Company Focusing On Point of Care Technology For Assessment of TBI / Concussion
BETHESDA, MD. December 12th, 2011 – BrainScope® Company, Inc. today 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 $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 (TBI). It is expected to provide objective and timely adjunctive assessment of structural brain injury and functional impairment from TBI, including its milder forms known as 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 categorization of brain injury, based on patterns identified in brain electrical activity. The Ahead™ M-100 is intended to be utilized as an adjunct to standard clinical practice to aid in the rapid and effective assessment of military service members suspected of TBI at the point of care. Early identification and categorization of even the mildest forms of brain injury are the first steps in providing proper care to ensure optimal recovery.
"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 U.S. military on this very serious issue and are looking forward to commencing our trial in emergency departments across the country."
In May of this year, BrainScope reached concurrence with the U.S. 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 utilizing 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.
Backed by Revolution LLC (created by AOL co-founder Steve Case), Alafi Capital, Brain Trust Accelerator Fund, Draper Fisher Jurvetson, Portage Ventures and ZG Ventures, BrainScope is a medical neurotechnology company that is developing a new generation of hand-held, simple-to-use, non-invasive instruments designed to aid medical professionals in rapidly and objectively assessing brain function. BrainScope devices in development are based on a proprietary technology platform, which integrates databases of brainwave recordings with advanced developments in digital signal processing, sophisticated algorithms, miniaturized hardware and disposable headset sensors. BrainScope's initial focus is on traumatic brain injury (TBI) and its milder forms known as concussion. BrainScope's unique device is being developed to meet a long-standing clinical need for improved early identification, staging and triage for head-injured patients. BrainScope devices under development for use in the United States for assessment of traumatically-induced head injury and concussions are for investigational use only and have not been submitted to FDA for premarket review. For more information, please visit www.brainscope.com.