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. Q30 received FDA clearance to market the Q-Collar in the US on February 26th. Information on product availability and pre-orders will be updated to this site and our social media channels ongoing.
FDA Authorizes Marketing of Novel Device to Help Protect Athletes’ Brains During Head Impacts
THE BRAIN INJURY EPIDEMIC
The prevalence of brain injuries in athletes and soldiers indicates a clear need for new, innovative solutions that seek to reduce the risk and severity of such injuries.
BRAIN INJURIES IN SPORTS
Data from the Centers for Disease Control and Prevention estimate the yearly incidence of sports- and recreation-related brain injuries in the U.S. to be between 1.6 and 3.8 million. Increasingly, there is growing concern in the sports medicine community around the effects of smaller, repeated head impacts, also known as RHI.
BRAIN INJURIES IN THE MILITARY
Military personnel, whether in training or conflict environments, are also impacted significantly. According to the Defense and Veterans Brain Injury Center, more than 333,000 U.S. service members have been diagnosed with brain injuries since 2000. These injuries are typically a result of head impacts and blast waves.
AIDS IN THE PROTECTION OF THE BRAIN FROM THE EFFECTS ASSOCIATED WITH REPETITIVE SUB-CONCUSSIVE HEAD IMPACTS
The Q-Collar is a non-invasive 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.
Medical Device Classification
The Q-Collar is classified as a Class II medical device and was reviewed by the FDA through the De Novo pathway.
Q30 INNOVATIONS MILESTONES
Swipe through to view key landmarks and events over the last decade.
First commercial production of the Q-Collar and engineering validation studies.
Continued clinical trials, including football, soccer and SWAT teams, as well as additional laboratory studies.
Successful completion of the Q-Collar Pivotal clinical trail comprised of 450 high school athletes.
Usability studies involving elite and professional athletes. Design validation of the Q-Collar to confirm durability and reliability.
Submission of application to the FDA for commercialization approval.
Partnership with U.S. Army Medical Materiel Development Activity to study the suitability and feasibility of the Q-Collar with active US service members.
FDA APPLICATION TIMELINE
THE Q-COLLAR STORY
The inspiration for the Q-Collar came from a team of doctors who recognized the limitations of external protection against TBI. Watch the video to see the full story.
To date, the most common attempt to reduce head injuries has been the use of helmets. However, helmets do not prevent the movement of the brain within the skull, also known as “brain slosh.” Rapid acceleration and deceleration movement of the brain leads to the twisting and tearing of neurons, which is the cause of TBI.
The Q-Collar was designed to apply compressive force to the muscles around the jugular veins that leads to a temporary increase in intracranial blood volume. This increase in blood volume results in an expansion of the venous structures within the skull. We believe that this increase, in turn, holds the brain in a more stable state while the Q-Collar is being worn and reduces the ability of the brain to slosh inside the skull when exposed to head impacts.
Repeated hits to the head have been shown to result in structural changes to an athlete’s brain over the course of a season. Q30 Innovations is thinking beyond the helmet to find innovative ways to help address this issue.
The Science Behind the Q-Collar
Watch the video to see the science behind the Q-Collar.
Protection From Within
Hear from Dr. Julian Bailes, Chairman of Neurosurgery at Northshore University Hospital, discussing the Q-Collar’s intended ability to reduce the movement of the brain inside the skull.
Q30 & THE Q-COLLAR
Q30 Innovations, LLC, is a research and development company dedicated to developing innovative products intended to reduce brain injury. The Q-Collar has not yet received FDA clearance and is not available for purchase in the United States at this time.
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