87% of US adults with CKD don't know they have it. 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.
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.
Recognition
First place, Innovation Track, DCI Network AI Conference 2026
Milestones for the company, not evidence about the model.
Market Opportunity
A costly 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)
- $130B+
- Annual Medicare spending on CKD & kidney failure (USRDS)
- US adults with CKD (CDC)
- 37M
- US adults with CKD (CDC)
- Of US adults with CKD are unaware they have it (CDC)
- 87%
- Of US adults with CKD are unaware they have it (CDC)
- Medicare cost per dialysis patient per year (USRDS)
- ~$100K
- Medicare cost per dialysis patient per year (USRDS)
Sources: clinical references
Why Upstream, Why Now
The field is asking for the missing first step
Diabetes and high blood pressure are leading causes of CKD. ADA standards call for urine albumin and eGFR testing at least annually in all adults with type 2 diabetes, yet the urine test is often missing in routine care. A 2026 PHTI assessment urges purchasers to prioritize earlier identification and completed lab testing, and a 2026 ISN expert forum emphasizes early, integrated case finding. NephroSense is building the clinician-reviewed prioritization step. Its prospective benefit remains to be measured.
ADA
Standards of Care in Diabetes 2026, Section 11
Assess urine albumin-to-creatinine ratio and eGFR at least annually in all people with type 2 diabetes.
A clinical practice guideline. It does not evaluate kidney decision-support tools.
Read the source (opens in a new tab)PHTI
Virtual Solutions for CKD Management, September 2026
Purchasers should prioritize early patient identification, and solutions should ensure lab testing is completed.
A US assessment of care for diagnosed CKD stages 3 to 5. Diagnosis-only solutions were outside its scope; it did not assess NephroSense.
Read the source (opens in a new tab)ISN
International Expert Forum on cardiovascular-kidney-metabolic health, Kidney International 2026
Participants emphasized early, integrated case finding and joint kidney-cardiovascular risk assessment.
A consensus meeting report, not a test of any product.
Read the source (opens in a new tab)
These sources support the problem and how it should be measured. They do not report NephroSense results.
Go-to-market
Health systems now, biopharma research next
Health systems are the focus today: they build durable platform revenue and supply the clinical data the evidence work runs on. Biopharma research contracts are the second track, built on that foundation. The tracks are sequential, 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.
Business Model
A proposed pricing architecture
Our initial commercial hypothesis for health systems, alongside sponsor-funded evidence studies. Both are proposed and will be tested in paid engagements.
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.
Proposed pricing
Our initial commercial hypothesis: a health-system platform fee tied to covered lives, plus a component tied to each completed confirmatory kidney test. Pricing and buyer economics are proposed and will be tested in paid deployments. 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 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.
NephroSense flags risk
A score with a confidence signal
The clinician reviews
The basis for the score is visible
The clinician decides
Every clinical decision remains the provider's
Competitive Advantage
Where durable advantage comes from
The model creates the first signal. Durable advantage depends on trusted deployment, verified outcomes and rights to learn from each site. We are building those assets through measured clinical workflows.
Works with existing labs
No new test or hardware is needed to generate the flag: NephroSense AI works from a routine adult lab workup and vitals already on file. Confirmatory kidney testing remains necessary.
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.
Visible to the clinician
Every prediction carries an explicit confidence signal, so the basis for the score is visible rather than assumed.
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. Retrospective external testing on an independent US cohort is complete; the result is company-reported, unpublished and not yet peer reviewed.
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
External testing & publication...In Progress
Retrospective external testing on an independent US cohort is complete, by company analysis. The active gate is publication: the manuscript is in preparation and not yet peer reviewed.
Phase 4
Prospective clinical evaluation
Prospective evaluation in live clinical workflows, measuring whether a flag leads to completed confirmatory testing.
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.