Galatea Surgical, a wholly owned subsidiary of Tepha Inc., announced today the FDA 510k clearance of its GalaFORM™ 3D Surgical Scaffold (“GalaFORM 3D”) for use in plastic and reconstructive surgery.  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 50^th Anniversary meeting of ASAPS in San Diego, California. 

Andy Joiner, President and CEO of Tepha commented, “One of the cornerstones of Galatea is our commitment to surgeon and patient education. We are honored to be a Premier Partner of ASAPS, an organization that is focused on providing its members with access to state-of-the-art educational and practice development programs. Innovation is an important driver of what we do at Galatea, and we are pleased to be launching GalaFORM 3D, a first of its kind resorbable scaffold, in conjunction with the 50^th anniversary of ASAPS.  Galatea is committed to engineering innovative new products that offer significant surgeon and patient benefits and providing access to this new technology to ASAPS and it membership.”

GalaFORM 3D is 510(k) cleared by the FDA and is indicated for soft tissue support and to repair, elevate, and reinforce soft tissue where weakness or voids exist.  Galatea has been a technology leader and innovator in the field of surgical scaffolds for plastic and reconstructive surgery since commencing the clinical evaluation of its GalaFLEX flat mesh in 2011.   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 committed to both innovation and careful clinical evaluation in order to meet the needs of plastic surgeons and their patients.

William P. Adams, a Dallas based board certified plastic surgeon commented, “Scaffolds play an important role in aesthetic surgery, where we deal with rejuvenating weakened tissue. We have studied soft-tissue support products through the years, but they are much different; they don’t add long-term tissue strength and aren’t as biocompatible. Galatea scaffolds are made of an easily absorbable monofilament, rather than a multifilament, which reduces infection.  GalaFORM 3D is a novel scaffold with out-of-the-box shape to better fit the patient’s natural curves.  I’m looking forward to using this game-changing 3D scaffold in my patients that require soft tissue support.”