BrainScope Biomarker Adds Significant Prognostic Accuracy for Rapid Assessment of TBI

BrainScope Company Inc. has announced publication of data demonstrating that prediction of a computed tomography positive traumatic brain injury (TBI) is significantly improved when the electroencephalography (EEG) based biomarker from its Ahead 300 is used in addition to the most commonly considered predictive risk factor, Loss of Consciousness (LOC). The results of this study entitled “Increased prognostic accuracy of TBI when a brain electrical activity biomarker is added to Loss of Consciousness (LOC),” were published in the American Journal of Emergency Medicine. Results of this study show an 83 percent improvement in the prediction of TBI using the Ahead 300 compared to that obtained using a history of LOC alone or LOC plus traumatic amnesia, the two most commonly used clinical diagnostic indicators for TBI.
 
Today, the vast majority of those who present to the emergency room with mild symptoms following head injury receive a computed tomography (CT) scan, although studies show that more than 90 percent of those scans are found to be negative for intracranial brain injury. Indicators of the risk of intracranial injury following closed head injury have been under discussion and the focus of study for several years, with the consensus being that LOC or LOC with post traumatic amnesia are the best clinical predictive indications for TBI. This study importantly demonstrates the ability to achieve a significantly higher predictive accuracy when the BrainScope Ahead 300 is used. The lead author on the study, Dallas C. Hack, M.D., Col. (Ret.) and former director of the Combat Casualty Research Program at the U.S. Army Medical Research and Materiel Command, commented, “This study adds more evidence that these EEG classification algorithms have a greater clinical utility than ‘Loss of Consciousness’ when assessing TBI risk in patients presenting with a recent head injury.”
 
With increased awareness of the risks associated with unnecessary exposure to radiation from head CT and the recognition that CT scans are not sensitive to the full spectrum of TBI injuries (including concussion), the ability of the Ahead 300 to improve prediction represents an important contribution to patient care.

“The BrainScope Ahead 300 brings the power of advanced signal processing, machine learning and quantitative analysis using rapid, easy to use handheld technology to emergent care settings where it can have significant, immediate impact on triage and patient care,” said Leslie Prichep, Ph.D., chief scientific officer of BrainScope and adjunct professor of psychiatry at the NYU School of Medicine.
 
Developed in partnership with the U.S. Department of Defense through six research contracts, the BrainScope Ahead 300 leverages state-of-the-art handheld technology and a disposable sensor headset. The Ahead 300 proprietary algorithms are based on quantitative brain electrical activity collected through BrainScope’s EEG capability, and leverage advanced signal processing methods and machine learning technology to enhance the clinical utility of EEG beyond that of conventional methods.

The BrainScope Ahead 300 allows for head-injured patients to be rapidly and objectively assessed by the clinician at the point of care, thereby significantly improving their clinical diagnosis and ultimately, proper patient triage and medical management. Further, the ease of use of this handheld system will allow utilization beyond the emergency room into urgent care and concussion clinics as well as sports and military environments, as an adjunct to acute TBI assessment where imaging may be unavailable, allowing for significantly reduced costs, radiation exposure and wait times associated with hospital visits and unneeded CT scans.
 
“This significant publication provides even further important evidence that the objectivity from BrainScope’s Ahead 300 EEG capability can substantially alter much of the symptoms-based assessment of head-injured patients. The Ahead 300 provides the physician an objective, comprehensive yet fully accessible capability to help them make a far more informed clinical diagnosis right then and there, in a multitude of settings,” said Michael Singer, CEO of BrainScope.
 
BrainScope is a medical neurotechnology company that is developing a new generation of handheld, easy-to-use, non-invasive devices designed to aid medical professionals in rapidly and objectively assessing various neurological conditions, starting with traumatic brain injury including concussion. BrainScope has partnered with the U.S. Department of Defense for the development of its TBI assessment technology, and was named both an original recipient and final awardee of the GE-NFL Head Health Challenge I. BrainScope has also received significant funding from private investors to accelerate its development efforts, with backing from Revolution (created by AOL co-founder Steve Case), ZG Ventures, Maryland Venture Fund, Brain Trust Accelerator Fund, and Difference Capital. BrainScope devices in development are based on a proprietary technology platform, which integrates databases of thousands of brainwave recordings with advanced digital signal processing, sophisticated algorithms, miniaturized hardware and disposable headset sensors, which are all covered by an extensive intellectual property portfolio of more than 100 issued and pending patents. BrainScope has received four U.S. Food and Drug Administration clearances and ISO 13485:2003 certification.
 
The development of the Ahead 300 was supported by the U.S. Army Medical Research and Materiel Command under Contract No. W81XWH-14-C-1405, and by the U.S. Army Contracting Command, Aberdeen Proving Ground, Natick Contracting Division under Contract No. W911QY-14-C-0097. The approved funding source is the Defense Medical Research and Development Program.