Traumatic brain injury (TBI) is a condition that arises after mechanical injury to the brain. According to the Centers for Disease Control and Prevention, an estimated 5.3 million Americans currently live with TBI-related disability, with an annual total cost in 2010 estimated at $76.5 billion, including $11.5 billion in direct medical costs and $64.8 billion in indirect costs including lost wages, lost productivity, and nonmedical expenditures. The Department of Defense has reported over 300,000 cases of TBI in U.S. military personnel between 2000 and August 2014. In the EU, Canada, and Australia combined, it is estimated that approximately 1.8 million people have experienced TBI. While many individuals recover fully, approximately 40 percent of individuals with mild TBI experience persistent postconcussive symptoms three to six months post-injury that may interfere with their return to work or school, including difficulties with memory, decision making, attention, movement, and emotional functioning. These issues not only impact the injured individuals, but also can have lasting effects on their families and communities.
As of August, 2014 we have entered into a Cooperative Research and Development Agreement (CRADA) with the U.S. Veterans Administration for a clinical trial to evaluate eTNS for patients with TBI in a Phase I clinical trial. Under the CRADA, we are supplying eTNS systems for use in this investigator-initiated trial. Neuroimaging data from our earlier PET scan study suggest that eTNS can influence the activity of certain brain areas associated with the cognitive functions that are disrupted in TBI. This effect may be able to help address cognitive impairments and this study will gather evidence related to this hypothesis, beginning in late 2014.
CAUTION: We have not received approval from the FDA to market our eTNS™ system of proposed sTNS™ system in the United States. Our eTNS™ system and proposed sTNS™ system are classified as investigational devices and are limited by Federal (or United States) law to investigational use only.