EDEN PRAIRIE, Minn., Jan. 27, 2015 /PRNewswire/ -- Celleration, Inc., a privately-held medical device company focused on developing and commercializing therapeutic ultrasound healing technologies, announced the publication of results from the IN-BALANCE VLU prospective, randomized controlled trial in the January edition of Ostomy & Wound Management.
IN-BALANCE was conducted in 22 US outpatient healthcare facilities comparing the percent wound area reduction after 4 weeks of treatment with guideline-driven standard care (SC) plus MIST® Ultrasound Healing Therapy (MIST + SC) to SC alone in nonresponding lower extremity venous leg ulcers (VLU). Of the 112 eligible participants, 81 were identified as non-responding during the two week run-in period and were randomized. The average wound size reduction at 4 weeks was 61.6% in the MIST+SC compared to 45% in the SC alone group (P = 0.02). The statistical significance was unchanged when adjusting for wound size and age. In addition, MIST Therapy showed a statistically significant reduction in pain (P = 0.01) during the same period.
"The results from the IN-BALANCE trial are exceptional," states study co-principal investigator Gary Gibbons, MD, FACS, vascular surgeon and Director of the South Shore Hospital Center for Wound Healing, Weymouth, MA. "Over 400 studies have been conducted on venous leg ulcers in the last 15 years and this study is one of only a few to demonstrate both clinically and statistically significant results."
Study co-principal investigator Vickie Driver, MS, DPM, FACFAS, President of the Association for the Advancement of Wound Care, Professor of Orthopedic Surgery Brown University School of Medicine (clinical), Section Chief, Podiatric Surgery Veterans Affairs Medical Center in Rhode Island and Director of Research at Rhode Island Hospital's Center for Wound Care and Hyperbaric Medicine, explains: "The lack of quality clinical evidence in wound care is a problem. The IN-BALANCE trial not only provides us the clinical evidence we need to select effective treatments for nonresponding venous leg ulcers, but provides us a road map on how wound care clinical studies should be conducted in the future."
The IN-BALANCE clinical data adds to an extensive list of high quality clinical studies supporting the use of MIST Therapy to accelerate healing in even the most difficult to treat wounds. "We believe the results from IN-BALANCE VLU clearly differentiate MIST Therapy from the vast array of wound care options by providing compelling evidence of superior healing rates," commented Mark Wagner, Celleration's president and CEO.
Venous leg ulcers affect more than 2.5 million in the US alone with an estimated economic burden of up to $18 billion annually. Today, standard care focuses mostly on compression to address the vascular insufficiency, but few technologies exist to address the microenvironment found in nonresponding wounds. Preclinical and pilot human data have demonstrated the beneficial effect of MIST Therapy on a wound's microenvironment. The IN-BALANCE VLU study demonstrates the benefit of MIST Therapy in a larger patient population.
About Celleration, Inc.:
Celleration, Inc. is a privately-held medical device company. Celleration develops and markets a proprietary technology that has been proven to accelerate healing in wounds by delivering therapeutic, low frequency ultrasound without direct contact of the delivery device to the wound surface. Celleration's core product, the MIST Therapy System, has been clinically shown to positively impact the wound healing process providing clinical and economic benefits to institutions treating nonresponding wounds. MIST Therapy has been performed more than 1.2 million times on over 85,000 patients.
SOURCE Celleration, Inc.