Case Study: TecTraum Pro-2-Cool SystemMedical device innovation that provides immediate treatment of concussions
One in five young people who play a contact sport have suffered at least one concussion, according to the Journal of the American Medical Association. Every case is different, but most miss not only games and practices, but also classes, while they recover. It’s a stressful time for the athletes and their families. We’re proud to be part of a team behind the TecTraum Pro-2-Cool™ System, the first device that provides immediate treatment of concussions that could shorten the recovery time.
A few years ago, a partner came to us with the patents for a device, intended for use by EMTs, that would cool the blood flowing to the head to mitigate damage to the brain after a serious head injury. We wondered if something like it could help with concussions. We consulted John Zak, a healthcare entrepreneur, and determined that there was nothing quite like that on the market. There were a lot of products that cooled the head or neck, but none had been proven or could make any claims about treating minor traumatic brain injury (MTBI), or concussion.
Meanwhile, we met with Sam Williams and Justin Fargas, retired NFL players looking for investment opportunities. While touring our Innovation Center, Sam saw the EC VUE electrocardiograph vest and commented that he’d really like to develop products that could help athletes recover from injuries. He had retired from the Oakland Raiders in 2011 due to ongoing symptoms from concussions. We told them about the brain-cooling technology we’d acquired, and both players were intrigued.
NS, Williams and Fargas, and other partners launched TecTraum, a new venture founded around the promising technology. Zak joined as CEO. The goal was to provide something new in the concussion space: immediate therapy. Even in recent years, as awareness of concussions in youth sports has grown, the advice has remained the same: rest, and follow up with your doctor. But our research showed that this left athletes and their parents worried and frustrated.
The Medical Device Innovation
The TecTraum Pro-2-Cool System changes that. Designed to be portable and easy to use, the Pro-2-Cool is a non-invasive hypothermic therapy device that provides localized cooling of the head and neck. Coolant (nine parts distilled water, one part isopropyl alcohol at 70 percent concentration) is cooled to 6°C (42.8°F) by the chiller assembly and circulated through the cooling garment to create conductive heat transfer from the head and neck. The Pro-2-Cool System is indicated to improve clinical signs and symptoms and reduce recovery time in adolescents with a mild traumatic brain injury.
Like icing a hurt knee or ankle, colder blood will reduce edema (the accumulation of fluid in tissue) and cellular damage, and help insulate the brain from further damage while it is in a weakened state.
Above: The TecTraum Pro-2-Cool System
The original technology brought to NS was lacking in several ways. The chiller required almost 30 minutes to get the coolant to the right temperature. Our engineers got this down to 10 minutes. Our design team studied anatomy in order to improve the garment, which was bulky and uncomfortable. Through testing, with NS associates and real student athletes, we determined that the garment areas covering the head and neck needed to be slightly different temps, to prevent a sensation like an “ice cream headache.” (Cooling the carotid artery in the neck is what provides treatment; cooling the head provides comfort.) We also added insulation to protect the supraorbital nerves near the Adam’s Apple, and added a hood for privacy during treatment. The garment and the soft case for transporting the Pro-2-Cool System can be branded in team colors.
The Pro-2-Cool is a Class II medical device. The system is limited to use by medical personnel such as nurses, technicians and athletic trainers on the order of a physician. The user applies the cooling garment to the patient, turns the unit on and follows the screen prompts to provide the cooling treatment.
Dr. Joseph Congeni, concussion specialist and director of Akron Children’s Hospital’s Sports Medicine Center, is overseeing the ongoing clinical trials. We expect results in early 2019.