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Cardium Announces New Research Findings: Excellagen Product Candidate Activates Platelet Release of PDGF, an Important Growth Factor Fundamental to the Wound Healing Process
Date:10/13/2010

rmulated collagen topical gel wound care dressing is currently the subject of a pending FDA 510(k) clearance application for marketing and sales in the United States.  

"These important new findings provide further insight into the significant and rapid healing response that our Excellagen product candidate demonstrated in the Matrix clinical study.  We believe that multiple treatments over a 12-week treatment period provide an opportunity to sustain accelerated healing rates and enhance the wound care management process for patients suffering with non-healing chronic diabetic foot ulcers.  We look forward to the market launch of Excellagen planned for this year, upon clearance by the FDA of our pending 510(k) notification, and to the development of new product extensions based on our custom formulated collagen product platform for additional wound healing applications," stated Christopher J. Reinhard, Cardium's Chairman and Chief Executive Officer.

About Excellagen

Excellagen is a highly-refined fibrillar bovine Type I collagen-based topical gel (2.6% collagen concentration) which has been evaluated in a controlled, double-blind randomized, multi-center Phase 2b clinical study at 23 U.S.-based medical centers for the treatment of chronic non-healing diabetic foot ulcers (the Matrix Study).  If the pending 510(k) notification to the FDA is cleared as submitted, Excellagen would be indicated for the management of wounds, including partial and full thickness wounds, pressure ulcers, diabetic ulcers, chronic vascular ulcers and certain other wounds, such as surgical and trauma wounds.  

Analysis of data from the Matrix Study indicates that the Excellagen product candidate appeared to be both safe and well tolerated, demonstrated improved wound area reductions and wound closure rates at 12 weeks following one or two treatments, and showed a statistically significant acceleration of wound healing during
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SOURCE Cardium Therapeutics
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