Risk factors
Establishment Labs Holdings (ESTA) risk factors
Item 1A of every Establishment Labs Holdings Inc. 10-K on file, and what changed from one year to the next. Readings are automated and can be wrong; check the filing for the exact wording.
- FY2025 10-K risk factors60 risks10 new5 dropped16 reworded
Establishment Labs is scaling US commercialization of Motiva Implants following FDA approval in September 2024. International expansion exceeds 100 countries while ongoing losses persist. Artificial intelligence and ESG compliance introduce new operational risks and costs.
Filed Feb 27, 2026 - FY2024 10-K risk factors55 risks
Establishment Labs faces risks from its limited U.S. operating history following recent FDA approvals for Motiva Implants and Motiva Flora.
Filed Feb 28, 2025