Assessment Across the Full Spectrum of
Brain Injury, Including Concussion 


Question 2

Is there a functional component
to the brain injury?

Question 1

Is there a structural component to
the brain injury?

(likely visible on a CT scan or advanced neuroimaging)?

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  • Helps determine patient disposition, including need for ER visit

  • Immediate on‐site assessment

  • Efficient, accurate, objective, comprehensive

  • Non‐invasive EEG‐based technology

  • Reduce unnecessary exposure to radiation

  • Neurocognitive tests and digitized concussion assessments

  • For patients ages 18+

  • For use within 3 days of mild head injury

  • Rx‐Only, not a stand‐alone diagnostic or replacement to CT

 

Comprehensive Assessment Metrics Configured for Your Needs

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Facts about Brain Injury and Concussion

4.8 million brain injury‐related ER visits every year

Taylor CA, Bell JM, Breiding MJ, Xu L. Traumatic Brain Injury–Related Emergency Department Visits,
Hospitalizations, and Deaths — United States, 2007 and 2013 MMWR Surveill Summ 2017;66(No. SS‐9):1–16. DOI:
http://dx.doi.org/10.15585/mmwr.ss6609a1


84% of ER visits for suspected head injury result in a CT Scan


95% of head injuries are mild in nature


91% of CTs performed for mTBI are negative and result in
potentially unnecessary radiation exposure.

Korley FK, Kelen GD, Jones CM, Diaz‐Arrastia R. Emergency Department Evaluation of Traumatic Brain Injury
in the United States, 2009–2010. J Head Trauma Rehabil 2016 Nov/Dec;31(6):379‐387.


99% 
BrainScope Sensitivity to even the smallest amount of detectable blood (≥1cc)


98%
BrainScope Negative Predictive Value

3. Hanley D, Prichep LS, Bazarian J, Huff JS, Naunheim R, Garrett J, Jones E, Wright DW, 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. Academic Emergency Medicine. 2017; online ahead of print, DOI:10. 1111/acem.13175


33.3%
Potential to reduce false positives compared with standard
clinical practice based on BrainScope One’s ability to accurately predict
which patients are likely CT‐positive

Huff JS, Naunheim R, Ghosh Dastidar S, Bazarian J, Michelson EW. Referrals for CT scans in mild TBI patients can be aided by the use of a brain electrical activity biomarker. American Journal of Emergency Medicine. 2017; in press, DOI:10.1016/j.ajem.2017.05.027


33%
Reduction in the overall number of CT scans referrals within the BrainScope One pathway compared to the clinical site practice decision pathway

Naunheim R & Kosco M, Washington University Barnes Jewish Medical Center, St. Louis, MO. Potential Significant Reduction in Unnecessary CT Scans in Emergency Departments Using an FDA Cleared Medical Device for Brain Injury Assessment; 2018.


75%
Reduction in Emergency Room CT referrals from Urgent Care Centers integrating BrainScope One

Alvaro R. Zeballos, M.D. & Devin Minior, M.D., BetterMed Urgent Care, Banner Urgent Care. Potential to Reduce Emergency Department Referrals From Urgent Care Centers By Up To 75% for Mildly Presenting Head Injured Patients; 2018. 


FDA Validation Trial:
Structural and Functional Brain Injury

  • Hanley, et al., J Neurotrauma, 2018.
    A brain electrical activity (EEG) based biomarker of functional impairment in traumatic head injury: a multisite validation trial

  • Naunheim, et al., American J Emergency Medicine, 2018.
    Using a brain electrical activity biomarker could aid in the objective identification of mild Traumatic Brain Injury patients

  • Hanley, et. al., Academic Emergency Medicine, 2017.
    Emergency Department triage of traumatic head injury using brain electrical activity: a prospective observational validation trial of clinical efficacy

  • Hack, et al., American J EmergencyMedicine, 2017.
    Demonstration of improved accuracy of prediction of CT+ with EEG compared with LDC alone

  • Huff, et al., American J Emergency Medicine, 2017.
    Referrals for CT scans in mild TBI patients can be by the use of a brain electrical activity biomarker


Technology Description and Explanation

  • Prichep, et al., J Computers Biology Medicine, 2014.
    Classification algorithms for the identification of structural injury in TBI using brain electrical activity

  • Prichep, et al., IEEE Transactions Neural Systems & Rehab Engin., 2012.
    Classification of Traumatic Brain Injury Severity Using Informed Data Reduction in a Series of Binary Classifier Algorithms


Neurocognitive Test Norming for Inclusion of Norms

  •  Vincent, et al., Applied Neuropsychology: Adult, 2016.
    Normative data for neurocognitive assessment on the Ahead 300

Structural Injury Assessment Development

  • Ayaz, et al., American J Emergency Medicine, 2015.
    Comparison of quantitative EEG to Current Clinical Decision Rules for head CT

  • Prichep, et al Neurotrauma, 2015.
    Identification of Hematomas in mTBI injury using an index of quantitative brain electrical activity

  • Michelson, et al., Academic Emergency Medicine, 2014.
    Identification of acute stroke using BrainScope technology

  • Hanley, et al., J Neurotrauma, 2013.
    Use of Brain Electrical Activity for the Identification of Hematomas in Mild TBI

  • O'Neil, et al., Western J Emergency Medicine, 2012.
    Quantitative brain electrical activity in the initial screening of mild traumatic brain injuries

  • Naunheim, et al., American J Emergency Medicine, 2011.
    Automated Electroencephalogram (EEG) Identifies Abnormalities in the ED

  • Naunheim, et al., American J Emergency Medicine, 2010.
    Novel method for detecting brain abnormality in a patient with epidural hematoma: A case report

  • Naunheim, et al., Brain Injury, 2010.
    Use of brain electrical activity to quantify TBI brain dysfunction in the ED


Major Findings in Current Practice

  • Michelson et al., Western J Emergency Medicine, 2018.
    Time spent in the ED for mild TBI patients

  • Curley et al., J of Head Trauma Rehabilitation, 2017. Accepted: Pre-Pub:
    lntracranial pathology (CT+) in ED patients with high GCS and high SAC score

  • O'Neil, et al., Military Medicine, 2014:
    CT positive brain injury in Mild TBI patients presenting with normal SAC

  • Huff & Johar, American J Emergency Medicine, 2014:
    Differences in interpretation of cranial CT in Emergency Department TBI patients by expert neuroradiologists