For use in patients with dermal wounds
Cardium Therapeutics (Cardium) has reported that its wholly-owned subsidiary, Tissue Repair has submitted a 510(k) premarket notification filing with the FDA seeking marketing clearance of its Excellagen product candidate based on positive data from the company’s recently completed Phase 2b Matrix clinical study.
The submission with the FDA covers ExcellagenXL and ExcellagenFX, advanced wound care management medical devices comprising customised 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.
Reportedly, 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, customised 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.
However, 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.
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 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.”