Reported in BioSpace: Bioetech, Pharmaceuticals and Clinical Research News
Within a few months, Prolight Diagnostics has moved from an initial evaluation to both a development agreement and a supply agreement with the US company BRAINBox Solutions. To many Swedish investors, BRAINBox is still a relatively unknown name. Yet its planned FDA submission could open the US market for Prolight’s point-of-care platform Psyros and establish for the first time an objective test to aid in the diagnosis and prognosis of concussion.
A difficult injury to diagnose
Concussion remains one of the most challenging diagnoses in emergency care throughout the world. The injury rarely shows up on a conventional scan, and the assessment relies heavily on the patient´s own account. Computed tomography detects acute bleeding but misses the subtle cellular damage typical of a concussion.
According to BRAINBox, US public hospital data states more than five million patients annually are specifically evaluated in emergency departments for concussion, also known as mild traumatic brain injury (mTBI) or acute traumatic encephalopathy (ATE). An additional significant number are simply categorized as “Unspecified Injury of Head,” and around 95 percent of those who were evaluated remain undiagnosed. Without an objective diagnosis, many leave without a clear answer. Some go on to develop lingering symptoms such as headaches, cognitive difficulties, fatigue or depression, and an injured brain is more vulnerable to a second impact.
TBI market growing faster than troponin
For Prolight the collaboration means stepping into entirely new territory. The company’s Psyros platform has so far primarily been developed for troponin within acute myocardial infarction diagnostics. According to Customer Market Insights, the global troponin market is expected to grow by 12,6 per cent annually to reach USD 4,2 billion by 2033.
The global market for biomarkers linked to TBI (traumatic brain injury) was valued at just over USD 1 billion in 2024. According to Grand View Research it is expected to grow by 18.8 per cent annually to reach USD 4.7 billion by 2033. Key drivers are a rising number of injuries, increased awareness leading to more patients seeking a diagnosis, demand for rapid point-of-care testing, and more personalised care.
From evaluation to supply agreement
The collaboration between Prolight and BRAINBox gained momentum this spring after an analytical evaluation of three biomarkers using a 260-patient sample from their proprietary sample bank. The samples were a subset of the more than 2000 available from BRAINBox’s ongoing, HeadSMART II pivotal clinical study. The results showed that the markers could be transferred quickly to the Psyros platform with high analytical precision.
In July 2026, the companies signed an agreement covering development of advanced multiplex cartridges that analyse all three biomarkers simultaneously, along with software and the initial purchase of pilot instruments. In September, a supply agreement for Psyros instruments and cartridges followed, for the antcipated first year supply post-FDA clearance and market launch in the US. The company also plans to file for in vitro diagnostic regulatory (IVDR) clearance in the EU.
Recentlly, Prolight reported an initial purchase order from BRAINBox under the supply agreement announced in September 2026. The order value amounted to approximately SEK 19,9 million (2 million USD). The order covers commercial products for BRAINBox’s diagnostic and prognostic solution for TBI, which incorporates Prolight’s point-of-care platform Psyros. The purchase order was placed to secure delivery ahead of BRAINBox´s planned US launch.
Diagnosis and prognosis in one score
BRAINBox Solutions is based in Richmond, Virginia, and is led by its experienced diagnostic founder Donna Edmonds. Its product franchise, BRAINBox TBI, differs from pure biomarker tests by measuring both the biological and functional impact. The test combines three components along with demographic data: a panel of patent protected, blood-based protein biomarkers, a digital cognitive test, demographic data, and the physician’s clinical assessment. The neurocognitive segment is being integrated with certain components from BrainCheck, Inc.
A machine learning model weighs the results into a single risk score, much like the established risk models cardiology uses for chest pain. The system is designed to answer two questions: whether the patient has a brain injury, and how high is the risk is of long-term symptoms. The diagnostic part is intended for use up to 96 hours after the injury, while the prognostic components of the study set estimates the risk of lingering symptoms up to three months from the presenting injury. The company also has a signficant body of clincial samples from an earlier study measuring subjects up to 6 months post-injury as well as subjects from a geriatric cohort.
FDA has granted BRAINBox TBI Breakthrough Device Designation. The designation provides closer dialogue with the FDA, the opportunity to agree in advance on data requirements and clinical study design, and prioritised review of the marketing application, as well as potential reimbursement benefits from the U.S. Centers for Medicare & Medicaid Services (CMS).
The pivotal HeadSMART II study
The regulatory submission will be supported by the pivotal HeadSMART II study, which is designed to evaluate sensitivity and specificity for both the acute diagnosis and the prognosis of long-term symptoms. The study is led by prominent emergency physicians and neurologists in the US and has now enrolled more than 2,000 patients. In parallel, studies are running in older populations alongside studies adapted for children.
BRAINBox Solutions founder comments
To get a deeper insight into BRAINBox Solutions and the ongoing activities, BioStock contacted CEO and founder Donna Edmonds.
Your data indicates that roughly 95 per cent of concussions go undiagnosed. How much of that gap can be closed by a more precise objective test at the point of care?
Our current clinical findings, published in JAMA in October 2025 suggest we may be able to identify the up to 1/3 or more of the patients who presented that continue to have symptoms at 30 days post injury. A point-of-care device can be useful for monitoring suspected patients for post concussive syndrome and continuing to follow them as needed.
Blood-based concussion diagnostics already exist on the market. What distinct clinical advantages does your multi-modal approach offer compared to standalone biomarker tests?
The current individual biomarkers are non-specific for brain injury and do not take into consideration the category or location of cells which can be affected. Functional testing and other specific demographics are required to improve the sensitivity and specificity of the test and therefore the score it delivers. The score, which integrates the biomarkers with functional testing along with clinical assessment and demographic data, is the first to provide objective measures for concussion and long-term symptoms.
Your diagnostic score relies on a machine learning model combining blood, cognition and clinical assessment. How do you ensure the algorithm remains robust and accurate across highly diverse patient demographics?
Ensuring that an algorithm performs accurately and reliably across a diverse patient population requires an evidence-based approach to model development, validation, and clinical safety. Our algorithms are developed on a large, representative, high-quality training dataset, and their performance will be validated on an independent dataset drawn from a demographically diverse cohort, demonstrating that the algorithm remains robust to demographic variation. The resulting diagnostic score is intended to support, not replace, clinical judgment. To use it appropriately, clinicians need a clear understanding of its intended use, the patient populations in which it has been validated, its known limitations, and the uncertainty associated with its outputs. When a patient falls outside the validated population or the input data are unreliable, the system should clearly communicate that limitation.
Given the breadth of our biomarker portfolio we are developing tests specifically for geriatric and pediatric populations.
Securing reimbursement is often the most demanding hurdle for new diagnostics in the US. How are you positioning the health-economic case for payers ahead of commercial rollout?
There are already established codes in place for Multi-Marker Assays based on Algorithms we can rely on. Added reimbursement codes are in place under the now established CPT category of Neuro Category 1 of CPT/CLFS Reimbursement codes. We have also conducted Health Economic studies to demonstrate the benefit of the appropriate diagnosis, patient disposition, and appropriate follow up.
Emergency departments have relied on CT scans for decades to rule out severe head trauma. Aside from securing reimbursement, what do you anticipate will be the biggest challenge in actually changing the ingrained clinical routines of emergency physicians?
Following the rapid uptake of cardiac markers, where I joined the clinical leadership in establishing the standard of care, the key elements are publications and direct education.
With 12 publications on our work to date and several more in process, they become the foundation. We actively participate in and have podium presentations at the key clinical and laboratory meetings, all utilizing Principal Investigators from our 27 sites in the US and New Zealand.
You selected Prolight’s Psyros platform for the point-of-care biomarker analysis. What factors drove that decision?
After doing feasibility and analytic work with several other devices, the Psyros Platform was the most reliably sensitive and had the best reproducible results. The fact the company has also demonstrated they can measure up to 4 markers on a single panel creates the architecture for a series of tests which span the full neurology continuum of injury and disease. Each panel then can be complemented by the relevant functional testing to contribute to the requirements for our full portfolio, which to date, consists of 14 families and 23 issued patents in the space.
You have now completed enrollment of over 2,000 patients in HeadSMART II. What does the upcoming timeline look like regarding final data analysis, FDA submission, and expected market launch?
Given our decision to contract Prolight as our Point of Care Partner, we are scheduling our first “Pre-Submission” meeting with FDA shortly to introduce them, and gain final insights into adjustments they may suggest, as we prepare to complete the training set analysis and finalize the validation on the device.
Following validation and FDA market, clearance the US launch will commence with our committed early adopters.