Galderma Announces Regulatory Approval for Restylane® SHAYPE™, a New Hyaluronic Acid Injectable Designed for Augmenting the Chin Region

177
galderma logo

Galderma, the emerging pure-play dermatology category leader, announced today it has received approval from Health Canada for Restylane® SHAYPE™, a hyaluronic acid (HA) injectable designed for temporary augmentation of the chin region.2 Engineered to build and shape on bone with deep injection for a bone-mimicking effect,1,2,3,4† Restylane® SHAYPE™ will be available in Canada as of February 2024.

The chin is a critical component of overall appearance that influences the balance of facial proportions, profile, and shape.5,6,7,8 Genetics and age can impact overall chin definition,6,9 which may cause the appearance of a double chin, or “weak chin.” For decades, there has been heavy reliance on implants to create structure in the lower face, with no non-surgical options available offering qualities close to an implant.

Powered by new NASHA HD™ technology from Galderma,4 Restylane® SHAYPE™ has the highest G’ (“G prime”) of the Restylane® range.1,11 The firmest HA gel available on the market,1,2* Restylane® SHAYPE™ allows aesthetic injectors to shape, project and elongate the chin2,3 for natural-looking results from any angle.3‡ As a minimally modified and particularly firm HA gel,10 Restylane® SHAYPE™ is the injectable closest to the HA naturally found in skin10 and can be readily reversed.2,12,13

“Restylane® SHAYPE™ is the next generation in HA, going beyond currently available options for chin augmentation. Developed with leading experts, this innovative breakthrough has a unique ability to create the strength and support needed for a bone-mimicking effect. This makes Restylane® SHAYPE™ an ideal choice for lower face shaping, offering durable, natural-looking results for up to 12 months without retreatment.”

BALDO SCASSELLATI SFORZOLINI, M.D., Ph.D.
GLOBAL HEAD OF R&D
GALDERMA

In a pivotal 12-month study conducted at nine sites across Canada, 91% of patients agreed they still had aesthetic improvements at 12 months, and 84% of patients would agree to be treated with Restylane® SHAYPE™ again. Furthermore, up to 97% of patients would recommend treatment with Restylane® SHAYPE™ to a friend and 95% of patients felt their results looked natural.3

“A product with a significant ability to create a bone-mimicking effect without the downtime of surgery has long been an unmet need, highlighted by the community of plastic surgeons, dermatologists, and aesthetic injectors all over the world. The development of the ideal gel required a significant increase in firmness to create the strength and support needed to shape the lower face. Now, through meticulous clinical evaluation, Galderma has achieved the development of a safe and effective HA injectable for chin remodeling.”

DR. ANDREAS NIKOLIS, M.D., Ph.D., FRCSC, BOARD-CERTIFIED PLASTIC SURGEON
PRINCIPAL INVESTIGATOR, RESTYLANE® SHAYPE PIVOTAL STUDY
MONTREAL, CANADA

Other regulatory reviews around the world are ongoing, and Galderma is working to bring this latest innovation to as many countries as possible.

SOURCEBusinessWire
Previous articleWingderm® Launches Lasermach2, Revolutionizing Hair Removal Solution, at IMCAS World Congress 2024 in Paris
Next articleMAP Health partners with Nuchido for NAD+ learning