BrainScope™ Positioned to Identify Traumatic Brain Injuries Suffered by Military Troops

BrainScopeTM Positioned to Identify Traumatic Brain Injuries Suffered by Military Troops Companyʼs Hand-Held Brain Assessment Devices under Development Addresses
Congressional Call to Drive Accelerated Development of New Traumatic Brain Injury Technologies

WASHINGTON–(BUSINESS WIRE)– March 23, 2009 –With awareness growing around the need for new ways to detect traumatic brain injuries, BrainScope Company Inc. today announced completion of data acquisition in high school athletes with mild traumatic brain injury (mTBI) as part of an on-going investigational study of its brain assessment device. This comes at a time when Congress is seeking increased efforts to accelerate the development of new treatments for neurological conditions with the recent neurotechnology bill, and the Defense Centers of Excellence for Psychological Health and Traumatic Brain Injury has issued a call for a uniform test for traumatic brain injury to be performed on all troops who are exposed to a blast or othe violent event in wartime.

The company is continuing its research of mTBI in eight Emergency Departments nationwide with its data collection device. These brain function assessment tools under development are mobile, non-invasive, hand-held wireless devices designed to provide a determination of whether brain trauma has occurred and could potentially be used to identify military troops sustaining traumatic brain injuries.

Historically, attempts to use electrophysiological measurements in natural settings have been limited due to lack of portability, the difficulty of placing a large array of electrodes on the scalp of the patient, and access to medical expert assessment at the initial point of care. With its capabilities designed to meet the need for first-on-scene assessments of brain function – in an ambulance, emergency department, the sports field or battlefield – BrainScopeʼs device focuses on the detection of traumatic brain injury. This new generation of technology in development will operate as a digital translator of electrical brain activity, allowing medical professionals to quickly obtain adjunct clinical information based on a quantitative assessment of a patientʼs need for further diagnostic evaluation and appropriate treatment.

“Clinical trials of BrainScopeʼs brain function assessment devices are under clinical study to assess their capability to perform,” said CEO Michael Singer. “Our investigative technology has the potential to create a highly useful capability for assessment of traumatic brain injury. We support the National Neurotechnology Initiative Act and commend its champions for making this issue a priority.”

BrainScope is researching advances in digital instrumentation by investigating brain electrical activity to enable rapid automated analysis of abnormalities in brain function. BrainScope is aiming to develop technology that addresses traditional constraints through the use of a disposable compact frontal electrode headset for data collection, miniaturized hardware, and advanced non-linear computer algorithms that perform quantitative analysis of brain electrical activity and calculate the probability that a particular diagnostic profile exists, such as traumatic brain injury.

As many as 360,000, or 20 percent, of combat veterans have suffered at least one mild concussion, according to latest Pentagon estimates. 1.5 million traumatic brain injuries (TBIs) are reported in the U.S. every year, and a suspected three million such injuries go unreported. TBI is one of the most common reasons for treatment in hospital emergency departments and the nationʼs number one sports injury, with approximately 2-4 million sports and recreation related concussions annually in the U.S. according to the Centers for Disease Control, many of which are not properly evaluated or treated. TBI is the “signature injury” of the wars in Iraq and Afghanistan, a leading cause of death and disability among young people and a growing risk for older Americans.

In August 2008, BrainScope presented and published preliminary information collected with its data collection device by two of its leading clinical facilities at a meeting of the National Neurotrauma Society (NNS). BrainScopeʼs technology was used to assess degree of abnormality in brain electrical activity in patients presented to Emergency Departments (ED) with concussions with normal imaging (CO-) and traumatic head injuries with positive imaging (HI+). The study was conducted in collaboration with Washington Universityʼs Barnes Jewish Hospital and New York

Universityʼs Bellevue Hospital Center and enrolled 75 patients, all of whom gave informed written consent.

“We are very excited about the potential of this new technology which may be able to show a functional degree of abnormality in the brain based on the electrical activity. The idea that we might be able to use this, real time, to evaluate changes in patients seen in the ED will be a useful adjunct to current clinical practices which will change the way we evaluate patients with concussions,” said Rosanne Naunheim, MD, Associate Professor of Emergency Medicine at Washington University School of Medicine and practicing Emergency Physician at Barnes Jewish Hospital in St. Louis, Missouri.

In the military arena BrainScope is investigating the development of a device that, if successful, could help identify and track those whose brain function is altered due to traumatic injury or blast concussion in the field. “I believe our nationʼs combat soldiers could benefit from an objective assessment tool that quickly and accurately assesses mild TBI in the field,” added Singer. “We understand the need for urgency and we are dedicated to answering the call for a universal method for assessing traumatic brain injury among members of the military and all others who could benefit.”

Currently, BrainScope is in clinical data collection trials of concussion-focused research protocols and general altered mental status patients with leading universities and hospitals in the United States including Washington University in St. Louis (Barnes Jewish Hospital), New York University (Bellevue Hospital and Tisch Hospital), William Beaumont Hospital in Michigan and Waukesha Memorial Hospital in Wisconsin. BrainScope devices under development for the identification of mTBI and concussions are for investigational use only and have not been submitted for FDA review. The company is pending FDA clearance for its first product, ZOOM, an advanced 8-channel brain electrical activity data collection system with post-hoc statistical analysis.

About BrainScopeTM

The BrainScope Company, Inc., is a privately held neurotechnology company that is developing a new generation of hand-held, simple-to-use, non-invasive instruments to aid medical professionals in rapidly, accurately, and objectively assessing brain function at the initial point of care. They are the first completely mobile, hand-held devices in development that could provide an objective determination of whether brain trauma has occurred. BrainScope devices are based on a revolutionary, proprietary, and clinically validated technology platform, which integrates the worldʼs largest database of brainwave recordings with cutting-edge developments in Digital Signal Processing (DSP), advanced linear and non-linear algorithms, miniaturized hardware, and disposable headset sensors. BrainScopeʼs technology development is a collaborative effort among BrainScope engineers, medical researchers, and scientists at NYU School of Medicineʼs Brain Research Laboratories, and mathematicians, scientists and engineers at Plain Sight Systems, Inc., a developer of information extraction solutions centered at Yale University. The Companyʼs principal investors include Revolution LLC (the investment arm of AOL co-founder Steve Case), Alafi Capital and ZG Ventures.