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.
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