Establishment Labs' Motiva Breast Forms Advance Toward FDA Approval for Reconstruction Procedures; Stock Climbs 1.06%

SelfCustodyIssues · 2025-12-31T15:45:18+00:00

Establishment Labs submitted its Motiva breast forms to the FDA for reconstruction approval, building on prior successes with FDA-cleared implants. Strong clinical evidence supports safety and efficacy, positioning the company for market growth.

SelfCustodyIssues

2025-12-31 15:45:18

Abstract generation in progress

Establishment Labs Holdings Inc. (ESTA) has taken a significant step forward in expanding its portfolio, submitting its Motiva breast forms to the U.S. Food and Drug Administration for approval in both primary and revision breast reconstruction applications. The company’s stock reflected investor confidence in the development, closing trading at $76.45, up 1.06%.

The submission leverages comprehensive clinical evidence from the Motiva U.S. IDE Study, which evaluated outcomes across 274 post-mastectomy reconstruction patients. The study population included 220 cases requiring primary reconstruction and 54 requiring revision procedures, providing robust data on the safety and efficacy of Motiva SmoothSilk Round and Ergonomix implants in reconstruction scenarios.

Market Momentum Follows Prior FDA Clearance

The breast reconstruction submission builds on strong commercial traction following the FDA’s September 2024 approval of Motiva implants for breast augmentation. That initial clearance has generated substantial market adoption, with the company reporting more than 60,000 Motiva implants sold across the United States since receiving approval.

Expanding Clinical Infrastructure

Beyond implants, Establishment Labs has already established meaningful market presence in the reconstruction space through its Motiva Flora tissue expander, which received FDA clearance in 2023. The product has gained traction within the medical community, with adoption across more than 200 cancer centers nationwide for breast reconstruction following cancer treatment.

The combination of Motiva breast forms, tissue expanders, and supporting clinical infrastructure positions Establishment Labs to serve an expanding market as it pursues regulatory approval for the reconstruction indication.

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