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Cardium Announces New Orthobiologics Product Initiative Extending Gene Activated Matrix Technology to Deliver Bone Growth Factors
Date:7/30/2009

res, are costly and debilitating. Aging is another important factor affecting hard tissue injuries, and as populations survive to greater ages, both the incidence of non-healing bone injuries and their consequences have increased.

Orthopedic surgeons for decades have been using a patient's own bone (autologous bone) to improve healing. Harvesting bone from a second site to augment healing has been the gold standard but not without drawbacks such as pain, longer surgical times and more anesthesia. Certain patients including those at risk for poor healing are not candidates for autologous grafts. A host of substitutes have been used with varying success. They include processed cadaver bone (allograft), demineralized bone matrices, synthetic materials and growth factors, primarily bone morphogenetic proteins.

Market data indicates that there are more that 500,000 surgical spine fusion procedures performed annually in the U.S. for patients with degenerative disc disease. These surgical fusion procedures utilize autograft, bone graft substitutes or BMPs to facilitate vertebrae fusion. The use of BMP growth factor proteins is becoming more widely adopted in part to reduce the need for harvesting surgical procedures and the inherent risks associated with these surgeries.

The orthobiologics market now has several protein products. Medtronic's INFUSE((R)), approved in 2002 uses BMP-2 in a collagen sponge for spinal fusion. Stryker also has a BMP protein product known as OP-1 under a compassionate use exemption for certain orthopedic applications. BioMimetic's GEM 21S((R)) Growth-factor Enhanced Matrix received FDA approval in November 2005 for the treatment of periodontal bone defects. GEM 21S, which is now owned and being marketed by Luitpold Pharmaceuticals, Inc., utilizes the same growth factor as Excellarate, PDGF. Medtronic's INFUSE((R)) product dominates the bone morphogenetic protein market with over
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SOURCE Cardium Therapeutics
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