Establishment Labs Seeks FDA Approval For Motiva Implants In Breast Reconstruction

(RTTNews) - Establishment Labs Holdings Inc. (ESTA) on Monday said it has submitted Motiva implants to the U.S. Food and Drug Administration for approval in primary and revision breast reconstruction.

The submission is supported by data from the Motiva U.S. IDE Study, which included 274 post-mastectomy reconstruction patients, comprising 220 primary and 54 revision cases. The company said Motiva SmoothSilk Round and Ergonomix implants represent state-of-the-art innovation in plastic surgery.

Motiva implants were previously approved by the FDA for breast augmentation in September 2024. Since that approval, more than 60,000 Motiva implants have been sold in the United States, the company said.

In addition, the Motiva Flora tissue expander was cleared for use in the U.S. in 2023 and is currently used at more than 200 cancer centers for breast reconstruction following breast cancer.

Establishment Labs closed Friday's trading at $76.45, up 1.06%.