Serica Technologies Receives FDA 510(k) Clearance for SeriScaffold(TM) Technology for Soft Tis...( Potential applications in re...)

Potential applications in reconstructive and aesthetic plastic surgery

MEDFORD, Mass., Feb. 25 /PRNewswire/ -- Serica Technologies, Inc., a growth-stage medical device company developing silk-based biomaterial platforms for tissue regeneration, today announced it has received 510(k) clearance from the U.S. Food and Drug Administration (FDA) for its SeriScaffold(TM) silk-based, long term bioresorbable scaffold technology.

"We are delighted to receive FDA clearance under the 510(k) process. This 510(k) clearance represents a major milestone for Serica as well as for our bioengineered silk-based biomaterial for soft tissue repair applications," said Gregory H. Altman, PhD, President and CEO, Serica Technologies.

The SeriScaffold platform technology has the potential to provide a new solution as an off-the-shelf, long-term bioresorbable scaffold for support and repair of weakened or damaged connective tissue. Most notably, SeriScaffold could be used as a sophisticated tissue repair scaffold for the approximately 60,000 women who, according to the American Society of Plastic Surgeons, annually undergo reconstructive procedures resulting from illnesses such as breast cancer.

"Major challenges still exist for both surgeons and patients faced with breast reconstruction and other forms of plastic and reconstructive surgery," said John E. Gross, MD, FACS, Associate Professor of Surgery at the University of Southern California (USC/Keck) School of Medicine and a prominent practicing plastic surgeon in Greater Los Angeles. "For example, in many types of breast surgeries, either following mastectomy, mastopexy (breast lift) or body contouring procedures, there is a significant need for scaffolding technology that can immediately support a geometrically complex implantation site at the time of surgery, and provide the body both the time and st
'/>"/>