BrainScope Company, Inc.

Last updated
BrainScope Company, Inc.
IndustryMedical neurotechnology
Headquarters
Bethesda, Maryland
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 a multimodal medical device that provides clinicians with the ability to identify structural and functional mild traumatic brain injuries (mTBIs) in their patients, such as brain bleeds and concussions. It uses electroencephalographic data, artificial intelligence, machine learning technology, cognitive performance and clinical assessments to help identify mTBIs.

The electroencephalographic 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 uses neurocognitive tests (Procedural Reaction Time & Match to Sample), which are performed by the patient on the device, as well as using a library of digitized concussion assessments.

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.

Closed-head injury is a type of traumatic brain injury in which the skull and dura mater remain intact. Closed-head injuries are the leading cause of death in children under 4 years old and the most common cause of physical disability and cognitive impairment in young people. Overall, closed-head injuries and other forms of mild traumatic brain injury account for about 75% of the estimated 1.7 million brain injuries that occur annually in the United States. Brain injuries such as closed-head injuries may result in lifelong physical, cognitive, or psychological impairment and, thus, are of utmost concern with regards to public health.

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.

<span class="mw-page-title-main">Blunt trauma</span> Trauma to the body without penetration of the skin

Blunt trauma, also known as blunt force trauma or non-penetrating trauma, describes a physical trauma due to a forceful impact without penetration of the body's surface. Blunt trauma stands in contrast with penetrating trauma, which occurs when an object pierces the skin, enters body tissue, and creates an open wound. Blunt trauma occurs due to direct physical trauma or impactful force to a body part. Such incidents often occur with road traffic collisions, assaults, and sports-related injuries, and are notably common among the elderly who experience falls.

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 amnesia (PTA) is a state of confusion that occurs immediately following a traumatic brain injury (TBI) in which the injured person is disoriented and unable to remember events that occur after the injury. The person may be unable to state their name, where they are, and what time it is. When continuous memory returns, PTA is considered to have resolved. While PTA lasts, new events cannot be stored in the memory. About a third of patients with mild head injury are reported to have "islands of memory", in which the patient can recall only some events. During PTA, the patient's consciousness is "clouded". Because PTA involves confusion in addition to the memory loss typical of amnesia, the term "post-traumatic confusional state" has been proposed as an alternative.

Post-traumatic seizures (PTS) are seizures that result from traumatic brain injury (TBI), brain damage caused by physical trauma. PTS may be a risk factor for post-traumatic epilepsy (PTE), but a person having a seizure or seizures due to traumatic brain injury does not necessarily have PTE, which is a form of epilepsy, a chronic condition in which seizures occur repeatedly. However, "PTS" and "PTE" may be used interchangeably in medical literature.

The Rivermead Post-Concussion Symptoms Questionnaire, abbreviated RPQ, is a questionnaire that can be administered to someone who sustains a concussion or other form of traumatic brain injury to measure the severity of symptoms. The RPQ is used to determine the presence and severity of post-concussion syndrome (PCS), a set of somatic, cognitive, and emotional symptoms following traumatic brain injury that may persist anywhere from a week, to months, or even more than six months.

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.

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.

<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.

A sports-related traumatic brain injury is a serious accident which may lead to significant morbidity or mortality. Traumatic brain injury (TBI) in sports are usually a result of physical contact with another person or stationary object, These sports may include boxing, gridiron football, field/ice hockey, lacrosse, martial arts, rugby, soccer, wrestling, auto racing, cycling, equestrian, rollerblading, skateboarding, skiing or snowboarding.

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.

<span class="mw-page-title-main">Shield-X</span>

Shield-X Technology Inc. is a developer and manufacturer of impact-diverting technology. Shield-X's decal, is designed to enhance helmet performance in contact sports and activities where traumatic brain injury (TBI) such as concussions occur, including American football, ice hockey, and cycling.

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.

David Lozoff Brody is an American neurologist, academic, and author most known for his research on the clinical treatment of traumatic brain injury (TBI) and neurodegenerative diseases in civilian and military personnel. He is a Clinical Neurologist at the Walter Reed National Military Medical Center and a professor of Neurology at Uniformed Services University of the Health Sciences, as well as a professor of Neurology and Biomedical Engineering at Washington University.

References

  1. ↑ "Medics start using scanner that could detect TBI earlier". Stars and Stripes. Retrieved 2018-06-25.
  2. 1 2 Olivas, Denise (2017-07-27). "UMC uses new equipment for brain care". KVIA. Retrieved 2018-06-25.
  3. 1 2 3 Orcutt, Mike. "Is This the Diagnostic Tool We've Been Waiting for in Concussion Testing?". MIT Technology Review. Retrieved 2018-06-25.
  4. ↑ Hanley, Daniel; Prichep, Leslie S.; Bazarian, Jeffrey; Huff, J. Stephen; Naunheim, Rosanne; Garrett, John; Jones, Elizabeth B.; Wright, David W.; O'Neill, John (2017-03-31). "Emergency Department Triage of Traumatic Head Injury Using a Brain Electrical Activity Biomarker: A Multisite Prospective Observational Validation Trial". Academic Emergency Medicine. 24 (5): 617–627. doi: 10.1111/acem.13175 . ISSN   1069-6563. PMID   28177169.
  5. ↑ Huff, J. Stephen; Naunheim, Rosanne; Ghosh Dastidar, Samanwoy; Bazarian, Jeffrey; Michelson, Edward A. (2017). "Referrals for CT scans in mild TBI patients can be aided by the use of a brain electrical activity biomarker". The American Journal of Emergency Medicine. 35 (11): 1777–1779. doi:10.1016/j.ajem.2017.05.027. ISSN   0735-6757. PMID   28579138.
  6. ↑ "US firm launches device to rapidly diagnose concussion". The Irish Times. Retrieved 2018-07-10.
  7. ↑ "510(k) Premarket Notification". www.accessdata.fda.gov. Retrieved 2018-06-27.
  8. ↑ "510(k) Premarket Notification". www.accessdata.fda.gov. Retrieved 2018-06-27..
  9. ↑ "BrainScope Initiates Teenage and Young Adult Multi-Site Clinical Study for Concussion Assessment Product" . Retrieved 2018-06-20.. This study was for the company's third algorithm, the Concussion Index.
  10. ↑ "Whitman High School Chosen for Concussion Research Study" . Retrieved 2018-06-25.
  11. 1 2 Heath, Thomas (2015-07-23). "Bethesda's BrainScope scores $500k from NFL, General Electric". Washington Post. ISSN   0190-8286 . Retrieved 2018-06-13.
  12. ↑ "Term Sheet -- Thursday, August 31". Fortune. Retrieved 2018-06-25.
  13. ↑ "Portfolio | DBL Partners". www.dblpartners.vc. Retrieved 2018-06-14.
  14. ↑ "BrainScope Completes $16 Million Equity Fundraise" . Retrieved 2018-06-13.
  15. ↑ "Quickly assessing brain bleeding in head injuries using new device". ScienceDaily. Retrieved 2018-06-25.
  16. ↑ Bernhard, Blythe. "Working to prevent, diagnose concussions in kids". stltoday.com. Retrieved 2018-06-25.
  17. ↑ "BrainScope Receives Frost & Sullivan Best Practices Award in Traumatic Brain Injury Assessment" . Retrieved 2018-06-26.
  18. ↑ Foundation, The Galien. "The Galien Foundation Debuts 2017 Prix Galien USA Nominees in "Best Biotechnology Product," "Best Pharmaceutical Product," and "Best Medical Technology" Categories". www.prnewswire.com. Retrieved 2018-06-13.
  19. ↑ "2017 Greater Washington Innovation Awards winners and finalists announced". INSIDENOVA.COM. Retrieved 2018-06-14.
  20. ↑ "Moxie Award 2017 Winners - Moxie Award". Moxie Award. Retrieved 2018-06-25.
  21. ↑ "Business Notes: Bethesda Firm Named Emerging Life Science Business of the Year" . Retrieved 2018-06-14.
  22. ↑ "NFL, GE announce six final winners of Head Health Challenge I". NFL.com . Archived from the original on May 12, 2017. Retrieved 2018-06-26.
  23. ↑ "BrainScope Company, Inc. Awarded Montgomery County Emerging Business of the Year | BioSpace". BioSpace. Retrieved 2018-06-25.
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