BrainScope
Reimagining Brain Diagnostics with Innovative Solutions

Brain disorders are the leading cause of disability, costing trillions of dollars each year, yet today’s tools for neurological assessment are insufficient. Traditional brain imaging tools are costly, burdensome, and generally not available at the point of care, while other neurological assessment tools heavily rely on clinically observed symptoms that may not accurately reflect the underlying issues.

Advancements in machine learning are transforming the way brain irregularities can be assessed and diagnosed. Pairing this modern AI technology with time-honored electroencephalography (EEG) enables the creation of biomarkers that help clinicians assess brain abnormalities more precisely.

BrainScope is scaling new peaks in the neurodiagnostic space with development of EEG-based biomarkers for point-of-care assessment of neurological conditions. BrainScope has enjoyed commercial success in brain trauma, its first indication, with a non-invasive solution that can aid in quickly ruling out intracranial bleeding and objectively assessing concussions at the same time. The product is the first of its kind to receive FDA clearance.

“The system for assessing head injuries is broken across every market, including emergency departments, primary care, sports, and the military. Other than CT scans, there are no objective markers in use for brain injury assessment, and CTs cannot help diagnose concussions. Patients, providers, and survivors are searching for better answers. BrainScope can address these pain points, and we are on a mission to provide access to our breakthrough technology across these markets and communities,” says Laurie Silver, CEO.

Addressing Industry Pain Points

There are 4 million CT scans performed for head injuries each year in US emergency departments (ED). These patients are exposed to radiation levels 20 times greater than chest X-rays. Over 90 percent of these examinations show no signs of bleeding, and the limited ability of CTs to only identify structural injuries leads to undetected concussions.

Hospital EDs are clogged up with mild head-injured patients and are seeking ways to discharge them more quickly. The lack of efficiency creates dissatisfaction among patients who, after spending multiple hours in the ED, are sent home without a proper diagnosis. Furthermore, undetected concussions can lead to severe and debilitating complications such as Chronic Traumatic Encephalopathy (CTE), a condition seen in deceased former athletes.

Assessing Brain Trauma the BrainScope Way

BrainScope’s biomarkers address patients’ plights with remarkable efficacy. BrainScope helps clinicians rule out brain bleeds in about 15 minutes, allowing them to focus on the subset that cannot be ruled out. BrainScope’s customers have reduced head CTs by up to 60 percent, substantially minimizing patients’ length of stay while also providing objective data on concussion status.

The diagnostic process begins with a clinician or technician applying eight peel-and-stick electrodes to a patient’s forehead, recording brain signals that are fed into BrainScope’s three biomarker algorithms. The Structural Injury Classifier (SIC) predicts the likelihood of the absence of intracranial bleed on a CT with 99 percent sensitivity, detecting as little as one cubic centimeter of blood.

BrainScope’s other FDA-cleared biomarkers—the Brain Function Index and the Concussion Index—assess concussion likelihood and severity, providing objective information not available in any other tool.

BrainScope’s novel solution has significantly improved hospital and patient outcomes. After deploying the device, Adventist Health Kern County’s three hospitals witnessed a 40 percent decrease in head CTs and a 58 percent reduction in patients’ length of stay. The reliability of the device ensured that patients could be discharged immediately if no brain bleed was indicated, simplifying the healthcare process and improving the patient experience.

BrainScope is now expanding into other markets, such as sports and the U.S. military. BrainScope won the NFL-GE Head Health Challenge, and the technology is being used in high school and college teams. For the military, BrainScope is demonstrating its ability to help streamline patients to appropriate follow-on care. The company is also involved in the military’s INVICTA study evaluating the impact of heavy weapons blast exposure on the brain, a subject of recent media and congressional scrutiny.

BrainScope can address these pain points, and we are on a mission to provide access to our breakthrough technology across these markets and communities.

Addressing Other Neurodiagnostic Pain Points

BrainScope’s vision extends beyond head injury to encompass brain disease and wellness. As the company’s CSO, Dr. Leslie Prichep, noted, “The lack of reliable standards for assessing brain health makes the pressing need for quantitative markers that reflect brain dysfunction more imperative.” To address this, the company incubated a deep-learning neurotechnology platform with the potential to analyze EEG data across various neurological issues, including Alzheimer’s, Parkinson’s, and stroke.

A retrospective study using BrainScope’s brain bleed biomarker for stroke assessment suggested higher sensitivity than CT machines in the identification of ischemic stroke and high accuracy in distinguishing stroke from “stroke mimics.” This brain bleed biomarker also has potential application in monitoring patients taking today’s Alzheimer’s drugs. These patients have a high risk of amyloid-related imaging abnormalities (ARIA), small brain bleeds that can be fatal. BrainScope’s technology could substantially reduce the need for frequent neuroimaging, making these drugs safer and more accessible. BrainScope also received funding from the Alzheimer’s Drug Discovery Foundation to develop a biomarker to predict Mild Cognitive Impairment and Alzheimer’s earlier than conventional tools.

Paving the Path for a Promising Future

BrainScope’s machine learning and EEG-based biomarkers offer significant advantages over traditional markers. These modern solutions are non-invasive, rapid, inexpensive, and can detect abnormalities even when physical symptoms are absent.

BrainScope has 83 globally issued patents extensible to future indications. Investments upward of $100 million in private funding and $30 million in research funding across eight military research contracts have enabled the company to develop and validate its FDA-cleared biomarkers. It aims to de-risk drug development and enhance the identification and monitoring of patients in clinical trials and post-market surveillance by facilitating the identification of novel drug targets, enriching trial enrollment, and monitoring treatment side effects.

BrainScope is poised to revolutionize neurodiagnostics with its innovative use of EEG and AI. It is transforming emergency care and setting new standards for brain health diagnostics. A deep-seated commitment to continued advancements across various neurological conditions paves the way for a future where brain health is assessed in a more precise and comprehensive manner.