THE Q-COLLAR IS THE ONLY FDA CLEARED PRODUCT THAT HELPS PROTECT ATHLETES’ BRAINS DURING HEAD IMPACTS.

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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 effects associated with repetitive sub-concussive head impacts. On February 26th, 2021, Q30 received FDA clearance to market the Q-Collar in the US, confirming both the Q-Collar’s safety and effectiveness. 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

Read the full FDA News Release here.

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.

THE Q-COLLAR

AIDS IN THE PROTECTION OF THE BRAIN FROM 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 effects associated with repetitive sub-concussive head impacts.

Research & Development

Q30 Innovations has invested in more than 20 independent laboratory and clinical studies at leading research institutions to test the safety and efficacy of the Q-Collar.

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Medical Device Classification

The Q-Collar is classified as a Class II medical device and was cleared by the FDA through the De Novo pathway. 

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FDA Application Process

The Q-Collar’s application to the FDA for clearance to market the product in the United States was authorized by the FDA in February of 2021.

Canada Commercialization

The Q-Collar is commercially available in Canada and is distributed there under license from Health Canada. Visit www.qcollar.ca to learn more.

Q30 INNOVATIONS MILESTONES

Swipe through to view key landmarks and events over the last decade.

2010-2011

Initial laboratory testing of the protective benefits of jugular vein compression.

2011-2014

Engineering design and prototyping of the Q-Collar.

2014

First human performance and pilot clinical (high school hockey) studies of the Q-Collar.

2015

First commercial production of the Q-Collar and engineering validation studies.

2015-2018

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. 

2017-2019

Usability studies involving elite and professional athletes. Design validation of the Q-Collar to confirm durability and reliability.

2019

Commercial launch of the Q-Collar in Canada, under license from Health Canada.

2020

Submission of application to the FDA for commercialization approval.

2021

Q30 receives FDA clearance to market the Q-Collar in the US on February 26th.

Click the link below to read the full FDA News Release.

FDA CLEARANCE TIMELINE

Q-Collar FDA Application Timeline
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.

SCIENCE

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. 

Contact Us

Please feel free to contact us using the info below.

For media inquiries, please contact: aroper@q30.com

257 Riverside Ave,
Westport, CT 06880

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Q30 & THE Q-COLLAR

Q30 Innovations, LLC, is dedicated to developing innovative products intended to reduce brain injury. 

© 2021 Q30 Innovations, LLC. All Rights Reserved.

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