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news.Natural protein-based alternative to synthetic materials and graft products
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Serica Technologies, a medical device company, has received 510(k) clearance from the FDA for its SeriScaffold silk-based, long term bioresorbable scaffold technology.
According to the company, 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.
The SeriScaffold platform technology provides a natural protein-based alternative to synthetic materials and graft products harvested from human or animal cadaver tissue, the company said.
Gregory Altman, president and CEO of Serica, said: 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.
Serica is actively seeking a strategic partner to advance the SeriScaffold product array, particularly in the aesthetic and reconstructive surgery market, while the company continues to advanced its ligament and tendon platform technology in the orthopedic marketplace.
Serica Technologies formerly Tissue Regeneration is a medical device company pioneering silk-based biomaterial platforms for tissue regeneration. Serica’s proprietary products currently in preclinical and clinical development are being studied in the areas of orthopaedic and sports medicine, aesthetic and reconstructive plastic surgery and other structural tissue repair needs, and drug delivery applications. Serica’s R&D and manufacturing facility are located at Medford, MA.