Galatea Surgical, Subsidiary of Tepha Inc., Announces Publication of GalaFLEX™ Post-Market Study Results
Published: May 01, 2018
LEXINGTON, Mass., May 1, 2018 /PRNewswire/ -- Galatea Surgical, a wholly owned subsidiary of Tepha, Inc., announced today the publication of a clinical study investigating the clinical performance of its GalaFLEX™ Surgical Scaffold when used in elective mastopexy for soft tissue support. Mastopexy, the surgical lift of weakened breast tissue without implants, is one of the fastest growing aesthetic surgical procedures. The results of this study also were discussed by the investigators with leading plastic surgeons at the American Society of Aesthetic Plastic Surgery ("ASAPS") Annual Meeting currently being held in New York City. The GalaFLEX scaffold is a biologically derived, bioresorbable, monofilament mesh device that is manufactured from Tepha's proprietary P4HB™ polymer technology and has received FDA clearance for soft tissue support in plastic and reconstructive surgery.
Published in the May issue of the Aesthetic Surgery Journal, The Use of Poly-4-Hydroxybutyrate (P4HB) Scaffold in the Ptotic Breast: A Multicenter Clinical Study is a prospective, observational study that assessed the one-year performance and safety of GalaFLEX. The study, with 62 patients treated by six leading plastic surgeons, concluded that GalaFLEX scaffold safely and successfully supports the elevated breast tissue in mastopexy and reduction mammaplasty, with maintained support at 1 year.
Dr. William P. Adams Jr., principal investigator and Dallas, Texas plastic surgeon comments, "The results of this study reinforce my personal seven-year positive experience with the GalaFLEX P4HB scaffold. The availability of GalaFLEX is allowing me to offer mastopexy to the increasing number of women who are seeking an aesthetic repair that is sustainable, and does not involve a breast implant."
Galatea Surgical, a Premier Partner of the American Society for Aesthetic Plastic Surgery, is displaying its complete portfolio of products at its booth at this year's ASAPS meeting being held at the Jacob K. Javits Conference Center in New York City from April 26th -May 1st. At the 2017 ASAPS meeting in San Diego, CA, Galatea announced the FDA 510(k) clearance of the first and only three-dimensional scaffolds for plastic and reconstructive surgery. GalaSHAPE™ 3D and GalaFORM™ 3D scaffolds offer strong tissue support during the first six months after implantation as well as potentially facilitating surgical placement leading to reduced OR and anesthesia time.
Andy Joiner, CEO of Tepha Inc. and Galatea Surgical commented, "Tepha has a demonstrated history of commitment to scientific evidence, and we are pleased with the results of this most recent clinical study. We believe that the results of this study represent strong evidence that we have been successful in designing a soft tissue scaffold that offers aesthetic surgeons and their patients a strong and completely resorbable scaffold that supports and elevates weakened tissue with results that will be sustained for at least one year."
ABOUT TEPHA INC:
Tepha Inc, founded in 1998 and headquartered in Lexington, MA, is an innovator, manufacturer and distributor of biomaterials. Tepha's products are designed 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 twenty-three 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. To date, products made from P4HB have been successfully used in more than 3,000,000 surgical procedures worldwide, and have been the subject of over 30 published clinical and scientific papers.
For more information visit: www.Tepha.com or by contacting:
Veronica Welch at 1-508-643-8000
SOURCE Tepha Inc.