Celleration initiates enrollment in MIST Therapy study for VLU

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 is a very well-designed study that will significantly add to the body of evidence surrounding venous leg ulcer prevention, education and management and in particular the role of advanced therapies like MIST."

"The design of IN-BALANCE VLU was based on input from the world's leading wound care clinicians and researchers," commented Mark Wagner, Celleration's president and CEO. "We believe the results from IN-BALANCE VLU will clearly differentiate MIST Therapy from the vast array of wound care options by providing compelling evidence of superior healing rates and a thorough understanding of the mechanism of actions of MIST Therapy."