Serica Technologies Inc, Medford, Mass received 510(k) clearance from the US Food and Drug Administration (FDA) for its SeriScaffold™ 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 chief executive officer, Serica Technologies.
The SeriScaffold technology provides a natural protein-based alternative to synthetic materials and graft products harvested from human or animal cadaver tissue, which could provide a new solution for support and repair of weakened or damaged connective tissue. SeriScaffold could be used as a sophisticated tissue repair scaffold for women who 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. "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 structure necessary for optimal healing. A silk-based scaffold that supports immediate tissue infiltration and maintains its integrity over a longer term, as it is being bioresorbed by the body, may be significant in addressing these clinical needs."
[Source: Original Press Release]