Cardium Therapeutics has filed a new 510(k) submission for its current FDA-cleared Excellagen advanced wound care product based on the company's supplemental research and development activities.
The new 510(k) submission describes Excellagen as a dermal wound matrix with structural and functional properties that play essential roles in wound healing and with potential to enhance platelet activation when used in Platelet Rich Plasma (PRP) therapy.
Excellagen is a syringe-based, professional-use, pharmaceutically-formulated 2.6% fibrillar Type I bovine collagen gel that functions as an acellular biological modulator designed to accelerate the growth of granulation tissue and to activate the wound healing process.
This submission is supported by in vitro research findings including electron microscopy data for more specific labeling to include the unique structural and biological properties of Excellagen.
In addition, the company plans to modify Excellagen’s packaging to include individually pouched applicator syringes and a large volume syringe applicator to allow for easier use in larger-sized wounds.
Cardium chairman and CEO Christopher J Reinhard noted the company believes the research data provided to the FDA in its recent 510(k) submission provide further insight into the significantly accelerated and activated healing response seen with its Excellagen advanced wound care product.
"Excellagen has multiple attributes that are beneficial to the promotion of wound healing, including activation of human platelets and the release of platelet-derived growth factor (PDGF).
"These findings are consistent with the role of platelet activation and the release of growth factors for one to two days following application of Excellagen to newly-debrided wounds," Reinhard added.