Over 30% Reduction in Unnecessary Head CT Scans When Integrating FDA-Cleared BrainScope One
BETHESDA, Md.--(BUSINESS WIRE)--May 6, 2019--BrainScope announced today the publication of a study conducted by physicians at Washington University Barnes Jewish Medical Center in St. Louis in the peer-reviewed journal The American Journal of Emergency Medicine entitled “Reduction in unnecessary CT scans head-injury in the emergency department using an FDA cleared device.” The study demonstrated that the FDA-cleared BrainScope One medical device reduced the use of unnecessary head CT scans by nearly one-third in a hospital emergency room setting when compared to the use of standard clinical practice.
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Emergency Room (ER) visits for mild Traumatic Brain Injury (mTBI) have greatly increased due to increased awareness of potential consequences of such injuries, with roughly 5 million Americans seeking medical care for head injury in ERs each year. While the vast majority (>80%) of head-injured patients who go to the ER receive a head CT scan, more than 90% of them are found to be negative. This practice unnecessarily exposes these patients to radiation, increases the use of hospital ER resources, and lengthens throughput times.
BrainScope’s flagship BrainScope One product, which is commercially available today, is a multi-modal, comprehensive, handheld system that helps clinicians objectively and rapidly assess and triage head injured patients directly at the point of care. BrainScope One is the first and only FDA-cleared medical device to offer capabilities to assess the full spectrum of brain injury – from concussions (functional abnormality) to brain bleeds (structural injury) – for those with mTBI. BrainScope One is being successfully used in a cross-section of market segments including: urgent care and occupational health clinics; concussion clinics; hospital emergency rooms; the U.S. military; university sports and student health centers; professional sports; and pharmaceutical clinical trials.
In the study, ninety-one (91) patients presenting to the ER within 3 days of sustaining a closed head injury (with a mean time since injury of 10.8 hours) were evaluated at Barnes-Jewish Hospital Washington University Medical Center ER. Patients were 18-76 years of age, and all but one had a Glasgow Coma Scale (GCS) score of 15 (one patient GCS=14). Eighty-two percent (82%) of the injuries were caused either by motor vehicle collisions or falls. All ninety-one patients were referred for a head CT scan, which was read by the site neuroradiologist and evaluated for related traumatic brain injury. Patients also received a 5-10 minute BrainScope EEG-based Structural Injury Classifier (“SIC”) evaluation using a proprietary disposable EEG headset, which is rapidly and easily placed on the forehead region. Physician assistants, nurses and/or technicians administered the BrainScope evaluation, which utilizes proprietary Artificial Intelligence (AI) - based algorithms to provide clinically-relevant information to determine whether a patient is likely CT positive (structural brain injury) or likely CT negative (no structural brain injury).
The study demonstrated that BrainScope One can help health care professionals determine the need for a CT scan, helping avoid unnecessary imaging and associated radiation exposure to patients, reduce throughput times and better triage patients who require a CT scan. Based on this study, integrating BrainScope’s EEG-based objective SIC into the decision-making process for CT referrals would have led to a significant reduction of unnecessary CT scans by approximately 31%. Importantly, this decrease in CT use and its associated radiation would be achieved without incurring any false negative cases (100% sensitivity in the study). This study confirmed BrainScope’s overall CT referral rate reduction results published by Huff and colleagues (2017) 1 in a retrospective study of the data collected in the BrainScope FDA validation study 2.
The paper’s lead author, Dr. Rosanne Naunheim, stated, “The use of such rapidly obtained, objective information has the potential to reassure ED physicians in making confident clinical decisions that their patients do not need a CT, and will go a long way toward decreasing unnecessary radiation, decreasing the cost of care.”
“These results clearly demonstrate the powerful capabilities of BrainScope One. Over the past decade, we have created a proprietary multi-modal, multi-parameter FDA-cleared technology that is used by clinicians today in a variety of settings to assess for both structural injury, as well as functional injury known as concussion,” stated Michael Singer, BrainScope CEO. “In partnership with the U.S. Department of Defense through 8 research contracts, our technology has been created and validated through over 20 clinical studies, 27 peer reviewed publications, and 7 FDA Clearances. We continue to demonstrate BrainScope’s clinical utility to cost effectively help clinicians assess the millions of American head-injured patients. Our current customers confirm the great benefit of our medical technology for assessment of the full range of mild traumatic brain injury and concussion.”
For more information about the BrainScope technology, visit www.brainscope.com/products.
The publication can be found and cited as follows: R. Naunheim, M.K. Koscso and R. Poirier, Reduction in unnecessary CT scans head-injury in the emergency department using an FDA cleared device, American Journal of Emergency Medicine, https://doi.org/10.1016/j.ajem.2019.04.037.
BrainScope’s mission is to revolutionize the rapid and objective assessment of brain-related conditions, starting with concussion and mild traumatic brain injury, utilizing multiple integrated assessment capabilities, artificial intelligence (AI) and digitization within a culture of quality, excellence and entrepreneurialism. The Company’s first product, BrainScope One, incorporates a multi-modal, multi-parameter panel of assessment capabilities including EEG-based technology that is non-invasive for mildly presenting head-injured patients, 18-85 years old, within 3 days after injury and is not a replacement to CT scan. BrainScope’s technology platform integrates databases of thousands of brainwave recordings with AI technology and miniaturized hardware and disposable headset sensors, all of which are covered by an extensive intellectual property portfolio of over 100 issued and pending patents globally. BrainScope has received seven FDA clearances and ISO 13485:2016 Certification. It has 27 peer-reviewed publications on its technology. Recent white papers authored by third parties have also shown the potential for BrainScope One to reduce head injury referrals to hospital emergency departments by up to 75% and to reduce healthcare costs for insurers and patients by over 30%.
BrainScope has partnered with the U.S. Department of Defense (DoD) for the development of its mTBI and concussion assessment technology. BrainScope has been the recipient of several prestigious awards, including the Frost & Sullivan 2017 Best Practices Award for New Product Innovation in the Traumatic Brain Injury Assessment Solutions Market, was a two-time winner of the GE-NFL Head Health Challenge, and has received two nominations for the Prix Galien Best Medical Technology (2017 and 2018), regarded as the equivalent of the Nobel Prize for medical devices. BrainScope has received significant funding from private investors including DBL Partners, ZG Ventures, Revolution (created by AOL co-founder Steve Case), and Difference Capital (DCF.TO). For more information, please visit www.brainscope.com.
1 Huff JS, Naunheim R, Ghosh Dastidar S, et al. Referrals for CT scans in mild TBI patients can be aided by the use of a brain electrical activity biomarker. Amer J Emerg Med. 2018;35:1759-1783.
2 Hanley D, Prichep L, Bazarian J, et al. Emergency Department triage of traumatic head injury aided by using a brain electrical activity marker: A multisite prospective observational validation trial. Acad Emerg Med. 2017; 24(5):617-627.
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