Cardium (CXM) Files FDA 510(k) Application for Marketing Clearance of ExcellagenXL(TM) Topical Gel and Flowable Collagen

December 3, 2009 10:54 AM EST
Get Alerts CXM Hot Sheet
Price: $0.76 --0%

Overall Analyst Rating:
    BUY (= Flat)

Trade Now! 
Join SI Premium – FREE
Cardium Therapeutics (Amex: CXM) announced today that its wholly-owned subsidiary, Tissue Repair Company, submitted a 510(k) premarket notification filing with the U.S. FDA seeking marketing clearance of its Excellagen(TM) product candidate based on positive data from the Company's recently completed Phase 2b Matrix clinical study. Today's submission with the FDA covers ExcellagenXL(TM) and ExcellagenFX(TM), advanced wound care management medical devices comprising customized collagen protein-based topical gels designed for use by health care professionals for patients with dermal wounds, which can include diabetic ulcers, pressure ulcers, venous ulcers, tunneled/undermined wounds, surgical and trauma wounds, second degree burns, and other types of wounds.

The 510(k) submission is based in part on positive findings from the Company's Phase 2b Matrix clinical study, reported on October 14, 2009, demonstrating substantial improvements in wound healing responses in patients with non-healing diabetic foot ulcers following one or two applications of Excellagen, an enhanced, customized collagen-based gel matrix. ExcellagenXL is designed for use by health care professionals in a clinical setting and as an adjunct to standard of care topical wound therapy, which in the case of diabetic ulcers typically includes surgical debridement and off-loading. The ExcellagenFX kit is designed for use by health care providers in a clinical setting in the treatment of larger soft tissue or tunneling wounds that may occur with pressure, venous and diabetic ulcers, and surgical wounds. The ExcellagenFX flowable matrix product allows for deeper administration and direct intimate contact with the wound bed in these more complex, irregular and difficult to access wounds.

Based on the unique properties of the highly purified and enhanced Type-I collagen protein used, Excellagen gel requires storage at standard refrigeration temperatures (2°C - 8°C) and will be packaged in sterile, pre-filled single-use syringes for topical administration by health care professionals. Other categories of advanced wound care products are manufactured with alginates, hydrogels and hydrocolloids in structured, membrane or granular product configurations, or require hydration, mixing and reconstitution immediately prior to patient administration. The Company's Excellagen fibrillar collagen protein gel is a physiologic formulation consisting of a bioactive and biodegradable material that promotes effective wound management by providing a moist protective barrier and stimulates the natural wound healing process through the promotion of cell migration and capillary in-growth to support tissue regeneration.

ExcellagenXL is currently planned for use at one- to two-week intervals (with weekly outer dressing changes) and as an adjunct to surgical debridement. ExcellagenXL will be supplied in a kit configuration containing four single-use 1.0 cc syringes, each containing 0.5 cc of Excellagen gel, and four sterile flexible applicators to facilitate topical administration over the wound site. The ExcellagenFX kit will consist of one single-use 10.0 cc syringe containing 4.0 cc of Excellagen gel, and one single-use sterile flexible applicator designed for deeper administration at the wound site and is planned for use in more complex and difficult to access deep soft tissue wounds.

You May Also Be Interested In





Related Categories

Corporate News, FDA