Cardium Reports Non-Healing Wounds Continue to Challenge Patients and Healthcare...(to 20 weeks and (2) enhance acceptance b...),Health

With this targeted registration profile, Cardium believes that Excellarate offers the unique potential to become an important new therapeutic class that, in certain cases, may supplant the use of current healing agents and medical devices, and, in certain wounds and under various medical conditions, may be used in concert with other agents and current therapies within an expanding spectrum of advanced wound care solutions. The Company believes that, because of the complex nature of lower extremity diabetic ulcers, patients will benefit from the availability of a multitude of wound healing agents and therapies that can be tailored to appropriately address their specific medical conditions.

Benchmarks with Current Therapy

Regranex Topical Gel - As referenced in JAAPA, current therapy includes the use of a topical protein-based growth factor gel, Regranex (becaplermin; 0.01% recombinant platelet-derived growth factor-B). Regranex is currently the only FDA-approved advanced care biologic topical agent for the treatment of patients with lower extremity neuropathic diabetic foot ulcers. It was initially developed by Johnson & Johnson and is currently marketed by Systagenix. Regranex which is patient administered, requires daily application followed by a daily cleansing 12 hours after the drug treatment over a 20-week period. As a result, during the prescribed 20-week treatment period, Regranex patients are required to undertake approximately 280 interventions (drug administrations and cleansings) to achieve the potential maximum healing effect.

Bioengineered Skin Substitutes - In addition to protein-based therapy, the JA
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