Biocomposites Granted SFDA Clearance For GeneX(R) In P.R.China

Main Category: Bones / Orthopedics
Also Included In: Regulatory Affairs / Drug Approvals
Article Date: 24 Feb 2009 - 5:00 PDT

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Biocomposites announced that the company's unique bone graft substitute geneX®, has been cleared for use by the State Food and Drug Administration (SFDA) of the People's Republic of China.

geneX® is a synthetic bone graft material with a unique bi-phasic composition manufactured through a proprietary process that confers the product with a reproducible negative surface charge. This property stimulates bone cell activity, accelerating bone formation and fusion by harnessing key proteins and directing osteoblast adhesion and proliferation for rapid osteogenesis. geneX® is fully resorbable and is completely replaced by bone.

Commenting on the clearance, Dr Simon Zhou, General Manager of Biocomposites (Shanghai) Ltd said "In the fast growing Chinese market, surgeons and patients can now take full advantage of the significant benefits that geneX® brings over traditional bone graft substitutes".

Commenting on geneX®, Professor James B. Richardson of RJAH Oswestry Orthopaedic Hospital, UK said "One of the clever things with geneX® over the previous calcium phosphates, is the negative surface charge. This demonstrates an improved affinity for the kind of proteins that cells produce to make fractures heal."

"Using geneX® in combination with mesenchymal stem cells, we are getting some of the best results we've seen. The negative surface of the bone graft helps to keep the stem cells at the fracture site. Also the patients' own naturally occurring local cells will be happy to move towards the negative surface."

Biocomposites' Managing Director 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. The encouraging clinical results are supportive of the scientific evidence thus far generated, for the unique affinity that geneX® shows for bone forming cells."

About the company

Biocomposites is a privately held, leading developer, manufacturer and distributor of synthetic, tissue regeneration products. Since 1997, 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, sales and marketing are directed from the company's headquarters in Keele, Staffordshire, UK. Biocomposites also has two regional companies, based in Shanghai, P.R.China and Wilmington, North Carolina, USA.

geneX® and Biocomposites® The Next Regeneration™ are registered trademarks of Biocomposites Ltd.

Biocomposites

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