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Cardium Provides Update on Excellagen 510(K) Registration and Commercialization Plans
Date:8/2/2011

SAN DIEGO, Aug. 2, 2011 /PRNewswire/ -- Cardium Therapeutics (NYSE Amex: CXM) reported on the status of the 510(k) application seeking clearance from the U.S. Food and Drug Administration (FDA) to market its Excellagen topical wound care management medical device comprising 2.6% formulated bovine Type I collagen gel for the treatment of dermal wounds.  In addition to diabetic foot ulcers, dermal wounds for which Excellagen is intended include partial and full-thickness wounds, pressure ulcers, venous ulcers, chronic vascular ulcers, tunneled/undermined wounds, surgical wounds (donor sites/graft, post-Moh's surgery, post-laser surgery, podiatric, wound dehiscence), trauma wounds (abrasions, lacerations, second-degree burns and skin tears) and draining wounds.

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Cardium reports that in the second quarter it completed and submitted supplemental information related to the process for manufacturing the "market ready" Excellagen product candidate (conducted by Scotland-based Devro Medical Limited and U.S.-based fill/finish providers), which was a key requirement for clearance. While the FDA can always request additional information, the Company believes that its filing addressed all outstanding requests. Cardium also reports that it has initiated production of commercial supplies for its Excellagen product candidate at Devro and fill/finish providers. Following initial market launch, and in order to improve coordination and manufacturing efficiencies associated with the Company's U.S.-based fill/finish and packaging providers, Cardium intends to transfer the final steps for formulated collagen manufacturing to a U.S.-based operation while continuing to utilize key starting materials (collagen in solution) produced and supplied b
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SOURCE Cardium Therapeutics
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