Allgens Medical Technology Co., Ltd, a Beijing-based innovator in regenerative medicine materials and implantable devices listed on the Shanghai Stock Exchange (SHA: 688613), has secured marketing approval from the Medical Device Authority (MDA) of Malaysia for its flagship product, BonGold, an artificial bone repair material.
BonGold is a biomimetic mineralized collagen artificial bone repair material, boasting independent intellectual property rights. It closely resembles natural bone tissue in both composition and microstructure, offering a highly biomimetic solution for orthopedic bone defect repair without restrictions related to bone grafting. Post-implantation, BonGold facilitates guided bone regeneration, gradually being replaced by new bone tissue, demonstrating its efficacy as an implantable medical device with commendable bone tissue regeneration and repair capabilities.
This home-grown biomimetic artificial bone repair material has already achieved significant regulatory milestones, obtaining a Category III medical device license in China in 2011, and the prestigious 510(k) market clearance in the US in 2015, marking it as the first domestically produced artificial bone to receive such approvals in China.- Flcube.com
