months after Stage 2 readout
  • FDA approval / rejection decisionNot yet scheduled

Trial & regulatory timeline

Chronological, most recent first