Richmond, VA, – March 4, 2024 – BRAINBox Solutions today announced current and upcoming presentations of clinical trends and data at three leading, upcoming medical conferences from the HeadSMART II pivotal trial in adult patients and the National Institutes of Health (NIH) funded clinical trial in geriatric patients of its BRAINBox TBI™ concussion diagnostic and prognostic test.  Concussion is also known as ATE (Acute Traumatic Encephalopathy) or mTBI (mild traumatic brain injury).

 The presentations, by BRAINBox Scientific Advisory Board members, are at the:

  • 42nd Annual Emergencies in Medicine conference in Park City, Utah, held Feb.25-March 1, 2024. A presentation as well as a poster were delivered. The presentation title is, “Biomarker Profiles Distinguish Geriatric Acute TBI from Dementias: Results from the HeadSMARTII Geriatric Feasibility Study.”  The poster title is: “Biomarker Profiles Distinguish Geriatric TBI from Dementias:  Results From the HeadSMART Geriatric Feasibility Study.”
  • AD/PD 2024 International Conference on Alzheimer’s, Parkinson’s and Related Neurological Diseases to take place March 5-9, 2024 in Lisbon, Portugal; Ramon Diaz-Arrastia, MD, PhD, Presidential Professor of Neurology in Penn’s Perelman School of Medicine will deliver a podium presentation, titled, “Biomarker Profiles Distinguish Geriatric Acute TBI from Dementias:  Results from the HeadSMARTII Geriatric Feasibility Study.” Additional data beyond the Emergencies in Medicine presentation will be included.
  • The 14th Annual Traumatic Brain Injury Conference, May 2-3 in Washington, D.C. Damon R. Kuehl, MD, the Vice Chair of Research and Academic Affairs in the Department of Emergency Medicine at Virginia Tech Carilion, School of Medicine will deliver a presentation entitled, “An Update and Lessons Learned from HeadSMART II (HEAD Injury Serum Markers and Multi-Modalities for Assessing Response to Trauma II) and the NIH Funded “HeadSMART Geriatrics.”

“Acute traumatic encephalopathy is a major clinical issue that cuts across age groups,” said Dr. Frank Peacock, MD, FACEP, FACC, FESC. “These presentations highlight the breadth of clinical data being assembled to evaluate the diagnostic and prognostic potential of the BRAINBox TBI test across a spectrum of age groups. The test is designed to fill a pressing need for an objective test to diagnose concussions and determine a patient’s prognosis at the time of injury.” Dr. Peacock is lead investigator in the HeadSMARTII trial and Professor, Vice Chair for Research, Henry JN Taub Department of Emergency Medicine, Baylor College of Medicine.

“These two trials have made substantial progress, as enrollment in both is expanding and, in the case of HeadSMART II, almost completed,” said Donna Edmonds, BRAINBox Solutions’ CEO. “These presentations provide an opportunity to update the clinical community, which has shown high interest in our test as the first object diagnostic and prognostic concussion test. We are also very encouraged by the preliminary data from our collaboration that will enable the blood biomarker component of the test to go on a point-of-care instrument so it can be used in any clinical setting. The ability to assess biomarkers at the point of care is key to use of the test in outpatient as well as emergency department settings. Our Pediatric Pilot Study is now complete, and we will be proceeding with our final product development offerings to serve the 10-18 year old population, where so many sports injuries put the youth population at risk.”

BRAINBox TBI is a multi-modal test that combines clinical data, neurocognitive testing, symptom reporting and blood-based biomarkers, with proprietary AI algorithms to generate an objective score for diagnosis up to 96 hours from the time of injury. In addition, a prognosis report is generated, providing the likelihood of injury-related symptoms occurring at 30 days and up to three months after the event.

The HeadSMART II study is a multi-national, multi-site trial, in adult subjects designed to support an application for regulatory clearance by the U.S. FDA. To date the study has enrolled more than 1300 patients with suspected concussions, as well as additional, healthy and trauma controls and over 500 subjects in our Normative Data Base for NeuroCognitive Assessment. The data collected from the trials will be used to analyze the BRAINBox TBI test’s sensitivity and specificity of concussion diagnosis compared to expert clinical diagnosis, and the sensitivity and specificity of the risk for chronic symptoms as compared to the post-concussion symptoms at predefined time points.

The geriatric study, supported by a $3.5 million grant from the National Institutes of Health, is evaluating a refinement of the TBI test equilibrated for the geriatric population and designed to enable rapid concussion diagnosis and prognosis at the bedside with a single device. To date, 200 patients with suspected concussion have been enrolled in the trial.

About BRAINBox Solutions
BRAINBox Solutions is developing the first AI‐enabled, multi‐modality approach for the diagnosis and prognosis of Mild Traumatic Brain Injury, now commonly referred to as a concussion. The company seeks to establish a clinical best‐practice standard for the diagnosis and prognosis of concussion providing information which can support the ability to guide interventions. The initial product incorporates a panel of proprietary, patented blood biomarkers that can be read in a few moments on a point‐of‐care instrument or using standard laboratory systems, as well as neurocognitive testing, to provide a single‐system score that measures the severity of the injury and post-concussive symptoms. The company is led by key physician and scientific thought leaders in the field and an experienced, clinically focused management team.