DOD-backed BrainScope wins FDA clearance for traumatic brain injury diagnostic

BrainScope's wearable Ahead device--Courtesy of the University of Virginia School of Medicine

Physicians have gained access to a new tool to assess traumatic brain injury (TBI) in the emergency room. The FDA has cleared BrainScope's Ahead 100 device that uses a wearable device to provide an electroencephalograph that is analyzed to assess the structural condition of a patient's brain after head injury. The first-line diagnostic device for TBI is typically a computed tomography (CT) scan.

The startup counts among its backers the U.S. Department of Defense, which has awarded it more than $27 million in support of the development of the Ahead system. BrainScope investors include Revolution (AOL co-founder Steve Case's venture effort), Shaman Ventures, ZG Ventures, State of Maryland Venture Fund, Brain Trust Accelerator Fund and Difference Capital.

The FDA cleared the Ahead 100 system to evaluate adult patients presenting with a potential mild traumatic brain injury within the prior 24 hours, according to BrainScope. It is not intended to be used as a substitute for a CT scan, but the company clearly expects it to be used as an initially diagnostic ahead of a CT scan.

The Ahead system is intended to be an initial diagnostic prior to a CT scan.--Courtesy of the University of Virginia School of Medicine

BrainScope said it has completed a miniaturized prototype of the Ahead system that incorporates smartphones; this system will be used in all upcoming development activities.

"Many of these patients present with very mild symptoms, yet may have life-threatening bleeds in the brain," said Dr. J. Stephen Huff, associate professor of Emergency Medicine and Neurology at the University of Virginia School of Medicine and the clinical principal investigator of the company's B-AHEAD II Trial.

"An objective, accurate capability that can rapidly help identify and categorize patients with even the mildest forms of brain injury could help save lives, reduce radiation exposure, and decrease costs to the healthcare system. The performance and clinical utility of the Ahead 100 is superior to that of standard of practice tools," he said. Huff estimates that about two million patients in the U.S. go into emergency rooms to be evaluated for head injuries.

The most recent data from the company on the Ahead system showed it had 96% sensitivity in detecting a hematoma. That indicates that there were rarely false positives in the 324-patient study. Specificity, which indicates the rate of false negatives, was 44% and was permitted to be lower in exchange for high sensitivity, according to the company. In the study, all subjects received CT scans with 278 patients showing no evidence of a TBI.

"This is a landmark event in the assessment of head injury," Dr. Daniel Hanley, the Jeffrey & Harriet Legum professor of acute care neurology at Johns Hopkins University, director of the Johns Hopkins Brain Injury Outcomes Services division, and medical advisory board member for BrainScope, said in a statement. "I am greatly impressed by the performance of the Ahead 100 for discriminating clinically important mild traumatic brain injury and believe this device is a practical, safe and transformative adjunct to acute CT scan."

- here is the release

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