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Cardium Announces New Excellagen FDA 510(k) Submission Based On Expanded Structural And Functional Properties
Date:8/5/2013

/span>, Chairman and CEO of Cardium.  "Excellagen has multiple attributes that are beneficial to the promotion of wound healing, including activation of human platelets and the release of platelet-derived growth factor (PDGF). These findings are consistent with the role of platelet activation and the release of growth factors for one to two days following application of Excellagen to newly-debrided wounds."

Regarding the Company's CE mark submission, in first quarter 2013, Cardium received ISO 13485:2003 certification (a requirement for CE marking) for Excellagen by BSI, one of the world's leading certification bodies.  With the successful completion of ISO certification, the Company reported that it had completed its initial submission of required documentation, including the technical file and design dossier for its CE mark application.  The CE mark process involves interaction between the Company and its notified body, BSI.  Since the initial submission, Cardium has received  requests for supplemental information from BSI.  Based on the current status, all information requested has been provided to BSI and the Company believes this process should lead to CE mark certification for its FDA-cleared advanced wound care product. 

About Excellagen

Excellagen is a syringe-based, professional-use, pharmaceutically-formulated 2.6% fibrillar Type I bovine collagen homogenate that functions as an acellular biological modulator to activate the wound healing process and significantly accelerate the growth of granulation tissue.  Excellagen's FDA clearance provides for very broad labeling including partial and full-thickness wounds, pressure ulcers, venous ulcers, diabetic ulcers, chronic vascular ulcers, tunneled/undermined wounds, surgical wounds (donor sites/graft, post-Mohs surgery, post-laser surgery, podiatric, wound dehiscence), trauma wounds (abrasions, lacerations, second-degree burns and skin tears)
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SOURCE Cardium Therapeutics
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