Galderma has received EU Medical Device Regulation (MDR) approval for Restylane Shaype, expanding its Restylane portfolio with an injectable designed for structural facial shaping and chin augmentation.
Powered by NASHA HD technology, Restylane Shaype is indicated for deep injection to build and shape on bone. Galderma describes it as the first bone-mimicking hyaluronic acid (HA) injectable for facial shaping, offering structural enhancement without surgery.
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The EU approval follows regulatory clearances in Canada and Brazil, expanding the product’s international market access and giving clinicians another option for addressing facial structure and balance.
According to Galderma’s global head of R&D, Baldo Sforzolini, the approval expands clinicians’ ability to address structural concerns in ways traditional HA fillers are not designed to.
With its focus on structural enhancement rather than conventional soft-tissue filling, Restylane Shaype strengthens Galderma’s position in the growing facial balancing and injectable aesthetics market.
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