Allgens Medical Science and Technology, Co, Ltd, a privately held orthobiologics company based in Beijing, China, today announced that the United States Food and Drug Administration has granted 510(k) clearance for its next generation Bone Graft (Bongold™ Mineralized Collagen Composite).Bongold™ represents a new class of synthetic biomaterials designed for optimized intra-operative handling and biologic responsiveness at the defect site. Bongold™ comprises a clinically proven bi-phasic mineral component embedded within type I collagen woven network of fibers. Bongold’ unique composition and structural properties deliver a bone graft that is tailored to support bone bonding and sustained remodeling as the healing process occurs.
Ethan Shen, CEO of Allgens said, “We are very pleased to receive FDA clearance for Bongold™ Mineralized Collagen Composite. Allgens was founded in 2004 with the goal to develop and commercialize proprietary first-in-class products in the bioactive, polymer, collagen and cellular bone graft spaces, and it is already a leading manufacturer of advanced synthetic bone graft in the Chinese market. The Bongold™ clearance represents the 1st step in our attainment of that goal of entering into the US bone graft market, the biggest medical device product market in the world. Looking forward, we will continue to develop our pipeline of products in a continued effort to offer a unique breadth of products all under the Allgens umbrella.”
Allgens is a leading medical device company focused on developing innovative proprietary platforms in synthetic bone graft products for a broad range of spinal and orthopedic fusion procedures. Allgens’ global mission is to develop and commercialize new and innovative products focused on improving bone regeneration and remodeling for related clinical procedures. For additional information on allgens, please visit our website at www.allgensusa.com