A Canadian technology that aims to fundamentally change the way concussions are diagnosed has received US, fully executed patenting. The first of its kind, clinical scientists at Neurolytixs Inc. have identified a number of blood metabolites that in preliminary studies accurately identify brain injuries. Leveraging artificial intelligence, this technology might significantly impact young athletes who suffer from concussions annually with up to 96% accuracy.
Neurolytixs commenced clinical trials in the State of Michigan in February 2022. Having obtained a pre-submission review from the U.S. Food and Drug Administration (FDA) to begin the trial process, the innovation team has begun testing their new proprietary technology to diagnose concussions. This work puts the innovation on the regulatory path to full FDA approval – aiming to bring the invention to households, schools, and clinics everywhere in the near future.
The team now has proprietary IP to address this global problem and has received substantial commercial interest across North America in this technology because of its robust preliminary results. “Our founding investors deeply believe in the global impact this tool will hopefully have,” says Peter George, CEO of Neurolytixs. “And now as we administer our pivotal studies, institutional capital investors are paying attention.”
“This US patent is a remarkable milestone that reflects the extraordinary commercialization potential of this innovation,” says Neurolytixs co-founder Adrian Uthay. “Neurolytixs’ tool is a “Made in Canada” market disruptor with global potential, and that momentum is now being recognized.”
Currently, concussions are diagnosed subjectively through physical, cognitive, and behavioural methodologies, which can be misinterpreted and manipulated – threatening the long-term brain health and recovery of concussed patients.
“Better diagnosis is key to protecting the long-term health and well-being of millions of young athletes globally,” says Dr. Douglas Fraser, co-founder, and developer of the Neurolytixs technology. “With 50% of concussions going undiagnosed in youth sports, this might be a game-changer for children and youth who participate in organized sports in Canada and around the world.”
The two-step process for mTBI diagnosis is fast and efficient. Step one is for individuals to document their “chemical fingerprint” by submitting a baseline finger-prick blood sample at the start of the sporting season. This baseline is important as it provides the most accurate, personalized assessment for patients. If a possible concussion occurs, a new finger-prick blood sample is then sent to the lab for testing within a 72-hour window post-incident and is compared with the athlete’s original baseline sample, as well as a population reference range.
This step will help determine if the patient has had a concussion or not within 20 minutes. The diagnostic tool will also help remove injured athletes from play to prevent further acute injury and optimize strategies for proper recovery protocols. Parents, coaches, teachers, doctors, and medical professionals everywhere will be able to access and administer the simple test.
This tool has been researched and developed over a number of years and we believe that it has the potential to heavily impact traumatic brain injury diagnosis. “The general consensus amongst doctors is if it’s 70% accurate, it’s a good test. Our preliminary, peer-reviewed studies yield an accuracy up to 96%.
In the medical community, that is very rare,” says Dr. Fraser. “This could be transformational for parents and young athletes, but it’s also important to other groups as well. Imagine the benefit to our other populations– similar technology can be life-saving for those who experience serious injury from falls, car crashes, and blasts.”
More information on the ongoing clinical trials and the future of this technology is available from Neurolytixs.
Dr. Douglas Fraser, Peter George, and Adrian Uthay founded Neurolytixs following the discovery of a novel blood-test for concussion diagnosis in London, Ontario. Neurolytixs was created to provide rapid and accurate diagnostics for mild traumatic brain injury (mTBI) using dried plasma spot and metabolite measurements via a mass spectrometer. Neurolytixs has licensed and fully executed patented technology that revolutionizes mTBI diagnostics. Neurolytixs works in partnership with HeadCheck Health, Lawson Health Research Institute/Western University, MaRS/Techstars Accelerators, Ontario Centre for Innovation, and the Ontario Brain Institute.