BrainScope completes large-scale BrainScope One mTBI validation study

BrainScope said today that it completed a validation study of its BrainScope One device designed to assess head injuries, exploring its ability to assess mild traumatic brain injuries in adolescent and young adult populations.

The Bethesda, Md.-based company ‘s FDA-cleared BrainScope One device is a multi-modal device designed to aid in the objective and rapid assessment and triage of head injury patients, and can assess the “full spectrum of brain injury” including concussions and brain bleeds.

BrainScope said that the study included data from nearly 1,700 subjects and more than 4,000 evaluations performed between 2015 and 2019. In the study, researchers aimed to create and validate an objective, personalized capability to assess concussions and readiness to return to activities in males and females between the ages of 13 and 25.

“These large studies add important information to the understanding of the pathophysiology of concussion, leading to better assessment capabilities which can improve short and long-term outcomes of head-injured patients,” chief scientific officer Leslie Prichep said in a prepared statement.

The company said that it released preliminary results related to concussion assessment capabilities for potential severity and the likelihood of prolonged recovery in the journal Computers in Biology and Medicine in January. Results from the study indicated highly significant differences in the BrainScope EEG-based biomarker at the time of injury between 177 concussed patients and controls with no significant differences at when Return-to-Play was clinically determined.

BrainScope added that progressive recovery over time was also objectively demonstrated, and that results supported the hypothesis that some of the more severely injured subjects may have been allowed to return to play too soon.

“We are extremely pleased to have concluded these substantial clinical studies over 4 years, the results of which are extremely exciting as we work in the near-term through appropriate regulatory processes to bring important new concussion assessment capabilities to the market. In particular I want to thank the U.S. Department of Defense, the NFL, GE, and BrainScope investors for their financial support of this major initiative which has yielded such excellent results,” CEO Michael Singer said in a press release

The company said that $9.9 million in funding for the study came from the U.S. Department of Defense. The trial was also supported by private funding and by funds from the NFL-GE Head Health Challenge.

In January, BrainScope said that it won FDA clearance to include a new indication language for its BrainScope One concussion assessment device.

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