CLEVELAND– TecTraum Inc., dedicated to providing the world’s first point-of-care treatment for concussions, announced complete enrollment status for a clinical trial that began in fall of 2019 using its flagship technology, pro2cool®.
The pro2cool® system is a novel, noninvasive hypothermic therapy device designed to reduce the severity of concussion symptoms and allow patients to return to their pre-injury baseline sooner. The device provides localized cooling for the head and neck to lower blood temperature before it enters the brain. In previous clinical trials, researchers observed significant improvements in clinical outcomes through the cooling of the brain within days of the concussion.
Following the successful completion of pilot studies, clinical investigators enrolled 174 patients between the ages of 12 and 21 in the largest single concussion therapy trial known to validate the effectiveness, safety, and tolerability of the system. “As the principal investigator in the study we are thankful for the hard work of the research team from Akron Children’s Hospital. We also appreciate the coordination and communication demonstrated in this study by all of the researchers in this multicenter effort.” – Dr. Joseph Congeni, Akron Children’s Hospital
According to the U.S. Centers for Disease Control and Prevention (CDC), as many as 3.8 million sports and recreation-related concussions occur each year in the United States alone. Additionally, from 2001 to 2012, the rate of emergency room visits doubled for treating children with concussions. With the pro2cool® system receiving designation from the Food and Drug Administration (FDA) as a breakthrough device, TecTraum is strongly positioned for revolutionizing the treatment of concussions and providing an essential medical device for young athletes.
