TecTraum Inc., a provider of 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,” says Joseph Congeni, MD, 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.
Clinical and Development Partners
Four leading pediatric medical centers have served as investigational sites—University of Michigan’s C.S. Mott Children’s Hospital, Akron Children’s Hospital, Dayton Children’s Hospital, and Cincinnati Children’s Hospital Medical Center, recently named by U.S. News and World Report as 2021’s top children’s hospital in the Midwest and the fourth-ranked children’s hospital nationwide.
TecTraum developed pro2cool through a partnership with Nottingham-Spirk, a world-renowned design firm and developer of numerous successful medical devices.
“We are thankful to our research team at the University of Michigan and the young athletes and families who were eager to participate in this project,” says Ingrid Ichesco, MD, pediatric sports medicine specialist at University of Michigan Health C.S. Mott Children’s Hospital and researcher at Michigan Medicine.
Hypothermic therapy has been shown to have clinical efficacy in a variety of cardiovascular injuries, including cardiac arrest and myocardial infarction (heart attack). The physiologic neuroprotective benefit from cooling the injured region is believed to occur at the cellular level. By interrupting the body’s naturally occurring localized inflammatory response with the introduction of cold therapy, the cellular metabolic cascade is dampened, thereby minimizing the ensuing damage caused by the body in response to injury.
“Although pro2cool was originally designated for sports-related concussions, TecTraum sees potential applications for its product outside of youth sports. Whether sustaining a concussion on or off the field, TecTraum’s goal is to provide immediate, effective relief that will limit brain injury and improve patient outcomes,” says John Zak, TecTraum CEO.
TecTraum anticipates submission of clinical trial data to the FDA for consideration of market clearance later this year 2022, with a commercial launch of the pro2cool system in Q1 of 2023.