Therapy Areas: Oncology
Galderma secures EU MDR certification for Sculptra, expanding use to multiple body areas
5 December 2025 -

Dermatology specialist Galderma (SWX:GALD) announced on Friday that its regenerative biostimulator Sculptra has received EU Medical Device Regulation (MDR) certification, extending its use beyond facial applications to the gluteal area, posterior thighs, décolletage, and upper arms.

This expanded indication positions Sculptra to address broader aesthetic goals, including improvements in skin quality, firmness, lift, projection, and contour.

Clinical studies show progressive enhancements across these body areas, including improved skin texture and cellulite appearance.

Galderma said that the certification affirms Sculptra's safety, efficacy, and quality as a regenerative biostimulator. The company noted rising patient demand for comprehensive aesthetic solutions, with nine out of ten women reporting concerns beyond the face.

Growing interest in non-surgical body treatments, particularly for gluteal shaping, underscores the relevance of Sculptra's collagen and elastin–boosting effects.

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