Investor Overview
87% of CKD patients are undiagnosed. A routine adult lab workup carries the signal to find them; today it just isn't being connected. NephroSense AI flags hidden kidney risk from routine blood work for clinician review, and supports KDIGO-standard care decisions. Dialysis costs roughly $100,000 per patient per year in Medicare (USRDS); earlier recognition can enable earlier nephrology follow-up, and what that is worth at a given site is a question a pilot has to answer.
We don't replace any tests. We connect existing data faster, so the right patients get follow-up sooner.
Last updated: August 2026
The Model
Evidence Compounds; Access Is What It Buys
Health-system data relationships make a cohort reachable. Sponsor-funded retrospective studies run against it. The publications and external validation that follow are what the next institution can check rather than take on trust — and each turn hardens the platform that opens the next relationship.
- Health-system data relationships
- Institutional agreements, IRB approval and a data use agreement are what make a de-identified cohort reachable at all.
- Sponsor-funded retrospective studies
- A sponsor brings the question and the setting; the analysis runs model-to-data against a cohort that already exists.
- Publications & external validation
- Findings written up, co-authored and replicated on someone else's data become work the next institution can check rather than take on trust.
- Deployable platform & pilots
- Each study hardens the platform, and a site running it in a real workflow is where the next data relationship starts.
Market Opportunity
A $130B+ Problem Hiding in Plain Sight
Chronic kidney disease is one of the most expensive and underdiagnosed conditions in healthcare. Earlier recognition can enable earlier nephrology follow-up and delay progression to dialysis and transplant.
Annual Medicare spending on CKD & kidney failure (USRDS)
US adults with CKD (CDC)
Of US adults with CKD are unaware they have it (CDC)
Medicare cost per dialysis patient per year (USRDS)
Sources: clinical references
Go-To-Market · Two Parallel Tracks
Two revenue tracks de-risk health-system sales
Health systems build durable ARR and supply the clinical data the evidence work runs on; biopharma research contracts can monetize while integration and validation mature. The tracks are sequential in maturity, not two equal cash engines.
Health systems: validate → deploy
Anchor conversations and external validation. Budget on a 6–18 month first-contact-to-contract cycle; do not book unpapered revenue.
Biopharma: sponsor-funded evidence collaborations
Cohort-discovery and retrospective analyses funded from medical-affairs and clinical-development budgets. Research contracts and co-authorship, not software licences — and health-system data is what makes the work possible.
FQHCs, ACOs + kidney VBC
Expand with external validation, references, and a repeatable implementation playbook.
Why the U.S. first
Reimbursement, data access, regulatory clarity — Concentrate commercial proof in one market; keep international relationships warm for later entry.
One operating plan, two buyers: near-term evidence revenue + recurring health-system platform ARR.
Business Model
B2B SaaS & Enterprise Commercialization
Dual-revenue model combining near-term pharma evidence contracts with long-term health system platform ARR.
Target Customers
Federally Qualified Health Centers (FQHCs) and health systems serving high-risk, underserved populations where CKD prevalence is highest and earlier risk identification delivers the greatest clinical and economic value.
Revenue Model
Per-screening SaaS fee with volume-based pricing tiers. Illustrative example: earlier CKD identification and follow-up can help delay or avoid dialysis, which costs Medicare roughly $100,000 per patient per year (USRDS).
EHR Integration
The product runs today on a routine adult panel entered directly or uploaded as a lab report, and returns a PDF report and FHIR R4-shaped output. Embedded EHR deployment — reading results automatically and returning structured risk into the chart — is in development.
Regulatory Strategy
Clinical Decision Support
NephroSense AI is designed as a Clinical Decision Support tool with physician oversight, not a standalone diagnostic.
21st Century Cures Act Exemption
NephroSense AI is designed to qualify for the Clinical Decision Support exemption under the 21st Century Cures Act. We have not yet received FDA classification or clearance; regulatory status will evolve as the product advances through clinical validation. The tool provides risk scores and supporting explanations to assist qualified healthcare professionals. It does not provide diagnoses. All clinical decisions require physician review and independent clinical judgment.
Competitive Advantage
Defensible Moat
NephroSense AI combines four key advantages that are difficult to replicate together.
Works With Existing Labs
No new blood tests or hardware required. NephroSense AI flags hidden kidney risk from a routine adult lab workup and vitals already on file.
Routine-Lab Clinical Decision Support
Primary workflow reads a routine adult lab workup. No additional screening order is needed to generate the prioritization — confirmatory testing follows a flag.
Explainable AI
Every risk score comes with clear reasoning clinicians can review, trust and act on.
FHIR R4 Interoperability
Output is built on HL7 FHIR R4 so results exchange with existing clinical systems using a standard rather than a bespoke interface. Embedded EHR deployment is in development.
Roadmap
Path to Market
Retrospective feasibility demonstrated on a US adult clinical cohort. Independent external validation is in progress and is not yet complete.
Each phase is an evidence gate, not a release date. A phase is marked complete only when the evidence behind it exists; the claims this site makes never run ahead of the gate that has been cleared.
Phase 1
Prototype & FeasibilityComplete
Routine-lab clinical decision support; retrospective feasibility demonstrated on a US adult clinical cohort. Adult-only screening workflow.
Phase 2
Explainability & Clinical FramingComplete
Uncertainty quantification, referral urgency, and clinical considerations to support clinician follow-up decisions. Designed as Clinical Decision Support with physician oversight.
Phase 3
Independent External Validation...In Progress
The active evidence gate is independent external validation on independent cohort data.
Phase 4
Prospective Clinical Evaluation
Prospective evaluation in live clinical workflows, after independent external validation is complete.
Phase 5
Regulatory Pathway
We are pursuing the Clinical Decision Support pathway under the 21st Century Cures Act CDS exemption. NephroSense AI has not been cleared or classified by FDA; regulatory status will evolve as prospective validation advances alongside health-system and payer partnerships.
Diligence starts with the evidence
We share the feasibility write-up, the validation plan and the go-to-market detail on request.
Disclaimer
NephroSense AI is a Clinical Decision Support tool for use by licensed healthcare professionals with physician oversight. It does not provide medical diagnoses and does not replace any laboratory or diagnostic tests. By integrating a patient's existing clinical data faster, it helps clinicians prioritize who needs confirmatory testing and follow-up sooner. All clinical decisions must be made by qualified healthcare providers based on a complete patient evaluation. This page is for informational purposes and does not constitute an offer of securities.