Image courtesy of BrainScope
The U.S. Department of Defense has awarded BrainScope a $4.5 million research contract to create and integrate ocular capabilities into its handheld, multi-parameter mild traumatic brain injury (mTBI) and concussion products.
The Bethesda, Md.-based company’s initial product, BrainScope One, is the first FDA-cleared medical device that can assess the full spectrum of brain injury – from concussions (functional abnormality) to brain bleeds (structural injury). BrainScope One uses EEG and other parameters to help the clinician to reach a diagnosis. With this research contract, BrainScope will add specific capabilities to assess the patient’s eyes. These features will be incorporated in future versions of BrainScope’s products, according to a company statement.
“We are extremely honored and humbled to receive this research contract to continue our work in partnership with the U.S. Department of Defense to develop these important assessment capabilities for concussion and mild traumatic brain injury,” said BrainScope CEO Michael Singer in the statement. “We understand the significant need to incorporate multiple parameters, all on a single device. Using our proprietary AI and multi-modal technologies, we will rapidly ramp up our efforts on this important project.”
BrainScope One, cleared as Ahead 300, incorporates a multi-modal panel of capabilities including EEG-based technology for mildly presenting head injury patients, 18 to 85 years old, within three days of the injury. It is not a replacement for a CT scan. 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 more than 30%, according to the company.
BrainScope has partnered with the U.S. Department of Defense to develop its TBI assessment technology. BrainScope One is being used by the U.S. military domestically and abroad, as well as by urgent care and occupational health clinics, concussion clinics, hospital emergency rooms, university sports and student health centers, professional sports, and pharmaceutical clinical trials.
The company announced one year ago that it would begin developing a pediatric application for BrainScope One. In May 2018, it announced the beginning 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.
“We are aggressively pursuing this very large demographic with plans to introduce a teenage-focused product in the near-term,” Singer said in a separate statement.
BrainScope One was also recently nominated for the second time for the annual Prix Galien USA Awards for “Best Medical Technology” product.
