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 signs and symptoms of concussion. Designated by the U.S. Food and Drug Administration as a Breakthrough Device, pro2cool® offers the potential for clinically significant improvements for patients who have suffered a mild traumatic brain injury (mTBI, or concussion) in a low-risk, easy-to-use, point-of-care delivery system. Currently, the pro2cool® system is an investigational use only device and has not yet received market authorization from the FDA.
The New Standard in Concussion Treatment:
My Concussion Story
“Going through the process of designing and developing the pro2cool® 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 considered a Class 2 medical device that first received FDA Breakthrough Device designation in June 2021. A large multi-site clinical trial for pro2cool® was completed in April 2022, with planned submission of data to the FDA for consideration of market authorization in Q4 2023. Currently, the pro2cool® system is an investigational use only device and has not yet received market authorization from the FDA.