BrainScope completed a nearly five year $9.9 million U.S. Department of Defense research contract supporting the development and validation of an objective marker of the presence and severity of a concussion. After blinded, validated clinical trial, the system demonstrated the ability to aid clinicians to assess concussion at the time of injury, reflect the severity of the injury, and aid in their assessment of readiness to return to activity. BrainScope has expanded on this work to study adolescents as well as a contract with NFL-GE Head Health Challenge I.

The Research

The BrainScope “Concussion Index” is an EEG-based multimodal marker for concussion. The company conducted validated, blinded clinical studies involving 1,700 patients from 2015 through 2019 at 52 clinical investigator sites. The studies have included over 4,000 high school and college and concussion clinic evaluations.

The sponsors sought to validate the clinical utility of the Concussion Index for assessing the likelihood of concussion with both high sensitivity and specificity, in patients aged 13-25 who sustained a closed head injury. Endpoints included use of the Concussion Index as an important objective element of the clinical assessment of the severity of the concussive injury and in the evaluation of readiness for the return of duty reported Dotmed HealthCareBusiness Daily.

Who is BrainScope?

The has raised approximately $52 million. A medical neuro-technology firm utilizing artificial intelligence to assess a variety of neurological conditions, beginning with mild traumatic brain injury (mTBI), including concussion. The company was founded in 2006 and is headquartered in Bethesda, Maryland, a strategic location for federal contracts.

The company’s IP, BrainScope One, uses electroencephalographic (EEG) data collected with a disposable headset and works with partners and clients to identify biomarkers that both predict the likelihood that a patient’s structural brain injury would be visible on a CT scan and assess the likelihood of brain functional impairment by comparing the patient’s brain function to that of non-head injured individuals. BrainScope One also includes neurocognitive tests, performed by the patient on the device, and an extensive library of digitized concussion assessments.

Its technology was created through 21 clinical studies at over 52 clinical investigator sites over the last decade. They have contributed to 24 investigator-initiated peer-review journal articles—their work has resulted in 5 FDA clearances

TrialSite News estimates the company employs approximately 75 and cost structure of $12 million per year.

Lead Principal Investigator

Dr. Leslie Prichep, Chief Scientific Officer, BrainScope

Source: HealthCare Business

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