Pivotal Trial of First Objective Concussion Diagnostic and Prognostic Test Nearing Completion

RICHMOND, Va.May 4, 2023 /PRNewswire/ — BRAINBox Solutions today announced it will report on summary demographic and clinical trends data from the HeadSMART II pivotal trial of its concussion diagnostic and prognostic test, BRAINBox TBI, at two upcoming medical conferences. The company was selected to present at podium presentations at the Society for Academic Emergency Medicine annual meeting (May 16-19 in Austin, TX), to be delivered by Damon Kuehl, MD, Vice Chair for Research in the Department of Emergency Medicine for Carilion Clinic, Vice Chair of the Virginia Tech Carilion School of Medicine’s Department of Emergency Medicine, and BRAINBox Scientific Advisory Board (SAB) member; and at the 13th Annual Traumatic Brain Injury Conference, (June 19-20Washington, DC), to be delivered by W. Franklin Peacock MD FACEP, Principal Investigator, and Professor of Emergency Medicine, Vice Chair for Research in the Department of Emergency Medicine at Baylor College of Medicine, and also a BRAINBox SAB member.

The multi-national, multi-site trial, which is very near completion, is enrolling over 1300 patients with suspected concussions, also known as mild Traumatic Brain Injury (mTBI) or Acute Traumatic Encephalopathy as well as additional healthy and trauma controls. It is designed to support an application for regulatory clearance by the U.S. FDA.

“The podium presentations at these important conferences underscore the growing interest in and the need for an objective test as well as the trial’s potential to define for the first time, objective diagnostic criteria for this condition and provide an assessment of post-concussive symptom risk,” said Donna Edmonds, BRAINBox Solutions’ CEO. “We are now convinced that this objective test has the potential to change clinical practice. We are moving forward expeditiously to complete the trial in the very near term and to advance the test towards a regulatory submission for FDA clearance.”

The HeadSMARTII trial, which was rigorously designed in collaboration with leading experts in traumatic brain injury and emergency medicine, is being conducted in adults (18 years old or older). The study includes state of the art expert adjudication panels, as there is no quantitative, “gold-standard” diagnostic for concussion currently available. The company recently commenced enrollment in an NIH-supported, multi-center clinical trial in geriatric patients and is currently completing initial pilot clinical trial in pediatric subjects (18 years of age or younger).

The BRAINBox TBI multi-modal test 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 clinical study sites were selected to reflect real world practice and include Level I Trauma Centers, Emergency Departments and Urgent Care settings in systems and community-based hospitals.