BRAINBox Solutions reports progress on its pivotal HeadSMART II trial, a point-of-care partnership, and machine learning models for distinguishing TBI from dementia in older adults.

BRAINBox Solutions is reporting progress across several fronts in its traumatic brain injury (TBI) diagnostic program, including the near-completion of a pivotal clinical trial designed to support a regulatory submission to the Food and Drug Administration (FDA) and promising early results from a point-of-care collaboration.

The company’s HeadSMART II trial, which is evaluating more than 2,000 samples, is designed to support an FDA marketing clearance submission for its concussion diagnostic test in adults. At the 16th Annual TBI Conference on March 30 in Philadelphia, W. Franklin Peacock, MD, principal investigator and professor of emergency medicine in the Department of Emergency Medicine at Baylor College of Medicine, delivered a podium presentation updating attendees on the trial’s progress.

“We have made substantial progress across key aspects of our development programs and business,” says Donna Edmonds, chief executive officer of BRAINBox Solutions, in a release.

Point-of-Care Collaboration Shows Early Promise

In parallel with its lab-based test development, BRAINBox has entered into a collaboration with Prolight Diagnostics to incorporate its biomarkers into Prolight’s Psyros single-molecule platform. An analytical evaluation demonstrated strong performance across a combination of three brain injury biomarkers, with results showing that multiple biomarkers can be transferred onto the Psyros single-molecule-counting platform.

Based on those results, the companies are moving to the next phase of the collaboration: an evaluation of all three assays using a bank of 260-patient samples drawn from the HeadSMART II trial.

“Delivery of our tests at the point-of-care is a central part of our strategy,” says Edmonds, in a release. “We recently entered into a collaboration with a leading developer of [point of tech] technology, Prolight Diagnostics, which has reported promising initial results in incorporating our biomarkers into its Psyros single-molecule platform. Based on these results, we are proceeding to the next validation phase.”

Machine Learning Models Target Geriatric TBI Diagnosis

BRAINBox also presented data at two recent scientific meetings on a machine learning-based approach to differentiating TBI from dementia in elderly patients—a clinical challenge with significant implications for both diagnosis and prognosis.

At the annual Emergencies in Medicine conference (March 1–5) and the AD/PD Advances in Science and Therapy Conference (March 19–20), the company presented posters describing multimodal models that integrate biomarker profiles, digital neurocognitive testing, specialized neuroimaging metrics, and coexisting conditions. The solution is being developed in collaboration with Peacock and Damon Kuehl, MD, professor in the Department of Emergency Medicine at the Virginia Tech Carilion School of Medicine.

The models are intended for integration into BRAINBox’s geriatric TBI test and, longer term, may support diagnosis and prognosis of neurodegenerative diseases such as Parkinson’s disease and Alzheimer’s disease.

The National Institutes of Health is funding the company’s clinical trial for the geriatric patient population.

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