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
— 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 and is currently in clinical trials with an anticipated completion of a multi-site clinical trial in October 2021, and planned submission of data to FDA for consideration of market clearance in April 2022. TecTraum anticipates a commercial launch of the pro2cool® system for treatment of concussions in early 2022.