Cleveland-based TecTraum has announced that its flagship pro2cool system to treat sports-related concussions has received Breakthrough Device designation from the U.S. FDA. The novel, noninvasive hypothermic therapy device is 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 the blood enters the brain. According to the company, researchers have observed significant improvements in clinical outcomes through the cooling of the brain within days of the concussion.

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. While many people who suffer a concussion receive no medical attention, an average of 283,000 emergency department visits per year for sports and recreation–related traumatic brain injuries occurred among children from 2010 to 2016.

The FDA’s Breakthrough Device program is intended to offer patients and healthcare providers timely access to medical devices that show promise to “provide for more effective treatment or diagnosis of life-threatening or irreversibly debilitating diseases or conditions.”

“We are extremely proud to have TecTraum recognized by the FDA as a leader in concussion therapy as we work to commercialize the first-ever FDA-approved treatment for concussions,” says John Zak, MD, MBA, TecTraum CEO. “Although our initial focus is on filling an unmet medical need for athletes, we anticipate demonstrating in the future that people who suffer concussions caused by falls, motor vehicle accidents, or through military service also can benefit from the pro2cool medical device.”

Development and Clinical Partners

TecTraum developed pro2cool through a partnership with Nottingham-Spirk, a design firm and developer of medical devices. Following the successful completion of pilot studies, TecTraum is nearing completion of a large multisite pivotal clinical trial to validate the effectiveness, safety, and tolerability of the system in patients between the ages of 12 and 21.

TecTraum plans to complete enrollment of its pivotal clinical trial by the end of 2021, with commercialization beginning in early 2022. Four pediatric medical centers serve 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.

According to the company, hypothermic therapy (“cold therapy”) has been shown to have clinical efficacy in a variety of cardiovascular injuries, including cardiac arrest and myocardial infarction (heart attack). The physiologic 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.

“The FDA has provided input on the design and implementation of the trial,” says Joseph Congeni, MD, director of sports medicine at Akron Children’s Hospital and the lead principal investigator of the multisite pivotal trial. “We all recognize that concussion is a growing burden—clinically, financially, and emotionally—in the United States. Based on previously published data, we are hopeful that our current trial will demonstrate the efficacy, safety, and tolerability of this noninvasive treatment for mild traumatic brain injury, also known as concussion.”

Although pro2cool was originally designed for athletes, TecTraum sees potential applications for its product outside of youth sports. According to the company, TecTraum’s goal is to provide immediate, effective relief that will limit brain injury and improve patient outcomes for concussions sustained on or off the field.