FDA’s decision on Excellagen expected March 3rd (NYSE Amex:CXM)

Tissue Repair Company is a subsidiary of Cardium Therapeutics, Inc. (NYSE Amex:CXM). The former already submitted a 510(K) premarket notification application to the United States of America’s Food & Drug Administration (FDA). The 510(K) submission was made to get the regulator’s approval to bring Excellagenâ„¢ into the market. According to the company, it contains favorable data from the second stage of the Phase 2 Matrix clinical trial – which the company had lately conducted. The submission includes information on both the ExcellagenXLâ„¢ and ExcellagenFXâ„¢ – two medical devices of the same product line. On December 3, 20009, Cardium announced that the FDA is expected to decide whether Excellagen could be marketed or not within March 3, 2010.

Both ExcellagenXL and ExcellagenFX contain topical gels – that are made of Type 1 collagen proteins. These gels help in healing skin wounds – such as second degree burns, wounds caused by surgery or shock, ulcers causing by diabetes or pressure, and venous ulcers. Both of the medical devices must be used by licensed physicians and in clinical settings.

The collagen proteins have been purified intensively and thus have powerful effects. The gel must be stored under low temperatures – more specifically, at 2°C – 8°C. If they are marketed, they would be sold in sterile packages (most probably, in one-time syringes) so that they can easily be used by physicians.

After the news of the FDA acceptance was released, Christopher J. Reinhard, who is the CEO and also the Chairman of Cardium, discussed about the company’s future plans:

“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”.