The FDA granted 510k clearance to Galatea Surgical’s GalaFORM™ 3D Surgical Scaffold (“GalaFORM 3D”) for plastic and reconstructive surgery. The scaffold is indicated for soft tissue support and to repair, elevate, and reinforce soft tissue where weakness or voids exist.
Based on Tepha’s proprietary P4HB™ bioresorbable polymer technology, GalaFORM 3D is the only 3-dimensionally contoured, surgical scaffold with a reinforcing rim, designed to uplift the body’s natural shape, provide easier placement and reduce procedure time.
Galatea is a Premier Partner of the American Society for Aesthetic Plastic Surgery (ASAPS), and will commercially launch GalaFORM 3D at the upcoming 50th Anniversary meeting of ASAPS in San Diego, California.
The launch of the rimmed GalaFORM 3D Surgical Scaffold follows the launch earlier this year of GalaSHAPE 3D, the market’s first 3D surgical scaffold for plastic and reconstructive surgery. Galatea Surgical is a wholly owned subsidiary of Tepha Inc.