MIST® Therapy Demonstrates Better Healing and Reduced Recidivism in Split Thickness Donor Site Randomized Controlled Trial

EDEN PRAIRIE, Minn., March 26, 2015 /PRNewswire/ -- Celleration, Inc., a privately-held medical device company focused on developing and commercializing therapeutic ultrasound healing technologies, announced the Journal of the American College of Surgeon has accepted for publication, "A Prospective Randomized Controlled Trial Comparing the Effects of Noncontact Low-Frequency Ultrasound to Standard Care in Healing Split Thickness Donor Sites" and has posted the manuscript online.

This prospective, randomized, controlled trial compared the effects of Noncontact, Low-Frequency Ultrasound (MIST Therapy) plus standard care (SC) to standard care alone in subjects with split thickness donor sites (median donor site area 136.0 cm²).  The MIST + SC group demonstrated faster mean time to heal (MIST + SC 12.1 days, SC 21.3 days, P=0.04).  All MIST + SC subjects had fully healed by 4 weeks compared to only 71% that received standard care alone. Pain and itching scores were reduced in the MIST + SC group versus SC alone. The MIST + SC group also remained healed with a recidivism rate of only 8% at the 6 week follow up visit versus 45% in the SC group.  At baseline, all subjects were free of infection.  Throughout the course of the study, only 8% of the MIST + SC group were treated for suspected infection compared to 50% in the SC group.

"Skin graft donor sites are notoriously painful with potential complications of delayed healing and infection.  In this population rapid healing is critical to reducing morbidity and cost,"   states study investigator Lisa Gould MD, PhD, FACS, Medical Director of the Wound Recovery & Hyperbaric Medicine Center at Kent Hospital in Providence Rhode Island. "Given the remarkable results from this study, MIST Therapy should be considered for treatment of acute surgical skin graft donor sites, particularly in subjects who are at higher risk for surgical site infections or delayed healing."

Current treatment of split thickness donor sites is focused on creating an environment that allows for new tissue growth and prevents infection.  Effective healing relies on management of wound bacteria, reduction of inflammation and restoration of perfusion, but few technologies exist that can address the microenvironment of the wound.  Preclinical and pilot human data have demonstrated the beneficial effect of MIST Therapy on a wound's microenvironment showing destruction of bacteria cells, disruption of biofilm, reduction of pro-inflammatory cytokines and increases in angiogenic factors.

"The results from this study demonstrate the ability of MIST Therapy to provide superior clinical outcomes in an acute wound," commented Mark Wagner, Celleration's president and CEO. "This highlights another challenging patient population that can benefit from the use of MIST Therapy to improve both clinical and economic outcomes."

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 both acute and chronic 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 acute and chronic wounds. MIST Therapy has been performed more than 1.2 million times on over 85,000 patients.

SOURCE Celleration, Inc.