BETHESDA, Md.--(BUSINESS WIRE)--BrainScope, a medical neurotechnology company focused on concussion and mild traumatic brain injury (mTBI) assessment, announced today the initiation of a large, multi-site clinical research study enrolling subjects ages 13-25 years who sustained a head injury from a variety of causes, including sports-related head injuries. Designed as a prospective, observational investigation, eligible patients who sustained a head injury will be recruited from concussion clinics and high schools surrounding the participating universities conducting the study.
“The initiation of this large clinical study is a significant milestone in the development of BrainScope’s next-generation brain injury assessment products to include teenage patients suspected of a concussion,” said Michael Singer, CEO of BrainScope. “We are aggressively pursuing this very large demographic with plans to introduce a teenage-focused product in the near-term,” stated Singer.
There are currently over 44 million children participating in football, soccer, lacrosse and many other sports where head injury occurs each year in the United States. It is estimated that there are up to 3.8 million sports-related and recreation-related concussions annually in the U.S. Currently, many of these concussions are diagnosed using purely subjective, symptom-based methods.
BrainScope is a neurotechnology company using Artificial Intelligence (AI) and multi-modal capabilities on handheld devices to aid in rapid and objective assessment of neurological conditions, beginning with concussion and mild traumatic brain injury (mTBI). The company’s first product introduced in 2017, BrainScope One, incorporates a multi-modal panel of capabilities including EEG-based technology that is non-invasive for mildly presenting patients, 18-85 years old, within 3 days after head 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, which are all covered by an extensive intellectual property portfolio of over 100 issued and pending patents. BrainScope has received five FDA clearances and ISO 13485:2003 Certification. BrainScope has partnered with the U.S. Department of Defense for the development of its TBI assessment technology, and BrainScope One is currently being fielded by the U.S. military. 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 received a nomination 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.