Interim study population data to be presented at American Association for Clinical Chemistry Annual Scientific Meeting and Lab Expo
Richmond, VA – July 6, 2022 – BRAINBox Solutions today announced that at the American Association for Clinical Chemistry (AACC) Annual Scientific Meeting and Lab Expo in Chicago, July 24-28, the company will participate in two presentations, one which will take place on July 27, 2022 given by the study’s principal investigator, W. Franklin Peacock, MD FACEP Professor of Emergency Medicine and Vice Chair for Research in the Department of Emergency Medicine at Baylor College of Medicine. The presentation entitled, “What will your Dr do?” will include a brief update on the ongoing HeadSMART II clinical trial (Head injury Serum markers and Multimodalities for Assessing Response to Trauma) for its concussion (mild traumatic brain injury or mTBI) diagnostic and prognostic test. The trial is the first to follow concussion patients’ symptoms using a multi-modality approach over time. The presentation will focus on the characteristics of the patients enrolled to date and the impact of their injury over three months.
Separately, BRAINBox CEO Donna Edmonds and Dr. Peacock will participate on a panel as part of the DX/PX Partnering Conference from 4-5 PM on July 26, 2022, entitled, “Establishing a new diagnostics gold standard in biomarkers. The importance of clinical involvement in launching novel diagnostics to change standard of care.”
The company’s test, BRAINBox TBI, is the first objective test designed to assist in the diagnosis of concussion and provide an assessment of the risk of chronic injury. The HeadSMART II clinical trial is aimed at generating data to support an application for U.S. regulatory clearance and has received Breakthrough Designation by the FDA. The test will include neurocognitive testing, symptom reporting and blood biomarkers, along with 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 HeadSMART trial’s primary endpoints include mTBI diagnosis as determined by the BRAINBox TBI test compared with the Gold Standard diagnosis based on evaluation by an expert adjudication committee. The secondary endpoint relates to mTBI prognosis.
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 minutes 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. Learn more at: www.brainboxinc.com