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.
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Former Secretary of Veterans Affairs and
United States Army Surgeon General to Chair Company’s Medical Advisory Board
WASHINGTON, D.C.-May 04, 2009 – The BrainScope Company, Inc., the developer of medical devices with initial emphasis on brain injury assessment, today announced that retired Lieutenant General James Peake, M.D. will join its Board of Directors and will become Chairman of its Medical Advisory Board. Backed by Revolution LLC (the investment arm of AOL co-founder Steve Case), ZG Ventures and Alafi Capital, BrainScope is a health technology company that is developing a new generation of hand-held, simple-to-use, non-invasive instruments designed to aid medical professionals in rapidly, accurately, and objectively assessing brain function at the initial point of care. BrainScopeʼs products could eventually be used for assessment of suspected brain trauma in soldiers, athletes and accident victims.
Most recently Dr. Peake served as the Secretary of Veterans Affairs and formerly as United States Army Surgeon General. Dr. Peakeʼs military and medical career also includes service as a surgeon, as a commander of several Army medical units in the U.S. and Korea, and a tour in Vietnam with the 101st Airborne Division. He is a highly decorated United States Army officer, having received a Silver Star, a Bronze Star with V and the Purple Heart for his service in Vietnam, as well as several other distinctions including the Distinguished Service Medal and the Legion of Merit in the course of his service.
“Dr. Peake is an extraordinary, mission-driven leader whose more than 38 years of accomplishments in military medicine – on and off the battlefield – will help bring to fruition the promise BrainScope holds for soldiers, athletes, and everyday people who experience brain trauma,” said BrainScope Chief Executive Officer Michael Singer.
Dr. Peake grew up in a strong U.S. military family. His father began as an enlisted man in the Army and became an officer who spent most of his 30-year career in the Medical Service Corps. Dr. Peake’s mother was an Army nurse, and his brother was a naval aviator. After graduating from the U.S. Military Academy at West Point in 1966, Dr. Peake was commissioned as a second lieutenant in the U.S. Army Infantry. He attended Cornell University Medical College after Vietnam and is also a 1988 graduate of the United States Army War College.
After retiring from the Army in 2004, as a Lieutenant General, Dr. Peake served as Executive Vice President and Chief Operating Officer of Project HOPE, a non-profit international health foundation operating in more than 30 countries. Dr. Peake became Secretary of Veterans Affairs in December 2007.
“I am delighted to be involved both as a Board member and as Chairman of the BrainScopeʼs Medical Advisory Board to help develop novel products to rapidly assess traumatic brain injury,” said Dr. Peake. “BrainScopeʼs technologies hold great promise to change the way in which brain injuries are assessed and treated, a problem I have seen first hand both in the army and at the Veterans Administration.”
BrainScopeʼs Board of Directors will consist of 6 members: Dr. Peake; Venture Capitalists Miles Gilburne, Moshe Alafi and Phil Himelstein; Steve Case; and BrainScope CEO Michael Singer.
About BrainScopeTM
The BrainScope Company, Inc., is a privately held health technology 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. BrainScope devices in development are based on a revolutionary and proprietary technology platform, which integrates databases of brainwave recordings with advanced developments in Digital Signal Processing (DSP), sophisticated linear and non-linear algorithms, miniaturized hardware, and disposable headset sensors.
]]>New Investment and Leadership to Fuel Growth
Revolution LLC, Alafi Capital and ZG Ventures to Provide New Investment
Revolution Founder Steve Case Joins BrainScope’s Board of Directors
Venture Capitalist Miles Gilburne Named Co-Chairman
Health and Technology Executive Michael Singer Named CEO
WASHINGTON–(BUSINESS WIRE)– Oct. 29, 2008 — BrainScope Company, Inc., developers of a new generation of non-invasive hand-held devices that are designed to quickly assess a patientʼs brain function and potentially identify dysfunction to help medical professionals prescribe appropriate treatment, today announced several new initiatives to fuel its growth. Revolution LLC, Alafi Capital and ZG Ventures have increased their investment in the company, and BrainScope has named two new appointments to their senior executive team. In addition, the company announced it will be headquartered in the Washington, D.C. metropolitan area.
With a BrainScope device, medical professionals use this objective tool designed to quickly and accurately assess brain function at the initial point of care. Based on 30 years of clinical data, the BrainScope technology platform, BxTM, integrates the worldʼs largest database of brainwave recordings with cutting-edge developments in Digital Signal Processing (DSP), advanced mathematics, miniaturized hardware, an easy-to-use user interface and disposable headset sensors. Bx technology was developed in collaboration with NYUʼs Brain Research Laboratories, and mathematicians, scientists and engineers at Yale University.
Steve Case, co-founder of AOL and founder of Revolution, has increased his investment in BrainScope and joined its Board of Directors. In addition, Miles Gilburne, the managing partner of ZG Ventures, has been named as BrainScopeʼs Co-Chairman of the Board, along with medical device venture capitalist Phillip Himelstein. With almost 30 years of experience as a venture capitalist, corporate strategist and lawyer spanning the bioinformatics, information technology, media and communications industries, Gilburne understands the opportunity for innovative products at the intersection of information technology and the biosciences, as well as the challenges in developing and bringing those new products to market.
“BrainScope has combined cutting-edge signal processing technology and sophisticated database analysis with state-of-the-art device engineering to create a new generation of tools for rapid, inexpensive and non-invasive capture and analysis of brain function,” said Gilburne. “We believe these devices have the potential to do for medical problems affecting the brain what the EKG has done for medical problems affecting the heart. I have no doubt that this technology is going to change many lives for the better.”
The company also announced that it has hired as CEO, Michael Singer, who has been involved in the health and technology industry at both start-ups and large corporations for nearly two decades. Most recently, Singer was president of Revolution Health Investments for Revolution LLC. Singer has a proven success record in making start-ups and small companies into profitable and well-respected organizations involved in medical devices, healthcare information and consumer health.
“We are glad Michael has decided to join BrainScope as its new CEO,” said Steve Case. “In the last three years, Miles and I have had the opportunity to see Michael at work and we are very impressed by his knowledge of the healthcare industry as well as his leadership and operational capabilities.”
“I am delighted to join the BrainScope team, which has developed path-breaking medical technologies created and developed by the founder of the company, Elvir Causevic, that will give clinicians important tools at their fingertips for rapid neuro assessment,” said Singer. “BrainScope has invested heavily in the right areas of technology development and clinical efficacy. The next step is to focus on commercialization of these capabilities. I could not be more optimistic about the market receptivity of these next-generation products that we will offer, and I look forward to working with Elvir and the rest of the management team going forward.”
In addition to BrainScope, Revolution maintains its broad health portfolio through investments in Waterfront Media, one of the largest online health destinations; RediClinic, a leading convenient are provider; Extend Health, a leading provider of defined contribution programs; and SparkPeople, an online community that empowers users to change their lives for the better.
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About Revolution LLC
Revolution LLC was created by AOL Co-Founder Steve Case to create products and services that empower people and promote consumer-centered change. Today Revolution owns businesses in the healthcare, financial services, resorts, wellness and digital sectors.
About Alafi Capital
Alafi Capital is a private venture capital firm that has been active in healthcare investing for over 25 years. Early and mid-stage investments in the U.S. and Europe are considered, with emphasis on product-oriented biotechnology, life science technologies, imaging and diagnostics, and medical devices. Included among Alafi Capitalʼs past successes are Amgen, Biogen, Molecular Devices, Tanox, Qiagen, Novocor, Oxford Glycosciences, and Applied Biosystems.
About BrainScope
The BrainScope Company, Inc. is a privately held neurotechnology company that is developing a new generation of safe hand-held and mobile devices that are designed to help healthcare professionals quickly and accurately assess brain function.
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