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= BrainScope Company, Inc. =

BrainScope Company, Inc. (BrainScope) is a medical neurotechnology firm using artificial intelligence to assess a variety of neurological conditions, beginning with mild traumatic brain injury (mTBI), including concussion. BrainScope was founded in 2006 and is headquartered in Bethesda, Maryland.

BrainScope's markets include the military, emergency departments, urgent care and occupational medicine centers, and sports at the collegiate and professional levels.

Technology
BrainScope One uses artificial intelligence and multi-modality to help clinicians rapidly assess mild head-injured patients for structural and functional brain injuries, including concussions, with a non-invasive handheld device and a disposable headset.

Using electroencephalographic (EEG) data collected with a disposable headset, BrainScope One objective biomarkers both predict the likelihood that a patient's structural brain injury would be visible on a CT scan and assess the likelihood of brain functional impairment by comparing the patient's brain function to that of non-head injured iindividuals. BrainScope One also includes neurocognitive tests, performed by the patient on the device, and an extensive library of digitized concussion assessments.

BrainScope One's technology platform was created through 21 clinical studies at over 55 clinical sites spanning a decade, contributing to 23 investigator-initiated peer-review journal articles and resulting in 5 FDA clearances.

An independent validation trial conducted using BrainScope One determined that the device's sensitivity to "≥1 mL of blood was ... 98.6%" and that its accurate CT-scan predictions can lead to a "reduction in the number of false positives of 33%."

BrainScope One is FDA cleared as an Rx-only device for use on patients 18-85 years of age who have suffered a mild head injury (Glasgow Coma Scale score of 13-15 and mTBI) within the previous 72 hours. BrainScope One was originally cleared by the FDA as the Ahead 300 under 510(k) K161068 in September 2016. Subsequent modifications to device Indications for Use regarding concussion/mTBI capabilities were FDA cleared under 510(k) K181179 in May 2018.

The company initiated a clinical research study on patients 13-25 years of age in May 2018 as part of its initiative to "introduce a teenage-focused product in the near-term."

Partners
BrainScope has raised over $60 million in private capital and has received $30 million in research contracts, including funding from the United States Department of Defense and General Electric and the National Football League through their Head Health Challenge competition. Among the company's private investors are Revolution LLC, an investment firm founded by AOL co-founder Steve Case; DBL Partners, a venture capital firm that also backs Tesla and Pandora; and the Maryland Venture Fund.

BrainScope's other development partners include New York University School of Medicine and Johns Hopkins University and its clinical partners include Emory University, the University of Virginia and Washington University in St. Louis.

Awards

 * Winner of the 2017 Frost & Sullivan Best Practices Award - Traumatic Brain Injury New Product Innovation
 * Finalist for the 2017 Prix Galien Foundation USA Award for Best Medical Technology Product
 * Greater Washington Health & Life Sciences 2017 Innovator of the Year
 * Winner of the 2017 Moxie Award for Healthcare
 * Maryland Emerging Life Science 2016 Business of the Year
 * Two-time winner of the GE NFL Head Health Challenge, 2014 and 2015
 * 2012 Montgomery County Chamber of Commerce Verl Zanders Emerging Business of the Year