WILMINGTON, N.C.--(BUSINESS WIRE)--Biocomposites (www.biocomposites.com) announced today that the company’s unique bone graft substitute, geneX putty, has received FDA 510(k) clearance.
geneX 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.
Commenting on the FDA clearance, Biocomposites’ president Stephen Bratt said, “geneX is derived from years of peer reviewed science and extensive in-vitro and in-vivo research. By exploiting our unparalleled expertise in synthetic calcium composite technology, we have developed a new class of biomaterial, which represents a significant advance in bone grafting options for the surgeon”.
Presented in a pre-loaded syringe, geneX putty combines optimized handling and unmatched migration resistance with unique surface chemistry to trigger osteoblast differentiation for superior bone growth.
The release of geneX putty adds to Biocomposites’ impressive family of synthetic bone grafts, which includes the original FDA cleared geneX paste, an injectable setting matrix that is also engineered with the pioneering negatively charged surface chemistry.
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, which suggests 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".
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 BMP’s. Biocomposites has again shown its capability to offer innovative and cost effective products to the surgeon. We were the first company to bring resorbable calcium composite devices to the field of arthroscopic sports medicine and this latest first in bone grafting for spine and trauma is a reflection of the company’s focus to develop biomaterials that stimulate the appropriate cell response in-vivo”.
About the company:
Biocomposites is a privately held leading developer, manufacturer and distributor of synthetic, tissue regeneration products. The company has developed a broad range of products that addresses the clinical and economic needs of medical specialties in orthopaedics and dentistry. Research, manufacturing, marketing and international sales are directed from the company’s headquarters in Keele, UK. Sales companies are also based in Wilmington, NC and Shanghai.
® geneX and Biocomposites® The Next Regeneration™ are registered trademarks of Biocomposites Ltd.
Contacts
Biocomposites Inc.
Wilmington, NC.
Bob Pelosi, Senior Vice President,
910-350-8015.
rp@biocomposites.com
www.biocomposites.com
