Aug. 5, 2013
/PRNewswire/ -- Cardium Therapeutics (NYSE MKT: CXM) today announced that it has filed a new 510(k) submission for its current FDA-cleared Excellagen
advanced wound care product to reflect additional and specific structural and functional properties of Excellagen based on the Company's supplemental research and development activities.
The new 510(k) submission further characterizes Excellagen as a dermal wound matrix with structural and functional properties that play essential roles in wound healing. Excellagen is a physiologically formulated homogenate of bovine dermal Type I collagen in its native, 3-dimensional fibrillar structural configuration that provides a scaffold for cellular infiltration and wound granulation, and which activates blood platelets that can trigger the release of essential growth factors. The submission is supported by
research findings including electron microscopy data that should allow for more specific labeling to include the unique structural and biological properties of Excellagen and its utilization to potentially enhance platelet activation when used in concert with Platelet Rich Plasma (PRP) therapy. 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 such as those found in limb salvage, orthopedic surgery and other surgical applications.
"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," stated
Christopher J. Reinhard
, Chairman and CEO of Cardium. "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."
Regarding the Company's CE mark submission, in first quarter 2013, Cardium received ISO 13485:2003 certification (a requirement for CE marking) for Excellagen by BSI, one of the world's leading certification bodies. With the successful completion of ISO certification, the Company reported that it had completed its initial submission of required documentation, including the technical file and design dossier for its CE mark application. The CE mark process involves interaction between the Company and its notified body, BSI. Since the initial submission, Cardium has received requests for supplemental information from BSI. Based on the current status, all information requested has been provided to BSI and the Company believes this process should lead to CE mark certification for its FDA-cleared advanced wound care product.