Therapy, On and Off the Field
TecTraum Inc. has designed and developed the world’s first-ever medical device treatment for concussions, potentially reducing the effects of brain injury. Designated by the U.S. Food and Drug Administration as a Breakthrough Device, pro2cool® offers the potential for clinically significant improvements for patients that have suffered a mild traumatic brain injury (mTBI, or concussion) in a low-risk, easy-to-use, point-of-care delivery system.
The New Standard in Concussion Treatment:
My Concussion Story
In the arena of contact sports, concussions are caused by high-impact collisions between athletes, resulting in mild traumatic brain injuries (TBI) that affect your brain function. It is important that a concussed athlete be evaluated by a clinician or health care professional to determine the severity of the head injury. In the case of concussions, TecTraum’s pro2cool® system can treat patients within eight days of the injury, by providing immediate relief and therapy to minimize damage. TecTraum’s pro2cool® empowers coaches, trainers, and physicians to treat and care for athletes when it matters most, both on and off the field.
“Going through the process of designing and developing the Pro-2-Cool® system and learning more about cooling therapy as a neuro-protectant gives us the confidence to say, not only is it possible hypothermic cooling of the brain works for treating concussions, but it is rather probable.”
— Sam Williams and Justin Fargas, former NFL football players
pro2cool® is a class 2 medical device that received FDA Breakthrough Device designation in June 2021. A large multi-site clinical trial for pro2cool® was recently completed in April 2022, with planned submission of data to the FDA for consideration of market authorization in May 2023. TecTraum anticipates a commercial launch of the pro2cool® system for treatment of concussions in late 2023.