concussion

BrainScope Announces Publication Describing Proprietary Concussion Biomarker to Assess Potential Severity and Predict Prolonged Recovery

BrainScope Announces Publication Describing Proprietary Concussion Biomarker to Assess Potential Severity and Predict Prolonged Recovery

Future Capability Could Aid in Objective Return-to-Activity Decisions

BETHESDA, MD. 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. 

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.

About BrainScope

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.

BrainScope Receives FDA Clearance for Multi-Modal, Multi-Parameter Concussion Assessment

BrainScope Receives FDA Clearance for Multi-Modal, Multi-Parameter Concussion Assessment

New Concussion-Specific FDA Labeling Adds to Existing BrainScope Claims Complements Multi-Modal Technology Platform and Extensive Intellectual Property Portfolio To Address New Brain and Behavioral Health Conditions

BETHESDA, MD. January 2, 2019– BrainScope®, a medical neuro-technology company focused on concussion and mild traumatic brain injury (mTBI) assessment, announced today that it has received FDA clearance to include additional language in its product’s Indications for Use (IFU), adding key terminology related to “multi-modal, multi-parameter assessment” of “concussion” and “mild Traumatic Brain Injury”, as well as an expanded and clarified overall IFU.  In addition to being able to objectively and reliably identify patients who may have a brain bleed using the product’s Structural Injury Classifier, BrainScope One uses the same electroencephalogram (EEG) signal and other capabilities on the device to objectively determine the likelihood of the presence and severity of a concussion.  All capabilities are summarized on a panel of multimodal, multi-parameter results, greatly facilitating clinical concussion assessment.

“This additional FDA labeling for our product, BrainScope One, recognizes the unique capabilities of our FDA-Cleared medical device with labeling distinctively and specifically for this particular disease state,” stated Michael Singer, CEO of BrainScope. “Years ago in working with our partner, the Department of Defense, we realized and learned from them the importance of multi-modality and objectivity.  Combining a full range of concussion assessment capabilities on one handheld platform provides the clinician a timely and easy-to-use tool for collecting the objective data they need to facilitate their clinical diagnosis, right then and there, for this debilitating brain disease state.”

“Throughout most of 2018, we maintained an interactive dialogue with the FDA on the labeling pertaining to our concussion assessment capabilities and, as part of this ongoing discussion, we provided substantial data for their consideration.  This has led to BrainScope’s 6th FDA Clearance.  This thorough vetting by the FDA shows our commitment to and respect for adherence to the regulatory process as it relates to human brain health, and in particular to the increasing national awareness of the significant problem of concussion,” added Singer. 

BrainScope further announced that with a global patent portfolio of over 100 issued and pending patents, a substantial portion of these patents relate specifically to multi-modality capabilities applicable to all neurological conditions and disease states.  “For over a decade, we have created a platform comprised of unparalleled AI-based technology, clinical evidence, peer-reviewed literature and regulatory knowledge, supported by a vast IP portfolio.  Given our success in developing BrainScope One for mTBI and concussion assessment, we have received considerable interest from third-parties to further develop the BrainScope multi-modal assessment platform for other neurological disease states beyond concussion,” stated Singer.

About BrainScope

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 25 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 payors and patients by over 30%.

BrainScope has partnered with the U.S. Department of Defense 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. For more information, please visit www.brainscope.com

BrainScope Honors Veterans Day and Supports U.S. Army Deployment of Traumatic Brain Injury (TBI) and Concussion Assessment Devices

BETHESDA, MD. November 13, 2018– BrainScope®, a medical neuro-technology company focused on concussion and mild traumatic brain injury (mTBI) assessment, announced today that it has fulfilled orders for over 170 BrainScope One handheld devices and over 7,500 individual patient headsets to U.S. Army bases across the world. U.S. Army medics and clinicians continue to receive the training necessary to support the assessment of military personnel that may have experienced an mTBI, providing access for service members at home and abroad.

BrainScope Receives Prix Galien Award Nomination for Its Concussion and Traumatic Brain Injury Assessment Product

BETHESDA, MD.--(BUSINESS WIRE)--BrainScope today announced its second consecutive nomination for the 2018 Annual Prix Galien USA Awards for “Best Medical Technology” product. Its flagship BrainScope One product is a multi-modal, comprehensive, handheld capability to help clinicians objectively and rapidly assess and triage head injured patients directly at the point of care.