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BrainScope Company, Inc.

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BrainScope Company, Inc.
IndustryMedical neurotechnology
Headquarters
Bethesda, Maryland
Key people
Michael E. Singer,

Chief Executive Officer

Daniel J. Moore, Chairman of the Board

Laurie Silver, Chief Financial Officer

Leslie S. Prichep, Ph.D., Chief Scientific Officer

Jean Case, Board Member

Miles R. Gilburne, Board Member

James B. Peake, M.D., LTG, Board Member

Cynthia Ringo, Board Member

Gail Wilensky, Ph.D., Board Member
ProductsNon-invasive mild traumatic brain injury (concussion) assessment platform
Websitehttp://brainscope.com/

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.[1][2]

Technology

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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.[3]

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.[2][4] 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%."[5][6]

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.[7] Subsequent modifications to device Indications for Use regarding concussion/mTBI capabilities were FDA cleared under 510(k) K181179 in May 2018.[8]

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."[9]

Partners

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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.[4][10][11] 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.[12][13][14]

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.[4][15][16]

Awards

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  • Winner of the 2017 Frost & Sullivan Best Practices Award - Traumatic Brain Injury New Product Innovation[17]
  • Finalist for the 2017 Prix Galien Foundation USA Award for Best Medical Technology Product[18]
  • Greater Washington Health & Life Sciences 2017 Innovator of the Year[19]
  • Winner of the 2017 Moxie Award for Healthcare[20]
  • Maryland Emerging Life Science 2016 Business of the Year[21]
  • Two-time winner of the GE NFL Head Health Challenge, 2014 and 2015[11][22]
  • 2012 Montgomery County Chamber of Commerce Verl Zanders Emerging Business of the Year[23]

References

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  1. ^ "Medics start using scanner that could detect TBI earlier". Stars and Stripes. Retrieved 2018-06-25.
  2. ^ a b Olivas, Denise (2017-07-27). "UMC uses new equipment for brain care". KVIA. Retrieved 2018-06-25.
  3. ^ Brunner, Melissa. "Inside the head game: Washburn among first with new BrainScope device". Retrieved 2018-06-25.
  4. ^ a b c Orcutt, Mike. "This new technology could help clinicians rapidly test for concussions on sidelines and battlefields". MIT Technology Review. Retrieved 2018-06-25.
  5. ^ Hanley, Daniel; Prichep, Leslie S.; Bazarian, Jeffrey; Huff, J. Stephen; Naunheim, Rosanne; Garrett, John; Jones, Elizabeth B.; Wright, David W.; O'Neill, John (2017-03-31). "Emergency Department Triage of Traumatic Head Injury Using a Brain Electrical Activity Biomarker: A Multisite Prospective Observational Validation Trial". Academic Emergency Medicine. 24 (5): 617–627. doi:10.1111/acem.13175. ISSN 1069-6563.
  6. ^ Huff, J. Stephen; Naunheim, Rosanne; Ghosh Dastidar, Samanwoy; Bazarian, Jeffrey; Michelson, Edward A. (2017). "Referrals for CT scans in mild TBI patients can be aided by the use of a brain electrical activity biomarker". The American Journal of Emergency Medicine. 35 (11): 1777–1779. doi:10.1016/j.ajem.2017.05.027. ISSN 0735-6757.
  7. ^ "510(k) Premarket Notification". www.accessdata.fda.gov. Retrieved 2018-06-27.
  8. ^ "510(k) Premarket Notification". www.accessdata.fda.gov. Retrieved 2018-06-27.
  9. ^ "BrainScope Initiates Teenage and Young Adult Multi-Site Clinical Study for Concussion Assessment Product". Retrieved 2018-06-20.
  10. ^ "Whitman High School Chosen for Concussion Research Study". Retrieved 2018-06-25.
  11. ^ a b Heath, Thomas (2015-07-23). "Bethesda's BrainScope scores $500k from NFL, General Electric". Washington Post. ISSN 0190-8286. Retrieved 2018-06-13.
  12. ^ "Term Sheet -- Thursday, August 31". Fortune. Retrieved 2018-06-25.
  13. ^ "Portfolio | DBL Partners". www.dblpartners.vc. Retrieved 2018-06-14.
  14. ^ "BrainScope Completes $16 Million Equity Fundraise". Retrieved 2018-06-13.
  15. ^ "Quickly assessing brain bleeding in head injuries using new device". ScienceDaily. Retrieved 2018-06-25.
  16. ^ Bernhard, Blythe. "Working to prevent, diagnose concussions in kids". stltoday.com. Retrieved 2018-06-25.
  17. ^ "BrainScope Receives Frost & Sullivan Best Practices Award in Traumatic Brain Injury Assessment". Retrieved 2018-06-26.
  18. ^ Foundation, The Galien. "The Galien Foundation Debuts 2017 Prix Galien USA Nominees in "Best Biotechnology Product," "Best Pharmaceutical Product," and "Best Medical Technology" Categories". www.prnewswire.com. Retrieved 2018-06-13.
  19. ^ "2017 Greater Washington Innovation Awards winners and finalists announced". INSIDENOVA.COM. Retrieved 2018-06-14.
  20. ^ "Moxie Award 2017 Winners - Moxie Award". Moxie Award. Retrieved 2018-06-25.
  21. ^ "Business Notes: Bethesda Firm Named Emerging Life Science Business of the Year". Retrieved 2018-06-14.
  22. ^ "NFL, GE announce six final winners of Head Health Challenge I | NFL.com". www.nfl.com. Retrieved 2018-06-26.
  23. ^ "BrainScope Company, Inc. Awarded Montgomery County Emerging Business of the Year | BioSpace". BioSpace. Retrieved 2018-06-25.
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