BRAINBox Solutions Provides Updates on Clinical, Development, and Corporate Progress in BRAINBox TBI Concussion Diagnostic/Prognostic Test Program

Updates on HeadSMART II, Geriatric trials presented at clinical meetings

Promising early results in Prolight Diagnostics Point-of-Care collaboration

Multi-model models presented for TBI, neurodegeneration differential diagnosis

RICHMOND, Va., March 30, 2026 /PRNewswire/ -- BRAINBox Solutions today provided an update on the clinical, development, and corporate progress in its BRAINBox TBI diagnostic/prognostic test program. The BRAINBox tests for concussion (also known as mild traumatic brain injury [mTBI]; or acute traumatic encephalopathy [ATE]) are designed to fill a major clinical need by providing an objective standard to identify mTBI patients and those at risk for persistent symptoms to guide care interventions. The program is aimed at developing precision solutions across age groups and for use in point-of-care (PoC) settings and by laboratory settings.

"We have made substantial progress across key aspects of our development programs and business," said Donna Edmonds, BRAINBox's CEO. "At three recent conferences, we presented updates on our pivotal HeadSMART II clinical trial for our initial test, in adults, and on the National Institutes of Health-funded clinical trial of our test for geriatric patients. We also presented data supporting our multi-modal approach to distinguish TBI from dementias in elderly populations, which is essential to both diagnosis and prognostic assessments. These models, longer term, open the door to diagnosis and prognosis beyond TBI to neurodegenerative diseases such as Parkinson's Disease and Alzheimer's Disease.

"Delivery of our tests at the point-of-care is a central part of our strategy," Edmonds noted. "We recently entered into a collaboration with a leading developer of PoC 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."

HeadSMART II and Geriatric Clinical Trials Update Presentation – TBI Conference
At the 16^th Annual TBI Conference on March 30, in Philadelphia, HeadSMART II W. Franklin Peacock MD FACEP, Principal Investigator, and Professor of Emergency Medicine in the Department of Emergency Medicine at Baylor College of Medicine delivered a podium presentation, "An Update on HeadSMART II: Advancing Precision Strategies for Traumatic Brain Injury Detection and Management."

The HeadSMART II trial, which is nearing completion, is evaluating more than 2000 samples and is designed to support a regulatory submission to the U.S. Food and Drug Administration to support marketing clearance.

Prolight Diagnostics Collaboration on Point-of-Care
Prolight recently announced positive results of an analytic evaluation demonstrating strong performance of the company's Psyros platform across a unique combination of three brain injury biomarkers. The results demonstrated that multiple biomarkers can be readily transferred onto the Psyros unique single-molecule-counting platform and reinforcing its potential to improve patient care for broad clinical use. Based on these promising results, the companies are proceeding to the next phase of the collaboration, an evaluation of all three assays using a bank of 260-patient samples from the HeadSMART II trial.

Machine Learning-Based, Multimodal Solutions for Precision Testing of Geriatric Patients
At the annual Emergencies in Medicine conference, March 1-5, and the AD/PD Advances in Science & Therapy Conference, March 19-20, the company presented posters describing a machine-learning based solution for differential diagnoses of TBI and dementia. The expanded models use biomarker profiles, digital neurocognitive testing, specialized neuroimaging metrics, and coexisting conditions to more accurately diagnose TBI in the elderly and provide better prognostic risk assessment. The solution will be integrated into the BRAINBox geriatric TBI test. The solution is being developed by the company in collaboration with two of the company's key scientific advisory board members, Dr. Peacock, and Damon Kuehl, MD, and Professor of the Virginia Tech Carilion School of Medicine's Department of Emergency Medicine.

About BRAINBox Solutions 

BRAINBox Solutions is developing the first AI‐enabled, multi‐modality approach for the diagnosis and prognosis of Mild Traumatic Brain Injury, now commonly referred to as a concussion. The company seeks to establish a clinical best‐practice standard for the diagnosis and prognosis of concussion providing information which can support the ability to guide interventions. The initial 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. Learn more at: www.brainboxinc.com

For more information, contact:
Donna Edmonds
CEO
1‐804‐724‐0009

SOURCE BRAINBox Solutions, Inc.