BETHESDA, Md.--(BUSINESS WIRE)--BrainScope Company, Inc. today announced a publication describing the use of its flagship product, BrainScope One, in an independent clinical trial demonstrating the potential reduction of one-third (33.3%) of unnecessary computed tomography (CT) scans of mildly presenting head injured patients in hospital emergency rooms (ERs). The study entitled “Referrals for CT scans in mild TBI patients can be aided by the use of a brain electrical activity biomarker” was published online in the peer-reviewed American Journal of Emergency Medicine.
According to recent publications, approximately five million patients are seen in U.S. hospital ERs each year with closed head injuries, and millions more do not seek evaluation. The vast majority (>80%) of these patients receive a CT scan, of which over 90% are CT negative for structural brain injury, creating needless radiation exposure to patients. Further, 95% of all head injured patients who visit the ER present with mild symptoms. Extrapolating the 33.3% potential reduction using BrainScope One across the incidence rate of mildly presenting TBI patients who receive unnecessary CT scans in ERs, there is the potential for a reduction of over 1 million unnecessary CT scans per year by incorporating BrainScope One into standard clinical practice.
The study compared two different decision pathways for CT scan referrals in mild head injured patients. The first was clinical site practice (referral decision of the evaluating physician), and the second was based on the BrainScope One Structural Injury Classifier, indicating whether a patient would likely be CT positive. Use of the BrainScope output resulted in a 33.3% reduction in the number of false positives (those referred for a CT scan that was found to be negative) compared with clinical site practice. In addition, a significantly lower (p<0.01) false discovery rate (the proportion of those referred for CT scans that are found to be CT negative) was found using the BrainScope One output.

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“BrainScope One showed the potential to significantly reduce over-scanning without compromising overall clinical performance as evidenced by the one-third reduction of false positives,” said Michael Singer, CEO of BrainScope. “Given patient and physician concerns about unnecessary radiation exposure from head CT scans and wait times in ERs measured in multiple hours, the use of BrainScope One in clinical practice could have a significant positive impact on long term patient health and satisfaction, as well as substantial savings to the healthcare system.”