regulatory
confidence high
sentiment positive
materiality 0.72
Estab. Labs ready to submit PMA Module 4 for Motiva implants in Q1 2023; targets $500M revenue by FY2026
ESTABLISHMENT LABS HOLDINGS INC.
- Notified FDA it is ready to submit Module 4 of pre-market approval for Motiva Implants in the U.S.
- Expects to file Module 4 during Q1 2023, working with FDA on optimal timing.
- CEO to present at 41st J.P. Morgan Healthcare Conference on January 12, 2023.
- Company targets $500 million in annual revenue for fiscal year 2026.
- Presentation materials furnished as Exhibit 99.1; forward-looking statements noted.