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Serica Presents New Data Showing Potential to Reduce Failure in Rotator Cuff Repair Using a Bioresorbable Silk-Based Implant in Animal Model
MEDFORD, Massachusetts, and DUNDEE, Scotland, July 2 /PRNewswire/ -- - A second study indicates initial safety, efficacy of silk-based implant for ACL repair in animal model. Serica Technologies today reported first data on the use of a non-mammalian derived silk-based long-term bioresorbable implant for rotator cuff tendon (RCT) repair, which demonstrated potential to reduce primary repair failure following surgery, in an animal model. Data presented at the British Orthopaedic Research Society (BORS) meeting in Scotland showed that the SeriCuff(TM) Scaffold helped to re-establish the tendon footprint and resulted in significantly increased repair strength three months following surgery, in a sheep rotator cuff repair model. "There is documented high incidence of re-tear following rotator cuff tendon repair, which is necessitating the development of new clinical strategies for tendon footprint augmentation," said Gregory H. Altman, Ph.D., President and CEO, Serica Technologies. "Our device is showing potential as a preventative measure to rotator cuff re-ruptures in mid to large RCT tears, thereby avoiding the need for surgical revision." In a podium presentation, "Infraspinatus Tendon Footprint Reinforcement with a Bioengineered Long-Term Bioresorbable Silk Fibroin Tendon Overlay in a Sheep Rotator Cuff Repair Model," Rebecca Horan, PhD, the study's lead investigator and Serica's Senior Director, Research and Development, reported that 10 sheep were implanted with the SeriCuff device. The animals were able to walk following surgery, with return to a normal gait at an average of six days. Pain scores diminished throughout the first two weeks after surgery. A 42% increase in repair strength was reported with the SeriCuff device reinforced repair at three months, and the device supported the formation of Sharpy's fibers in the remodeling tendon tissue. In a second study presented at the meeting, "Clinical, Mechanical and Histopathological Evaluation of a Bioengineered Long-Term Bioresorbable Silk Fibroin Graft in a One Year Goat Study for Development of a Functional Autologous Anterior Cruciate Ligament," Horan also reported on the SeriACL(TM) Graft, a non-mammalian derived long-term bioresorbable multi-bundled silk-based implant for repair of the anterior cruciate ligament (ACL) in the knee. In this study, 43 goats were implanted with the SeriACL Graft and pre-clinical results demonstrated the safety of the device, with initial indications of efficacy. About the Technology Serica is developing natural silk biomaterials designed to help stabilize soft connective tissue structures -- such as ligaments and tendons -- following surgical repair. The company's grafts for ACL and rotator cuff tendon repair, as well as its surgical meshes and gels, are comprised of the fiber of the B. mori silkworm. Silk has a proven track record of safety over centuries of human use and Serica's technology seeks to provide predictable and controlled bioabsorption by the body, which is a major advantage in many tissue repair and reconstructive surgical procedures. Serica's biomaterials are intended to act as "scaffolds" to provide support and relief to damaged tissues, and promote restored function. These implants are designed to allow the natural tissue to heal and resume normal function, as the implant is slowly resorbed by the body during the recovery period. In clinical studies, Serica's 100 percent silk-based products are shown to be bioresorbed at slower rates than other common structural proteins, such as collagen, to facilitate healing. Its products require no re-hydration or advance preparation for surgical implantation. Serica Technologies, Inc., formerly Tissue Regeneration, Inc., is a growth-stage medical device company pioneering silk-based biomaterial platforms for tissue rejuvenation. Incorporated in 1998, Serica's proprietary products currently in preclinical and clinical development are being studied in the areas of orthopedic and sports medicine, aesthetic and reconstructive plastic surgery and other structural tissue repair needs. Serica's team of engineers and scientists are located in a state-of-the-art 22,000-square-foot office, R&D and manufacturing facility in Medford, MA. For more information about Serica Technologies, please visit http://www.sericainc.com. Web site: http://www.sericainc.com






