Scientific Research and Trials Suggest Innovative Q-Collar Has Potential to Reduce Risk of Traumatic Brain Injuries on the Battlefield
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WESTPORT, Conn., April 23, 2020 /PRNewswire/ -- Q30 Innovations today announced an agreement with the United States Army Medical Materiel Development Activity (USAMMDA) to study its innovative Q-Collar for the potential to be used by U.S. Service Members that may be at risk of traumatic brain injury. The Q-Collar is a medical device designed to reduce the risk and severity of traumatic brain injury in contact sports or other activities that may result in blunt force impacts. Q30 Innovations has completed over eight years of laboratory and clinical trials that have shown that the Q-Collar helps protect the brain from damage caused by blunt force head impacts.
In March 2020, Q30 Innovations has submitted its De Novo application to the US Food and Drug Administration. The device is already approved for distribution in Canada.
"Our fighting men and women deserve innovative new tools to confront the next generation of threats and reduce the risk of traumatic brain injuries on the battlefield. Q30 Innovations is honored to partner with USAMMDA in the quest to find a solution and protect service members today and for their futures," said Tom Hoey, Co-Founder and Co-CEO of Q30. "We are committed to meeting this challenge and focused on conducting independent and comprehensive, medical and scientific research to test the capabilities of the Q-Collar and demonstrate its ability to protect the brain."
The technology behind the Q-Collar was first envisioned by doctors who identified the movement of the brain inside the skull, or "slosh", as a key cause of structural changes to the brain as result of blunt force impacts. By inventing a simple, yet innovative, device worn around the neck, these doctors theorized they could help reduce the movement of the brain and prevent concussion. The Q-Collar uses the body's own physiology to help stabilize the brain by applying light pressure to the jugular veins. This pressure slightly increases blood volume inside the skull and helps reduce the brain's movement—which causes brain injuries.
"User feasibility and suitability feedback is essential when developing products for Service Members," said Brian Dacanay, a product manager at USAMMDA, a subordinate organization of the U.S. Army Medical Research and Development Command. "Evaluation of medical devices is completed under military unique scenarios similar to the devices intended environment to ensure that there are no safety and effectiveness impacts to the mission. Specifically, we are interested in the safety and effectiveness of Q-Collar in blast scenarios identifying weaknesses of medical devices at an early stage of development allows us to provide feedback to optimize a product when used in the battlefield or in training."
Some preliminary research has been completed in regard to blast, a prevalent occurrence in US Military operations and training, including an animal study performed at the Naval Medical Research Center and a study involving paramilitary/SWAT personnel in Cincinnati. The data suggests that the Q-Collar has potential to help protect the brain from a blast-induced traumatic brain injury (bTBI).
The National Defense Authorization Act for Fiscal Year 2020 included Directive Report Language requesting that the Army "prioritize and initiate active research" on "collar-based technology that when worn around the neck has been shown to reduce the frequency and severity of bTBIs."
In October 2019, Q30 signed a Cooperative Research and Development Agreement (CRADA) with USAMMDA based at Fort Detrick, MD. Under the CRADA, Q30 and USAMMDA have agreed to explore the potential applicability for the Q-Collar to be used in the unique military operational and training environments.
The severe impact of bTBIs has recently been highlighted by the January 7, 2020 Iranian missile attack on the Ain al-Asad Airbase in Iraq. Despite technology that provided early warning of incoming rocket attack, shelters and personal protective equipment to minimize injury from projectiles and fragments, soldiers were exposed to blast waves that caused brain injuries. Reuters reported that over 100 service members stationed on the base during the attacks have been diagnosed with traumatic brain injuries.
"For too long, our warfighters have been at risk of traumatic brain injury caused blunt force and blast waves. Even the best helmets and other protective equipment have not been able to address this concern. We applaud Congress and the Department of Defense for making this a priority in the recent Defense Authorization Act. We are proud to be part of the solution and look forward to working with USAMMDA," said Mr. Hoey.