Cardium Says New Excellagen FDA 510(k) Submission Based on Expanded Structural, Functional Properties

Cardium Therapeutics

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 in vitro 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.