Good news! The silk material hernia repair product, which has been clinically validated by multiple centers, has been approved

Happy News

Product registration certificate approved

On March 25, 2024, the "Silk Protein Hernia Repair Patch" independently developed by Zhejiang Xingyue Biotechnology Co., Ltd. officially obtained the Class III Medical Device Registration Certificate (Registration Certificate No.: National Medical Device Approval 20243130536) from the National Medical Products Administration (NMPA), and was launched with shock!

This product is a mesh patch made of mulberry silk through processes such as warp knitting and degumming. Its composition is silk fibroin and it is suitable for open abdominal external repair of inguinal hernia. The product is implanted in weak or deficient 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 is expected to ultimately be repaired through tissue regeneration in the body.

Silk fibroin has good biocompatibility, biosafety, biodegradability, tissue regeneration, excellent biomechanics and processability, and has great application prospects in medical devices, biopharmaceuticals, skincare, food and health care, and biochips. It will become a new platform material that stands alongside polymer synthetic materials, metal alloy materials, and animal tissue derived materials.

The Xingyue Biotechnology team has established a large-scale production line for medical silk materials, achieving four firsts in the medical field: the first silk fibroin third class medical device product (silk fibroin membrane dressing), the first silk fibroin third class implantable medical device (silk fibroin hernia repair patch) that has officially entered clinical trials, the first silk fibroin tissue repair material master document (M2021005-000), and the first silk fibroin raw material industry standard "Tissue Engineering Medical Device Silk Protein". Successfully brought silk materials into the medical world. At present, the international standard "Tissue engineered medical products - Characterization and evaluation of silk fiber as a starting material for TEMPs" that participated in the drafting has officially entered the solicitation of opinions, and Chinese medical silk materials are going global.

The Xingyue Biotechnology team has promoted the development of medical silk material technology, helping the traditional silk industry transform from "daily clothing use" to "healthy application", greatly enhancing the use and added value of silk, occupying the two major scientific and technological innovation highlands of "life and health" and "new materials", solving the problem of medical biomaterials being "choked", and at the same time developing high-quality silk medical new quality productivity, promoting the realization of common prosperity.