Sculptra, the first proven regenerative biostimulator, has received European Union (EU) Medical Device Regulation (MDR) certification, expanding its current clinical application for the face to include gluteal area, posterior thighs, décolletage, and upper arms1
Studies investigating the efficacy of Sculptra on areas beyond the face show patients experienced progressive improvements in skin quality (including the improvement in cellulite appearance), firmness, lift, projection, and contour
Sculptra’s versatility and new indication allow practitioners to shift patient treatment goals beyond rejuvenation toward enhancement, meeting evolving patient needs
The certification validates Sculptra’s safety performance, efficacy, and quality, reinforcing Galderma’s commitment to innovation and meeting evolving patient
ZUG, Switzerland--(BUSINESS WIRE)--Galderma (SIX: GALD), the pure-play dermatology category leader, today announced the certification of Sculptra for body indications in the European Union (EU) following its certification under the EU Medical Device Regulation (MDR). This expands Sculptra’s current clinical use on the face, to include four new areas: gluteal area, posterior thighs, décolletage, and upper arms. Sculptra can be used across these areas to address varied treatment goals – from improving skin quality (including the improvement in cellulite appearance), to enhancing firmness, as well as lift, projection, and contouring.1-5 Sculptra’s versatility allows practitioners to meet each patient’s unique needs, delivering natural-looking, long-lasting improvements across face and body.
Meeting the moment: evolving patient needs
As aesthetic expectations shift, patients are seeking more holistic treatment approaches that address the body as well as the face. Nine out of ten women report aesthetic concerns beyond the face, including skin laxity, volume loss, and cellulite.6 The gluteal silhouette, in particular, is a focal point of beauty and confidence, with growing demand for non-surgical treatments that enhance its shape and definition.7 Sculptra’s regenerative effects on collagen and elastin as well as its ability to restore skin quality (including the improvement in cellulite appearance), firmness, lift, projection, and contour make it uniquely suited to meet these evolving needs.1-5,8-12
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“Sculptra’s new and expanded indications mark an important evolution in how we approach aesthetic medicine – moving from facial rejuvenation to full-body restoration. With its proven ability to improve firmness, volume, and skin quality beyond the face, this certification empowers us to treat our patients more holistically, combining science, artistry, and confidence in a truly individualized way.”
FLAVIA RADKE, M.D. PLASTIC SURGEON VITA AESTHETICA, GERMANY
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