BETHESDA, MD. July 25, 2019 - BrainScope announced today that it has successfully completed a nearly five year, $9.9 million U.S. Department of Defense research contract supporting the development and validation of an objective marker of the presence and severity of concussion. In a large blinded validation study, the system demonstrated its ability to help clinicians assess concussion at the time of injury, reflect severity of injury, and aid in their assessment of readiness to return to activity. BrainScope extended the work performed under this Department of Defense contract to include adolescents funded through private investment from BrainScope and a second award from the NFL-GE Head Health Challenge I.
BETHESDA, MD. June 24, 2019 - BrainScope announced today the appointment of Susan Hertzberg as Chief Executive Officer. This is the 4th equity-backed venture that Hertzberg will helm. She is a proven commercial stage leader with an impressive track record of bringing innovative products and services to market and profitably scaling and delivering exceptional market growth.
In her new role, Hertzberg will drive the global strategy and commercialization of BrainScope’s traumatic brain injury (TBI) and concussion tools in the traditional healthcare, military and sports arenas and will expand the platform capabilities of its signature product Brainscope One to include objective assessments for brain diseases like depression and Alzheimer’s.
“BrainScope is growing rapidly given the high demand and need for non-invasive, point of care FDA-Cleared medical devices to objectively assess concussion and mild TBI,” said Founding CEO Michael Singer, who will move into the Executive Chairman role. “I am thrilled to have Susan join us and apply her unique talents and experience to scale our business and make these tools ubiquitous in the market. Her mission-driven, patient-centric approach and dynamic leadership style is a great fit and will help BrainScope reach its full potential for this very large market opportunity,” added Singer.
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.
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.”
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.
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.”
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.
BETHESDA, MD. November 13, 2018– BrainScope®, a medical neuro-technology company focused on concussion and mild traumatic brain injury (mTBI) assessment, announced today that it has fulfilled orders for over 170 BrainScope One handheld devices and over 7,500 individual patient headsets to U.S. Army bases across the world. U.S. Army medics and clinicians continue to receive the training necessary to support the assessment of military personnel that may have experienced an mTBI, providing access for service members at home and abroad.
Artificial Intelligence and Multi-Modal Capabilities to Optimize Personalized Concussion Assessment
BETHESDA, MD. September 4, 2018– BrainScope today announced that it has been awarded a research contract by the United States Department of Defense (DOD) valued at $4.5 million to create and integrate ocular capabilities into its handheld, multi-parameter mild Traumatic Brain Injury (mTBI) and concussion products.
BrainScope’s initial product in the market, BrainScope One, is the first FDA-cleared medical device to offer capabilities to assess the full spectrum of brain injury – from concussions (functional abnormality) to brain bleeds (structural injury) using EEG and other parameters which together provide the clinician a panel of capabilities to help with their clinical diagnosis. With this research contract, BrainScope will add specific capabilities related to assessment of the patient’s eyes which will be incorporated in future versions of BrainScope’s products.
BETHESDA, MD.--(BUSINESS WIRE)--BrainScope today announced its second consecutive nomination for the 2018 Annual Prix Galien USA Awards for “Best Medical Technology” product. Its flagship BrainScope One product is a multi-modal, comprehensive, handheld capability to help clinicians objectively and rapidly assess and triage head injured patients directly at the point of care.
An Economic and Actuarial Model Demonstrates Substantial Cost Benefit to Health Insurers and Patients
BETHESDA, MD. June 28, 2018 – BrainScope announced today the release of a white paper which demonstrates a significant positive impact on the costs to the healthcare system from integrating BrainScope One into the assessment of mild traumatic brain injury / concussion. Escalating awareness of the consequences of traumatic brain injury, even when mild, has resulted in an increasing burden to the healthcare system of $76.5 billion annually. Overall findings of the white paper, authored by a well-respected team comprised of an economist and actuaries, demonstrated that the use of BrainScope One in the Emergency Department and Community settings (including Urgent Care Centers) could result in a significant reduction of costs of up to 32.2%. This is accomplished by a combination of diversion from hospital emergency departments to less expensive care settings, as well as a significant reduction in the number of unnecessary CT scans…
BETHESDA, MD May 31, 2018 – BrainScope, a medical neurotechnology company focused on concussion and mild traumatic brain injury (mTBI) assessment, announced today the initiation of a large, multi-site clinical research study enrolling subjects ages 13-25 years who sustained a head injury from a variety of causes, including sports-related head injuries. Designed as a prospective, observational investigation, eligible patients who sustained a head injury will be recruited from concussion clinics and high schools surrounding the participating universities conducting the study.
“The initiation of this large clinical study is a significant milestone in the development of BrainScope’s next-generation brain injury assessment products to include teenage patients suspected of a concussion,” said Michael Singer, CEO of BrainScope.“We are aggressively pursuing this very large demographic with plans to introduce a teenage-focused product in the near-term,” stated Singer.
BrainScope One Provides Objective, Actionable Information for Assessment of Mildly Presenting Head Injured Patients in Urgent Care Centers, Emergency Departments, and Other Settings
BETHESDA, MD. MAY 7, 2018 – BrainScope announced today the release of a white paper authored by Urgent Care physicians which demonstrated that the FDA-cleared BrainScope One had the potential to reduce unnecessary Emergency Department referrals by up to seventy-five percent. BrainScope One offers a rapid (within minutes) assessment of the full spectrum of traumatic brain injury (TBI), including concussion, using digital electroencephalography (EEG) and other modalities, facilitating accurate and timely decision-making for first responders, clinicians, and other health practitioners at the point of care wherever an injury occurs.
Close to 5 million people who experience a TBI seek care and treatment at hospital Emergency Departments (EDs) in the U.S. each year, where over 80% of these patients are evaluated using a computed tomography (CT) scan of the head to detect brain tissue damage, or intracranial lesions, that may require treatment. Over 90% of these CT scans are found to be negative, unnecessarily exposing patients to radiation, long wait times, and high costs.
BETHESDA, MD. APRIL 30, 2018 – BrainScope announced today the release of a white paper authored by physicians at Washington University Barnes Jewish Medical Center in St. Louis, which demonstrated that the FDA-cleared BrainScope One had the potential to reduce the use of unnecessary head CT scans by one-third in a hospital Emergency Department setting.
Today most patients seen in the emergency room with a suspected head injury receive a computed tomography (CT) scan of the head to detect brain tissue damage, or intracranial lesions, that may require treatment; however, the vast majority of these patients do not have detectable intracranial lesions visible on the CT scan. The availability of BrainScope One can help health care professionals determine the need for a CT scan and help prevent unnecessary neuroimaging and associated radiation exposure to patients.
Using data entered in BrainScope’s national Registry, the white paper authors compared 64 patients who were referred for CT scan…
BETHESDA, MD. September 7, 2017 – BrainScope Company, Inc., the medical neurotechnology company which created the first FDA-cleared handheld medical device, BrainScope One, for assessment of the full spectrum of traumatic brain injury, announced it will immediately commence development of a pediatric capability. The pediatric product will be similar to the currently-available BrainScope One, which is a handheld, easy-to-use, rapid, objective capability to aid the clinician in the assessment of mildly presenting adult head injured patients at the point of care. It is designed to help the clinician assess the full spectrum of brain injury, including whether a patient has structural brain injury likely visible on CT, as well as whether a patient has functional brain impairment, including concussion. BrainScope One measures and interprets the patient’s brain electrical activity and neurocognitive function, and offers a panel of objective data to help physicians make their clinical diagnosis.
BETHESDA, MD. August 30, 2017 – BrainScope Company, Inc., the medical neurotechnology company which created the first FDA-cleared handheld medical device for assessment of the full spectrum of traumatic brain injury, today announced it has completed a $16 million equity financing. New investor DBL Partners joined previous backers Revolution LLC, ZG Ventures, Maryland Venture Fund and other existing and new investors in the round, which the company will use to support the commercial launch of its flagship BrainScope One medical device, as well as for continued research and development initiatives.
“We are delighted to have closed this financing with such outstanding investors. This investment acknowledges our leadership position as the first and only handheld, objective, FDA-cleared medical device for traumatic brain injury assessment. The financing will not only help the company drive commercial sales within various markets, but will also provide capital for research and development to broaden our product portfolio,” stated Michael Singer, CEO of BrainScope.
BETHESDA, MD. July 10, 2017 – BrainScope Company, Inc. today announced that it has received the Frost & Sullivan 2017 Best Practices Award for New Product Innovation in the Traumatic Brain Injury Assessment Solutions Market.
“A pioneer in quantitative TBI assessment, Brainscope is poised for rapid and expansive growth. Frost & Sullivan firmly believes that BrainScope is set to become the respected and recognized clinical standard for mild head injury assessment,” stated Patrick Riley, Principal Analyst at Frost & Sullivan. The full write up of the award can be found here.
Frost & Sullivan has 50 years of experience researching technical and economic trends and best practices to provide clients with a complete picture of their position within an industry. As part of this ongoing research, Frost & Sullivan identifies companies that have successfully introduced new and innovative products into their markets, with emphasis on product quality and customer value. This process involves extensive primary and secondary research across the entire value chain of specific products. The 2017 New Product Innovation Award for Product Innovation in the Traumatic Brain Injury Assessment Solutions Market compared top manufacturers in three key areas: understanding demand, nurturing the brand, and differentiating from the competition. BrainScope received top marks in all areas of the research.
“We are honored to be recognized by Frost & Sullivan, whose analysts closely track our industry. We greatly appreciate the recognition for our innovation in developing and introducing our FDA-cleared product, BrainScope One, which addresses the very significant need for objective and comprehensive brain injury assessment,” stated Michael Singer, CEO of BrainScope.
FDA-Cleared BrainScope One Provides Proprietary, Objective EEG-Based Biomarker for Brain Injury, Including Concussion
BETHESDA, MD. June 14, 2017 – BrainScope Company, Inc. today announced a publication describing that its EEG-based Brain Function Index (BFI) was demonstrated to have a significant relationship with the severity of functional impairment in mild head injured patients in a large (720 patient) multisite independent validation trial. BrainScope includes the BFI as a core component of its recently FDA-cleared BrainScope One product, which provides EEG and other information presented as a comprehensive panel on a handheld device for assessment of the full spectrum of traumatic brain injury.
Published online in the peer-reviewed Journal of Neurotrauma in an article entitled “A brain electrical activity (EEG) based biomarker of functional impairment in traumatic head injury: a multisite validation trial”, the findings support the BFI as a quantitative biomarker of brain function impairment, which scaled with severity of impairment in mild brain injury patients.
Over 1 Million CT Scans Could Be Eliminated Annually in the U.S. by Incorporating BrainScope One into Standard Clinical Practice
BETHESDA, MD. June 1, 2017 – BrainScope Company, Inc. today announced a publication describing the use of its flagship product, BrainScope One, in an independent clinical trial demonstrating the potential reduction of one-third (33.3%) of unnecessary computed tomography (CT) scans of mildly presenting head injured patients in hospital emergency rooms (ERs). The study entitled “Referrals for CT scans in mild TBI patients can be aided by the use of a brain electrical activity biomarker” was published online in the peer-reviewed American Journal of Emergency Medicine.
According to recent publications, approximately five million patients are seen in U.S. hospital ERs each year with closed head injuries, and millions more do not seek evaluation. The vast majority (>80%) of these patients receive a CT scan, of which over 90% are CT negative for structural brain injury, creating needless radiation exposure to patients.
BETHESDA, MD. May 23, 2017 – BrainScope Company, Inc. today announced the results of a study spanning over six years demonstrating that sports-related concussions can be objectively assessed using BrainScope’s proprietary electroencephalography (EEG) based Brain Function Index (BFI). Published in the peer-reviewed Journal of Head Trauma Rehabilitation, the study entitled “The Use of an Electrophysiological Brain Function Index in the Evaluation of Concussed Athletes” was conducted at 14 colleges and high schools, and funded in part through an award received under the NFL-GE Head Health Challenge I. In the study, 354 male contact sports athletes, 110 of whom sustained a concussion, were evaluated with results demonstrating that concussive injury significantly affected brain function, which was reflected in the BFI of the concussed athletes.
BrainScope’s BFI, derived from characteristics of brain electrical activity that most closely reflect the physiology of concussion, was found to show highly significant differences between concussed athletes at the time of injury compared with non-injured athletes. Furthermore, at both pre-season baseline and 45 days following the injury, concussed athletes and the non-injured control group exhibited equivalent BFI scores, suggesting that the BFI can potentially provide an objective marker of concussive injury and recovery over time.
The Centers for Disease Control and Prevention estimates that there are up to 3.8 million sports and recreation related concussions in the United States each year. Further, a 2014 JAMA publication reported head injury related hospital emergency room (ER) visits have increased...