BETHESDA, MD. September 7, 2017 – BrainScope Company, Inc., the medical neurotechnology company which created the first FDA-cleared handheld medical device, BrainScope One, for assessment of the full spectrum of traumatic brain injury, announced it will immediately commence development of a pediatric capability. The pediatric product will be similar to the currently-available BrainScope One, which is a handheld, easy-to-use, rapid, objective capability to aid the clinician in the assessment of mildly presenting adult head injured patients at the point of care. It is designed to help the clinician assess the full spectrum of brain injury, including whether a patient has structural brain injury likely visible on CT, as well as whether a patient has functional brain impairment, including concussion. BrainScope One measures and interprets the patient’s brain electrical activity and neurocognitive function, and offers a panel of objective data to help physicians make their clinical diagnosis.
BrainScope will begin recruiting leading clinical sites around the U.S. to conduct clinical studies in a pediatric patient population for development of this first-of-its-kind product to objectively assess the full spectrum of brain injuries in adolescents and children.
"We are excited to start development of a pediatric capability very much akin to that which we offer today with BrainScope One,"? stated Michael Singer, CEO of BrainScope. "There is an urgent, obvious need for a rapid, objective medical device to help clinicians determine the presence of brain injury, including concussion, that a pediatric patient might sustain following head injury, particularly in sports environments but also in everyday life. In addition to the national discussion on concussions and their long-term consequences, clinicians are particularly concerned about radiation exposure in children from unnecessary head CT scans. This device has the promise to directly address both significant concerns."?
There are currently over 44 million children participating in sports such as football, soccer, lacrosse and many other sports where head injury occurs each year in the United States. It is estimated that there are up to 1.9 million sports- and recreation-related concussions in children annually in the U.S. Currently, many of these concussions are diagnosed using purely subjective, symptom-based methods. A recent study by the Institute of Medicine and the National Research Council Committee on Sports-Related Concussions in Youth noted, "As the diagnosis of concussion is currently based primarily on symptoms, there is a major need for objective diagnostic markers of concussion."?
BrainScope has announced several publications this year describing the use of BrainScope One in a large (720 patient) multisite independent validation clinical trial, demonstrating: a) 99% sensitivity to the presence of the smallest amount of detectable blood (≥1cc) on an independent read of the CT scan, with negative predictive value (NPV) of 98%; b) the potential reduction of one-third (33.3%) of unnecessary CT scans of mildly presenting head injured patients in hospital emergency rooms; and c) a significant relationship between BrainScope One’s EEG-based Brain Function Index (BFI) and the severity of functional impairment in mild head injured patients.
BrainScope has been the recipient of several prestigious awards over the past few months, including the Frost & Sullivan 2017 Best Practices Award for New Product Innovation in the Traumatic Brain Injury Assessment Solutions Market, as well as a nomination for the 2017 Prix Galien USA Best Medical Technology, regarded as the equivalent of the Nobel Prize in medical technology research, with a winner to be chosen in October.
BrainScope One is currently available to a cross-section of market segments including urgent care clinics, occupational health clinics, hospital emergency rooms, university and professional sports, and the U.S. military and government.
Huff JS, Naunheim R, Ghosh Dastidar S, Bazarian J, Michelson EA. Referrals for CT scans in mild TBI patients can be aided by the use of a brain electrical activity biomarker. Am J Emerg Med. 2017 May 22. pii: S0735-6757(17)30409-6. DOI:10.1016/j.ajem.2017.05.027.
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. Acad Emerg Med 2017 May; 24(5):617-627. doi:10.1111/acem.13175.
Hanley D, Prichep LS, Badjatia N, Bazarian J, Chiacchierini R, Curley K, Garrett J, Jones E, Naunheim R, O'Neil B, O'Neill J, Wright DW, Huff JS. A Brain Electrical Activity (EEG) Based Biomarker of Functional Impairment in Traumatic Head Injury: A Multisite Validation Trial. J Neurotrauma. 2017 Jun 9; online ahead of print, DOI: 10.1089/neu.2017.5004.
Bryan MA, Rowhani-Rahbar A, Comstock RD, Rivara F; Seattle Sports Concussion Research Collaborative. Sports- and Recreation-Related Concussions in US Youth. Pediatrics. 2016 Jul; 138(1). pii: e20154635. doi: 10.1542/peds.2015-4635.
Committee on Sports-Related Concussions in Youth; Board on Children, Youth, and Families; Institute of Medicine; National Research Council; Graham R, Rivara FP, Ford MA, Spicer CM, editors. Sports-Related Concussions in Youth: Improving the Science, Changing the Culture. Washington (DC): National Academies Press (US); 2014 Feb. https://www.nap.edu/read/18377/chapter/1.
BrainScope Company, Inc. ("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 (FDA cleared as Ahead 300), uses EEG-based technology that is non-invasive for mildly presenting patients 18-85 years old and within 3 days after head injury. 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), DBL Partners, ZG Ventures, Maryland Venture Fund, Brain Trust Accelerator Fund, and Difference Capital. For more information, please visit www.brainscope.com.