Cardium Therapeutics announced that it has received 510(k) clearance from the U.S. Food and Drug Administration (FDA) to market and sell the Company's new Excellagenô professional-use, sterile, syringe-based advanced wound care product for the management of diabetic foot ulcers and other dermal wounds.
Directions for use indicate the application of Excellagen immediately following surgical debridement, which is routinely practiced in the treatment of diabetic foot ulcers and other dermal wounds.
AdvertisementExcellagen is a highly-refined fibrillar flowable bovine collagen topical gel (2.6%) that will initially be marketed as a sterile, syringe-based advanced wound care product for the management of diabetic foot ulcers following surgical debridement procedures. In addition to diabetic foot ulcers, Excellagen is also cleared for use in the management of other dermal wounds including partial and full-thickness wounds, pressure ulcers, venous ulcers, chronic vascular ulcers, tunneled/undermined wounds, surgical wounds (donor sites/grafts, post-Moh's surgery, post-laser surgery, podiatric, wound dehiscence), trauma wounds (abrasions, lacerations, second-degree burns and skin tears) and draining wounds.
The Company believes that Excellagen provides a new sterile, syringe-based advanced wound care option as there are no other collagen-based wound management products available for professional use in the United States that are considered comparable to Excellagen in terms of its overall formulation, fibrillar nature and product format. Other professional use collagen-based products include granulated collagens that require mixing prior to use, as well as a variety of sheet-based products.
Cardium's Excellagen fibrillar collagen topical gel also represents a new technology and product platform that allows for the potential development of a portfolio of other advanced wound care and therapeutic products. Cardium's Gene Activated Matrix (GAM) technology represents one extension of Cardium's newly FDA-cleared flowable, fibrillar collagen-based matrix for the localized topical delivery of agents that could include anti-infectives, antibiotics, peptides, proteins, small molecules, DNA, stem cells, differentiated cells and conditioned cell media. The Excellagen product is based on Cardium's newly-established manufacturing process, which allows for sterile fill of ready-to-use, single-use syringes for topical application. In addition, the advancement of Excellagen provides the opportunity to perform post-clearance studies to pursue therapeutic claims for the treatment of non-healing diabetic foot and pressure ulcers, as well as other wounds, following findings from 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 journal official journal of the Wound Healing Society, Wound Repair and Regeneration, (2011) 19: 302-308, available at www.cardiumthx.com/pdf/ExcellagenPaper_WoundRepair.pdf.
"This FDA regulatory clearance is a significant milestone for Cardium and represents an important step forward in the advancement of our Excellagen technology platform, which we developed and commercially advanced following Cardium's acquisition of the Tissue Repair Company. We look forward to the launch of Excellagen and to helping address the large and rapidly-growing advanced wound care market. We are continuing to work with potential new collaborative partners and exploring additional product opportunities for our Excellagen formulation and additional advanced wound care products that could be based on the Excellagen technology platform. The business focus of our portfolio is centered on health sciences and regenerative medicine and we look forward to initiating the late-stage/registration Aspire clinical study for our Generxģ angiogenic therapy as a potential new treatment option for patients with myocardial ischemia due to advanced coronary disease," stated Christopher J. Reinhard, Chairman and Chief Executive Officer of Cardium.
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