BrainScope ®, a medical neuro-technology company focused on concussion and mild traumatic brain injury (mTBI) assessment, announced today that it had concluded both algorithm development and clinical validation studies in adolescent and young adult populations using its objective, EEG-based technology.
The purpose of the studies was to create and validate an objective, personalized capability for assessment of concussion and readiness to return to activities in males and females between the ages of 13-25. The studies conducted from 2015 through 2019 at 52 clinical sites included nearly 1,700 patients and healthy controls, with over 4,000 evaluations. Funding sources for the studies included a $9.9 million research contract from the U.S. Department of Defense, award funding from the NFL-GE Head Health Challenge (in which BrainScope was a two-time awardee), and BrainScope private funding.
“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,” stated Michael Singer, CEO of BrainScope. “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.”
In January, BrainScope announced that researchers had published preliminary results related to a concussion assessment capability for potential severity and likelihood of prolonged recovery from concussions in the peer-reviewed journal Computers in Biology and Medicine. The paper entitled, “A multimodal biomarker for concussion identification, prognosis and management” describes a study which enrolled 568 concussed and matched control patients between the ages of 13-25. Results from this study demonstrated highly significant differences in the BrainScope EEG-based biomarker at the time of injury between the 177 concussed patients and controls, and no significant differences at when Return-to-Play was clinically determined. Progressive recovery over time was also objectively demonstrated, especially in the prolonged recovery group. Results also supported the hypothesis that some of the more severely injured subjects may have been allowed to return to play too soon.
“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,” added Leslie Prichep, PhD, Chief Scientific Officer of BrainScope.
BrainScope’s flagship BrainScope One product, which is commercially available today, is a multi-modal, comprehensive, handheld capability to help clinicians objectively and rapidly assess and triage head injured patients directly at the point of care. BrainScope One is the first FDA-cleared medical device to offer capabilities to assess the full spectrum of brain injury – from concussions (functional abnormality) to brain bleeds (structural injury). BrainScope One is currently being fielded by the U.S. military, both stateside and internationally. BrainScope One is also being used in a cross-section of market segments including: urgent care and occupational health clinics; concussion clinics; hospital emergency rooms; university sports and student health centers; professional sports; and pharmaceutical clinical trials.