Press Release

Over 30% Reduction in Unnecessary Head CT Scans When Integrating FDA-Cleared BrainScope One

Over 30% Reduction in Unnecessary Head CT Scans
When Integrating FDA-Cleared BrainScope One

Use in the Emergency Room demonstrates BrainScope One can reduce patient radiation exposure, decrease use of hospital resources, and shorten throughput times

BETHESDA, MD. May 6, 2019 - BrainScope announced today the publication of a study conducted by physicians at Washington University Barnes Jewish Medical Center in St. Louis in the peer-reviewed journal The American Journal of Emergency Medicine entitled “Reduction in unnecessary CT scans head-injury in the emergency department using an FDA cleared device.” The study demonstrated that the FDA-cleared BrainScope One medical device reduced the use of unnecessary head CT scans by nearly one-third in a hospital emergency room setting when compared to the use of standard clinical practice.

Emergency Room (ER) visits for mild Traumatic Brain Injury (mTBI) have greatly increased due to increased awareness of potential consequences of such injuries, with roughly 5 million Americans seeking medical care for head injury in ERs each year. While the vast majority (>80%) of head-injured patients who go to the ER receive a head CT scan, more than 90% of them are found to be negative. This practice unnecessarily exposes these patients to radiation, increases the use of hospital ER resources, and lengthens throughput times.

BrainScope’s flagship BrainScope One product, which is commercially available today, is a multi-modal, comprehensive, handheld system that helps clinicians objectively and rapidly assess and triage head injured patients directly at the point of care. BrainScope One is the first and only FDA-cleared medical device to offer capabilities to assess the full spectrum of brain injury – from concussions (functional abnormality) to brain bleeds (structural injury) – for those with mTBI. BrainScope One is being successfully used in a cross-section of market segments including: urgent care and occupational health clinics; concussion clinics; hospital emergency rooms; the U.S. military; university sports and student health centers; professional sports; and pharmaceutical clinical trials. 

In the study, ninety-one (91) patients presenting to the ER within 3 days of sustaining a closed head injury (with a mean time since injury of 10.8 hours) were evaluated at Barnes-Jewish Hospital Washington University Medical Center ER.  Patients were 18-76 years of age, and all but one had a Glasgow Coma Scale (GCS) score of 15 (one patient GCS=14). Eighty-two percent (82%) of the injuries were caused either by motor vehicle collisions or falls. All ninety-one patients were referred for a head CT scan, which was read by the site neuroradiologist and evaluated for related traumatic brain injury. Patients also received a 5-10 minute BrainScope EEG-based Structural Injury Classifier (“SIC”) evaluation using a proprietary disposable EEG headset, which is rapidly and easily placed on the forehead region. Physician assistants, nurses and/or technicians administered the BrainScope evaluation, which utilizes proprietary Artificial Intelligence (AI) - based algorithms to provide clinically-relevant information to determine whether a patient is likely CT positive (structural brain injury) or likely CT negative (no structural brain injury).

 

The study demonstrated that BrainScope One can help health care professionals determine the need for a CT scan, helping avoid unnecessary imaging and associated radiation exposure to patients, reduce throughput times and better triage patients who require a CT scan. Based on this study, integrating BrainScope’s EEG-based objective SIC into the decision-making process for CT referrals would have led to a significant reduction of unnecessary CT scans by approximately 31%. Importantly, this decrease in CT use and its associated radiation would be achieved without incurring any false negative cases (100% sensitivity in the study).  This study confirmed BrainScope’s overall CT referral rate reduction results published by Huff and colleagues (2017)[1] in a retrospective study of the data collected in the BrainScope FDA validation study[2].  

The paper's lead author, Dr. Rosanne Naunheim, stated, "The use of such rapidly obtained, objective information has the potential to reassure ED physicians in making confident clinical decisions that their patients do not need a CT, and will go a long way toward decreasing unnecessary radiation, decreasing the cost of care."

“These results clearly demonstrate the powerful capabilities of BrainScope One.  Over the past decade, we have created a proprietary multi-modal, multi-parameter FDA-cleared technology that is used by clinicians today in a variety of settings to assess for both structural injury, as well as functional injury known as concussion,” stated Michael Singer, BrainScope CEO.  “In partnership with the U.S. Department of Defense through 8 research contracts, our technology has been created and validated through over 20 clinical studies, 27 peer reviewed publications, and 7 FDA Clearances.  We continue to demonstrate BrainScope’s clinical utility to cost effectively help clinicians assess the millions of American head-injured patients. Our current customers confirm the great benefit of our medical technology for assessment of the full range of mild traumatic brain injury and concussion.”

For more information about the BrainScope technology, visit www.brainscope.com/products.

The publication can be found and cited as follows:  R. Naunheim, M.K. Koscso and R. Poirier, Reduction in unnecessary CT scans head-injury in the emergency department using an FDA cleared device, American Journal of Emergency Medicine, https://doi.org/10.1016/j.ajem.2019.04.037

About BrainScope

BrainScope’s mission is to revolutionize the rapid and objective assessment of brain-related conditions, starting with concussion and mild traumatic brain injury, utilizing multiple integrated assessment capabilities, artificial intelligence (AI) and digitization within a culture of quality, excellence and entrepreneurialism.  The Company’s first product, BrainScope One, incorporates a multi-modal, multi-parameter panel of assessment capabilities including EEG-based technology that is non-invasive for mildly presenting head-injured patients, 18-85 years old, within 3 days after injury and is not a replacement to CT scan. BrainScope’s technology platform integrates databases of thousands of brainwave recordings with AI technology and miniaturized hardware and disposable headset sensors, all of which are covered by an extensive intellectual property portfolio of over 100 issued and pending patents globally. BrainScope has received seven FDA clearances and ISO 13485:2016 Certification. It has 27 peer-reviewed publications on its technology. Recent white papers authored by third parties have also shown the potential for BrainScope One to reduce head injury referrals to hospital emergency departments by up to 75% and to reduce healthcare costs for insurers and patients by over 30%.

BrainScope has partnered with the U.S. Department of Defense (DoD) for the development of its mTBI and concussion assessment technology.  BrainScope has been the recipient of several prestigious awards, including the Frost & Sullivan 2017 Best Practices Award for New Product Innovation in the Traumatic Brain Injury Assessment Solutions Market, was a two-time winner of the GE-NFL Head Health Challenge, and has received two nominations for the Prix Galien Best Medical Technology (2017 and 2018), regarded as the equivalent of the Nobel Prize for medical devices. BrainScope has received significant funding from private investors including DBL Partners, ZG Ventures, Revolution (created by AOL co-founder Steve Case), and Difference Capital (DCF.TO). For more information, please visit www.brainscope.com.


[1] Huff JS, Naunheim R, Ghosh Dastidar S, et al. Referrals for CT scans in mild TBI patients can be aided by the use of a brain electrical activity biomarker. Amer J Emerg Med. 2018;35:1759-1783.

[2] Hanley D, Prichep L, Bazarian J, et al. Emergency Department triage of traumatic head injury aided by using a brain electrical activity marker: A multisite prospective observational validation trial. Acad Emerg Med. 2017; 24(5):617-627.

BrainScope Completes Large-Scale Clinical Studies of Concussion in Universities, High Schools and Concussion Clinics

BrainScope Completes Large-Scale Clinical Studies of Concussion in Universities, High Schools and Concussion Clinics

Culmination of Four-Year Project With
U.S. Department of Defense and NFL-GE Research Funding

BETHESDA, MD. March 28, 2019– BrainScope®, a medical neuro-technology company focused on concussion and mild traumatic brain injury (mTBI) assessment, announced today that it had concluded both algorithm development and clinical validation studies in adolescent and young adult populations using its objective, EEG-based technology. The purpose of the studies was to create and validate an objective, personalized capability for assessment of concussion and readiness to return to activities in males and females between the ages of 13-25. The studies conducted from 2015 through 2019 at 52 clinical sites included nearly 1,700 patients and healthy controls, with over 4,000 evaluations. Funding sources for the studies included a $9.9 million research contract from the U.S. Department of Defense, award funding from the NFL-GE Head Health Challenge (in which BrainScope was a two-time awardee), and BrainScope private funding.

“We are extremely pleased to have concluded these substantial clinical studies over 4 years, the results of which are extremely exciting as we work in the near-term through appropriate regulatory processes to bring important new concussion assessment capabilities to the market,” stated Michael Singer, CEO of BrainScope. “In particular I want to thank the U.S. Department of Defense, the NFL, GE, and BrainScope investors for their financial support of this major initiative which has yielded such excellent results.”

In January, BrainScope announced that researchers had published preliminary results related to a concussion assessment capability for potential severity and likelihood of prolonged recovery from concussions in the peer-reviewed journal Computers in Biology and Medicine.  The paper entitled, “A multimodal biomarker for concussion identification, prognosis and management” describes a study which enrolled 568 concussed and matched control patients between the ages of 13-25. Results from this study demonstrated highly significant differences in the BrainScope EEG-based biomarker at the time of injury between the 177 concussed patients and controls, and no significant differences at when Return-to-Play was clinically determined. Progressive recovery over time was also objectively demonstrated, especially in the prolonged recovery group. Results also supported the hypothesis that some of the more severely injured subjects may have been allowed to return to play too soon. 

 “These large studies add important information to the understanding of the pathophysiology of concussion, leading to better assessment capabilities which can improve short and long-term outcomes of head-injured patients,” added Leslie Prichep, PhD, Chief Scientific Officer of BrainScope.

BrainScope’s flagship BrainScope One product, which is commercially available today, 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. 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). BrainScope One is currently being fielded by the U.S. military, both stateside and internationally. BrainScope One is also being used in a cross-section of market segments including: urgent care and occupational health clinics; concussion clinics; hospital emergency rooms; university sports and student health centers; professional sports; and pharmaceutical clinical trials. 

About BrainScope

BrainScope’s mission is to revolutionize the rapid and objective assessment of brain-related conditions, starting with concussion and mild traumatic brain injury, utilizing multiple integrated assessment capabilities, artificial intelligence (AI) and digitization within a culture of quality, excellence and entrepreneurialism.  The Company’s first product, BrainScope One, incorporates a multi-modal, multi-parameter panel of assessment capabilities including EEG-based technology that is non-invasive for mildly presenting head-injured patients, 18-85 years old, within 3 days after injury and is not a replacement to CT scan. BrainScope’s technology platform integrates databases of thousands of brainwave recordings with AI technology and miniaturized hardware and disposable headset sensors, all of which are covered by an extensive intellectual property portfolio of over 100 issued and pending patents globally. BrainScope has received seven FDA clearances and ISO 13485 Certification. It has 26 peer-reviewed publications on its technology. Recent white papers authored by third parties have shown the potential for BrainScope One to decrease unnecessary head CT scans by one-third, to reduce head injury referrals to hospital emergency departments by up to 75%, and to reduce healthcare costs for insurers and patients by over 30%.

BrainScope has partnered with the U.S. Department of Defense (DoD) for the development of its mTBI and concussion assessment technology.  BrainScope has been the recipient of several prestigious awards, including the Frost & Sullivan 2017 Best Practices Award for New Product Innovation in the Traumatic Brain Injury Assessment Solutions Market, was a two-time winner of the GE-NFL Head Health Challenge, and has received two nominations for the Prix Galien Best Medical Technology (2017 and 2018), regarded as the equivalent of the Nobel Prize for medical devices. BrainScope has received significant funding from private investors including DBL Partners, Revolution (created by AOL co-founder Steve Case), ZG Ventures and Maryland Venture Fund. For more information, please visit www.brainscope.com.

The clinical study was supported in part by the U.S. Army Contracting Command, Aberdeen Proving Ground, Natick Contracting Division, under Contract No. W911QY-14-C-0098. Any opinions, findings and conclusions or recommendations expressed in this material are those of the author(s) and do not necessarily reflect the views of the US Army Contracting Command, Aberdeen Proving Ground, Natick Contracting Division.

BrainScope Announces Publication Describing Proprietary Concussion Biomarker to Assess Potential Severity and Predict Prolonged Recovery

BrainScope Announces Publication Describing Proprietary Concussion Biomarker to Assess Potential Severity and Predict Prolonged Recovery

Future Capability Could Aid in Objective Return-to-Activity Decisions

BETHESDA, MD. January 15, 2019– BrainScope®, a medical neuro-technology company focused on concussion and mild traumatic brain injury (mTBI) assessment, announced today that researchers have published preliminary results related to a multi-modal concussion assessment capability for potential severity and likelihood of prolonged recovery from concussions.  Published in the peer-reviewed journal Computers in Biology and Medicine, the paper entitled, “A multimodal biomarker for concussion identification, prognosis and management” describes a study which enrolled 568 concussed and matched control patients between the ages of 13-25 from 29 colleges and 19 high schools.  Subjects were tested at the time of injury and at multiple time points during recovery. 

Results from this study demonstrated highly significant differences in the BrainScope biomarker between the 177 concussed patients and controls at the time of injury and no significant differences at clinically determined Return-to-Play.  Progressive recovery over time was also demonstrated, especially in the prolonged recovery group.  Results also supported the hypothesis that some of the more severely injured subjects may have been allowed to return to play too soon. 

“Today there is a reliance on self-report and subjective sideline evaluations.  This large feasibility study demonstrated the potential clinical utility of a multi-modal biomarker to provide a means for objective personalized tracking from time of injury throughout recovery of brain function after concussive injury,” stated Dr. Leslie Prichep, Chief Scientific Officer of BrainScope. 

“This substantial project was initiated several years ago in collaboration with the Department of Defense with a mutual vision of creating an objective, multi-modal biomarker to help determine a concussed patient’s level of severity and potential duration of recovery after head injury – leading to Return-to-Activity decisions,” added Michael Singer, BrainScope CEO. “These results are extremely exciting as we work to bring this important assessment capability to the market in the near-term.”

BrainScope noted that while this capability is not currently included in its FDA-cleared product, BrainScope One, the multi-modal biomarker employs BrainScope’s technology platform and Intellectual Property portfolio.

About BrainScope

BrainScope’s mission is to revolutionize the rapid and objective assessment of brain-related conditions, starting with concussion and mild traumatic brain injury, utilizing multiple integrated assessment capabilities, artificial intelligence (AI) and digitization within a culture of quality, excellence and entrepreneurialism.  The Company’s first product, BrainScope One (cleared as Ahead 300), incorporates a multi-modal, multi-parameter panel of assessment capabilities including EEG-based technology that is non-invasive for mildly presenting head-injured patients, 18-85 years old, within 3 days after injury and is not a replacement to CT scan. BrainScope’s technology platform integrates databases of thousands of brainwave recordings with AI technology and miniaturized hardware and disposable headset sensors, all of which are covered by an extensive intellectual property portfolio of over 100 issued and pending patents globally. BrainScope has received six FDA clearances and ISO 13485 Certification. It has 26 peer-reviewed publications on its technology. Recent white papers authored by third parties have shown the potential for BrainScope One to decrease unnecessary head CT scans by one-third, to reduce head injury referrals to hospital emergency departments by up to 75%, and to reduce healthcare costs for insurers and patients by over 30%.

BrainScope has partnered with the U.S. Department of Defense (DoD) for the development of its mTBI and concussion assessment technology, and BrainScope One is currently being fielded by the U.S. military, both stateside and internationally. BrainScope One is also being utilized in a cross-section of market segments including: urgent care and occupational health clinics; concussion clinics; hospital emergency rooms; university sports and student health centers; professional sports; and pharmaceutical clinical trials.  BrainScope has been the recipient of several prestigious awards, including the Frost & Sullivan 2017 Best Practices Award for New Product Innovation in the Traumatic Brain Injury Assessment Solutions Market, was a two-time winner of the GE-NFL Head Health Challenge, and has received two nominations for the Prix Galien Best Medical Technology (2017 and 2018), regarded as the equivalent of the Nobel Prize for medical devices. BrainScope has received significant funding from private investors including DBL Partners, Revolution (created by AOL co-founder Steve Case), ZG Ventures and Maryland Venture Fund. For more information, please visit www.brainscope.com.

The clinical study was supported in part by the U.S. Army Contracting Command, Aberdeen Proving Ground, Natick Contracting Division, under Contract No. W911QY-14-C-0098. Any opinions, findings and conclusions or recommendations expressed in this material are those of the author(s) and do not necessarily reflect the views of the US Army Contracting Command, Aberdeen Proving Ground, Natick Contracting Division.

BrainScope Receives FDA Clearance for Multi-Modal, Multi-Parameter Concussion Assessment

BrainScope Receives FDA Clearance for Multi-Modal, Multi-Parameter Concussion Assessment

New Concussion-Specific FDA Labeling Adds to Existing BrainScope Claims Complements Multi-Modal Technology Platform and Extensive Intellectual Property Portfolio To Address New Brain and Behavioral Health Conditions

BETHESDA, MD. January 2, 2019– BrainScope®, a medical neuro-technology company focused on concussion and mild traumatic brain injury (mTBI) assessment, announced today that it has received FDA clearance to include additional language in its product’s Indications for Use (IFU), adding key terminology related to “multi-modal, multi-parameter assessment” of “concussion” and “mild Traumatic Brain Injury”, as well as an expanded and clarified overall IFU.  In addition to being able to objectively and reliably identify patients who may have a brain bleed using the product’s Structural Injury Classifier, BrainScope One uses the same electroencephalogram (EEG) signal and other capabilities on the device to objectively determine the likelihood of the presence and severity of a concussion.  All capabilities are summarized on a panel of multimodal, multi-parameter results, greatly facilitating clinical concussion assessment.

“This additional FDA labeling for our product, BrainScope One, recognizes the unique capabilities of our FDA-Cleared medical device with labeling distinctively and specifically for this particular disease state,” stated Michael Singer, CEO of BrainScope. “Years ago in working with our partner, the Department of Defense, we realized and learned from them the importance of multi-modality and objectivity.  Combining a full range of concussion assessment capabilities on one handheld platform provides the clinician a timely and easy-to-use tool for collecting the objective data they need to facilitate their clinical diagnosis, right then and there, for this debilitating brain disease state.”

“Throughout most of 2018, we maintained an interactive dialogue with the FDA on the labeling pertaining to our concussion assessment capabilities and, as part of this ongoing discussion, we provided substantial data for their consideration.  This has led to BrainScope’s 6th FDA Clearance.  This thorough vetting by the FDA shows our commitment to and respect for adherence to the regulatory process as it relates to human brain health, and in particular to the increasing national awareness of the significant problem of concussion,” added Singer. 

BrainScope further announced that with a global patent portfolio of over 100 issued and pending patents, a substantial portion of these patents relate specifically to multi-modality capabilities applicable to all neurological conditions and disease states.  “For over a decade, we have created a platform comprised of unparalleled AI-based technology, clinical evidence, peer-reviewed literature and regulatory knowledge, supported by a vast IP portfolio.  Given our success in developing BrainScope One for mTBI and concussion assessment, we have received considerable interest from third-parties to further develop the BrainScope multi-modal assessment platform for other neurological disease states beyond concussion,” stated Singer.

About BrainScope

BrainScope’s mission is to revolutionize the rapid and objective assessment of brain-related conditions, starting with concussion and mild traumatic brain injury, utilizing multiple integrated assessment capabilities, artificial intelligence (AI) and digitization within a culture of quality, excellence and entrepreneurialism.  The Company’s first product, BrainScope One (cleared as Ahead 300), incorporates a multi-modal, multi-parameter panel of assessment capabilities including EEG-based technology that is non-invasive for mildly presenting head-injured patients, 18-85 years old, within 3 days after injury and is not a replacement to CT scan. BrainScope’s technology platform integrates databases of thousands of brainwave recordings with AI technology and miniaturized hardware and disposable headset sensors, all of which are covered by an extensive intellectual property portfolio of over 100 issued and pending patents globally. BrainScope has received six FDA clearances and ISO 13485 Certification. It has 25 peer-reviewed publications on its technology. Recent white papers authored by third parties have shown the potential for BrainScope One to decrease unnecessary head CT scans by one-third, to reduce head injury referrals to hospital emergency departments by up to 75%, and to reduce healthcare costs for payors and patients by over 30%.

BrainScope has partnered with the U.S. Department of Defense for the development of its mTBI and concussion assessment technology, and BrainScope One is currently being fielded by the U.S. military, both stateside and internationally. BrainScope One is also being utilized in a cross-section of market segments including: urgent care and occupational health clinics; concussion clinics; hospital emergency rooms; university sports and student health centers; professional sports; and pharmaceutical clinical trials.  BrainScope has been the recipient of several prestigious awards, including the Frost & Sullivan 2017 Best Practices Award for New Product Innovation in the Traumatic Brain Injury Assessment Solutions Market, was a two-time winner of the GE-NFL Head Health Challenge, and has received two nominations for the Prix Galien Best Medical Technology (2017 and 2018), regarded as the equivalent of the Nobel Prize for medical devices. For more information, please visit www.brainscope.com

Ron Klain Joins BrainScope Board of Directors

Ron Klain Joins BrainScope Board of Directors

Brings Extensive Experience in Industry, Government and Public Health

BETHESDA, MD. December 11, 2018– BrainScope®, a medical neuro-technology company focused on concussion and mild traumatic brain injury (mTBI) assessment, announced today that Ron Klain, Executive Vice President and General Counsel of the investment firm Revolution, has joined BrainScope’s Board of Directors. 

Klain has served as Chief of Staff to U.S. Vice Presidents Joe Biden and Al Gore and Attorney General Janet Reno, was the White House Ebola Response Coordinator, and served as a Senior Aide to President Obama. He was also a Partner and National Practice Group Chair at O’Melveny & Myers LLP. He gained national notice as General Counsel for the Gore Recount Committee in 2000, in recognition of which he was selected as one of National Law Journal’s “Lawyers of the Year” and was featured in the HBO film Recount. Active in a number of civic and non-profit groups, he has served as Chairman of the Board of the Vice President’s Residence Foundation, and a member of the Board of Visitors of Harvard Law School.  He serves as a contributing columnist at The Washington Post.  Klain is a summa cum laude graduate of Georgetown University (where he serves as an Adjunct Professor) and holds a JD, magna cum laude, from Harvard Law School, where he was an Editor of the Harvard Law Review.  He follows in holding the BrainScope Board seat previously held by Jean Case.

“We are thrilled to have Ron join our Board of Directors, providing exceptional private and public sector expertise, and notably in public health. Ron adds additional expertise to our existing Board of Directors, being highly accomplished in industry, the government and healthcare. We also greatly appreciate and recognize the substantial contributions from Jean Case over her many years of service on the Board,” stated Dan Moore, BrainScope Chairman.

Ron Klain added, "As a member of the Revolution team that first backed BrainScope more than a decade ago -- and the father of two sons who have experienced concussions -- I'm honored to join BrainScope's Board of Directors and be a part of its important and innovative work. I believe that BrainScope has already shown its potential to be truly transformative in this critical field, and I look forward to working with my fellow Board members and the BrainScope team in growing the company and its impact."


About BrainScope

BrainScope’s mission is to revolutionize the rapid and objective assessment of brain-related conditions, starting with concussion and mild traumatic brain injury, utilizing multiple integrated assessment capabilities, artificial intelligence (AI) and digitization within a culture of quality, excellence and entrepreneurialism.  The Company’s first product, BrainScope One (cleared as Ahead 300), incorporates a multi-modal panel of capabilities including EEG-based technology that is non-invasive for mildly presenting head-injured patients, 18-85 years old, within 3 days after injury and is not a replacement to CT scan. BrainScope’s technology platform integrates databases of thousands of brainwave recordings with AI technology and miniaturized hardware and disposable headset sensors, all of which are covered by an extensive intellectual property portfolio of over 100 issued and pending patents globally. BrainScope has received five FDA clearances and ISO 13485 Certification. It has 25 peer-reviewed publications on its technology. Recent white papers authored by third parties have shown the potential for BrainScope One to decrease unnecessary head CT scans by one-third, to reduce head injury referrals to hospital emergency departments by up to 75%, and to reduce healthcare costs for payers and patients by over 30%.

BrainScope has partnered with the U.S. Department of Defense for the development of its mTBI and concussion assessment technology, and BrainScope One is currently being fielded by the U.S. military, both stateside and internationally. BrainScope One is also being utilized in a cross-section of market segments including: urgent care and occupational health clinics; concussion clinics; hospital emergency rooms; university sports and student health centers; professional sports; and pharmaceutical clinical trials.  BrainScope has been the recipient of several prestigious awards, including the Frost & Sullivan 2017 Best Practices Award for New Product Innovation in the Traumatic Brain Injury Assessment Solutions Market, was a two-time winner of the GE-NFL Head Health Challenge, and has received two nominations for the Prix Galien Best Medical Technology, regarded as the equivalent of the Nobel Prize for medical devices. For more information, please visit www.brainscope.com.

BrainScope Honors Veterans Day and Supports U.S. Army Deployment of Traumatic Brain Injury (TBI) and Concussion Assessment Devices

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.

BrainScope Receives $4.5 Million Department of Defense Contract to Add Ocular Assessment to Future Concussion Products

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.     

BrainScope Receives Prix Galien Award Nomination for Its Concussion and Traumatic Brain Injury Assessment Product

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.

Over 30% Potential Cost Reduction to Payers and Patients through Integration of BrainScope One for Mild Traumatic Brain Injury / Concussion Assessment

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…

BrainScope Initiates Teenage and Young Adult Multi-Site Clinical Study for Concussion Assessment Product

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.

Using BrainScope One in Urgent Care Centers Shows Potential 75% Reduction in Head Injury Referrals to Emergency Departments

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.   

BrainScope One Demonstrated the Potential to Reduce Head CT Scans By One-Third in Emergency Department Use

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…

BrainScope Initiates Development of Pediatric Product for Objective Assessment of Traumatic Brain Injury, Including Concussion

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.

BrainScope Completes $16 Million Equity Fundraise

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.

BrainScope Receives Frost & Sullivan Best Practices Award in Traumatic Brain Injury Assessment

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.

Strong Utility of BrainScope’s Brain Function Index for Head Injury Assessment Demonstrated in Validation Trial

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.

One-Third Potential Reduction in Unnecessary Head CT Scans Demonstrated in BrainScope One Study

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.

Multi-Year Study Using BrainScope's Brain Function Index Suggests Compelling Utility as an Objective Biomarker for Concussion

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 One Revolutionizes Brain Injury Assessment for Urgent Care Clinics

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.

BrainScope Biomarker Adds Significant Prognostic Accuracy for Rapid Assessment of Traumatic Brain Injury

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.