Investor Overview
90% 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. At a fraction of up to $200K/yr in dialysis costs, the ROI speaks for itself.
We don't replace any tests. We connect existing data faster, so the right patients get follow-up sooner.
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.
CKD treatment market
Americans affected
Undiagnosed in early stages
Annual dialysis cost per patient
Adjacent R&D Track
Beyond Kidney
A routine adult lab workup carries signal beyond kidney function. We are pursuing adjacent multi-system risk readouts as an internal research track, not as a current product claim.
~61M
US adults 65+
Census Vintage 2024
~60%
Pre-frail or frail
Bandeen-Roche, 2015 (NHATS)
~$80B / yr
Older-adult fall cost
CDC, 2020
Multi-system reserve and functional-risk research is an internal R&D track at NephroSense AI, not a current product claim. Prospective validation is being designed under research collaborations and grant applications. Nothing in this section reflects current product capability or commercial availability.
Business Model
B2B SaaS for Health Systems
Per-screening fee model aligned with value-based care incentives.
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. Every screening that catches CKD early can save the healthcare system up to $200,000 per year in avoided dialysis costs, creating strong ROI for payers and providers.
EHR Integration
FHIR R4 integration enables zero-friction deployment into existing clinical workflows. NephroSense AI reads lab results directly from the EHR, runs inference, and returns structured risk scores. No manual data entry required.
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 feature-level 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. No new costs, no new workflow.
Routine-Lab Clinical Decision Support
Primary workflow reads a routine adult lab workup. No new orders, no new patient touches, no new EHR forms.
Explainable AI
Every risk score comes with transparent, feature-level explanations giving clinicians clear reasoning they can trust and act on.
FHIR R4 Integration
Standards-based EHR integration enables zero-friction deployment into existing clinical workflows at health systems of any size.
Roadmap
Path to Market
From validated prototype to clinical deployment.
Phase 1
Prototype & ValidationComplete
Routine-lab clinical decision support; feasibility demonstrated on a US adult clinical cohort. Adult-only screening workflow; prospective validation planned.
Phase 2
Explainability & Clinical FramingComplete
Explainability and uncertainty quantification, referral urgency, and feature-level explanations to support clinician follow-up decisions. Designed as Clinical Decision Support with physician oversight.
Phase 3
Pilot Program...In Progress
Deploy at select FQHCs for prospective clinical validation with real patient populations. External validation on independent cohort data.
Phase 4
Regulatory Pathway
NephroSense AI is positioned as Class II clinical decision support -- not a Class III device that requires the heavy FDA (PMA) approval process. We pursue this streamlined CDS pathway, aligned with the 21st Century Cures Act CDS exemption, so health systems can adopt it today while we scale to additional systems and payer partnerships.
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.