FDA grants breakthrough device designation to hypothermic therapy for concussion

The FDA has designated a novel, noninvasive hypothermic therapy device designed to reduce concussion symptom severity as a breakthrough device, according to a press release.

The device, pro2cool, was developed by TecTraum Inc.

“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,” TecTraum CEO John Zak, MD, MBA, said in a press release. “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.”

Research has shown a link between significant improvements in clinical outcomes and cooling of the brain within days of a concussion. Pro2cool offers localized cooling for the head and neck to reduce blood temperature before it enters the brain.

With pilot studies having been completed, TecTraum will soon complete a large multisite pivotal clinical trial to evaluate effectiveness, safety and tolerability of pro2cool among patients aged 12 to 21 years, according to the release.

“The FDA has provided input on the design and implementation of the trial,” Joseph Congeni, MD, director of sports medicine at Akron Children’s Hospital and lead principal investigator of the multisite pivotal trial of pro2cool, said in the release. “We all recognize that concussion is a growing burden — clinically, financially and emotionally — in the U.S. 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.”