Said to demonstrate improvements in wound healing responses in patients with non-healing diabetic foot ulcers
Cardium Therapeutics (Cardium) has filed 510(K) application to US Food and Drug Administration (FDA) for its ExcellagenXL topical gel and ExcellagenFX flowable collagen protein-based matrix.
The company anticipates approval based on the positive data from the recently completed Phase 2b Matrix clinical study. These collagen protein-based topical gels products are intended to treat dermal wounds, which can include diabetic ulcers, pressure ulcers, venous ulcers, tunneled or 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. It demonstrated 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.
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. T
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.
Christopher Reinhard, chairman and CEO of Cardium, said: “The submission of our FDA 510(k) premarket notification for Excellagen collagen protein-based product candidate for topical administration to partial and full-thickness wounds represents an important first step forward in the commercialization of our Excellagen technology platform. Our advanced wound healing technology platform also involves Cardium’s Gene Activated Matrix technology which covers DNA-based wound healing, as well as DNA-based orthobiologics.
“The Excellagen product platform provides us with a more near-term opportunity to introduce these products into the large and rapidly-growing market for advanced wound care. As recently reported, we plan to develop and introduce additional new product opportunities by incorporating other agents into the Excellagen formulation, including antimicrobials, DNA and or other biologics, which will be designed to address particular wound healing and other tissue repair applications.”