Galderma, listed on the SIX exchange as GALD and recognized as a global leader in dermatology, has announced that Sculptra has received certification in the European Union for body treatments following its approval under the EU Medical Device Regulation. This marks an important expansion for Sculptra, which was previously cleared for use only on the face. Its approved clinical use now includes the gluteal area, the back of the thighs, the décolletage and the upper arms. Across these areas, Sculptra can support a wide range of treatment goals such as improving skin quality including a visible reduction in the look of cellulite, enhancing firmness, restoring projection and sculpting contours. Its adaptable nature gives practitioners greater freedom to tailor results so that patients can achieve subtle and long lasting improvements for both facial and body concerns.
Health Technology Insights: TurnOnGreen to Power New High-Precision Medical Laser
As patient expectations evolve, more people are looking for aesthetic options that address the body as much as the face. Research shows that nine out of ten women have cosmetic concerns that extend beyond facial features and many cite issues such as skin laxity, loss of volume and cellulite. The shape of the gluteal area has become a major point of focus with increasing interest in treatments that shape and define this region without resorting to surgery. Sculptra supports this shift in demand because it encourages the body to rebuild collagen and elastin over time. This regenerative effect helps improve skin firmness and overall quality while also supporting lift, structure and contour.
Health Technology Insights: Lipocine Reports Positive Phase 3 Safety for LPCN 1154
Studies carried out on the gluteal area, back of the thighs, décolletage and upper arms have consistently shown measurable progress in skin quality including smoother texture and improvement in cellulite appearance as well as increased firmness, lift, projection and contour. First changes were often noticed one month after treatment and each area demonstrated strong clinical and patient reported outcomes. In the buttocks, physicians rated eighty four percent of patients as improved or better on the Global Assessment of Improvement Scale at the six month mark and ninety six percent of treated individuals said they were highly satisfied. In the thighs, visible refinement was noted within a month and at the one year point every participant reported visual improvement. Ninety three percent reported less sagging and ninety seven percent were pleased with the overall look of their thighs with eighty three percent saying they would choose the treatment again. For the décolletage, thirteen percent saw fewer wrinkles within the first month and wrinkle severity eased in ninety three percent of patients by month nine. More than eighty percent were happy with the improvement in firmness and texture. In the upper arms, patients showed clearer signs of firmer and smoother skin within two months after completing a three session plan and overall satisfaction was strong.
This new MDR certification fits into Galderma wider transition strategy for Europe which includes its full aesthetic injectable lineup such as the Restylane range along with its dermatology devices. The certification verifies that Sculptra meets all updated requirements for safety quality and performance within the EU. While this milestone gives Sculptra its official approval for body indications it also highlights Galderma ongoing investment in scientific research regulatory excellence and product innovation within aesthetics.
Sculptra first received approval in Europe in 1999 and introduced a new way to restore volume by encouraging the body to generate its own collagen. Over the last twenty five years it has grown into a highly adaptable treatment known for its regenerative benefits that reach all three layers of the skin. This makes it the first biostimulator with proven regenerative capabilities. With the newly expanded indication Sculptra is now set to deliver its trusted results beyond the face giving both practitioners and patients a broader path to achieving full body aesthetic enhancement supported by strong evidence and long term results.
Health Technology Insights: InteliChart Launches InteliSense to Power a New Era of Patient Engagement
To participate in our interviews, please write to our HealthTech Media Room at info@intentamplify.com
