Science and Technology

BRAINBox Solutions Leads the Charge in Concussion Diagnostics with Recent Trial Advancements

RICHMOND, Va., March 4, 2024 /PRNewswire/ -- Today, BRAINBox Solutions has emerged as a forefront innovator with their recent announcement detailing a series of presentations at prestigious medical conferences. These presentations will feature initial data on the utilization of the BRAINBox TBI™ test—a groundbreaking diagnostic and prognostic tool for concussions, alternatively known as Acute Traumatic Encephalopathy (ATE) or mild traumatic brain injury (mTBI)—on a state-of-the-art point-of-care platform developed in partnership with leading healthcare facilities.

Upcoming Medical Presentations Showcase Clinical Trial Advancements

The groundbreaking research encompasses findings from the HeadSMART II pivotal trial with adult subjects and a trial funded by the National Institutes of Health (NIH) focusing on geriatric patients. Leading the presentations are esteemed members of the BRAINBox Scientific Advisory Board.

Milestone Achievements at Esteemed Conferences

At the 42nd Annual Emergencies in Medicine conference in Park City, Utah, that took place between February 25 and March 1, 2024, two key insights were shared. The presentation, intriguingly titled "Biomarker Profiles Distinguish Geriatric Acute TBI from Dementias: Results from the HeadSMARTII Geriatric Feasibility Study," was complemented by a detailed poster sharing the same name, providing compelling evidence of how biomarker profiles can be instrumental in distinguishing between geriatric TBI and dementias.

The AD/PD 2024 International Conference on Alzheimer's, Parkinson's, and Related Neurological Diseases in Lisbon, Portugal, scheduled for March 5-9, 2024, promises to expand upon these findings. Dr. Ramon Diaz-Arrastia, a luminary in neurology from Penn's Perelman School of Medicine, will present additional data that goes beyond the Emergencies in Medicine conference insights.

Furthermore, the 14th Annual Traumatic Brain Injury Conference, occurring May 2-3 in Washington, D.C., will feature Dr. Damon R. Kuehl from Virginia Tech Carilion, School of Medicine. He will offer a presentation titled "An Update and Lessons Learned from HeadSMART II (HEAD Injury Serum Markers and Multi-Modalities for Assessing Response to Trauma II) and the NIH Funded 'HeadSMART Geriatrics.'"

Significance of Disease Across Age Groups and Clinical Data

"Acute traumatic encephalopathy is a major clinical issue that intersects various age demographics," stressed Dr. Frank Peacock, the lead investigator in the HeadSMARTII trial and esteemed Professor at the Baylor College of Medicine. This suite of presentations emphasizes the extensive clinical data, gauging the BRAINBox TBI test's potential to objectively diagnose and prognosticate concussions for a diverse age group. The instrument marks an innovative step towards fulfilling the urgent need for an objective concussion diagnostic technique that can assess a patient's prognosis immediately after injury.

Strides in Pediatric Trials and Point-of-Care Developments

Donna Edmonds, the dynamic CEO of BRAINBox Solutions, highlighted the remarkable strides the two clinical trials have taken. With patient enrollment expanding rapidly, HeadSMART II aims to attain completion soon. Edmonds underscored the high clinical interest in the trials as the first objective diagnostic and prognostic concussion tests. A pilot study focusing on the pediatric demographic has concluded, paving the way for the final product development designed for youth—specifically those between the ages of 10-18, who are vulnerable to sports-related injuries.

The anticipation is buoyed by promising preliminary data resulting from a collaborative effort, which is poised to enable the blood biomarker component of the test to be administered on a point-of-care instrument and thus, provide accessibility in varied clinical settings, from outpatient clinics to emergency departments.

A Multi-modal Approach to TBI Diagnosis and Prognosis

A highlight of the BRAINBox TBI is its multi-modal nature, integrating clinical and neurocognitive data, reported symptoms, along with blood-based biomarkers incorporating AI algorithms. This fusion yields a precise objective score that gauges the severity of the injury for up to 96 hours post-incident. Further, the generated prognosis report elucidates the probability of injury-related symptoms manifesting at both 30-day and three-month periods following the event.

The HeadSMART II Study's Pivotal Role for Regulatory Clearance

The HeadSMART II study, a cornerstone in BRAINBox Solutions' research endeavors, is a multinational, multisite oversight trial conducted on adult subjects, positioned to support regulatory approval by the U.S. FDA. At this juncture, the trial has seen the enrollment of over 1300 patients with suspected concussions, not to mention additional healthy subjects and trauma controls. Concurrently, the Normative Data Base for NeuroCognitive Assessment has accrued data from an impressive number of over 500 subjects.

Collected trial data will be critical for assessing the BRAINBox TBI test's sensitivity and specificity in diagnosing concussions in juxtaposition to expert clinical analysis, as well as for gauging the sensitivity and specificity of the risk of prolonged symptoms relative to post-concussion syndromes at predetermined temporal milestones.

Geriatric Study Enhancements Through NIH Support

The geriatric-focused study, buoyed by a generous $3.5 million NIH grant, ventures into refining the TBI test with specific calibrations for the geriatric crowd aimed at accelerating diagnosis and prognosis of concussions at the bedside with a singular device. To this end, the study has recorded the enrollment of 200 patients suspected of having suffered a concussion.

About BRAINBox Solutions

BRAINBox Solutions, at the edge of clinical innovation, spearheads the development of the first AI-enabled, multi-modality methodology for the diagnosis and prognosis of what is frequently referred to as a concussion, or Mild Traumatic Brain Injury. The organization is dedicated to setting a clinical benchmark for the diagnosis and management of concussions, delivering insights that can underpin intervention strategies. The brainchild product combines a proprietary panel of patented blood biomarkers quick and easy to read on a point-of-care device or standard lab systems, with neurocognitive assessments, rendering a comprehensive score reflective of injury severity and post-concussion symptoms.

Commanding the helm at BRAINBox Solutions are preeminent physician and scientific leaders in their field, steered by an experienced management team focused on clinical applications.

Explore more about the company and its visionary endeavors at www.brainboxinc.com.

For More Information, Please Contact:

Donna Edmonds

CEO, BRAINBox Solutions, Inc.

Phone: 1‐804‐724‐0009

BRAINBox Solutions remains resolute in delivering innovative solutions for the diagnosis and prognosis of traumatic brain injuries, showcasing a commitment to enhancing patient care across demographics. As they continue to showcase their findings and developments across the globe, their impact on the future of concussion management is poised to be significant and long-standing.

SOURCE

BRAINBox Solutions, Inc.