Biocomposites gains 510k for geneX putty


Biocomposites has announced that the company’s unique bone graft substitute, geneX putty, has received FDA 510k clearance.

The putty is a resorbable bone graft material manufactured through a proprietary process that confers the product with a reproducible negative surface charge. This property stimulates bone cell activity, accelerating bone formation by harnessing key proteins and directing osteoblast adhesion and proliferation for rapid osteogenesis.

Presented in a pre-loaded syringe, geneX putty combines optimised handling and unmatched migration resistance with unique surface chemistry to trigger osteoblast differentiation for superior bone growth.

Dr Mark Rodger, a leading spinal surgeon based in North Carolina said, "The negative surface charge technology of the geneX product is a very exciting development in the field of synthetic bone grafts. The clinical results I have seen to date using geneX convincingly demonstrate appositional growth of new bone.  This appears around the outside of the original material, suggesting osteoinduction due to the product’s novel surface chemistry. What is also impressive about this bone graft is that we are seeing complete resorption of the material and replacement by new bone".

President Stephen Bratt said, “geneX is the only synthetic biomaterial to show spine fusion equivalent to autograft when used as a stand alone graft material in the clinically relevant ‘Boden’ rabbit model. This response has previously only been demonstrated using BMPs.”