Demonstrating the safety and efficacy of the Q-Collar through rigorous scientific research has been Q30's focus over the past eight years.
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WESTPORT, Conn., May 14, 2020 /PRNewswire/ -- After eight years of scientific research and clinical trials, Q30 Innovations announced that it has submitted a request for De Novo classification to the U.S. Food and Drug Administration, seeking authorization to market the Q-Collar in the United States. The Q-Collar is a novel, externally-worn device designed to help protect the brain from the effects of head impacts in contact sports.
"Demonstrating the safety and efficacy of the Q-Collar through rigorous scientific research has been Q30's focus over the past eight years," said Tom Hoey, co-founder and co-CEO of Q30 Innovations. "Compiling the results of the independent studies conducted by leading academic and medical institutions for our FDA submission is a major milestone in our extensive research and development process. We look forward to working with the agency to be able to offer the Q-Collar to athletes in the United States."
The Q-Collar's FDA submission is 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 15 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 most recent, and largest, clinical trial included over 450 participants, split between male football and female soccer athletes. Half of the study participants wore the Q-Collar during an entire season of play, while the other half did not wear the Q-Collar during the season. The researchers at Cincinnati Children's Hospital, who conducted the study on Q30's behalf, relied on advanced imaging to capture the baseline structures of participants' brains, then assessed changes in the participants' brain structures as seen in post-season imaging.
Importantly, no device-related adverse events related to use of the Q-Collar have been identified in any of the clinical testing conducted on the Q-Collar.