FDA-Cleared BrainScope One Provides Proprietary, Objective EEG-Based Biomarker for Brain Injury, Including Concussion
BETHESDA, MD. June 14, 2017 – BrainScope Company, Inc. today announced a publication describing that its EEG-based Brain Function Index (BFI) was demonstrated to have a significant relationship with the severity of functional impairment in mild head injured patients in a large (720 patient) multisite independent validation trial. BrainScope includes the BFI as a core component of its recently FDA-cleared BrainScope One product, which provides EEG and other information presented as a comprehensive panel on a handheld device for assessment of the full spectrum of traumatic brain injury.
Published online in the peer-reviewed Journal of Neurotrauma in an article entitled "A brain electrical activity (EEG) based biomarker of functional impairment in traumatic head injury: a multisite validation trial"?, the findings support the BFI as a quantitative biomarker of brain function impairment, which scaled with severity of impairment in mild brain injury patients. These trial results were presented to the U.S. Food and Drug Administration (FDA) in support of endpoints, leading to FDA’s clearance in September 2016 to market BrainScope One (registered as Ahead 300).
The lead author of the study is Daniel Hanley Jr., M.D., the Jeffrey and Harriet Legum Professor of Acute Care Neurological Medicine and Director of the Brain Injury Outcomes Program at the Johns Hopkins University School of Medicine. Hanley noted, "This is a truly exciting discovery, as it opens up the door to quantitative assessment of concussion."?
Importantly, the BFI was derived using features of brain electrical activity associated with functional brain impairment reflecting current consensus on the physiology of concussive injury. In the study, mildly presenting adult patients were evaluated within three days of sustaining a closed head injury. Standard clinical evaluations were conducted, and 5-10 minutes of EEG were acquired from locations on the forehead. The study demonstrated that the mild functionally impaired group and the moderate functionally impaired group, both as compared to uninjured, were significantly different from the CT+ (structural injury visible on CT) TBI group (p=0.0009 and p=0.0026, respectively).
"This important study clearly indicates that when integrated into clinical assessment, the BFI provides an objective physiological biomarker to aid in the early diagnosis of functional brain injury, and thereby has potential to impact the sequelae of brain injury,"? stated Dr. Leslie Prichep, Chief Scientific Officer of BrainScope and Adjunct Professor of Psychiatry at the NYU School of Medicine.
BrainScope One is an FDA-cleared medical device for rapid, objective assessment of mildly presenting adult head injured patients across the full spectrum of brain injury at the point of care for up to three days following injury, and is designed to help the clinician address not only whether a patient has a functional brain injury, including concussion, but also whether a patient has structural brain injury visible on CT.
To aid in interpretability for assessment of brain injury, BrainScope One results include the EEG-based BFI expressed as a percentile of an age-regressed, non-head injured population. The head injured BFI percentile score is also displayed relative to the significance of the distance from the mean of the non-head injured population, categorized as "average"?, "below average"? (1.5 standard deviations from the mean) or "clearly below average"? (2 standard deviations from the mean).
In addition to the BFI, BrainScope One addresses structural brain injury with its Structural Injury Classifier (SIC), based on the same EEG, indicating whether a head injured patient is likely CT+, CT- or Equivocal. The SIC results of BrainScope’s FDA validation trial were published in the peer-reviewed journal Academic Emergency Medicine earlier this year, showing 99% sensitivity to the presence of the smallest amount of detectable blood on an independent read of the CT scan (≥1cc), with negative predictive value (NPV) of 98%.
"The results of our FDA validation trial, now expressed in two pivotal publications, clearly show the benefit of both the Brain Function Index and the Structural Injury Classifier as objective, EEG-based physiological biomarkers for assessment of the full spectrum of brain injury, from functional to structural injury, available at the point of care on a handheld medical device,"? stated Michael Singer, BrainScope’s Chief Executive Officer.
This is the 21st peer-reviewed publication supporting BrainScope’s technology. The full citation for this article is: Hanley D, Prichep L, Badjatia N, Bazarian J, Chiacchierini R, Curley K, Garrett J, Jones E, Naunheim R, O'Neil B, O'Neill J, Wright D, and Huff JS. A brain electrical activity (EEG) based biomarker of functional impairment in traumatic head injury: a multisite validation trial. Journal of Neurotrauma. June 2017, ahead of print. https://doi.org/10.1089/neu.2017.5004
The full citation for the previously published article relating to structural brain injury assessment (CT+/CT-) is: Hanley D, Prichep L, Bazarian J, Huff JS, Naunheim R, Garrett J, Jones E, Wright D, O'Neill J, Badjatia N, Gandhi D, Curley K, Chiacchierini R, O'Neil B, Hack D. Emergency Department triage of traumatic head injury using brain electrical activity biomarkers: a multisite prospective observational validation trial. Academic Emergency Medicine 2017; doi:10.1111/acem.13175.
BrainScope One is available to a cross-section of market segments including Urgent Care Clinics, Concussion Clinics, hospital Emergency Departments, university and professional sports, and the U.S. military and government.
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, beginning with traumatic brain injury (TBI), including concussion. The company’s first product introduced in 2017, BrainScope One, uses EEG-based technology that is non-invasive for mildly presenting patients 18-85 years old and within 3 days after head injury. BrainScope One measures and interprets brain electrical activity and a patient’s neurocognitive function, creating a panel of objective data to help physicians make their clinical diagnosis. BrainScope’s technology platform 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 over 100 issued and pending patents. BrainScope has received four FDA clearances and ISO 13485:2003 Certification. 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. For more information, please visit www.brainscope.com.
The development of BrainScope One 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 (http://cdmrp.army.mil/dmrdp/). Any views, opinions, conclusions and/or findings contained in this press release are those of BrainScope and should not be construed as an official Department of the Army position, policy or decision unless so designated by other documentation.