Benzinga | Apr 27, 2021 08:13AM EDT

Establishment Labs Completes Enrollment Of One Hundred Patient Motiva Mia IRB Study

Establishment Labs Also Announces CE Mark Filing of Tools for Motiva Mia System

Establishment Labs Holdings Inc. (NASDAQ:ESTA), a medical technology company focused on women's health, initially in the breast aesthetics and reconstruction market, today announced it has completed enrollment in its one hundred patient Motiva Mia(r) case series in Costa Rica. The Institutional Review Board (IRB) approved study began in December 2020 and follows the initial 2019 case series in Asia. Establishment Labs also announced that is has submitted the tools used in the Motiva Mia(r) breast enhancement procedure for CE mark.

Fifteen board-certified plastic surgeons from Costa Rica, Sweden, England, Brazil, Austria, Italy, Belgium, and the United States participated in the case series. The single-center study is a prospective, interventional, single-arm, feasibility study of women 18 years or older in primary minimally invasive breast enhancement.