WESTPORT, Conn., March 1, 2021 /PRNewswire/ -- Q30 Innovations is pleased to announce the FDA's recent authorization to market the Q-Collar in the United States. The FDA clearance is a major step forward in the company's mission to help better protect athletes from the effects of repeated head impacts.
The FDA's decision was based on a rigorous review of eight years of scientific research and clinical trials that demonstrate the safety and efficacy of the Q-Collar, including prospective, longitudinal studies in the United States with approximately 450 male and female athletes. The football study showed that over the course of a season of play, 77% of the collar wearing athletes had no significant changes in their deep brain tissues (white matter), compared to 73% of non-collar wearing participants who experienced significant changes. No adverse events have been associated with the use of the Q-Collar.
In announcing the clearance of the Q-Collar on Friday, February 26th, Christopher M. Loftus, M.D., acting director of the Office of Neurological and Physical Medicine Devices in the FDA's Center for Devices and Radiological Health said, "Today's action provides an additional piece of protective equipment athletes can wear when playing sports to help protect their brains from the effects of repetitive head impacts while still wearing the personal protective equipment associated with the sport."
The Q-Collar's FDA submission was supported by data from more than 20 independent laboratory and clinical trials that have been performed by several leading research institutions in the US and Canada. To date, the results of 17 of the studies have been published in peer reviewed medical journals. These include a series of human clinical trials involving male hockey, football and female soccer players.
The Q-Collar is a novel device intended to be worn around the neck of athletes aged 13 years and older during sports activities to aid in the protection of the brain from the effects associated with repetitive sub-concussive head impacts.
"FDA approval is the global gold standard for demonstrating the safety and efficacy of a medical device. For nearly a decade, we have invested in world class, independent scientific research conducted by leading academic and medical institutions to bring this novel device to the US marketplace. We thank the team at the FDA for their work and are pleased they have confirmed that that the Q-collar can aid in the protection of the brain from the effects of repetitive sub-concussive head impacts," said Tom Hoey, co-founder and co-CEO of Q30 Innovations. "This announcement is another major milestone for our company and we are proud to provide athletes with an effective, tested and verified solution to reduce the risk of traumatic brain injuries."
With FDA clearance, the company is working to make the Q-Collar available to athletes in the United States this summer. The Q-Collar has been on the market in Canada since 2019.
About Q30 Innovations
Based in Westport, CT, Q30 Innovations' mission is to help protect the brain from the effects of head impacts on the sports field and the battlefield. Since 2012, Q30 has worked with leading medical, academic, engineering and design institutions to research and develop the Q-Collar, an externally worn device that aids in the protection of the brain from the effects associated with repetitive sub-concussive head impacts. For more information, please visit www.q30innovations.com.
SOURCE Q30 Innovations