MEDFORD, MASS. — Medical-device company Serica Technologies Inc., based here, has received 510(k) clearance from the U.S. FDA for its SeriScaffold silk-based bio-resorbable scaffold technology, reports news source PRNewswire.
According to the PRNewswire report, the SeriScaffold 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. Further, it 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.
PRNewswire quotes Serica Technologies President and CEO Gregory H. Altman, Ph.D., as saying, “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.”
The SeriScaffold platform technology provides a natural protein-based alternative to synthetic materials and graft products harvested from human or animal cadaver tissue. “We believe our proprietary SeriScaffold technology has applications for a wide range of necessary procedures for patients requiring reconstructive plastic surgery, as well as for patients undergoing elective and other forms of soft tissue repair surgery,” says Dr. Altman. CST
