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 One is the first FDA-cleared medical device to offer multi-modal capabilities to assess brain injury from concussions (functional abnormality) to brain bleeds (structural injury) using EEG and other objective parameters available on a ruggedized, handheld device. BrainScope One’s capabilities include a digitized version of the Military Acute Concussion Evaluation ("MACE"?), which is being upgraded to the recently updated MACE2 as part of the Department of Defense’s efforts to strengthen multi-modal assessment for its service members.
According to the June 1, 2018 edition of Stars and Stripes®, "Researchers estimate 15 to 23 percent of service members returning from combat have suffered a TBI."? This same article, "Tackling TBI,"? points out that rather than making a subjective, symptom-based decision on whether a soldier has sustained a concussion or brain bleed, BrainScope One provides a quick and objective assessment to help answer the question "Should we let them go back on a mission?"?
The Department of Defense continues to maintain its focus on the care of service members who suffer from brain injuries. "This Veterans Day reminds us of the honor we have in aiding the care of our service members, knowing that concussion and brain health remain of paramount importance to the U.S. military,"? shared Michael Singer, CEO of BrainScope.
BrainScope’s mission is to revolutionize the rapid and objective assessment of brain-related conditions, starting with concussion and mild traumatic brain injury (mTBI), 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 panel of 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 five 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 payers and patients by over 30%.
BrainScope has partnered with the U.S. Department of Defense for the development of its TBI 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, regarded as the equivalent of the Nobel Prize for medical devices. For more information, please visit www.brainscope.com.
The views, opinions and/or findings contained in this report are those of BrainScope and should not be construed as an official Department of the Army position, policy or decision unless so designated by other documentation.