Surgical meshes are commonly used for a range of abdominal wall defect repair procedures, including reconstruction surgeries, bladder slings and hernia repair. Although major complications with permanent, synthetic meshes are rare, there is growing concern about infection, difficulties associated with revision surgery utilizing current mesh products, and scar-plate formation.
“We set out to evaluate our silk-based surgical scaffold as a robust, long-term, bioresorbable biomaterial, to address the limitations of today’s synthetic mesh products,” said Gregory H. Altman, PhD, President and CEO, Serica Technologies. “This study demonstrated that our silk-based surgical scaffold has the potential to support tissue regeneration and serve as a transitory scaffold during the natural repair process of soft tissue defects, while preserving tissue architecture and function.”
Data from this randomized, controlled study suggest that, when compared to currently available synthetic, non-resorbable surgical mesh product, Serica’s silk-based surgical scaffold produced an equivalent biological process, resulting in significantly greater tissue ingrowth. The silk-based scaffold bioresorbed at an ideal rate that supported the transfer of load-bearing responsibility to developing host repair tissue. Thirty-six rat subjects were randomized and evaluated at 30 and 94 days post implantation.
“The results from this study are very promising, and indicate that Serica’s silk-based surgical scaffold has great potential to support tissue regeneration in soft tissue defect repair,” said Paul P. Weitzel, MD, a noted orthopedic surgeon and Serica’s Vice President, Medical Affairs, Orthopaedics.
“These data show rapid ingrowth without the risk of stretching or bulk loss of mechanical integrity, and no shrinking or contraction due to scar encapsulation. We intend to conduct additional studies to further substantiate the performance of our silk-based, bioresorbable surgical scaffold in body wall repair,” added Altman.
About Serica’s Biomaterials
The body’s structural tissue can be destroyed, removed or weakened due to trauma, disease or aging. Serica is developing natural, silk biomaterials designed to act as “scaffolds” to provide support and relief to damaged tissues, in order to promote restored function. The company’s ligament grafts for ACL repair, surgical meshes and gels are comprised of the fiber protein of the B. mori silkworm, which has centuries of human use. In pre-clinical studies, Serica’s silk-based products are shown to be bioresorbed at slower rates than other common structural proteins, such as collagen, as well as other water soluble synthetic polymers, to enable optimal healing. Serica’s silk-based biomaterials require no re-hydration or advance preparation for surgical implantation.
Serica is developing products for a wide variety of applications where current materials fail to meet the needs of clinicians and patients, including connective tissue repair of the knee, shoulder, abdomen, breast, neck and face.
About Serica Technologies, Inc.
Serica Technologies, Inc., formerly Tissue Regeneration, Inc., is a growth-stage medical device company pioneering silk-based biomaterial platforms for tissue regeneration. Incorporated in 1998, 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 team of engineers and scientists are located in a state-of–the-art 26,000-square-foot office, R&D and manufacturing facility in Medford, MA. For more information about Serica Technologies, please visit www.sericainc.com.