BRAINSCOPE ANNOUNCES FDA CLEARANCE OF AHEAD® 100 DEVICE FOR ADJUNCTIVE ASSESSMENT OF TRAUMATIC BRAIN INJURY

Rapid Response, Non-Invasive, Non-Radiation Emitting Handheld System Offers Objective Assessment of Mildly-Presenting Head Trauma Patients

BETHESDA, MD. November 19, 2014 – BrainScope® Company, Inc. announced today that the United States Food and Drug Administration (FDA) has cleared the company’s Ahead® 100 device through the de novo classification process. The Ahead® 100 uses a patient’s electroencephalograph (EEG) to provide an interpretation of the structural condition of the patient’s brain after head injury. It is indicated for use as an adjunct to standard clinical practice to aid in the evaluation of patients who are being considered for a head Computerized Tomography (CT) scan, but should not be used as a substitute for a CT scan. It is to be used on patients who sustained a closed head injury within 24 hours, clinically present as a mild traumatic brain injury, and are between the ages of 18-80 years.

"Each year there are approximately 2 million patients in the United States alone who sustain head injuries and go to Emergency Departments for evaluation,” stated Dr. J. Stephen Huff, Associate Professor of Emergency Medicine and Neurology at the University of Virginia School of Medicine and the Clinical Principal Investigator of the B-AHEAD II Trial. “Many of these patients present with very mild symptoms, yet may have life-threatening bleeds in the brain. An objective, accurate capability that can rapidly help identify and categorize patients with even the mildest forms of brain injury could help save lives, reduce radiation exposure, and decrease costs to the healthcare system. The performance and clinical utility of the Ahead® 100 is superior to that of standard of practice tools. Also, the possibility of reduction of use of neuroimaging in patients with head injury is consistent with the Choosing Wisely campaign sponsored by several professional organizations.”

“This is a landmark event in the assessment of head injury,” added Dr. Daniel Hanley, the Jeffrey & Harriet Legum Professor of Acute Care Neurology at Johns Hopkins University, Director of the Johns Hopkins Brain Injury Outcomes Services division, and Medical Advisory Board member to BrainScope. “I am greatly impressed by the performance of the Ahead® 100 for discriminating clinically important mild Traumatic Brain Injury and believe this device is a practical, safe and transformative adjunct to acute CT scan.”

The BrainScope Ahead® 100 has been developed over six years of technology development and clinical studies at hospital Emergency Rooms across the country, creating an extensive database of head injured patients. “Using sophisticated classification algorithm methods we sought neurophysiological profiles or signatures of changes in brain electrical activity associated with traumatic structural brain injury,” explained Dr. Leslie Prichep, Director of the Quantitative Neurophysiological Brain Research Laboratories at the NYU School of Medicine and consultant to BrainScope. “One of the most important findings was the extremely high performance of the Ahead® 100 to identify the absence of structural brain injury after a patient has sustained a head injury. This provides important information to the clinician, contributing to a rule-out for one of the most prevalent concerns clinicians have with mildly presenting patients.”

“FDA clearance of our Ahead® 100 represents a major achievement in BrainScope’s mission to create an objective, non-invasive, patient-friendly assessment device for rapid and easy use in emergency settings,” said Michael Singer, President and CEO of BrainScope. “We are particularly grateful for the continuing strong partnership with the Department of Defense. Given our extensive clinical studies, we have maintained long-term relationships with many clinical sites, for which we are appreciative. Lastly, I would like to extend a special thank you to our employees who have worked tirelessly to achieve this milestone, and to their families who have supported them.”

BrainScope recently completed development of a prototype miniaturized Ahead® system using existing smartphone technology that will be utilized for all future development activities. In September, BrainScope announced that it had been awarded three contracts valued at $15.93 million by the United States Department of Defense (DOD) for continued research and development of the Ahead® system. These contracts will support further clinical studies and development of BrainScope’s Ahead technology in hospital Emergency Departments, and further its Traumatic Brain Injury (TBI) focus to concussion assessment technology with clinical studies in cooperation with university sports programs. These activities leverage six years of BrainScope studies in sports venues, including a current study with the Purdue Neurotrauma Group funded through the GE-NFL Head Health Challenge I.

“The FDA-cleared Ahead® 100 is our first generation technology. Over the last two years, we have focused on improving this technology, including adapting it for use on ubiquitous hardware platforms such as smartphones and tablets, and by benefitting from machine learning and proprietary algorithm classification techniques from increased data derived from our numerous clinical studies. We will direct all of our commercialization efforts for the Ahead® product family using these hardware platforms both for assessment of structural brain injury in urgent care settings, and for assessment of concussion on the battlefield and the sports field. We also have an eye to the future with our technology showing promise in other neurological indications, such as stroke and cognitive decline,” stated Singer.

Results from independent clinical studies utilizing BrainScope’s technology have been published through 14 articles in leading peer-reviewed neurotrauma and emergency medicine journals such as Journal of Neurotrauma, Brain Injury, Academic Emergency Medicine, The Journal of Head Trauma Rehabilitation and The American Journal of Emergency Medicine.

BrainScope holds 75 issued and pending patents related to its technology.

BrainScope has been awarded over $27 million of DOD research contracts for the development of its TBI assessment technology and has received significant funding from private investors to accelerate its development efforts.

 

 

 

About BrainScope®

Backed by Revolution (created by AOL co-founder Steve Case), Shaman Ventures, ZG Ventures, State of 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, including the Ahead® 200 and 300 series, for assessment of traumatically-induced head injury and concussion are for investigational use only. For more information, please visit www.brainscope.com.