What BRAINBox Solutions does

BRAINBox Solutions, Inc. is a privately held Delaware C-corporation, headquartered in Richmond, Virginia, developing an AI-enabled, multi-modality diagnostic and prognostic platform for mild traumatic brain injury (concussion / mTBI). The company's lead product, BRAINBox TBI, combines a proprietary panel of patented blood biomarkers (including β-synuclein, GFAP, neurogranin, von Willebrand Factor, astrotactin-2, MT3, and NSE) with a tablet-based neurocognitive assessment and clinical data, fused through proprietary machine-learning algorithms into a single integrated BRAINBox TBI score. The test is designed to aid diagnosis of concussion up to 96 hours post-injury and to provide a prognostic report on the likelihood of post-concussive symptoms at 30 days and up to 3 months, with an additional variant under development for differential diagnosis of TBI vs. neurodegenerative dementias in elderly populations. The platform is intended to run on both a proprietary point-of-care instrument (being co-developed with Prolight Diagnostics' Psyros single-molecule-counting platform) and on standard laboratory systems, supported by a patent portfolio of 22-24 issued patents worldwide.

BRAINBox is pre-revenue and pre-commercial, with commercial launch contingent on FDA submission following completion of the HeadSMART II pivotal trial (more than 2,000 patients across 18+ U.S. sites plus planned UK and New Zealand expansion). The company received FDA Breakthrough Device Designation in June 2019 and is currently positioned for a U.S. regulatory submission with peer-reviewed evidence published in JAMA Network Open in October 2025. Capitalization totals approximately $34 million to date, drawn from a $23 million Series A (Bioventures Investors-led, 2020), an ongoing Series B (Genoa Ventures-led, targeting approximately $18.5 million), a $3.5 million NINDS SBIR grant for the geriatric program, plus prior Virginia Catalyst and GE-NFL Head Health Challenge grants.

The go-to-market model combines direct enterprise sales to emergency departments, Level I trauma centers, urgent care, and specialty clinics (under newly appointed Chief Product and Commercial Officer Richard H. Noel, May 2026), with platform-channel distribution through the Prolight Diagnostics POC partnership and a test-to-treat ecosystem built jointly with Oragenics pairing BRAINBox diagnostics with the ONP-002 intranasal therapeutic. The planned revenue model is an instrument-plus-consumables razor-and-blade structure, with pricing not yet publicly disclosed. BRAINBox was spun out of ImmunArray in October 2018, inheriting biomarker IP originally licensed from Johns Hopkins University School of Medicine (Jennifer Van Eyk and Allen Everett).

Name

BRAINBox Solutions

Legal name

BRAINBox Solutions, Inc.

Website

https://brainboxinc.com

Company type

Private

Founded year

2018

Operating status

Operating

Headcount range

11–50 employees

Short description

BRAINBox Solutions is a pre-commercial, AI-enabled diagnostics company developing a multi-modality blood biomarker and neurocognitive test (BRAINBox TBI) to diagnose concussion and predict post-concussive symptom risk, targeting emergency departments, trauma centers, urgent care, sports medicine, military, and geriatric / pediatric populations.

Ownership category

akta.pro rank

Headquarters

HQ city

Richmond

HQ country

United States

HQ region

North America

Offices1 record

Markets served

GTM type

B2B

Offering type

Software

Cost components

Technology or R&D, Personnel, Operations, Marketing or Sales, Infrastructure, Supply Chain

Revenue model

1. Diagnostic Instrument Sales: Future revenue from sales/placement of the BRAINBox point-of-care instrument that runs TBI-associated blood-based biomarker panels. Targeted at emergency departments, urgent care, and outpatient clinical settings.
2. Consumables / Per-Test Reagent Cartridges: Recurring revenue from consumable biomarker test cartridges / lab-based panels used on the BRAINBox platform or standard laboratory systems. High-margin consumable stream supporting the installed base of instruments.
3. Strategic Platform / Co-Development Partnerships: BRAINBox-funded development programs with platform partners (e.g., Prolight Diagnostics Psyros cartridge) and test-to-treat partnerships (e.g., Oragenics) creating joint development and potential future licensing / royalty revenue.
4. Pre-Commercial / No Current Product Revenue: Company is pre-revenue and pre-commercial; commercial launch of BRAINBox TBI test is pending FDA submission following completion of the pivotal HeadSMART II trial (more than 2,000 patients). To date, capital has come from Series A, Series B, SBIR grants, NFL/GE Head Health Challenge grants, Virginia Catalyst, and other equity and grant funding.

Pricing tiers

Go-to-market motion4 records

Distribution channels5 records

Marketing channels7 records

Core offering

BRAINBox Solutions develops AI-enabled, multi-modality diagnostic and prognostic tests for concussion (mild traumatic brain injury). The lead product, BRAINBox TBI, combines a proprietary panel of patented blood biomarkers with tablet-based neurocognitive testing, integrated via proprietary machine learning algorithms to produce a single diagnostic score (up to 96 hours from injury) and a prognostic report of post-concussive symptom likelihood at 30 days and 3 months. The platform is designed for deployment on a proprietary point-of-care instrument or standard laboratory systems, with product variants tailored to adult, geriatric, and pediatric populations.

Product overview

BRAINBox Solutions is developing a single unified multi-modality diagnostic platform anchored by its lead product BRAINBox TBI, an AI-enabled concussion (mild traumatic brain injury) diagnostic and prognostic test that combines proprietary blood biomarker panels, neurocognitive testing, and clinical data into a single integrated score. The platform architecture spans multiple product variants addressing distinct patient populations: the adult BRAINBox TBI (lead, currently in pivotal HeadSMART II trial for FDA submission), the BRAINBox Geriatric TBI Test (equilibrated for elderly patients to differentiate TBI from dementia, NIH-funded), and the BRAINBox Pediatric TBI Test (in pilot/pivotal planning for 10-18 year olds). The platform is delivered through two instruments — a BRAINBox Point of Care Instrument for rapid bedside use (being integrated with Prolight Diagnostics' Psyros POC platform) and standard laboratory systems. BRAINBox is also building a test-to-treat ecosystem through a partnership with Oragenics to combine its diagnostic capabilities with ONP-002 intranasal therapeutic, and has secured FDA Breakthrough Device Designation for the BRAINBox TBI test.

Differentiator

Problem solved

Functional benefit

Brands

• BRAINBox TBI: Company's lead multi-modality diagnostic and prognostic product that combines a panel of proprietary blood biomarkers with neurocognitive testing to deliver a single integrated score characterizing injury severity and post-concussive symptom risk.
• BRAINBox ATE Test

Products and services

• BRAINBox TBI AI-enabled, multi-modality diagnostic and prognostic test for concussion (mild traumatic brain injury). Combines a proprietary panel of patented blood biomarkers with tablet/mobile neurocognitive testing, integrated via proprietary AI algorithms to generate a single BRAINBox TBI score for diagnosis up to 96 hours from injury and a prognostic report of post-concussive symptom likelihood at 30 days and up to 3 months. Currently completing pivotal HeadSMART II trial (n>2,000) to support FDA submission.
• BRAINBox Point of Care Instrument

Quantifiable outcome

• HeadSMART II pivotal trial enrolled 2,000+ subjects across 18+ U.S. clinical sites (plus UK/NZ) to support FDA submission.
• +4 more outcomes

Segments6 records

Ideal customer profiles5 records

Technology focussed Yes

API detail

Has API

No

API docs

API detail

Core technology

AI maturity

App detail

Integration1 record

AI capability6 records

Feature7 records

Partnerships

Ten partnerships are on record, tiered flagship poc technology partner, flagship test-to-treat partner, supporting pediatric study partner, core clinical research partner, flagship clinical research partner, core clinical research site, supporting clinical research site, core biomarker ip partner and supporting technology partner.

• Prolight Diagnosticsflagship poc technology partnerStrategic or Co-development Partner · 30 March 2026BRAINBox-funded collaboration with Prolight Diagnostics to integrate BRAINBox's TBI biomarkers into Prolight's Psyros single-molecule-counting point-of-care platform using a multiplex-enabled, dried-reagent cartridge. Initial evaluation demonstrated strong analytic performance across a unique combination of three brain injury biomarkers; the partners are advancing to evaluation of all three assays on a 260-patient sample bank from HeadSMART II. BRAINBox fully funds the next-phase program.
• Oragenics, Inc. (NYSE American: OGEN)flagship test-to-treat partnerStrategic or Co-development Partner · 10 February 2025Strategic partnership to develop the first intranasal therapy for mTBI / concussion, creating a comprehensive 'trigger-to-treat' platform that combines BRAINBox's multi-marker/multi-modality diagnostic capabilities with Oragenics' intranasal therapeutic candidate ONP-002. BRAINBox's diagnostic tools are planned for use in upcoming Phase IIa trials for precise patient selection and real-time monitoring of therapeutic efficacy.
• USA Hockeysupporting pediatric study partnerStrategic or Co-development Partner · 9 February 2023Funded collaboration with USA Hockey to evaluate biomarkers in blood and saliva for concussion in elite girls and boys high school hockey players. The study supports BRAINBox's pediatric test development by providing objective evidence of neurocognitive changes due to head impacts.
• Carilion Clinic / Virginia Tech Carilion School of Medicinecore clinical research partnerImplementation/ SI/ Consulting PartnerClinical collaboration partner on the NIH-funded HeadSMART Geriatrics trial under the leadership of Vice Chair of Emergency Medicine Damon Kuehl, MD. Site for the HeadSMART II pivotal trial in adult mTBI patients.
• Baylor College of Medicine (Dr. W. Frank Peacock, Principal Investigator)flagship clinical research partnerImplementation/ SI/ Consulting PartnerBaylor College of Medicine's Department of Emergency Medicine (Henry JN Taub) hosts Principal Investigator Dr. W. Frank Peacock IV, MD, FACEP, for the HeadSMART II pivotal trial and serves as a primary clinical research site.
• Stony Brook Hospital (State University of New York) — Dr. Adam Singercore clinical research siteImplementation/ SI/ Consulting PartnerHeadSMART II clinical trial site under the leadership of Adam Singer, MD.
• University of Pennsylvania — Dr. Danielle Sandsmarkcore clinical research siteImplementation/ SI/ Consulting PartnerHeadSMART II clinical trial site under the leadership of Danielle Sandsmark, MD, PhD.
• John Peter Smith Hospital (Integrated Emergency Services) — Dr. James d'Etiennesupporting clinical research siteImplementation/ SI/ Consulting PartnerHeadSMART II clinical trial site under the clinical leadership of James d'Etienne, MD, FACEP, MBA.
• Johns Hopkins University School of Medicine (Dr. Jennifer Van Eyk and Dr. Allen Everett)core biomarker ip partnerStrategic or Co-development PartnerLicensing partner for novel protein biomarkers for the diagnosis and monitoring of therapy across acute brain injury. The VERACIS laboratory, a wholly owned subsidiary of ImmunArray USA, was located on the Johns Hopkins campus. Patent-protected biomarkers developed with Johns Hopkins researchers form a core part of BRAINBox's IP portfolio.
• Quanterixsupporting technology partnerTechnology or IntegrationQuanterix and ImmunArray teaming up to address neurodegenerative disease: Quanterix gained access to ImmunArray's brain injury biomarker portfolio and ImmunArray gained access to Quanterix's digital biomarker technology (2016).

Scale indicators18 records

Recent moves7 records

Expansion highlights8 records

Emerging players

• Cytox: Emerging player in blood-based biomarker tests for neurodegenerative disease (Alzheimer's, Parkinson's). Comparable to BRAINBox's planned extension into neurodegenerative-disease differential diagnosis in elderly populations using overlapping biomarker panels.
• Quanterix: Ultra-sensitive single-molecule-array biomarker detection platform used in neurology and TBI biomarker research (including prior collaboration with ImmunArray/BRAINBox). Competes with BRAINBox on biomarker detection sensitivity and on enabling research-grade and emerging clinical applications in brain injury and neurodegeneration.

Broad incumbents

• Roche Diagnostics: Global diagnostic incumbent operating cobas and Elecsys immunoassay platforms plus the recently acquired LumiraDx POC business (where incoming BRAINBox CPO Richard Noel previously led integration). Competes with BRAINBox across both central-lab and POC channels and has the commercial scale to rapidly displace emerging TBI biomarker entrants.
• bioMérieux: Global in-vitro diagnostics company operating the BioFire molecular diagnostics platform. Previous employer of BRAINBox's incoming CPO. Competes broadly in clinical diagnostics including hospital and emergency-department settings where BRAINBox TBI would be deployed.
• Siemens Healthineers: Major diagnostics and imaging company operating the ADVIA Centaur and Atellica immunoassay platforms used in central laboratories and emergency-department-adjacent settings. Competes with BRAINBox on established hospital lab channels for biomarker-based TBI testing.
• Abbott Diagnostics: Large diagnostic incumbent that acquired Banyan Biomarkers' TBI assets and operates the i-STAT point-of-care platform widely deployed in U.S. emergency departments. Competes with BRAINBox on hospital formulary access, POC deployment channels, and integrated chemistry/immunoassay platforms used in TBI workups.

Others

• Meso Scale Diagnostics: Developer of high-sensitivity multiplexed biomarker detection platforms (Meso Scale Discovery / SECTOR instruments). Provides enabling biomarker detection technology used in TBI and neurology research and an indirect competitor/partner for biomarker-based clinical applications like BRAINBox TBI.

Direct peers

• Banyan Biomarkers: Direct competitor developing blood-based biomarker tests for traumatic brain injury (the proprietary BAI test). Most directly comparable to BRAINBox TBI in terms of product, indication, and clinical-trial-driven regulatory strategy. Banyan's TBI assets were acquired by Abbott, increasing competitive pressure from a much larger diagnostic incumbent.
• Prolight Diagnostics: POC platform developer of the Psyros single-molecule-counting instrument with multiplex-enabled dried-reagent cartridges. BRAINBox's POC technology partner and a comparable POC diagnostics player building biomarker-detection platforms for decentralized clinical settings.
• LumiraDx: Point-of-care diagnostic platform company (acquired by Roche in 2024) that built a POC platform combining immunoassay and molecular testing. Comparable to BRAINBox's planned POC instrument strategy and an analog for the commercial trajectory BRAINBox could pursue in the ED/urgent-care channel.

Market position

Strengths5 records

Weaknesses5 records

Competitive moat6 records

Key risks6 records

Key highlights7 records

Customer concentration

• LinkedInlinkedin.com/company/brainbox-solutions-inc

Compliance4 records

Revenue estimate

Valuation estimate

Number of profiles

Profiles11 records

Funding overview

Funding rounds6 records

Investors11 records

Funding detail is available on the Subscription and Enterprise plan.Contact sales →

M&A

Investments

M&A and investment is available on the Subscription and Enterprise plan.Contact sales →

Frequently asked questions about BRAINBox Solutions