Likelihood of CT+ vs. CT- Is One Component of the Ahead 300’s Configurable Panel of Capabilities for Mild Head Injury Assessment
BETHESDA, MD. February 16, 2017 – BrainScope Company, Inc. today announced a publication describing an independent clinical trial of 720 patients conducted in 11 U.S. Emergency Departments (EDs), validating the clinical efficacy of its Ahead 300 technology for the identification of Traumatic Brain Injury (TBI) in mildly presenting head injured patients. The results of this validation trial, “Emergency Department triage of traumatic head injury using brain electrical activity biomarkers: a multisite prospective observational validation trial" are published online in the peer-reviewed journal Academic Emergency Medicine. 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. Results of this validation study demonstrate the ability of the Ahead 300 technology to serve as a biomarker of traumatic structural brain injury. These trial results were presented to the U.S. Food and Drug Administration (FDA) in support of the primary endpoints, leading to FDA’s clearance to market the Ahead 300 device in September 2016.
BrainScope’s proprietary algorithms were derived from a database containing more than 7,000 evaluations. The algorithms were validated in this 720 patient study of head injured (both CT+ and CT-) and normal patients who presented to the ED having sustained a closed head injury within 72 hours, clinically presented as a mild traumatic brain injury, and were between the ages of 18-85 years. In this population with an average Glasgow Coma Scale (GCS) Score of 14.9 on a scale of 3-15, where 15 is normally responsive, sensitivity to the presence of the smallest amount of detectable blood on an independent read of the CT scan (≥1cc) was 99%, with negative predictive value (NPV) of 98%, and with specificity multiple times higher than standard decision rules such as the New Orleans Criteria and the Canadian CT Head Rule. In addition to identifying those patients who are likely CT+ or CT-, the Ahead 300 output identifies a small group of patients who are close to the threshold for likely CT+, allowing identification of those who may need further evaluation or observation, consistent with current medical practice (for example, “pre-hypertension").
“This important publication provides significant evidence that the performance of the Ahead 300 could substantially alter the acute assessment and management of head-injured patients by providing objective information, right then and there, derived from a now proven brain biomarker to help the physician make a far more informed clinical diagnosis," stated Michael Singer, CEO of BrainScope.
Five million patients are seen in U.S. Emergency Departments each year with closed head injuries, and millions more do not seek evaluation. Further, according to recent publications, 95% of all head-injured patients who visit the ED present with mild symptoms. The vast majority of these patients receive a CT scan, of whom over 90% are CT negative for structural brain injury, creating needless radiation exposure to patients. The Ahead 300 has the potential to significantly reduce costs, radiation exposure and wait times associated with hospital visits and unneeded CT scans.
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 ED 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.
“There is a megatrend in society of using machine learning and algorithms to perform activities quickly, easily and accurately that until recently were only performed manually. We see this in our lives in so many ways - setting up our transportation or even making restaurant reservations. BrainScope has pioneered this capability in the area of brain injury assessment allowing for millions of affected patients to be assessed quickly, easily and accurately," stated Singer.
Developed in partnership with the U.S. Department of Defense, the Ahead 300 leverages state-of-the-art handheld technology and disposable sensor headsets. The Ahead 300 proprietary algorithms are based on quantitative brain electrical activity collected through BrainScope’s electroencephalography (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 time was right for the development of this disruptive technology, leveraging the perfect storm of technological advances at the intersection of mobile computing technology, genomics, proteomics, big data and machine learning, allowing us to move EEG into a new era," stated Leslie Prichep, Ph.D., Chief Scientific Officer of BrainScope and Adjunct Professor of Psychiatry at the NYU School of Medicine.
In September 2016, BrainScope announced that the FDA cleared the company’s Ahead 300 device. This was the fourth FDA clearance obtained for BrainScope’s family of devices. The Ahead 300 is the first of BrainScope’s products to be commercially launched, as the company announced in January 2017. The Ahead 300 is available to a cross-section of market segments including Urgent Care Clinics, Concussion Clinics, Emergency Medicine Departments, and University and Professional Sports. BrainScope will also be selling the Ahead 300 to various branches of the U.S. military and government.
The full citation for this article 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 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 over 100 issued and pending patents. BrainScope has received four FDA clearances and ISO 13485:2003 Certification. For more information, please visit www.brainscope.com.
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 (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.