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Cardium Therapeutics To Develop A DNA-Based Orthobiologics Product Extending Gene Activated Matrix Technology To Deliver Bone Growth Factors

Cardium Therapeutics plans to develop a DNA-based orthobiologics product portfolio based on research and development by Cardium's Tissue Repair Company which will focus initially on non-union bone fractures for medically-compromised patients, and spinal fusion for patients with degenerative disc disease. Based on results observed with Tissue Repair's Excellarate product candidate, which is targeted to the repair of soft tissues (particularly diabetic ulcers), Cardium Therapeutics's orthobiologics initiative will build on and extend the underlying technology which has been developed by the Tissue Repair Company to hard tissue applications such as bone, including: use of Gene Activated Matrix or GAM to locally produce proteins capable of stimulating bone and other tissue growth; GAM delivery and ligand targeting and a substantial body of pre-clinical research and development supporting the use of GAM to deliver bone growth factors. The company initial focus will be on the development of Osteorate. It is a DNA-based non-surgical injectable bone graft gel to repair bone fractures and regenerate tissue in certain medically-compromised patient populations. It will be based on a reformulation of company's DNA-based Excellarate wound healing product candidate which is in late-stage clinical development and is designed to stimulate localized and sustained cellular production of platelet-derived growth factor-B (PDGF-B) protein as a treatment for patients suffering from non-healing diabetic foot ulcers. The Gene Activated Matrix technology allows for a broad spectrum of formulations which would include collagen, demineralized bone matrices, allograft and synthetic graft materials but is not be limited to above mentioned. Osteorate based on recently announced formulation advances, would be developed as a pre-mixed ready-to-use-syringe that would be stored in a physician's office at a temperature of about 4 degrees Celsius. PDGF-B protein is a well known bone growth mediator and is already used in several FDA approved products and medical devices for soft and hard tissue healing. The Gene Activated Matrix technology platform is expected to expand further with the use of other genes capable of promoting bone repair so as to biologically enhance surgical spinal fusion procedures in patients with degenerative disc disease. Exemplary genes include a chimeric variant of BMP-4 (chBMP4) that offers the potential for the sustained and localized cellular expression and release of Bone Morphogenetic Protein-4 (BMP-4) to potentially enhance spinal fusions. Cardium's Tissue Repair Company conducted a pre-clinical research study entitled Bone Induction by AdBMP-2/Collagen Implants demonstrated that local delivery of an adenovector encoding BMP-2 (AdBMP-2) in a collagen matrix rapidly induced new bone formation when compared to controls. The chBMP4 variant is believed to be even more effective for orthobiologics applications such as bone repair. "With the completion of the sale of our InnerCool Therapies operating unit to Royal Philips Electronics, the first monetization from Cardium's bio-medical investment portfolio, we have decided to expand our focus in regenerative medicine to include orthobiologics," reported Christopher J. Reinhard, Chairman and Chief Executive Officer of Cardium Therapeutics and Tissue Repair Company. "Cardium's Gene Activated Matrix technology and protein-producing DNA gene portfolio are important building blocks as we now broaden our strategy and development programs, that include cardiovascular and wound healing biologics, into the emerging new high growth market segment of orthobiologics."