PITTSBURGH, PA--(Marketwire - October 17, 2012) - Continuing its push to develop new clinical testing protocols for earlier and more accurate disease diagnosis, medical device manufacturer Neuro Kinetics, Inc. (NKI) (www.neuro-kinetics.com) said today that the U.S. Department of Defense (DOD) has awarded it a $2.4 million contract to advance the application of the company's I-Portal® oculomotor (eye movement) tracking technology for battlefield testing of combat brain injuries.
The DOD contract, awarded through its competitive Rapid Innovation Fund program, should allow NKI to develop sufficient clinical results to seek 510(k) certification from the U.S. Food and Drug Administration (FDA) for expanded use of its medical devices, including in the sports medicine and accident care fields, the company said.
"We have been researching new and broader applications of our technology for some time now, and our new contract with DOD underscores the progress we've made," said Howison Schroeder, NKI president and CEO. "We are honored to be working with DOD to accelerate our efforts while supporting our soldiers."
The I-Portal technology gauges neuro-physiologic functionality by measuring the eye's reflex to a variety of oculomotor stimuli taxing different parts of the brain. NKI's data shows that I-Portal can detect abnormalities caused by various forms of brain injuries, including often hard-to-detect mild Traumatic Brain Injuries (mTBI), also known as concussions.
The I-Portal test battery also suggests that the data derived is significantly more objective than current neuro-psychological tests that rely partially on patient self diagnosis.
The DOD contract will fund NKI research at two U.S. military basic training sites, Naval Medical Center San Diego (Navy) and Martin Community Hospital at Ft. Benning (Army). Principal investigators have been appointed at each site and preparations for the study have begun.
NKI's current FDA 510(k) permits use of the company's devices for the testing of various vestibular and balance-related diseases and conditions. The company has served audiologists, ENT's, neuro-otologists, neuro-ophthalmologists and neurologists around the world for more than 25 years.
NKI currently has installed systems at 35 DOD and U.S. Veterans Administration facilities that are used for research and patient care.
The crisis of returning combat soldiers suffering from brain injuries has been widely reported. The severity of head injuries ranges from a brief change in mental status or consciousness to extended unconsciousness and amnesia. In severe or multiple concussion cases, personality changes can occur with devastating results. mTBIs have been linked with Post-Traumatic Stress Disorder.
Currently there is no accepted clinical method to detect mTBI.
The Centers for Disease Control and Prevention estimates that at least 3.17 million Americans currently have a long-term or lifelong need for help to perform activities of daily living as a result of a brain injury.
"The eye is the portal to the brain," NKI's Schroeder said. "We are just beginning to fully appreciate how much we can understand about the brain through tracking eye movements. We believe our technology will become respected and used among a wide universe of medical specialists, and in the process we will improve patient care for millions."
Note: This work is supported by the US Army Medical Research and Materiel Command under Contract No. W81XWH-12-C-0205.