RICHMOND, VA. (December 16, 2020) ‐ BRAINBox Solutions today announced it is beginning enrollment in its pivotal clinical trial, HeadSMART II (Head injury Serum markers and Multi-modalities for Assessing Response to Trauma), of the company’s concussion diagnostic and prognostic test, BRAINBox TBI. The multi-national, multi-site trial, which will enroll up to 2,000 patients, aims to generate data to support an application for regulatory clearance by the U.S. FDA.
The BRAINBox TBI (Traumatic Brain Injury) test will be the first objective test designed to assist in the diagnosis of concussion and provide an assessment of the risk of chronic injury. The FDA has granted the test Breakthrough Device designation.
“We do not have a validated objective method to determine an early TBI diagnosis. While a head CT identifies anatomic abnormality, it does not predict post-concussive symptoms or disability at the time when interventions change outcomes. We need an early objective test,” said W. Franklin Peacock MD FACEP, the Principal Investigator of the study. Dr. Peacock is Professor of Emergency Medicine and Vice Chair for Research in the Department of Emergency Medicine at Baylor College of Medicine.
“The start of the HeadSMART II study is a key step in our program to bring this urgently needed capability to the emergency medicine community,” said Donna Edmonds, CEO of BRAINBox Solutions. She noted the company’s Series A financing is supporting the study.
The BRAINBox TBI test will include a panel of blood biomarkers, and a battery of neurocognitive tests combined in an easy to use application, using proprietary AI algorithms to generate an objective score for diagnosis up to 96 hours from the time of injury and a prognosis report for likely injury related symptoms up to three months after the event. The test can be used either at point of care or in clinical settings.
The study plans to enroll up to 2,000 patients from more than 18 sites across the US, and eventually the United Kingdom and New Zealand. The sites include Level I Trauma Centers, Emergency Departments and Urgent Care settings in systems and community-based hospitals. The range of sites is aimed at ensuring representation of real-world practice.
The first patients are being enrolled at several sites which have been intimately involved in the study’s protocol design and development. They include: John Peter Smith Hospital under the clinical leadership of James d’Etienne, MD, FACEP, MBA and Integrated Emergency Services group in Dallas; Stony Brook Hospital (State University of New York) under the leadership of Adam Singer, MD; Carilion Clinic in Virginia under the leadership of Vice Chair of Emergency Medicine Damon Kuehl, MD; Baylor School of Medicine in Houston under the leadership of Zubaid Rafique, MD, and University of Pennsylvania in Philadelphia under the leadership of Danielle Sandsmark, MD, PhD.
The data collected from the HeadSMART II study 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.
Additional information on the clinical trial can be found at here at clinicaltrials.gov.
About BRAINBox Solutions
BRAINBox Solutions is developing the first AI‐enabled, multi‐modality approach for the diagnosis and prognosis of Mild Traumatic Brain Injury, commonly referred to as a concussion. The company seeks to establish a clinical best‐practice standard for the diagnosis and prognosis of concussion. The 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.