Galatea also announced that the first surgical procedure utilizing GalaFLEX for an aesthetic breast surgical procedure outside the United States was performed by Patrick Mallucci, MD, FRCS, a leading London-based Plastic Surgeon.
The GalaFLEX Surgical Scaffold is made from a resorbable polymer called P4HB™, developed by Galatea's parent company, Tepha, Inc.
Dr. Adams commented, "Mastopexy, or breast lift, is a good choice for the many women seeking a rejuvenated, perkier appearance, but without a breast implant; however, maintaining the surgical correction of ptosis (drooping) is often a challenge due to the weakened condition of the underlying breast tissue.
”Our preliminary one year experience with GalaFLEX utilized to support the weakened tissue suggests that it can help to sustain our surgical correction with minimal risk to the patient."
Mr. Mallucci added, "I am very excited about the opportunity to utilize the GalaFLEX Surgical Scaffold in a variety of my aesthetic breast procedures. My first case went very smoothly and I was impressed with the ease of use and handling properties of the GalaFLEX mesh."
The GalaFLEX Surgical Scaffold is based on Tepha's P4HB™, resorbable polymer technology. P4HB (poly-4-hydroxybutyrate) is a proprietary polymer with a unique biomechanical and biocompatibility profile that is ideal for soft tissue repair and support procedures.
GalaFLEX Surgical Scaffold has a CE Mark (for European marketing) and is intended for use in breast surgery procedures for which soft tissue support may be needed to obtain the desired surgical result.
Tepha, 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.
