Cardium Therapeutics 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 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.
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