Silk Worms Its Way into Reconstructive and Plastic Surgery

Serica Technologies Inc. (Medford, MA) has received 510(k) clearance from the FDA for its SeriScaffold technology, a silk-based biomaterial developed for tissue regeneration. A bioengineered material for soft-tissue repair applications, SeriScaffold has the potential to serve as an off-the-shelf bioresorbable support for the long-term repair of weakened or damaged connective tissue, according to the manufacturer. For the approximately 60,000 women each year who undergo reconstructive surgery following such illnesses as breast cancer, the material could be used for sophisticated tissue repair.Serica's grafts for anterior cruciate ligament repair, surgical meshes, and gels are composed of fiber protein from the B. mori silkworm. Preclinical studies have demonstrated that the company's silk-based products bioresorb at slower rates than other common structural proteins such as collagen and other water-soluble synthetic polymers, optimizing the healing process. In addition, the silk-based biomaterials do not require rehydration or advance preparation before surgical implantation, according to the company. SeriScaffold also provides a natural protein-based alternative to synthetic materials and graft products harvested from human or animal cadaver tissue."Major challenges still exist for both surgeons and patients faced with breast reconstruction and other forms of plastic and reconstructive surgery," explains John E. Gross, associate professor of surgery at the University of Southern California Keck School of Medicine (Los Angeles). In many types of breast surgeries following mastectomy, mastopexy, or body contouring procedures, scaffolding is needed to support a geometrically complex implantation site at the time of surgery and provide 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," remarks Gross.Gregory H. Altman, president and CEO of Serica Technologies, states, "We plan to leverage the well-known physical properties of silk in additional surgical applications and will be initiating new clinical studies using our novel technology." The company's goal, he adds, is to develop a portfolio of tailored scaffold products to be available in many contoured shapes and sizes for patients undergoing breast reconstruction or augmentation.Altman believes that the technology has applications for a 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. Hence, the company is planning additional R&D to determine how SeriScaffold can be used in aesthetic augmentation and reconstructive surgical procedures. The silk-based material is also showing promise in other areas, including rotator cuff and hernia-repair surgeries."Serica is actively seeking a strategic partner to advance the SeriScaffold product array, particularly in the aesthetic and reconstructive surgery market," notes Altman. At the same time, the company is continuing to advance its ligament and tendon platform technology in the orthopaedic marketplace.