Future Capability Could Aid in Objective Return-to-Activity Decisions
BETHESDA, Md.–(BUSINESS WIRE)–January 15, 2019–
BrainScope®, a medical neuro-technology company focused on concussion and mild traumatic brain injury (mTBI) assessment, announced today that researchers have published preliminary results related to a multi-modal concussion assessment capability for potential severity and likelihood of prolonged recovery from concussions. Published in the peer-reviewed journal Computers in Biology and Medicine, the paper entitled, “A multimodal biomarker for concussion identification, prognosis and management” describes a study which enrolled 568 concussed and matched control patients between the ages of 13-25 from 29 colleges and 19 high schools. Subjects were tested at the time of injury and at multiple time points during recovery.
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The BrainScope One system is an easy-to-use, non-invasive, hand-held platform that empowers physicians to make more accurate TBI assessments quickly and at the point-of-care. BrainScope’s unique system leverages advanced digital signal processing, sophisticated algorithms and machine learning technologies to identify and evaluate key brain electrical activity biomarkers of TBI. (Photo: BrainScope Company Inc.)
Results from this study demonstrated highly significant differences in the BrainScope biomarker between the 177 concussed patients and controls at the time of injury and no significant differences at clinically determined Return-to-Play. Progressive recovery over time was also demonstrated, especially in the prolonged recovery group. Results also supported the hypothesis that some of the more severely injured subjects may have been allowed to return to play too soon.
“Today there is a reliance on self-report and subjective sideline evaluations. This large feasibility study demonstrated the potential clinical utility of a multi-modal biomarker to provide a means for objective personalized tracking from time of injury throughout recovery of brain function after concussive injury,” stated Dr. Leslie Prichep, Chief Scientific Officer of BrainScope.
“This substantial project was initiated several years ago in collaboration with the Department of Defense with a mutual vision of creating an objective, multi-modal biomarker to help determine a concussed patient’s level of severity and potential duration of recovery after head injury – leading to Return-to-Activity decisions,” added Michael Singer, BrainScope CEO. “These results are extremely exciting as we work to bring this important assessment capability to the market in the near-term.”
BrainScope noted that while this capability is not currently included in its FDA-cleared product, BrainScope One, the multi-modal biomarker employs BrainScope’s technology platform and Intellectual Property portfolio.
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 (cleared as Ahead 300), 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 six FDA clearances and ISO 13485 Certification. It has 26 peer-reviewed publications on its technology. Recent white papers authored by third parties have shown the potential for BrainScope One to decrease unnecessary head CT scans by one-third, 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, and BrainScope One is currently being fielded by the U.S. military, both stateside and internationally. BrainScope One is also being utilized in a cross-section of market segments including: urgent care and occupational health clinics; concussion clinics; hospital emergency rooms; university sports and student health centers; professional sports; and pharmaceutical clinical trials. 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, Revolution (created by AOL co-founder Steve Case), ZG Ventures and Maryland Venture Fund. For more information, please visit www.brainscope.com.
The clinical study was supported in part by the U.S. Army Contracting Command, Aberdeen Proving Ground, Natick Contracting Division, under Contract No. W911QY-14-C-0098. Any opinions, findings and conclusions or recommendations expressed in this material are those of the author(s) and do not necessarily reflect the views of the US Army Contracting Command, Aberdeen Proving Ground, Natick Contracting Division.
Laurie Silver, Chief Financial Officer