Establishment Labs secures FDA approval for expanded Motiva implants
- Establishment Labs received FDA approval for an expanded range of Motiva SmoothSilk breast implants in the U.S.
- The regulatory approval adds 28 new sizes, including smaller options down to 105 cc, to meet growing aesthetic trends.
- The company stated the commercial rollout for the new product sizes will begin before the end of the year.
Establishment Labs Holdings (NASDAQ:ESTA) secured U.S. Food and Drug Administration approval for an expanded range of Motiva SmoothSilk Round and Ergonomix breast implants.
The regulatory clearance introduces 28 new sizes to the U.S. portfolio—including implants as small as 105 cc—across Mini, Demi, and Full profiles.
"The growing 'ballerina or yoga breast' trend reflects what more women are seeking today, which tends to be smaller, natural and proportionate results," said Establishment Labs Chief Executive Officer Peter Caldini.
The expanded portfolio features 19 new sizes for the SmoothSilk Round line and 9 new sizes for the SmoothSilk Ergonomix line.
Following the announcement, Establishment Labs Holdings' share price was up at $42.10.
The medical technology manufacturer stated that the new size ranges will become commercially available to plastic surgeons before the end of the year.
Board-certified plastic surgeon Dr. Anna Steve noted that the smaller volume additions allow surgeons to precisely match implants to individual anatomical and aesthetic goals.
