BrainScope Company, Inc.

Last updated
BrainScope Company, Inc.
IndustryMedical neurotechnology
Headquarters
Key people
Susan Hertzberg,

Chief Executive Officer and Chairwoman

Laurie Silver, Chief Administrative Officer

Leslie S. Prichep, Ph.D., Chief Scientific Officer

Kim Bracuti Chief Financial Officer

Kent Butler Vice President of Sales

Jean Case, Former Board Member

Daniel J. Moore Board Member

Miles R. Gilburne, Board Member

James B. Peake, M.D., LTG, Board Member

Cynthia Ringo, Board Member

Gail Wilensky, Ph.D., Board Member
ProductsNon-invasive mild traumatic brain injury (concussion) assessment platform
Website brainscope.com

BrainScope Company, Inc. (BrainScope) is a medical neuro-technology firm utilizing EEG technology to assess the full spectrum of mild traumatic brain injury (mTBI), including functional injuries (such as a concussion), and structural injuries (such as a brain bleed). BrainScope was founded in 2006 and is headquartered in Bethesda, Maryland.

Contents

BrainScope's markets include the military, emergency departments, urgent care clinics, and both collegiate and professional-level sports programs. [1] [2]

Technology

BrainScope is an FDA-cleared, multimodal medical device that provides clinicians with the ability to identify structural (brain bleeds) and functional (concussions) mild traumatic brain injuries (mTBIs) in their patients. The device utilizes electroencephalographic (EEG) data, artificial Intelligence, machine learning technology, and cognitive performance and clinical assessments to identify objective markers of mTBI.

The electroencephalographic (EEG) data that is collected with a disposable electrode headset provides objective biomarkers to both predict the likelihood that a patient's structural brain injury would be visible on a CT scan and assess the likelihood of functional impairment in the brain by comparing the patient's brain function to that of non-head injured individuals. [2] [3] BrainScope also includes neurocognitive tests (Procedural Reaction Time & Match to Sample), which are performed by the patient on the device, as well as an extensive library of digitized concussion assessments. This technology could help clinicians rapidly test for brain bleeds and concussions in the Emergency Department and Urgent Care settings as well as on the sidelines and battlefields.

An independent validation trial conducted using BrainScope determined that the device's sensitivity to "≥1 mL of blood was ... 98.6%" and that its accurate CT-scan predictions can lead to a "potential reduction in the number of head C.T. scans in the Emergency Department by 31%." [4] [5]

BrainScope's technology was created through 28 clinical studies at over 90 clinical sites spanning over a decade, contributing to 32 investigator-initiated peer-review journal articles and resulting in eight FDA clearances. [6] BrainScope is FDA cleared as an Rx-only device for use on patients 18–85 years of age who have suffered a mild head injury GCS (Glasgow Coma Scale score of 13-15 and mTBI) within the previous 72 hours for its Structural Injury Classifier (SIC) and Brain Function Index (BFI) algorithms. The Concussion Index algorithm is FDA cleared for use on patients 13–25 years of age with a GSC score of 15 and can be used with 72 hours of acute injury, for baseline and throughout recovery. BrainScope was originally cleared by the FDA as the Ahead 300 under 510(k) K161068 in September 2016. [7] Subsequent modifications to device Indications for Use regarding concussion/mTBI capabilities were FDA cleared under 510(k) K181179 in May 2018. [8]

The company initiated a clinical research study on patients 13–25 years of age in May 2018 as part of its initiative to "introduce a teenage-focused product in the near-term." [9]

Partners

BrainScope has raised over $60 million in private capital and has received $30 million in research contracts, including funding from the United States Department of Defense and General Electric and the National Football League through their Head Health Challenge competition. [3] [10] [11] Among the company's private investors are Revolution LLC, an investment firm founded by AOL co-founder Steve Case; DBL Partners, a venture capital firm that also backs Tesla and Pandora; and the Maryland Venture Fund. [12] [13] [14]

BrainScope's other development partners include New York University School of Medicine and Johns Hopkins University, and its clinical partners include Emory University, the University of Virginia and Washington University in St. Louis. [3] [15] [16]

Awards

Related Research Articles

<span class="mw-page-title-main">Head injury</span> Serious trauma to the cranium

A head injury is any injury that results in trauma to the skull or brain. The terms traumatic brain injury and head injury are often used interchangeably in the medical literature. Because head injuries cover such a broad scope of injuries, there are many causes—including accidents, falls, physical assault, or traffic accidents—that can cause head injuries.

<span class="mw-page-title-main">Concussion</span> Medical condition

A concussion, also known as a mild traumatic brain injury (mTBI), is a head injury that temporarily affects brain functioning. Symptoms may include loss of consciousness; memory loss; headaches; difficulty with thinking, concentration, or balance; nausea; blurred vision; dizziness; sleep disturbances, and mood changes. Any of these symptoms may begin immediately, or appear days after the injury. Concussion should be suspected if a person indirectly or directly hits their head and experiences any of the symptoms of concussion. Symptoms of a concussion may be delayed by 1–2 days after the accident. It is not unusual for symptoms to last 2 weeks in adults and 4 weeks in children. Fewer than 10% of sports-related concussions among children are associated with loss of consciousness.

<span class="mw-page-title-main">Traumatic brain injury</span> Injury of the brain from an external source

A traumatic brain injury (TBI), also known as an intracranial injury, is an injury to the brain caused by an external force. TBI can be classified based on severity ranging from mild traumatic brain injury (mTBI/concussion) to severe traumatic brain injury. TBI can also be characterized based on mechanism or other features. Head injury is a broader category that may involve damage to other structures such as the scalp and skull. TBI can result in physical, cognitive, social, emotional and behavioral symptoms, and outcomes can range from complete recovery to permanent disability or death.

Neurometrics is the science of measuring the underlying organization of the brain's electrical activity. Certain brainwave frequencies are associated with general psychological processes. EEGs are used to measure the brain waves.

Post-concussion syndrome (PCS), also known as persisting symptoms after concussion, is a set of symptoms that may continue for weeks, months, or years after a concussion. PCS is medically classified as a mild traumatic brain injury (TBI). About 35% of people with concussion experience persistent or prolonged symptoms 3 to 6 months after injury. Prolonged concussion is defined as having concussion symptoms for over four weeks following the first accident in youth and for weeks or months in adults.

In medicine, a biomarker is a measurable indicator of the severity or presence of some disease state. It may be defined as a "cellular, biochemical or molecular alteration in cells, tissues or fluids that can be measured and evaluated to indicate normal biological processes, pathogenic processes, or pharmacological responses to a therapeutic intervention." More generally a biomarker is anything that can be used as an indicator of a particular disease state or some other physiological state of an organism. According to the WHO, the indicator may be chemical, physical, or biological in nature - and the measurement may be functional, physiological, biochemical, cellular, or molecular.

<span class="mw-page-title-main">Chronic traumatic encephalopathy</span> Neurodegenerative disease caused by head injury

Chronic traumatic encephalopathy (CTE) is a neurodegenerative disease linked to repeated trauma to the head. The encephalopathy symptoms can include behavioral problems, mood problems, and problems with thinking. The disease often gets worse over time and can result in dementia.

Post-traumatic epilepsy (PTE) is a form of acquired epilepsy that results from brain damage caused by physical trauma to the brain. A person with PTE experiences repeated post-traumatic seizures more than a week after the initial injury. PTE is estimated to constitute 5% of all cases of epilepsy and over 20% of cases of acquired epilepsy.

Traumatic brain injury can cause a variety of complications, health effects that are not TBI themselves but that result from it. The risk of complications increases with the severity of the trauma; however even mild traumatic brain injury can result in disabilities that interfere with social interactions, employment, and everyday living. TBI can cause a variety of problems including physical, cognitive, emotional, and behavioral complications.

<span class="mw-page-title-main">Electroencephalography</span> Electrophysiological monitoring method to record electrical activity of the brain

Electroencephalography (EEG) is a method to record an electrogram of the spontaneous electrical activity of the brain. The biosignals detected by EEG have been shown to represent the postsynaptic potentials of pyramidal neurons in the neocortex and allocortex. It is typically non-invasive, with the EEG electrodes placed along the scalp using the International 10–20 system, or variations of it. Electrocorticography, involving surgical placement of electrodes, is sometimes called "intracranial EEG". Clinical interpretation of EEG recordings is most often performed by visual inspection of the tracing or quantitative EEG analysis.

The fencing response is an unnatural position of the arms following a concussion. Immediately after moderate forces have been applied to the brainstem, the forearms are held flexed or extended for a period lasting up to several seconds after the impact. The fencing response is often observed during athletic competition involving contact, such as combat sports, American football, ice hockey, rugby union, rugby league and Australian rules football. It is used as an overt indicator of injury force magnitude and midbrain localization to aid in injury identification and classification for events including on-field and/or bystander observations of sports-related head injuries.

Jocelyn Faubert is a Canadian psychophysicist best known for his work in the fields of visual perception, vision of the elderly, and neuropsychology. Faubert holds the NSERC-Essilor Industrial Research Chair in Visual Perception and Presbyopia. He is the director of the Laboratory of Psychophysics and Visual Perception at the University of Montreal. Faubert has also been involved in the transfer of research and developments from the laboratory into the commercial domain. He is a co-founder and member of the Board of Directors of CogniSens Inc.

Automated Neuropsychological Assessment Metrics (ANAM) is a library of computer-based assessments of cognitive domains including attention, concentration, reaction time, memory, processing speed, and decision-making. ANAM has been administered nearly two million times in a variety of applications and settings. ANAM provides clinicians and researchers with tests to evaluate changes in an individual’s cognitive status over time.

<span class="mw-page-title-main">Computed tomography of the head</span> Cross-sectional X-rays of the head

Computed tomography of the head uses a series of X-rays in a CT scan of the head taken from many different directions; the resulting data is transformed into a series of cross sections of the brain using a computer program. CT images of the head are used to investigate and diagnose brain injuries and other neurological conditions, as well as other conditions involving the skull or sinuses; it used to guide some brain surgery procedures as well. CT scans expose the person getting them to ionizing radiation which has a risk of eventually causing cancer; some people have allergic reactions to contrast agents that are used in some CT procedures.

Quantitative electroencephalography is a field concerned with the numerical analysis of electroencephalography (EEG) data and associated behavioral correlates.

Jennie Louise Ponsford is an Australian neuroscience researcher at Monash University, Victoria who works on Traumatic Brain Injury (TBI). Ponsford is a clinical neuropsychologist, whose work is focused on developing a deeper understanding of the negative consequences of TBI, particularly those related to fatigue, sleep disturbance, attentional, memory and executive problems, psychiatric and behavioural disturbances and sexuality, and the development of rehabilitation interventions to improve long term recovery and quality of life in individuals with TBI.

Sleep disorder is a common repercussion of traumatic brain injury (TBI). It occurs in 30%-70% of patients with TBI. TBI can be distinguished into two categories, primary and secondary damage. Primary damage includes injuries of white matter, focal contusion, cerebral edema and hematomas, mostly occurring at the moment of the trauma. Secondary damage involves the damage of neurotransmitter release, inflammatory responses, mitochondrial dysfunctions and gene activation, occurring minutes to days following the trauma. Patients with sleeping disorders following TBI specifically develop insomnia, sleep apnea, narcolepsy, periodic limb movement disorder and hypersomnia. Furthermore, circadian sleep-wake disorders can occur after TBI.

A pediatric concussion, also known as pediatric mild traumatic brain injury (mTBI), is a head trauma that impacts the brain capacity. Concussion can affect functional, emotional, cognitive and physical factors and can occur in people of all ages. Symptoms following after the concussion vary and may include confusion, disorientation, lightheadedness, nausea, vomiting, blurred vision, loss of consciousness (LOC) and environment sensitivity. Concussion symptoms may vary based on the type, severity and location of the head injury. Concussion symptoms in infants, children, and adolescents often appear immediately after the injury, however, some symptoms may arise multiple days following the injury leading to a concussion. The majority of pediatric patients recover from the symptoms within one month following the injury. 10-30% of children and adolescents have a higher risk of a delayed recovery or of experiencing concussion symptoms that are persisting.

<span class="mw-page-title-main">Integra LifeSciences</span> Device manufacturing company

Integra LifeSciences Holdings Corporation is a global medical device manufacturing company headquartered in Princeton, New Jersey. Founded in 1989, the company manufactures products for skin regeneration, neurosurgery, reconstructive and general surgery. Integra artificial skin became the first commercially reproducible skin tissue used to treat severe burns and other skin wounds.

Ramon Diaz-Arrastia is an American neurologist and clinical investigator. He is the John McCrae Dickson, MD Presidential professor of Neurology at the University of Pennsylvania Perelman School of Medicine in Philadelphia, Director of Clinical Traumatic Brain Injury Research, and Attending Neurologist at the Hospital of the University of Pennsylvania and Penn Presbyterian Medical Center.

References

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