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Cardium Reports on New Excellarate(TM) Product Formulations to Expand Commercialization Potential Into Multiple Wound Healing Applications
Date:5/7/2009

roblasts and endothelial cells, which are critical for the effective stimulation of a variety of wound healing processes.

On May 6, 2009, Cardium announced the completion of recruitment for the Phase 2b MATRIX clinical trial to evaluate the safety and efficacy of Excellarate for the treatment of non-healing diabetic foot ulcers. The MATRIX Data and Safety Monitoring Board has reviewed safety data collected from study participants as of April 21, 2009 and reported that Excellarate appears to be both safe and well tolerated, with no serious adverse events attributable to the study product. Approximately 70% of the patients recruited in the MATRIX study have already completed their initial evaluation period with respect to key efficacy criteria, particularly the percentage of patients achieving complete wound closure, the rate of wound closure and the reduction of wound size at various time points. With confirmation of one or more medically meaningful responses, Cardium and TRC would expect to meet with the U.S. Food and Drug Administration (FDA) to review the complete safety and efficacy database from this Phase 2b clinical study and their plans for initiating a larger-scale Phase 3 pivotal study.

New Excellarate(TM) Product Formulations for Expanded Applications

In parallel with the Phase 2b study and in anticipation of a Phase 3 clinical study and future commercialization, the Company's continuing process development activities have led to an important breakthrough in product formulation that not only significantly simplifies the use of Excellarate, but opens the door to additional potential applications of the Excellarate technology in a number of other wound healing market opportunities. The product formulation that was used in the Phase 2b study required storage in a -70 degrees Celsius freezer and a two syringe mixing process prior to treatment. The new product formulation is designed to be ma
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SOURCE Cardium Therapeutics
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