Cardium Therapeutics to seek FDA marketing clearance for ExcellagenXL

Nov 3 2009

Cardium Therapeutics (NYSE Amex: CXM) today announced plans to submit a 510(k) premarket notification with the U.S. Food and Drug Administration (FDA) seeking marketing clearance of its ExcellagenXL(TM) product candidate. ExcellagenXL is an advanced wound care management medical device, which is a customized collagen-based topical gel designed for use by physicians in patients with topical wounds, which include diabetic ulcers as well as pressure ulcers, venous ulcers, surgical and trauma wounds, second degree burns, and other types of wounds. The Company expects to submit its FDA 510(k) application for ExcellagenXL during the current quarter.

The planned 510(k) filing is based in part on positive findings from the Company's Phase 2b Matrix clinical study, reported October 14, 2009, indicating that substantial improvements in wound healing responses were observed in patients with non-healing diabetic foot ulcers following one or two applications of ExcellagenXL. The ExcellagenXL topical gel wound care product is designed to promote a favorable environment for effective wound management by providing a moist protective barrier as well as a micro-scaffold that promotes cell migration and capillary in-growth.

ExcellagenXL is an advanced wound care device composed of highly-refined, soluble bovine dermal collagen (Type I), which is modified to reduce immunogenicity and promote its usefulness in wound settings. ExcellagenXL is planned for physician use in conjunction with standard of care wound therapy, which in the 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.