LEXINGTON, Mass., April 27, 2017 /PRNewswire/ -- 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 50th 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 50th 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 its 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."
ABOUT TEPHA INC:
Tepha Inc., founded in 1998 and headquartered in Lexington, MA, is a supplier of medical devices focused on the BioMaterials market. Tepha's products are designed and developed to elevate, support and reinforce areas of soft tissue weakness as well as to promote improved healing responses. To date, Tepha and its partners have received 23 510(k) clearances for devices marketed in the US as well as five CE Marks for products sold in Europe. Commercial products based on Tepha's resorbable P4HB polymer technology include: high tensile strength sutures for orthopedic soft tissue repair; mesh constructs for ventral and inguinal hernia repair; monofilament sutures for abdominal wall closure and plastic surgery; patches for tendon and ligament repairs; and mesh constructs used in face and breast lifts. To date, products made from P4HB have been successfully used in more than 1,000,000 surgical procedures worldwide, and have been the subject of over 30 published clinical and scientific papers.
The American Society for Aesthetic Plastic Surgery (ASAPS), is recognized as the world's leading organization devoted entirely to aesthetic plastic surgery and cosmetic medicine of the face and body. ASAPS is comprised of over 2,600 Plastic Surgeons; Active Members are certified by the American Board of Plastic Surgery (USA) or by the Royal College of Physicians and Surgeons of Canada and have extensive training in the complete spectrum of surgical and nonsurgical aesthetic procedures. International Active Members are certified by equivalent boards of their respective countries. All members worldwide adhere to a strict Code of Ethics and must meet stringent membership requirements.
SOURCE Tepha Inc.