Galderma wins EU approval for first bone-mimicking HA injectable Restylane Shaype

Regulation
โดย Business Wire·EU·Read original
Summary · why it matters

Galderma has received European Union approval for Restylane Shaype, the first-and-only hyaluronic acid injectable designed to mimic bone for chin augmentation. Powered by new NASHA HD technology, it is the firmest HA gel available and enables immediate, natural-looking lower-face shaping without surgery. In a pivotal 12-month study, 83% of people treated with Restylane Shaype showed improved structure and definition at three months, 66% at 12 months, and 84% of patients would agree to be treated with it again. The approval under the Medical Device Regulation marks a regulatory milestone for Galderma, with the product already approved in Canada and Brazil. Restylane Shaype is administered with a next-generation syringe for enhanced precision, and Galderma has developed the Shayping Technique to support individualized clinical use.

Impact on stocks 1

Health Care · 1 stocks
Galderma Group N
GALD
▲ PositiveRegulationrelevance

EU approval for Restylane Shaype is a regulatory milestone enabling market entry.