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Cardium Announces First International Marketing and Distribution Agreement for Commercialization of Excellagen™ in South Korea
Date:1/5/2012

he registration and reimbursement pricing process can typically be completed within about a year from application.  As part of the regulatory process in Korea, BL&H plans to provide the health authorities with the findings of Cardium's Matrix clinical study, which showed that formulated collagen can significantly accelerate reductions in wound radius immediately following application compared to standard of care therapy in diabetic foot ulcers, and can support platelet activation and release of the wound healing protein, Platelet-Derived Growth Factor (PDGF).  These findings were published in the peer-reviewed official journal of the Wound Healing Society, Wound Repair and Regeneration, (2011) 19: 302-308, available at www.cardiumthx.com/pdf/ExcellagenPaper_WoundRepair.pdf.

About Excellagen Formulated Fibrillar Collagen Gel

Cardium recently received 510(k) clearance from the U.S. Food and Drug Administration (FDA) to market and sell its Excellagen professional-use, sterile, syringe-based wound care product for the management of diabetic foot ulcers, pressure ulcers and other dermal wounds.  Excellagen is a highly-refined fibrillar flowable bovine collagen topical gel (2.6%) intended to support a favorable wound healing environment.  Excellagen is intended for use at one- to two-week intervals following surgical debridement (with weekly outer dressing changes) and will initially be supplied in the form of a kit consisting of four sterile, pre-filled, ready to use single-use syringes, each containing 0.5 cc of Excellagen formulated collagen topical gel (2.6%), and four sterile flexible applicators to facilitate topical administration to the wound site over a course of up to four treatments.  Detailed information about Excellagen, including the product's directions for use, is availa
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SOURCE Cardium Therapeutics
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11. Cardium Files FDA 510(k) Application for U.S. Marketing Clearance of ExcellagenXL(TM) Topical Gel and ExcellagenFX(TM) Flowable Collagen Protein-Based Matrix for Diabetic, Pressure and Venous Ulcers and Other Dermal Wounds
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