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Cardium Announces Plans to File FDA 510(k) Application for U.S. Marketing Clearance of ExcellagenXL(TM) Gel for Diabetic, Pressure and Venous Ulcers and Other Topical Wounds
Date:11/2/2009

e case of diabetic ulcers typically includes surgical debridement and off-loading. ExcellagenXL is expected to be indicated for use at two-week intervals (with weekly outer dressing changes) as an adjunct to surgical debridement, and supplied in a sterile single-use syringe along with a sterile flexible application needle to facilitate topical administration over the wound site. ExcellagenXL will be stored at standard refrigeration temperature (2 degrees C - 8 degrees C).

Cardium also announced plans to develop additional new product opportunities by incorporating other agents into Excellagen formulations, including antimicrobials, DNA and/or other biologics, which are designed to address particular wound healing and other tissue repair applications.

"We are pleased to announce plans to submit our FDA 510(k) premarket notification of our ExcellagenXL collagen-based topical gel. The 510(k) clearance process provides us with a potential near-term opportunity to introduce this product into the rapidly-growing market for advanced wound care. Applying our specialized formulation know-how and the unique properties of our collagen-based matrix technology, we also look forward to introducing additional Excellagen-based products in the near future," stated Christopher J. Reinhard, Chairman and Chief Executive Officer of Cardium.

About Cardium

Cardium is focused on the acquisition and strategic development of new and innovative bio-medical product opportunities and businesses that have the potential to address significant unmet medical needs and definable pathways to commercialization, partnering and other economic monetizations. Cardium's investment portfolio includes the Tissue Repair Company and Cardium Biologics, medical technology companies primarily focused on the development of innovative therapeutic products for wound healing, bone repair, and cardiovascular indications. In July 200
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SOURCE Cardium Therapeutics
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