Silk Road Brilliance: Innovative Silk Materials, Moving from Clothing to Medical Use: Multi center Clinical Validation of "Silk Protein Hernia Repair Patch" Helps the Development of Hernia and Abdominal Wall Surgery

Observing the academic tide along the Qiantang River, discussing the ultimate goodness along the ancient canal. On April 13-14, 2024, the 8th Oriental Hernia Forum and the 6th Qianjiang Hernia Forum were grandly held in the beautiful and livable city of Hangzhou. Academic leaders in Chinese hernia and abdominal wall surgery, along with over 200 academic leaders and renowned experts, gathered in Hangzhou to share an academic feast, carry on the past and open up the future, and jointly draw a blueprint.

Professor Tang Jianxiong, the leader of the Hernia and Abdominal Wall Surgery Group of the Chinese Medical Association's Surgery Credit Association, emphasized in his speech that in order to modernize, professionalize, standardize, and internationalize China's hernia surgery industry, the Hernia and Abdominal Wall Surgery Collaborative Group was established at the end of 1999 with the approval of the Chinese Medical Association's Surgery Branch. In June 2000, the first National Hernia and Abdominal Wall Surgery Academic Symposium was successfully held in Hangzhou, and the Hernia and Abdominal Wall Surgery Group of the Chinese Medical Association's Surgery Credit Association was established in the same year. Today, the 8th Oriental Hernia Forum left Shanghai for the first time and was held in Hangzhou, with profound significance.

At the meeting, Zhejiang Xingyue Biotechnology Co., Ltd. (referred to as Xingyue Biotechnology), a local national high-tech enterprise in Hangzhou, released a multi center clinical validated "silk fibroin hernia repair patch" developed over 14 years. The patch officially obtained the product registration certificate approved by the National Medical Products Administration on March 20, 2024, and its clinical indication is inguinal hernia in hernia and abdominal wall surgery. The evaluation report on the official website of the National Medical Products Administration shows that its working principle is "the product is implanted in weak or defective areas of the abdominal wall soft tissue, providing mechanical support in the early stages of implantation. As tissue repair progresses, the product slowly degrades, and it is expected to ultimately be repaired through tissue regeneration in the body

One of the main researchers on the safety and effectiveness of silk fibroin patches, Professor Wang Ping from Hangzhou First People's Hospital affiliated with Xihu University School of Medicine, gave a special academic report titled "The First Study on the Safety and Effectiveness of Silk Fibroin Hernia Repair Patch" at this conference, pointing out that silk fibroin is a Chinese characteristic medical material. A total of 5366 research papers on "silk fibroin" have been retrieved from the PubMed database since 2000. Silk fibroin has excellent biocompatibility and biosafety, as well as good mechanical properties. It can be slowly absorbed after enzymatic hydrolysis in vivo, and the degradation products are amino acids. The 0.4mm pore size warp knitted mesh design of the silk fibroin patch promotes rapid growth of cells, blood vessels, and other tissues. Studies on large animal models such as rectus abdominis muscle defects in pigs have shown that the biomechanical properties of regenerated and reshaped abdominal wall tissue from silk fibroin are comparable to normal abdominal wall tissue. Histology shows that the reshaped collagen is an ordered wavy structure. Silk fibroin, as a tissue regeneration material, will provide a new regeneration strategy for abdominal wall defects such as inguinal hernia.

Coinciding with the 8th Oriental Hernia Forum and the 6th Qianjiang Hernia Forum held in Hangzhou, with favorable timing, location, and people, silk materials have undergone "cocoon breaking and regeneration" from clothing to medical use, and silk technology has helped promote the development of hernia and abdominal wall surgery. During the conference, with the support and guidance of 20 Chinese hernia and abdominal wall surgery groups, disciplines, academic leaders, and renowned experts, and witnessed by over 200 clinical experts and scholars, the "Clinical Application Research of Silk Protein Hernia Repair Patch" was officially launched. From then on, the research on silk fibroin hernia patches officially entered the "2.0" era, which will open up the minimally invasive treatment research of laparoscopic TAPP/TEP, and carry out research on intra-abdominal IPOM and esophageal hiatal hernia.

Xingyue Biotechnology participated in the development of the industry standard for tissue engineering medical device silk fibroin in the Chinese pharmaceutical industry, as well as the international standard for silk fibroin as a starting material (ISO/TC 150/SC 7N 318), bringing silk materials to the medical world and Chinese medical silk to the world. As an explorer in the medical silk material industry, Xingyue Biotechnology never forgets its original intention, forges ahead, and empowers the high-quality development of silk medical materials and high-end medical equipment products with new quality productivity.