Establishment Labs Completes Breast Enhancement Study Enrollment

Establishment Labs Holdings Inc., a medical technology company focused on women’s health, initially in the breast aesthetics and reconstruction market, has completed enrollment in its 100-patient Motiva Mia 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 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.
 
“We are at the dawn of a new era in breast aesthetics. In this series we were able to reproduce and prove the reality of this revolutionary concept based on a standardized combination of implants and tools. Enhancing and beautifying the female breast in a safer, faster, and more predictable way without general anesthesia and with a minimal scar hidden in the axilla will attract patients who were previously reluctant to have this type of procedure,” said Charles Randquist, plastic surgeon from Victoriakliniken in Stockholm, Sweden.
 
According to Professor Marcos Sforza, head of the Medical Advisory Board at Establishment Labs, “After these one hundred patients, we have started to understand how well Motiva Mia can address many of the objections women have toward traditional breast augmentation. We were also very pleased to see how quickly plastic surgeons mastered this procedure, which we will further confirm with the IRB approved case series in Thailand.”
 
The Motiva Mia system is designed to provide a minimally invasive breast enhancement procedure in less time and with faster recovery than traditional breast surgery. The company has received registration in Costa Rica and a Free Sale Certificate (FSC) for the Motiva Mia system to begin regulatory approval processes worldwide. The Ergonomix2 Diamond implant used with Motiva Mia obtained CE marking in December 2020. In addition to the now completed patient series in Costa Rica, the company has also received IRB approval for a 60-patient multicenter study in Thailand with a similar protocol that is expected to begin later this year.
 
Motiva Implants are undergoing clinical investigation pursuant to U.S. Food and Drug Administration regulations for investigational medical devices.
 
“The completion of the one hundred patient case series in Costa Rica is not only a milestone for Establishment Labs but for all of plastic surgery,” said Juan José Chacón-Quirós, founder and CEO. “We have learned a tremendous amount and our initial enthusiasm for Motiva Mia has proven more than justified. The positive feedback that we have received from surgeons who have used the technology as well as from women in this series adds to our conviction that a true minimally invasive approach will open breast enhancement to a new group of women. I want to thank the clinical team and all the surgeons who were part of this important achievement.”