Cardium Therapeutics (NYSE:CXM) appealed to U.S. federal regulators for 510(k) clearance of its Excellagen wound care product after making several modifications and including more specific labeling.
Excellagen is a skin matrix that promotes wound healing. It is administered with a syringe and functions as an acellular biological modulator, a material that accelerates a natural biological process like cell regeneration.
Cardium included more specific labeling in its new application, providing evidence that Excellagen can enhance platelet activation when used alongside Platelet Rich Plasma therapy.
The San Diego, Calif.-based company also promised to modify packaging to include individually pouched applicator syringes and a large volume syringe applicator for bigger wounds.
"We believe the research data provided to the FDA in our recent 510(k) submission provide further insight into the significantly accelerated and activated healing response seen with our Excellagen advanced wound care product," CEO Christopher Reinhard said in prepared remarks.