AI Brain Device Reduces Need for CT Scans by Over 30 Percent

First FDA-cleared device uses AI to assess full spectrum of brain injuries

Full Source

By: Cami Rosso

Traumatic brain injury (TBI) is a disturbance of normal brain functions due to a head injury that everyone is at risk. The Centers for Disease Control and Prevention (CDC) estimates that 138 people die each day in the U.S. due to injuries that include TBI. However, diagnosing TBI often involves unnecessary exposure to radiation from CT (computed tomography) scans. Recently published a few weeks ago in The American Journal of Emergency Medicine, a peer-reviewed publication, physicians at Washington University Barnes Jewish Medical Center in St. Louis found an over 30 percent reduction in unnecessary CT scans for TBI evaluations in emergency rooms using the recently FDA-approved medical device from BrainScope Company, Inc.—a medical neuro-technology company with various public sector and private sector funding, including venture capital from Revolution, founded by Steve Case, the co-founder of America Online (AOL).

Those with moderate to severe TBI are at greater risk for both subsequent additional injuries and death by other causes. The CDC estimates that those with traumatic brain injury are at significantly greater risk to die from seizures (50 times), unintentional drug poisoning (11 times), infections (nine times), and pneumonia (six times), than those without TBI.

Older adults and children are particularly vulnerable to traumatic brain injuries. The CDC estimates that eight out of ten TBIs among older adults was caused by a fall. In children, sports and recreational activities are major causes of TBI.

Annually an average of approximately 283,000 of people under the age of 18 in the U.S. visit emergency rooms due to TBI from sports or recreational activities according to the March 15, 2019 Morbidity and Mortality Weekly Report (MMWR) released by the U.S. Department of Health and Human Services.

The annual average emergency room visits for U.S. children due to nonfatal TBI during 2010-2016 are mostly due to contact sports and playground play per the same report. For U.S. boys, football (52,088), basketball (19,057), bicycling (19,880), playground play (16,095), and baseball (11,888), and hockey (6,697) were the top causes of TBI annual emergency room visits during the report period. The number one cause for girls in the U.S. was soccer (11,670), followed closely by playground play (11,255), then basketball (10,617), gymnastics (7,284), bicycling (6,075), and softball (5,155). The activity with the least amount of TBI for children that resulted in annual emergency room visits, was bowling—113 boys and 47 girls on average each year during the MMWR report period.

Many TBI patients who undergo CT scans are unnecessarily exposed to radiation. According to a study published in the Journal of Head Trauma Rehabilitation in 2016, researchers from Johns Hopkins University School of Medicine, University of Rochester, and the Uniformed Services University of the Health Sciences, discovered that among the study participants who received CT scans for TBI evaluation, only 9 percent had CT evidence of traumatic abnormalities.

Additionally, the American Academy of Pediatrics estimates that 50 percent of children who visit the emergency room with head injuries receive CT scans, but a third of these scans are not medically necessary.

In the study published in The American Journal of Emergency Medicine, physicians evaluated 91 patients, who were all referred for a head CT scan at the emergency room at Barnes-Jewish Hospital Washington University Medical Center. These patients were also given a non-invasive BrainScope EEG-based Structural Injury Classifier (“SIC”) evaluation with a single-use, disposable electrode headset for the duration of five to ten minutes.

According to BrainScope, for those with mild TBI (mTBI), their flagship product 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).”

The brain electrical activity (EEG) of the patients were acquired from the frontal forehead using by BrainScope’s Ahead hand-held device that runs on Android OS with a user-friendly graphical user interface (GUI).

For the next step, non-EEG signals or artifacts were filtered using BrainScope’s algorithms. Using advanced signal processing, the brain activity traits are obtained and quantified to be used as biomarkers for input into algorithms.

According to BrainScope, the “binary discriminant classification functions were derived using methods including genetic algorithms, a form of evolutionary algorithms,” and “the final classifier functions consist of weighted combinations of selected linear and nonlinear features that reflect brain electrical activity which mathematically describes traumatic structural brain injury as distinguished from normal or concussed brain activity.”

The physicians discovered that “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%” according to the same report. Now the medical community has a non-invasive medical device that uses sophisticated artificial intelligence technology that can reduce exposure to unnecessary radiation for minor traumatic brain injury patients.

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.

Banner Health offers BrainScope in Northern Nevada

Full Source

By Bridget Chavez

FERNLEY, Nev. (KOLO) Patients in northern Nevada can benefit from a new technology that allows for quicker assessments of head injuries, including concussions. Doctors at Banner Health Center in Fernley and Fallon are now offering BrainScope. The technology is a non-invasive, hand-held device used to make head injury assessments on site in non-emergency situations.

"It is a wonderful tool that will help us screen for the presence of concussions without necessarily having to send our patients for a cat scan or emergency room visit," Sharon Maxwell, a physician's assistant, says.

In order for doctors to use BrainScope, patients must be between the ages of 18 and 85 years old and have an evaluation within three days of the injury. It is designed to be fast and efficient, and save patients precious time.

"It actually takes 30 minutes including the whole cognitive assessment, but in reality we only need two minutes of sufficient data to see what we need to do with the patient," Brendalyn Valdovinos, a medical assistant, says.

For both the center in Fernley and the clinic in Fallon, the goal is to assess and treat concussions earlier and eliminate CT scans where possible. Staff at both locations have been trained on the new device.

In emergency situations, always visit your nearest emergency room or call 911 immediately.


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.

Point of Care Concussion Assessment on Your College Campus with BrainScope

As your student heads back to college, peace of mind should be at top of mind.

BrainScope is an accurate, cost-effective, radiation-free medical device, cleared by the FDA, that offers a full assessment of your head injury. BrainScope can assist your physician in making an objective decision on whether to send you to the ER, start treatment for a concussion, or send you home with a clean bill of health.

While not a replacement to CT, a BrainScope assessment can be done at a fraction of the cost of a CT, it can be done at your neighborhood doctor’s office, urgent care setting or yes, even in the ER!

Ask your doctor about BrainScope!

Assessment of the Full Spectrum of Brain Injury in the Emergency Department with BrainScope

Traumatic brain injuries including concussion are among the most common and challenging diagnoses for a physician to make in an Emergency Department, especially in patients presenting with mild head injuries. BrainScope gives Emergency physicians and staff greater assurance to rapidly and objectively assess the full spectrum of brain injury, including the likelihood of a structural component to the injury (one likely visible on CT) and the likelihood of a functional component to the injury (such as concussion).

Point of Care Concussion Assessment In Your Urgent Care with BrainScope

When patients hurt their heads, where do they go? Your urgent care can be an option. The revolutionary, EEG-based, BrainScope One head injury assessment device allows for assessment at the point of care. It provides economic value to your practice while delivering comprehensive, objective assessment results that help guide providers in the early intervention of both structural and functional injuries, including concussion, allowing for better outcomes and superior patient care.

The Economic Impact of BrainScope Head Injury Assessment System

The BrainScope system, utilizing Electroencephalogram (EEG) technology cleared by the FDA, is the first objective, adjunctive device capable of assessing the full spectrum of mild traumatic brain injury (mTBI). Its ability to rapidly identify the likelihood of both structural brain injury and functional brain abnormalities outside of the emergency room offers an opportunity for dramatic improvement to the current treatment path for evaluating mTBI patients.

The benefits could include diversion from the emergency department, a major reduction in unnecessary CT scans, and early intervention for patients with functional injuries, including concussion—contributing to the best possible outcomes in the shortest possible time.

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

Jordan Valley Health Clinic Using New Device to Evaluate Brain Injuries

Full Source

By: Brea Douglas

SPRINGFIELD. Mo.--Jordan Valley Health Clinic is leading the charge in Springfield when it comes to properly  evaluating head injuries. The clinic is the only health care provider in the city to use a brainscope. 
    
Dr. Rafael Santiago-medical director for express care at Jordan Valley Health Clinic had athletes in mind when introducing the brainscope to the clinic.

"Say you're at a game right now you have a brain injury, you come to the express care, within 20-30 minutes, we're able to give you an answer with the status of your cognitive status. If you do require a CT scan because the brainscope tells you that you need a CT scan, then we refer you over to one of the area hospitals," says Dr. Santiago.

The device is put on a patient's head within 72 hours of a closed head injury. Within 20 minutes, it will determine if the brain is bleeding and if an athlete has a concussion. If the brain is bleeding, a CT scan is required, but Dr. Santiago says too often time patients get CT scans-exposing them to harmful radiation when the brainscope could help avoid that.

"This device does not expose the patient to radiation and it gives us an answer as to does the patient need a CT scan or not," says Dr. Santiago. 

The brainscope was introduced at Jordan Valley at just the right time. With winter approaching, weather related falls are expected-resulting in potential head injuries.

 "Icy roads, have slips and falls all those things are always in the back of our minds so it's important to know that there is another option out there. That just because you fell, hit your head and even knocked yourself out, the CT scan is not the only option now so we have other tools that allow us to evaluate that system," says Dr. Santiago. 

The brainscope is also more cost affective for Jordan Valley patients.

 "Our patient population is the underserved and underinsured so this can actually help somebody that really doesn't need to go through the expense of a CT scan so this helps us give them the best care possible," says Dr. Santiago. 

Right now the brainscope is only FDA approved for ages 18 to 85.

Eventually, Dr. Santiago wants to see brain scopes utilized at games for athletes who get head injuries. 

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.

Improved Assessment, Diagnosis and Management of Brain Injuries

Full Source

By David Stern

Recent events have served as sad yet significant reminders of the seriousness of head injuries or traumatic brain injuries (TBIs).

As the football season ramped up, two tragic incidents took place in October alone. Christion Abercrombie, a linebacker for Tennessee State University, was rushed to the hospital and underwent life-saving emergency brain surgery after suffering a severe head injury. In Georgia, Pike County High School linebacker Dylan Thomas also sustained a severe head injury and was rushed to the hospital for surgery, but he tragically passed away soon afterwards.

The frequency and health risks of traumatic brain injuries, which include sports-related concussions, are increasingly being discussed and studied. As indicated in Table 1, there are close to 4 million sports-related concussions each year, with an additional 50% not being reported. The risks of not properly diagnosing and treating a brain injury are severe.

A concussion temporarily disrupts mental function and if not treated, it can have debilitating long-term consequences. People with an untreated concussion may suffer from headaches and fatigue—sometimes for years. They are not as sharp as they should be mentally, and they have problems focusing.

Additionally, not promptly diagnosing a concussion and allowing an athlete to return to play even further increases their chance of harm. Right after a concussion, people are at much higher risk for further injury since they are not able to react or think quickly. Also, the brain is very sensitive after an injury. Reinjuring the brain while concussed can lead to very serious health problems—far more serious than one injury. Researchers have found that individuals who have suffered multiple concussions during their lifetime increase their chances of depression, post-traumatic stress syndrome (PTSD) and suicide by 1.5x to 3x.

Another very harmful immediate possible outcome of a head injury is a brain hemorrhage or brain bleed, which is a type of stroke. This can be a life-threatening situation. The presence of blood in the brain increases pressure on nearby brain tissue, and that reduces vital blood flow and can damage brain cells. Typically, a trip to the hospital for a CT Scan, a special X-ray test, is necessary to detect brain bleeding. Having the ability to quickly identify a brain injury and provide treatment can save lives. Yet, this can be challenging, as many tests are subjective and are generally focused on how the player feels, their ability to answer simple questions, repeat numbers and words in proper sequence and maintain balance. These types of tests cannot reliably identify brain injuries and the severity if present. Fortunately, there is a new device that is changing the way medical professionals evaluate and treat concussions. 

Electrical signals course through the brain and when someone has a brain injury these electrical signals change and are different from those that would be present in an uninjured brain.  The brain’s electrical signals can be measured and tracked by an electroencephalogram (EEG). A unique, FDA-cleared medical device named BrainScope® One uses the EEG signal to determine whether the patient likely has a brain bleed. The BrainScope One device has been thoroughly tested and has demonstrated that it can identify patients with as little as 1cc of brain blood with 99% success rate. This assessment function is referred to as a Structural Injury Classifier.

Dr. Manu Mehdiratta, a neurologist who specializes in concussion and works at the Trillium Health Centre in Mississauga, Canada explains, “The Structural Injury Classifier helps determine the need for a CT scan or advanced neuroimaging. Basically, this will tell you with a high level of certainty whether or not there is likely a  bleed in the brain, which is very useful.”

Dr. Leigh Vinocur, Emergency Room Physician, and Chief Medical Director at MedStar PromptCare Clinics says, “I was excited about BrainScope when I first learned about it because it’s 99 percent sensitive for picking up a structural injury and a bleed, even down to 1 cc of blood, which is such a small amount that sometimes doesn’t even show up on a CT scan.” 

In addition to being able to identify patients who may have a brain bleed, the BrainScope One uses the same EEG signal to determine the presence and severity of a concussion.  The device automatically and quickly compares the patient’s EEG to a large database of EEGs from healthy patients of the same age to determine their level of brain function impairment. This assessment function is appropriately named the Brain Function Index.

“Along with determining if there’s a structural injury, the BrainScope also uses EEG to determine if there is functional brain impairment,” Vinocur continues. “It uses big data from years and years of EEGs of normal brain function, so when you use it with an athlete it compares their EEG waves with those of thousands of people who never had a head injury. Then it can show you if the athlete’s Brain Function Index is lower than what it should be.”

In the words of Dr. Mehdiratta, “The Brain Function Index determines the degree of brain injury that’s occurred and guides clinical management and return to play decisions.” 

To further assess a patient’s level of brain impairment, BrainScope’s device also has two rapid neurocognitive (brain processing capability) tests. On the device, the patient takes these tests which measure  reaction time, decision making, attention span, and short-term memory, and once again their results are compared to healthy patients of the same age to assess their brain’s function.  In addition, an extensive digital library of standard concussion assessment tools is available on the device.

The BrainScope One’s ability to quickly provide this level of objective assessment in a sideline setting has quickly drawn the attention of Professional and University sports teams. For Stacey Czaplewski, MAEd, LAT, ATC, Head Athletic Trainer at Winona State University, the BrainScope One also helps athletes feel confident that they are receiving the best care possible. “We’ve been using the BrainScope for close to a year and what has been really positive about it is our student-athletes realize that it’s another layer of protection for them, and that it helps us treat their concussion and see when a referral is absolutely necessary,” she says. “When we pull it out it reassures them that we’re trying to test everything possible.”

Czaplewski also enjoys how quick and easy it is to use. “You get instantaneous feedback as soon as you download the data from the electrodes in the brainwaves, and the whole process only takes a few minutes,” she explains. “It’s also very simple to determine whether a referral is needed or not. The results are very easy to read and can help you decide what the next step should be.”

Dr. Mehdiratta shared, “For example, I recently treated a quarterback who had two concussions in a short period of time and his Brain Function Index was very low. As a result, we asked him not to play until we’re able see how he does with rehabilitation.”

Having this objective data to show athletes can be crucial to making sure they understand the significance of the injury. “It’s sometimes hard to get athletes to take their injury seriously,” says Vinocur. “They don’t want to miss out, they want to play in the big games, so they try to shake it off and minimize things. But now we have some objective data and we can show them how their Brain Function Index compares to thousands of people who have never had a concussion. It certainly makes it easier for the physician, athletic trainer, parent, and coach to get the athlete to understand it’s a significant injury and they need to rest and take time away from their sport.” 

Not only is the BrainScope One making concussion assessment easier and more objective, it is also making it more efficient. CT scans and trips to the emergency room can be costly and unnecessary, yet injured athletes often end up there anyway. That no longer has to be the case. 

“Though it doesn’t replace CT scans, I think the BrainScope is going to help reduce unnecessary CT scans,” says Mehdiratta. “In my practice, I’ve also seen that the BrainScope can reduce the cost of care and improve patient satisfaction overall.”

BrainScope One is currently FDA cleared for assessing people 18-85 years old, within three days of injury. 


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 Grand Rounds Series- Publication Navigator

The BrainScope One system provides objective data that helps clinicians answer two key questions in mildly presenting head-injured patients:

1. Is it likely that there is a structural brain injury that would be visible on a CT scan?

2. Is there evidence of functional brain impairment that could indicate a concussion?

The video below highlights a decade worth of research and development of the BrainScope One device. This includes 24 investigator-initiated publications describing clinical usability, the standard of care comparisons, and the validation of the BrainScope One algorithms.

Grand Round Videos Presented By Leslie Prichep, Ph.D Chief Scientific Officer, BrainScope Company Inc. Adjunct Professor, Department of Psychiatry New York University School of Medicine

The following four videos are intended to educate healthcare professionals on the fundamental scientific and clinical basis of the BrainScope One device. They are not intended to be a substitute for device labeling. Please consult with BrainScope for detailed device labeling such as Indications for Use and Instruction / Directions for Use.

BrainScope Grand Rounds Series- Validation Trial

The video below focuses on BrainScope One’s successful FDA validation trial providing an overview of algorithm development, trial design and a summary of the validation trial results.

Grand Round Videos Presented By Leslie Prichep, Ph.D Chief Scientific Officer, BrainScope Company Inc. Adjunct Professor, Department of Psychiatry New York University School of Medicine

BrainScope Grand Rounds Series- Brain Function Index

The video below explains one of two of BrainScope One’s EEG-based brain injury assessment capabilities, the Brain Function Index. The BFI compares the patient’s brain electrical activity to that of a comparable non-injured population to objectively determine the likelihood, and severity, of brain function impairment.

Grand Round Videos Presented By Leslie Prichep, Ph.D Chief Scientific Officer, BrainScope Company Inc. Adjunct Professor, Department of Psychiatry New York University School of Medicine

BrainScope Grand Rounds Series- Structural Injury Classifier

The video below explains one of two of BrainScope One’s EEG-based brain injury assessment capabilities, the Structural Injury Classifier. The SIC provides clinicians with objective results that indicate the likelihood of a structural brain injury being present or visible on a CT Scan.

Grand Round Videos Presented By Leslie Prichep, Ph.D Chief Scientific Officer, BrainScope Company Inc. Adjunct Professor, Department of Psychiatry New York University School of Medicine

Hurt Your Head? How Do You Rule Out A Brain Bleed? Do You Have A Concussion?

BrainScope One is a new, accurate, cost-effective, radiation-free medical device, cleared by the FDA, that offers a full assessment of your head injury. This assessment tool collects objective information right from your brain! BrainScope One answers two important questions for your doctor: Is there a structural injury? Is there a functional abnormality? BrainScope One can assist your physician in making an objective decision on whether to send you to the ER, start treatment for a concussion, or send you home with a clean bill of health. While not a replacement to CT, BrainScope One assessment can be done at a fraction of the cost of a CT, it can be done at your neighborhood doctor’s office, urgent care setting or yes, even in the ER!