BRAINBox Solutions has initiated the enrolment of subjects in the clinical trial of its concussion diagnostic and prognostic test, dubbed BRAINBox TBI (Traumatic Brain Injury).

HeadSMART II (Head injury Serum markers and Multi-modalities for Assessing Response to Trauma) is a multi-national, multi-site study, designed to enrol up to 2,000 patients, at more than 18 sites across the US, the UK and New Zealand.

The study sites include Level I Trauma Centres, Emergency Departments and Urgent Care settings in systems and community-based hospitals.

BRAINBox will use the clinical data from HeadSMART II study to analyse the sensitivity and specificity of concussion diagnosis using BRAINBox TBI test, compared to expert clinical diagnosis.

Furthermore, the data will be used for the evaluation of sensitivity and specificity of the risk for chronic symptoms, compared to the post-concussion symptoms at predefined time points.

The company said that its Series A financing is supporting the study.

The study data will support its regulatory application for the US Food and Drug Administration (FDA) approval of BRAINBox TBI.

HeadSMART II study principal investigator W Franklin Peacock said: “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.”

BRAINBox TBI test is first objective test for diagnosis of concussion

The US-based biotechnology firm claimed that its BRAINBox TBI test is the first objective test that helps in the diagnosis of concussion and evaluation of the risk of chronic injury.

The test was previously granted the FDA Breakthrough Device designation.

BRAINBox TBI test comprises a panel of blood biomarkers, and a battery of neurocognitive tests, in an easy-to-use application, and can be used either at point of care or in clinical settings.

The test uses AI algorithms to generate an objective score for diagnosis, up to 96 hours from the time of injury and a prognosis report for possible injury related symptoms up to three months after the event.

BRAINBox Solutions is engaged in developing the AI-powered, multi-modality approach for the diagnosis and prognosis of Mild Traumatic Brain Injury, commonly referred to as a concussion.

BRAINBox Solutions CEO Donna Edmonds said: “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.”