[August 26, 2014]

BrainScope® Announces Publication of Independent, Prospective Validation Study Demonstrating High Accuracy for Identification of Traumatic Intracranial Hematomas

BrainScope Company, Inc. today announced the publication of an independent, prospective validation study that demonstrated the potential clinical utility of its technology for the identification of acute traumatic intracranial hematomas in patients who present to hospital Emergency Departments. The results of this study, "Identification of Hematomas in Mild Traumatic Brain Injury Using an Index of Quantitative Brain Electrical Activity" appeared on-line ahead of print in the peer-reviewed Journal of Neurotrauma, authored by investigators from New York University School of Medicine and The Johns Hopkins University School of Medicine.

BrainScope's proprietary technology records brain electrical activity with a handheld, rapid, easy-to-use, non-invasive and non-radiation emitting device. The technology utilizes advanced signal processing methods and classification algorithms that quantify and characterize features of brain electrical activity associated with traumatic brain injury (TBI).

In this prospective validation study, ten minutes of brain electrical activity were recorded in 46 adult patients with traumatic hematomas with measureable blood (CT scan positive, =1cc of blood) and 278 head-injured control patients (CT scan negative). The mild presentation of the entire study population is reflected by 97% (313/324) of the patients in the study having a normal Glasgow Coma Scale (GCS (News - Alert)) score of 15 (on a scale of 3-15), with a mean value of 14.7 for the population with hematomas, and 14.9 for the control group. The volume of blood and distance from recording electrodes were measured by blinded independent experts. A previously derived classification algorithm developed by BrainScope (the "TBI-index") was used to identify the probability of a traumatic CT positive lesion in this clinically important independent population.

The study reported a sensitivity of 96% to hematomas, which was independent of type of hematoma, blood volume, or distance of the bleed from the recording electrodes on the forehead. Because of the life-threatening risk associated with undetected hematomas, specificity was permitted to be lower (44%) i exchange for extremely high sensitivity. In this study population (n=324), all subjects had been referred for CT scanning by standard clinical practice, of whom 278 were found to be CT negative. These results replicate previously peer-reviewed published findings (Hanley and colleagues, Journal of Neurotrauma, 2013) using the BrainScope technology in traumatic hematomas, and again importantly demonstrated that the distance and volume restrictions noted with other commercially available methods for detecting traumatic intracranial hematomas were not limitations of BrainScope's technology. These results lend further strong support to the potential enhanced clinical utility of the BrainScope TBI-Index as an important adjunct to acute assessment and triage of clinically important (potentially life-threatening) brain injuries.

"Often patients such as those in this study present with very mild symptoms of TBI and therefore pose difficult triage decisions upon clinical evaluation. It is not always clear whether the patient might have a clinically important traumatic brain injury (blood in the brain) requiring further clinical evaluation. The ability to determine the likelihood of presence of such injuries non-invasively and without radiation could result in a paradigm shift in the way emergency medicine for TBI is currently practiced," said Michael Singer, President and CEO of BrainScope. "This peer-reviewed publication, which independently validated the prior 2013 publication, provides further compelling evidence about the potential for our technology to help assess the existence of brain injuries shortly after injury. Whether in the military or civilian hospital emergency departments, there is a true need for an objective, adjunctive assessment tool for TBI beyond what currently exists. We are highly encouraged by the independent prospective replication of these results."

The full citation for this article is: Prichep, LS, Naunheim R, Bazarian J, Mould WA, Hanley D. Identification of hematomas in mild traumatic brain injury using an index of quantitative brain electrical activity. Journal of Neurotrauma. July 2014, ahead of print. doi:10.1089/neu.2014.3365.

Another peer-reviewed publication, which appeared on-line ahead of print in August 2014 in the journal Computers in Biology and Medicine, provides details on the technology implemented in the derivation of the algorithms which form the foundation of the BrainScope technology as applied in this study. The full citation for this second article is: Prichep LS, Ghosh Dastidar S, Jacquin A, Koppes W, Miller J, Radman T, O'Neil B, Naunheim R, Huff JS. Classification algorithms for the identification of structural injury in TBI using brain electrical activity. Computers in Biology and Medicine. 2014: 53, 125-133.

BrainScope devices under development for assessment of traumatically-induced head injury and concussion are for investigational use only.

About BrainScope^®

Backed by Revolution (created by AOL (News - Alert) co-founder Steve Case), Shaman Ventures, ZG Ventures, Maryland Venture Fund, Brain Trust Accelerator Fund, and Difference Capital, BrainScope is a medical neurotechnology company that is developing a new generation of hand-held, easy-to-use, non-invasive instruments designed to aid medical professionals in rapidly and objectively assessing TBI. BrainScope devices in development are based on a proprietary technology platform, which integrates databases of brainwave recordings with advanced digital signal processing, sophisticated algorithms, miniaturized hardware and disposable headset sensors. BrainScope's unique devices are being created to meet a long-standing clinical need for improved early identification, staging and triage of head injured patients. BrainScope devices under development for assessment of traumatically-induced head injury and concussion are for investigational use only. For more information, please visit www.brainscope.com.

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