The regenerative biostimulator is now certified for use in the gluteal area, posterior thighs, décolletage, and upper arms under the Medical Device Regulation.
Galderma has received new certification for its regenerative biostimulator, Sculptra, under the European Union (EU) Medical Device Regulation (MDR), expanding its clinical use from the face to four new body areas. The new indications are for the gluteal area, posterior thighs, décolletage, and upper arms.
The expanded approval allows practitioners to use Sculptra to improve skin quality, including the appearance of cellulite, and to enhance firmness, lift, projection, and contouring in these areas. The certification confirms that the product meets the updated safety, performance, and quality standards required by the EU MDR framework.
“Sculptra’s new and expanded indications mark an important evolution in how we approach aesthetic medicine—moving from facial rejuvenation to full-body restoration,” says Flavia Radke, MD, a plastic surgeon at Vita Aesthetica in Germany, in a release. “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.”
Supporting Clinical Data
Studies investigating Sculptra’s efficacy on the newly approved body areas showed progressive improvements in skin quality, firmness, and contour, with some results visible as early as one month after treatment.
Key findings from the studies include:
- Buttocks: At six months, 84% of patients were rated as having “improved” or more by physicians, and 96% of patients reported high satisfaction.
- Thighs: At one year, 100% of patients noted visual improvements, 93% reported reduced sagginess, and 97% were satisfied with the appearance of their thighs.
- Décolletage: By month nine, wrinkle severity visibly decreased in 93% of patients, with more than 80% satisfied with the improvement in skin quality, texture, and firmness.
- Upper Arms: Patients experienced visible improvement in skin firmness and quality just two months after a three-session treatment and reported satisfaction with the results.
“The certification of Sculptra for body indications in the EU marks an exciting evolution in injectable aesthetics,” says Flemming Ørnskov, MD, MPH, CEO of Galderma, in a release. “With these new body indications extending Sculptra’s trusted profile beyond the face, we are empowering practitioners to deliver natural-looking, long-lasting results across broader treatment areas, reinforcing Galderma’s commitment to innovation and holistic patient care.”
First approved in the EU in 1999, Sculptra works by stimulating the body’s own collagen production. This expanded indication for body applications allows practitioners to address growing patient demand for non-surgical treatments that provide a more holistic aesthetic approach.
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