11.19.14
Bethesda, Md.-based BrainScope Company Inc. has received U.S. Food and Drug Administration (FDA) clearance via the de novo (low risk) classification process for its Ahead 100 device. The device 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 is not intended 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,” said J. Stephen Huff, M.D., 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.”
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 Leslie Prichep, M.D., director of the Quantitative Neurophysiological Brain Research Laboratories at the NYU (New York University) 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 U.S. 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 used for all future development activities. In September, BrainScope announced that it had been awarded three contracts valued at $15.93 million by the U.S. Department of Defense 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 focus to concussion assessment technology with clinical studies in cooperation with university sports programs. These activities leverage the 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.
According to Singer, the company has spent the last two years improving Ahead 100, which is BrainScope’s first generation technology. The company aims to focus its commercialization efforts both for assessment of structural brain injury in urgent care settings, and for assessment of concussion on the battlefield and the sports field. Future goals include adapting the technology for use promise in other neurological indications, such as stroke and cognitive decline.
“Each year there are approximately 2 million patients in the United States alone who sustain head injuries and go to emergency departments for evaluation,” said J. Stephen Huff, M.D., 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.”
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 Leslie Prichep, M.D., director of the Quantitative Neurophysiological Brain Research Laboratories at the NYU (New York University) 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 U.S. 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 used for all future development activities. In September, BrainScope announced that it had been awarded three contracts valued at $15.93 million by the U.S. Department of Defense 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 focus to concussion assessment technology with clinical studies in cooperation with university sports programs. These activities leverage the 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.
According to Singer, the company has spent the last two years improving Ahead 100, which is BrainScope’s first generation technology. The company aims to focus its commercialization efforts both for assessment of structural brain injury in urgent care settings, and for assessment of concussion on the battlefield and the sports field. Future goals include adapting the technology for use promise in other neurological indications, such as stroke and cognitive decline.