TecTraum Inc.

TecTraum Inc. is pioneering the advancement of concussion therapy with the development of Pro2cool®, the world’s first FDA-designated Breakthrough Device for post-concussion cooling therapy. The company’s mission is to provide a safe, effective, and easy-to-use medical device that can be deployed in various settings to reduce the signs and symptoms of concussion, particularly in athletes. TecTraum emphasizes science before sales, conducting extensive clinical trials to validate the safety and efficacy of its technology. Our vision is to revolutionize concussion treatment and improve patient outcomes. Pro2cool® works by using selective localized external cooling of the head and neck. The technology leverages hypothermic therapy, or cold therapy, in the form of a precisely controlled thermoelectric cooling device and garment applied to the head and neck. Once the pro2cool® is in place, the chiller assembly reduces the temperature of a coolant mixture in the device to 6°C and circulates it through the cooling garment to create precision conductive heat transfer from the head and neck. The physiologic neuroprotective benefit from cooling the injured region occurs at the cellular level. By interrupting the body’s naturally occurring localized inflammatory response with the introduction of cold therapy, the cellular- based metabolic cascade is dampened, thereby minimizing the ensuing damage caused by the body in response to injury. Pro2cool® imparts a proven significant clinical difference through just two treatments at 6°C administered for 30 minutes each, separated by 72 hours from the time of diagnosis. Extensive data derived from a large pivotal clinical trial supports the efficacy of the device. The multisite trial, completed in 2022, was designed to enroll patients between the ages of 12 and 21. It is the first and only concussion treatment study of this population. Four leading pediatric medical centers – three in Ohio and one in Michigan – served as investigational sites: Akron Children’s Hospital, Cincinnati Children’s Hospital Medical Center, Dayton Children’s Hospital, and the University of Michigan’s C.S. Mott Children’s Hospital. In addition to the Breakthrough Device Designation, Pro2cool® has been studied in the largest known clinical trial for concussion therapy; has been issued a first ever Category III CPT reimbursement code by the American Medical Association; and, TecTraum has completed Quality System audits, and received certification as an FDA 13485 registered medical device manufacturer. The company is awaiting FDA clearance under the De Novo regulatory approval pathway. TecTraum has begun production and is looking to partner with the Department of Defense as well as MTEC members to demonstrate the unique and important capabilities of Pro2cool® in support of our Nation’s Warfighters.