The Artificial Bone Repair Product “Bongold” developed by AllGens, a Company Invested by the ZGC Development Group, was Successfully Licensed by FDA
Recently, the artificial bone repair product “Bongold” developed by AllGens, a company invested by the ZGC Development Group, has successfully obtained the market access license (No. K141725) from the Food and Drug Administration (FDA), qualified for sales and clinical use in the United States and other countries and regions where the FDA license is recognized.
The artificial bone repair product “Bongold”, made of mineralized collagen, derives from the patented technology of the research team of Cui Fuzhai, a professor of the Institute of Regenerative Medical Materials of Tsinghua University. The “Bongold”, with completely independent IP rights, has been successfully industrialized by Beijing AllGens Medical Technology co., Ltd., which is co-invested by the ZGC Group.
At present, it has successfully obtained 3 class III medical device registration certificates from CFDA and 1 market access license from the FDA. It has been used in more than 100,000 cases clinically. It is widely applied in repairing long bone, spine, skull and other bone defects, with effects close to that of autogenous bone.
After 18 months of application, review and many rounds of replies to the review opinions, “Bongold” finally obtained the FDA license. Such a major breakthrough will enable the product to play a leading and exemplary role in the industry. At the same time, it will also have a significant effect on moving up the position of China’s orthopedic implants in the industrial division and the value chain of global orthopedic medical devices.
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