TecTraum, a provider of point-of-care treatment for concussions, has received the US Food and Drug Administration (FDA) breakthrough device designation for its pro2cool technology to treat concussions.
Pro2cool system is a non-invasive hypothermic therapy device intended to reduce the severity of concussion symptoms and brings patients to their pre-injury baseline.
The device has been designed for localised cooling for the head and neck to reduce blood temperature before it enters the brain, said TecTraum.
The company said that the device was primarily intended for athletes. However, it is planning to use the device for several other applications outside of youth sports.
TecTraum CEO John Zak said: “We are extremely proud to have TecTraum recognised by the FDA as a leader in concussion therapy as we work to commercialise the first-ever FDA approved treatment for concussions.
“Although our initial focus is on filling an unmet medical need for athletes, we anticipate demonstrating in the future that people who suffer concussions caused by falls, motor vehicle accidents, or through military service also can benefit from the pro2cool medical device.”
TecTraum developed the pro2cool system, under the partnership with Nottingham-Spirk, a company engaged in designing and developing various medical devices.
According to the previous research, the cooling of the brain within days of the concussion has led to significant improvements in clinical outcomes.
Also, hypothermic or cold therapy has shown to have clinical efficacy in various cardiovascular injuries, including cardiac arrest and heart attack, said the company.
With the FDA breakthrough device designation, TecTraum is enabled to improve the concussions treatment using its pro2cool technology.
After pilot studies, the company is in the final stage of completion of a large multi-site pivotal clinical trial, designed to evaluate the effectiveness, safety, and tolerability of the system.
TecTraum intends to complete enrolment of the clinical trial by the end of this year, with plans to commercialise the device in early 2022.
Pro2cool multisite trial lead principal investigator Joseph Congeni said: “The FDA has provided input on the design and implementation of the trial. We all recognise that concussion is a growing burden, clinically, financially and emotionally, in the US.
“Based on previously published data, we are hopeful that our current trial will demonstrate the efficacy, safety and tolerability of this non-invasive treatment for mild traumatic brain injury, also known as concussion.”
