The Future of Post Concussion Intelligence

Objective. Blood-based. Actionable.

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The Hidden Scale of Concussion in America

The true scope of concussions and traumatic brain injuries (TBIs) in the U.S. is often underestimated, with official reports capturing only a fraction of the actual incidence. Here's a look at the disparity:

The "Official" Recorded Numbers

Based on healthcare administrative data from Emergency Department visits, hospitalizations, and deaths, the CDC reports:

~2.8 Million TBI-related events annually.

The "True Burden" (Recent 2025 Survey Data)

In 2025, the CDC released a landmark study (Daugherty et al.) that utilized self-reported national surveys. This approach allowed for the capture of concussions that were never reported to hospitals, including those treated in primary care, urgent care, or not treated at all. These findings reveal a significantly higher prevalence:

The actual number is estimated to be 17 to 30 times higher than hospital records indicate.

Youth (under 18)

Approximately 1 in 10 children (10%) sustained a concussion or TBI in a 12-month period.

Adults

Approximately 1 in 8 adults (12.5%) sustained a concussion or TBI in a 12-month period.

Total Estimated Count: When these percentages are applied to the U.S. population, it suggests that tens of millions of concussions, as many as 40 million events may occur annually, a dramatic increase from the 2.8 million events previously cited.

This significant discrepancy underscores a massive unmet clinical need for objective, scalable diagnostic tools across all concussion care settings.



The Challenge in Neurodiagnostics Today


Subjective Assessment

Current concussion evaluation relies heavily on symptom reporting and clinical observation. Athletes may underreport symptoms to return to play faster. Cognitive testing varies widely in sensitivity and specificity.

This creates dangerous gaps in clinical decision-making, particularly in time-sensitive scenarios where objective data is critical for athlete safety and long-term neurological outcomes.

Limited Biomarker Access

Traditional neuroimaging captures structural damage such as fracture, bleeding, infarction and edema, but often misses functional injury at the cellular level. Blood based FDA-approved biomarkers like UCH-L1 and GFAP are intracellular proteins and only released extracellularly when cells are severely damaged. Therefore, current biomarkers provide only limited temporal windows and lack sensitivity for recovery assessment for mild concussion.

The absence of longitudinal tracking tools leaves clinicians without clear recovery trajectories, making return-to-activity decisions inherently uncertain and potentially risky.

Introducing ConcussionTRAKâ„¢: Objective Brain Injury Intelligence

ConcussionTRAK leverages advanced advanced biomarker profiing to provide clinicians with precise, repeatable insights into brain injury status and recovery progression.

Blood-Based

Minimally invasive sample collection compatible with standard clinical workflows and point-of-care settings

Objective Data

Quantitative biomarker profiles that remove subjectivity from injury assessment and recovery decisions

Longitudinal Tracking

Serial monitoring capability enabling true recovery trajectory analysis and personalized return protocols

How ConcussionTRAKâ„¢ Works

The ConcussionTRAK platform transforms a simple blood draw into actionable neurological intelligence by monitoring post-injury molecular cascades to track recovery or disease progression, and is designed for real-world clinical environments.

01

Blood Collection

A small, teaspoon-scale volume of blood can be collected either by standard venipuncture performed by trained phlebotomists or through self-collected capillary blood (e.g., fingertip sampling) using compatible collection tubes. Samples remain stable for processing under established protocols, enabling flexible logistics across diverse clinical settings.

02

ConcussionTRAK assay

Our proprietary technology measures plasma levels of brain-derived exosomes and associated surface biomarkers.

03

Biomarker Analysis

When the brain is injured, various biomolecules are released locally to initiate recovery cascades or to trigger neuroinflammation. These biomolecules largely remain within the brain and are not readily released into the bloodstream. However, NanoSomiX scientists discovered that these biomolecules associate with nearby exosomes and subsequently enter the circulation. By monitoring changes in these biomolecules on the surface of exosomes, post-injury molecular cascades in the brain can be assessed through a blood test.

Why Our Exosomes Provide Superior Neurological Insight

Exosomes are nanoscale extracellular vesicles secreted by various cell types throughout the body. Because their molecular cargo reflects that of their parent cells, exosomes are considered a form of liquid biopsy for target tissues such as cancer and have been extensively studied over the past decades.

NanoSomiX is a pioneer in the discovery of brain-derived exosomes in peripheral blood and holds broad patent protection in this area. These exosomes originate from neurons and glial cells in the central nervous system and cross the blood–brain barrier, providing a unique molecular window into neurological processes that are inaccessible to conventional blood biomarkers.

Unlike most exosome research, which focuses primarily on exosomal cargo, the ConcussionTRAK platform leverages exosomes as vehicles for capturing locally released biomolecules, enabling analysis of tissue-specific microenvironments. For example, blood tests that measure inflammatory cytokines are widely used as indicators of systemic inflammation, but they do not reveal the anatomical source of that inflammation. In contrast, detecting cytokines on the surface of brain-derived exosomes directly indicates that inflammation is occurring in the brain.

This novel conceptual framework and its applications are protected by multiple issued patents and pending patent applications.

Clinical Applications Across the Care Continuum

Sports-Related Concussion

Objective data supporting return-to-play decisions, reducing reliance on symptom concealment and enabling safer athlete management protocols.

Military & Blast Injury

Longitudinal tracking for service members exposed to explosive forces or repeated subconcussive impacts during training and deployment.

Emergency & Acute Care

Prognostic information in emergency departments managing motor vehicle accidents, falls, and other traumatic presentations.

Recovery Monitoring

Serial testing to track healing progression, identify persistent dysfunction, and optimize rehabilitation strategies based on objective molecular evidence.

What Sets ConcussionTRAKâ„¢ Apart

Objectivity Over Subjectivity

ConcussionTRAK eliminates dependence solely on patient-reported symptoms and observer-dependent cognitive testing. Quantitative biomarker profiles provide reproducible, unbiased data that standardizes assessment across providers and settings.

Scalable Blood-Based Platform

Compatible with existing phlebotomy infrastructure and clinical laboratory workflows. Self-collection of capillary blood at injury sites. No specialized imaging equipment or lengthy neuropsychological batteries required, enabling deployment across diverse care environments from sidelines to hospitals.

Longitudinal Intelligence

Designed for serial monitoring from injury through full recovery. Baseline, acute, and follow-up testing creates personalized recovery curves that inform individualized return-to-activity timelines and detect incomplete healing.

Neuro-Specific Precision

Focused biomarker panel targeting brain-derived exosomes and their neurological signature. Greater specificity than general inflammatory or structural markers, reducing false positives from systemic injury or other confounding conditions.

Built on Rigorous Scientific Foundation

ConcussionTRAK is powered by translational research originating from NanoSomiX, a leader in exosome-based biomarker discovery and validation. The platform leverages years of foundational work characterizing brain-derived exosomes and their molecular signatures in neurological injury and disease.

Our biomarker panels have undergone extensive research to validate and establish sensitivity, specificity, and reproducibility across diverse patient populations. Ongoing clinical studies continue to expand the evidence base supporting ConcussionTRAK's utility in concussion, subconcussion, and TBI management.

The technology integrates proprietary assay principle, advanced molecular profiling,. This multi-layered approach ensures that results reflect true neurobiological status rather than technical artifacts or non-specific signals.

Meet the ConcussionTRAK Team

David Cohen

Multi-exit entrepreneur spanning media, environmental, technology, and security sectors. Successful track record with early stage go-to-market strategies, commercializing and positioning companies leading to exits.

Bill Liatsis

Experienced technology entrepreneur with focus in FinTech, Auto, and Healthcare. Recently built and sold CreditIQ to Cars Commerce (NYSE: CARS) in 2021.

Marcel Reece

Former NFL fullback and 4× Pro Bowler After retiring from playing, Reece transitioned into NFL front-office leadership, serving as Senior Vice President & Chief of Staff with the Las Vegas Raiders among other business endeavors.

Darden Bateau

Veteran CFO and operations leader with deep M&A, risk, tax, legal, and compliance experience. Set up and operated a >$1B family office at 14th&I. CFO at a $7B/year oil company. Six years at Deloitte & Touche, and operating leader at several early-stage ventures.

Gene Nestro

Global financial executive with over 35 years of experience. Gene has previously served as Chief Financial Officer for a publicly traded fiber-optics technology leader. He specializes in advanced financial systems, M&A integration, and corporate governance.

Masato Mitsuhashi, MD, PhD

Pediatrician and molecular technology expert. Former CSO at Hitachi Chemical Research Center and associate professor at UC Irvine. Pioneer in exosome isolation and characterization techniques.

Dennis Van Epps, PhD

R&D executive with experience across academia and industry. Former tenured professor at University of New Mexico Medical School and VP positions at Baxter Healthcare, Nexell Therapeutics, CancerVax and Allergan. Over 140 publications and 20+ patents.

John Osth, MBA

Experienced medical/scientific executive with roles spanning CEO, President, CFO, and R&D leadership. Former President of Baxter Healthcare's Immunotherapy Division and CEO of genomics startup Celula, Inc.

Jeff Phillips

Jeff brings 32 years of government affairs expertise, cultivating deep ties with local, state, and national officials, plus NCAA leaders. He excels in sports league dynamics, strategic development, and launching new programs.

Scientific Publications

Acute Brain Injury Research:

  1. Mitsuhashi M, Van Epps D et al. White Matter Matters: New Approach to the Brain's Hidden Half Using Circulating Oligodendrocyte-Derived Extracellular Vesicles. Cells. 2025 Nov 12;14(22):1771. doi: https://pmc.ncbi.nlm.nih.gov/articles/PMC12651410/. PMID: 41294823; PMCID: PMC12651410.
  1. Edwardson MA, Mitsuhashi M, Van Epps D. "Elevation of astrocyte-derived extracellular vesicles over the first month post-stroke in humans." Scientific Reports (2024) 14:5272. https://doi.org/10.1038/s41598-024-55983-w
  1. Hotta N, Tadokoro T, Henry J, et al. "Monitoring of Post-Brain Injuries By Measuring Plasma Levels of Neuron-Derived Extracellular Vesicles." Biomarker Insights. 2022;17. https://pubmed.ncbi.nlm.nih.gov/36324609/
  1. Kawata K, Mitsuhashi M, Aldret R. "A preliminary report on brain-derived extracellular vesicle as novel blood biomarkers for sport-related concussions." Front. Neurol., 12 April 2018. https://doi.org/10.3389/fneur.2018.00239

Additional publications spanning Alzheimer's disease, Parkinson's disease, ALS, and other neurological conditions demonstrate the broader platform capabilities. Link to full publication list at: https://www.concussiontrak.com/publications. Patents can be viewed at: https://www.concussiontrak.com/patents