BETHESDA, MD. November 13, 2018– BrainScope®, a medical neuro-technology company focused on concussion and mild traumatic brain injury (mTBI) assessment, announced today that it has fulfilled orders for over 170 BrainScope One handheld devices and over 7,500 individual patient headsets to U.S. Army bases across the world. U.S. Army medics and clinicians continue to receive the training necessary to support the assessment of military personnel that may have experienced an mTBI, providing access for service members at home and abroad.
Artificial Intelligence and Multi-Modal Capabilities to Optimize Personalized Concussion Assessment
BETHESDA, MD. September 4, 2018– BrainScope today announced that it has been awarded a research contract by the United States Department of Defense (DOD) valued at $4.5 million to create and integrate ocular capabilities into its handheld, multi-parameter mild Traumatic Brain Injury (mTBI) and concussion products.
BrainScope’s initial product in the market, BrainScope One, is the first FDA-cleared medical device to offer capabilities to assess the full spectrum of brain injury – from concussions (functional abnormality) to brain bleeds (structural injury) using EEG and other parameters which together provide the clinician a panel of capabilities to help with their clinical diagnosis. With this research contract, BrainScope will add specific capabilities related to assessment of the patient’s eyes which will be incorporated in future versions of BrainScope’s products.
BETHESDA, MD.--(BUSINESS WIRE)--BrainScope today announced its second consecutive nomination for the 2018 Annual Prix Galien USA Awards for “Best Medical Technology” product. Its flagship BrainScope One product is a multi-modal, comprehensive, handheld capability to help clinicians objectively and rapidly assess and triage head injured patients directly at the point of care.
An Economic and Actuarial Model Demonstrates Substantial Cost Benefit to Health Insurers and Patients
BETHESDA, MD. June 28, 2018 – BrainScope announced today the release of a white paper which demonstrates a significant positive impact on the costs to the healthcare system from integrating BrainScope One into the assessment of mild traumatic brain injury / concussion. Escalating awareness of the consequences of traumatic brain injury, even when mild, has resulted in an increasing burden to the healthcare system of $76.5 billion annually. Overall findings of the white paper, authored by a well-respected team comprised of an economist and actuaries, demonstrated that the use of BrainScope One in the Emergency Department and Community settings (including Urgent Care Centers) could result in a significant reduction of costs of up to 32.2%. This is accomplished by a combination of diversion from hospital emergency departments to less expensive care settings, as well as a significant reduction in the number of unnecessary CT scans…
BETHESDA, MD May 31, 2018 – BrainScope, a medical neurotechnology company focused on concussion and mild traumatic brain injury (mTBI) assessment, announced today the initiation of a large, multi-site clinical research study enrolling subjects ages 13-25 years who sustained a head injury from a variety of causes, including sports-related head injuries. Designed as a prospective, observational investigation, eligible patients who sustained a head injury will be recruited from concussion clinics and high schools surrounding the participating universities conducting the study.
“The initiation of this large clinical study is a significant milestone in the development of BrainScope’s next-generation brain injury assessment products to include teenage patients suspected of a concussion,” said Michael Singer, CEO of BrainScope.“We are aggressively pursuing this very large demographic with plans to introduce a teenage-focused product in the near-term,” stated Singer.
BrainScope One Provides Objective, Actionable Information for Assessment of Mildly Presenting Head Injured Patients in Urgent Care Centers, Emergency Departments, and Other Settings
BETHESDA, MD. MAY 7, 2018 – BrainScope announced today the release of a white paper authored by Urgent Care physicians which demonstrated that the FDA-cleared BrainScope One had the potential to reduce unnecessary Emergency Department referrals by up to seventy-five percent. BrainScope One offers a rapid (within minutes) assessment of the full spectrum of traumatic brain injury (TBI), including concussion, using digital electroencephalography (EEG) and other modalities, facilitating accurate and timely decision-making for first responders, clinicians, and other health practitioners at the point of care wherever an injury occurs.
Close to 5 million people who experience a TBI seek care and treatment at hospital Emergency Departments (EDs) in the U.S. each year, where over 80% of these patients are evaluated using a computed tomography (CT) scan of the head to detect brain tissue damage, or intracranial lesions, that may require treatment. Over 90% of these CT scans are found to be negative, unnecessarily exposing patients to radiation, long wait times, and high costs.
BETHESDA, MD. APRIL 30, 2018 – BrainScope announced today the release of a white paper authored by physicians at Washington University Barnes Jewish Medical Center in St. Louis, which demonstrated that the FDA-cleared BrainScope One had the potential to reduce the use of unnecessary head CT scans by one-third in a hospital Emergency Department setting.
Today most patients seen in the emergency room with a suspected head injury receive a computed tomography (CT) scan of the head to detect brain tissue damage, or intracranial lesions, that may require treatment; however, the vast majority of these patients do not have detectable intracranial lesions visible on the CT scan. The availability of BrainScope One can help health care professionals determine the need for a CT scan and help prevent unnecessary neuroimaging and associated radiation exposure to patients.
Using data entered in BrainScope’s national Registry, the white paper authors compared 64 patients who were referred for CT scan…
BETHESDA, MD. September 7, 2017 – BrainScope Company, Inc., the medical neurotechnology company which created the first FDA-cleared handheld medical device, BrainScope One, for assessment of the full spectrum of traumatic brain injury, announced it will immediately commence development of a pediatric capability. The pediatric product will be similar to the currently-available BrainScope One, which is a handheld, easy-to-use, rapid, objective capability to aid the clinician in the assessment of mildly presenting adult head injured patients at the point of care. It is designed to help the clinician assess the full spectrum of brain injury, including whether a patient has structural brain injury likely visible on CT, as well as whether a patient has functional brain impairment, including concussion. BrainScope One measures and interprets the patient’s brain electrical activity and neurocognitive function, and offers a panel of objective data to help physicians make their clinical diagnosis.
BETHESDA, MD. August 30, 2017 – BrainScope Company, Inc., the medical neurotechnology company which created the first FDA-cleared handheld medical device for assessment of the full spectrum of traumatic brain injury, today announced it has completed a $16 million equity financing. New investor DBL Partners joined previous backers Revolution LLC, ZG Ventures, Maryland Venture Fund and other existing and new investors in the round, which the company will use to support the commercial launch of its flagship BrainScope One medical device, as well as for continued research and development initiatives.
“We are delighted to have closed this financing with such outstanding investors. This investment acknowledges our leadership position as the first and only handheld, objective, FDA-cleared medical device for traumatic brain injury assessment. The financing will not only help the company drive commercial sales within various markets, but will also provide capital for research and development to broaden our product portfolio,” stated Michael Singer, CEO of BrainScope.
BETHESDA, MD. July 10, 2017 – BrainScope Company, Inc. today announced that it has received the Frost & Sullivan 2017 Best Practices Award for New Product Innovation in the Traumatic Brain Injury Assessment Solutions Market.
“A pioneer in quantitative TBI assessment, Brainscope is poised for rapid and expansive growth. Frost & Sullivan firmly believes that BrainScope is set to become the respected and recognized clinical standard for mild head injury assessment,” stated Patrick Riley, Principal Analyst at Frost & Sullivan. The full write up of the award can be found here.
Frost & Sullivan has 50 years of experience researching technical and economic trends and best practices to provide clients with a complete picture of their position within an industry. As part of this ongoing research, Frost & Sullivan identifies companies that have successfully introduced new and innovative products into their markets, with emphasis on product quality and customer value. This process involves extensive primary and secondary research across the entire value chain of specific products. The 2017 New Product Innovation Award for Product Innovation in the Traumatic Brain Injury Assessment Solutions Market compared top manufacturers in three key areas: understanding demand, nurturing the brand, and differentiating from the competition. BrainScope received top marks in all areas of the research.
“We are honored to be recognized by Frost & Sullivan, whose analysts closely track our industry. We greatly appreciate the recognition for our innovation in developing and introducing our FDA-cleared product, BrainScope One, which addresses the very significant need for objective and comprehensive brain injury assessment,” stated Michael Singer, CEO of BrainScope.
FDA-Cleared BrainScope One Provides Proprietary, Objective EEG-Based Biomarker for Brain Injury, Including Concussion
BETHESDA, MD. June 14, 2017 – BrainScope Company, Inc. today announced a publication describing that its EEG-based Brain Function Index (BFI) was demonstrated to have a significant relationship with the severity of functional impairment in mild head injured patients in a large (720 patient) multisite independent validation trial. BrainScope includes the BFI as a core component of its recently FDA-cleared BrainScope One product, which provides EEG and other information presented as a comprehensive panel on a handheld device for assessment of the full spectrum of traumatic brain injury.
Published online in the peer-reviewed Journal of Neurotrauma in an article entitled “A brain electrical activity (EEG) based biomarker of functional impairment in traumatic head injury: a multisite validation trial”, the findings support the BFI as a quantitative biomarker of brain function impairment, which scaled with severity of impairment in mild brain injury patients.
Over 1 Million CT Scans Could Be Eliminated Annually in the U.S. by Incorporating BrainScope One into Standard Clinical Practice
BETHESDA, MD. June 1, 2017 – BrainScope Company, Inc. today announced a publication describing the use of its flagship product, BrainScope One, in an independent clinical trial demonstrating the potential reduction of one-third (33.3%) of unnecessary computed tomography (CT) scans of mildly presenting head injured patients in hospital emergency rooms (ERs). The study entitled “Referrals for CT scans in mild TBI patients can be aided by the use of a brain electrical activity biomarker” was published online in the peer-reviewed American Journal of Emergency Medicine.
According to recent publications, approximately five million patients are seen in U.S. hospital ERs each year with closed head injuries, and millions more do not seek evaluation. The vast majority (>80%) of these patients receive a CT scan, of which over 90% are CT negative for structural brain injury, creating needless radiation exposure to patients.
BETHESDA, MD. May 23, 2017 – BrainScope Company, Inc. today announced the results of a study spanning over six years demonstrating that sports-related concussions can be objectively assessed using BrainScope’s proprietary electroencephalography (EEG) based Brain Function Index (BFI). Published in the peer-reviewed Journal of Head Trauma Rehabilitation, the study entitled “The Use of an Electrophysiological Brain Function Index in the Evaluation of Concussed Athletes” was conducted at 14 colleges and high schools, and funded in part through an award received under the NFL-GE Head Health Challenge I. In the study, 354 male contact sports athletes, 110 of whom sustained a concussion, were evaluated with results demonstrating that concussive injury significantly affected brain function, which was reflected in the BFI of the concussed athletes.
BrainScope’s BFI, derived from characteristics of brain electrical activity that most closely reflect the physiology of concussion, was found to show highly significant differences between concussed athletes at the time of injury compared with non-injured athletes. Furthermore, at both pre-season baseline and 45 days following the injury, concussed athletes and the non-injured control group exhibited equivalent BFI scores, suggesting that the BFI can potentially provide an objective marker of concussive injury and recovery over time.
The Centers for Disease Control and Prevention estimates that there are up to 3.8 million sports and recreation related concussions in the United States each year. Further, a 2014 JAMA publication reported head injury related hospital emergency room (ER) visits have increased...
BrainScope to Showcase New-to-Market Medical Technology at
Momentum 2017: UCAOA Urgent Care Convention and Expo
Bethesda, MD – BrainScope Company, Inc. today announced it will unveil its new FDA-cleared, objective comprehensive head injury assessment device, BrainScope One, at Momentum 2017: UCAOA Urgent Care Convention and Expo from April 30 to May 3 at the Gaylord Resort and Convention Center in National Harbor, Maryland.
BrainScope One is a revolutionary medical technology that gives urgent care physicians and staff greater assurance to objectively assess the full spectrum of brain injury, including concussion. This handheld, easy-to-use product was recently rebranded by the company from the Ahead 300 to BrainScope One.
Peer-Reviewed Publication Demonstrates BrainScope’s Ahead 300 Significantly Improves Prediction of TBI Beyond Standard Clinical Risk Factors Used Today
BETHESDA, MD. February 27, 2017 – BrainScope Company, Inc. today announced a publication demonstrating that prediction of a CT positive traumatic brain injury (TBI) is significantly improved when the electroencephalography (EEG) based biomarker from its Ahead 300 is used in addition to the most commonly considered predictive risk factor, Loss of Consciousness (LOC). The results of this study entitled “Increased prognostic accuracy of TBI when a brain electrical activity biomarker is added to Loss of Consciousness (LOC),” were published in the peer-reviewed American Journal of Emergency Medicine. Results of this study show an 83% improvement in the prediction of TBI using the Ahead 300 compared to that obtained using a history of LOC alone or LOC plus traumatic amnesia, the two most commonly used clinical diagnostic indicators for TBI.
Likelihood of CT+ vs. CT- Is One Component of the Ahead 300’s Configurable Panel of Capabilities for Mild Head Injury Assessment
BETHESDA, MD. February 16, 2017 – BrainScope Company, Inc. today announced a publication describing an independent clinical trial of 720 patients conducted in 11 U.S. Emergency Departments (EDs), validating the clinical efficacy of its Ahead 300 technology for the identification of Traumatic Brain Injury (TBI) in mildly presenting head injured patients. The results of this validation trial, “Emergency Department triage of traumatic head injury using brain electrical activity biomarkers: a multisite prospective observational validation trial” are published online in the peer-reviewed journal Academic Emergency Medicine.
Ahead 300 Offers Objective, Configurable Panel of Capabilities at the Point of Care
Company's First Commercial Product to Ship in Q1
BETHESDA, MD January 5, 2017 – BrainScope Company, Inc. announced today the market release of its flagship Ahead 300 product, and will initiate a limited launch to a select group of thought leadersthrough its Centers of Excellence program later in the first quarter. These institutions will represent a cross-section of market segments including Urgent Care Clinics, Concussion Clinics, Emergency Medicine Departments, and University and Professional Sports. BrainScope will also be selling the Ahead 300 to various branches of the U.S. military and government.
Panel of Multi-Modal Capabilities Will Aid Physicians
With Their Clinical Diagnosis of Head-Injured Patients
Company's First Commercial Product, Ahead 300, To Be Introduced in Coming Months
BETHESDA, MD. September 26, 2016 – BrainScope Company, Inc. announced today that the United States Food and Drug Administration (FDA) has cleared the company to market the Ahead 300, its most advanced medical device for use in assessing traumatic brain injury (TBI). Developed in partnership with the U.S. Department of Defense, the Ahead 300 provides a multi-modal device of clinically relevant measures, offering clinicians a comprehensive panel of data to assist in their diagnosis of the full spectrum of TBI, including concussion. The Ahead 300 represents an evolution from the three BrainScope products that have previously received FDA clearance, and with its substantial additional capabilities, will be the first product the company will sell commercially.
BETHESDA, MD – May 12, 2016 – BrainScope Company, Inc., a privately held neurotechnology company with an initial focus on traumatic brain injury (TBI) and concussion assessment, announced today that it received the Emerging Firm of the Year – Life Science Company Award by the Tech Council of Maryland (TCM).
The award was presented Wednesday at TCM’s 28th Annual Industry Awards Celebration Dinner & Reception. The awards dinner is attended by over 800 executives from the life science and technology communities, and is Maryland’s largest and most prestigious award ceremony of its kind. The criteria by which the award was judged included...
Boca Raton, FL. – March 22, 2016 – BrainScope Company Inc., a privately held neurotechnology company with an initial focus on traumatic brain injury (TBI) and concussion assessment, was one of a handful of companies featured at the NFL Annual Meeting today in Boca Raton, Fla.
BrainScope’s technology appeared in the NFL’s “Vision 20/20 Tech Lab” along with a collection of new technologies that are helping to enhance the game of football for the players, coaches and fans across all levels of football.