BrainScope announced that it has been awarded a contract by the United States Department of Defense for the “Assessment of head injury in the emergency department: clinical validation of the BrainScope Ahead technology.” This contract is valued at US$7.5 million over 18 months and is effective immediately.
BrainScope’s Ahead M-100 is being developed to address the unmet need for a medical device to aid in triage of patients who are suspected of traumatic brain injury. It is expected to provide objective and timely adjunctive assessment of structural brain injury and functional impairment from traumatic brain injury, including concussions.
The Ahead M-100 is a handheld, non-invasive, non-radiation emitting medical device in development that could provide a rapid and objective assessment and categorisation of brain injury, based on patterns identified in brain electrical activity. The Ahead M-100 is intended to be utilised as an adjunct to standard clinical practice to aid in the rapid and effective assessment of military service members suspected of traumatic brain injury at the point of care.
“We are honored to receive this award from the Department of Defense to begin this important clinical validation of the Ahead technology,” said Michael Singer, president and CEO of BrainScope. “We are excited to work with the US military on this very serious issue and are looking forward to commencing our trial in emergency departments across the country.”
In May 2011, BrainScope reached concurrence with the US Food and Drug Administration (FDA) on the key study design elements for clinical validation of the Ahead M-100 medical device.
In 2010 and 2011 results from clinical studies utilising BrainScope’s technology have been published in leading peer-reviewed neurology and emergency medicine journals such as Brain Injury, The Journal of Head Trauma Rehabilitation and The American Journal of Emergency Medicine.