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Celleration, Inc. Announces First Patient Enrollment in In-Balance VLU Randomized Control Trial
Date:5/14/2012

EDEN PRAIRIE, Minn., May 14, 2012 /PRNewswire/ -- Celleration, Inc., a privately-held medical device company focused on developing and commercializing therapeutic ultrasound healing technologies, announced the first patient enrollment in IN-BALANCE VLU (Inflammation, Bacteria, & Angiogenesis effects in Launching Venous Leg Ulcer healing: A Clinical Evaluation).  IN-BALANCE VLU is designed to expand on the vast body of evidence on MIST Therapy® that currently includes 12 peer-reviewed studies and a 444 patient meta-analysis supporting the clinical and economic benefits of the FDA cleared wound healing therapy.

IN-BALANCE VLU is a prospective, randomized, controlled, multi-center study of MIST Therapy in chronic lower extremity venous ulcers ("VLU").  The study will compare the effect of MIST Therapy on wound healing rates to traditional standard of care. The study will be performed at up to 20 study centers with an estimated 124 subjects enrolled in the study overall.  This study also includes sub-analyses of fluid and tissue samples to characterize cellular and molecular changes surrounding inflammation, angiogenesis and bio-burden impact of the treatments.

Venous leg ulcers are estimated to cost the U.S. healthcare system approximately $2-$3 billion annually and cause the loss of approximately two million working days per year. "With the significant economic and social cost of wound care rapidly rising, we must focus on conducting rigorous studies to fully understand both the biological mechanisms and healing outcomes of the many wound care treatment options to ensure we are selecting the most clinically efficacious and cost-effective treatment for each unique patient and wound," commented Gary Gibbons, MD, South Shore Hospital Center for Wound Care and Hyperbaric Medicine, Weymouth, MA.  "Celleration's IN-BALANCE VLU
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