Dermatology company Galderma (SWX:GALD) said on Tuesday that it has received European Union approval under the Medical Device Regulation for Restylane Shaype, a hyaluronic acid injectable for temporary augmentation of the chin region.
Powered by the company's NASHA HD technology, the product is designed for deep injection to build and shape on bone, providing immediate structural enhancement of the lower face without surgery.
Galderma said Restylane Shaype is the firmest hyaluronic acid gel available among market leaders in facial fillers and has the highest G' firmness measure within the Restylane range. In a pivotal 12-month study, 83% of treated patients showed improved structure and definition at three months (66% at 12 months), and 84% said they would agree to undergo treatment again.
The company has also developed the Shayping Technique, combining its AART methodology and Facial Assessment Scale to support individualised assessment and treatment of lower-face anatomy and facial balance.
The approval expands Galderma's Restylane portfolio and supports its focus on evolving aesthetic needs, including changes associated with medication-driven weight loss and menopause, which can affect bone density, structural support, and skin health.
Perrigo to acquire United States rights for Entocort from AstraZeneca
US FDA approves Boehringer Ingelheim's Pradaxa
Phase II clinical trial for potential treatment of androgenetic alopecia completed by Samumed
Life Sciences Partners collaborates on immuno-oncology with Bristol-Myers Squibb
Arsanis initiates first cohort in Phase one clinical trial of ASN100
Impax introduces generic Avodart (Dutasteride) Capsules, 0.5 mg
Mylan unveils generic FazaClo orally disintegrating tablets for treating schizophrenia