Real-World Evidence Infrastructure

Real-world evidence already exists. The challenge is getting to it.

NexusRWE generates regulatory-grade real-world evidence from hospital networks, designed to protect patient privacy throughout. Built for the FDA's landmark December 2025 distributed data framework.

FDA December 2025 Guidance · Medical Devices · Drugs & Biologics guidance in development
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The Problem

Hospital data could unlock faster approvals.
Until now, it couldn't leave the building.

Every day, hospitals generate data that could support medical device approvals — outcomes, safety signals, real-world performance. That evidence already exists. But privacy regulations, liability concerns, and IT constraints have made it nearly impossible to share. Approvals stall, cost more, and sometimes fail on evidence that was there all along.

In December 2025, the FDA issued final guidance removing the requirement for identifiable patient-level data in real-world evidence submissions. De-identified, distributed datasets may now be considered for device regulatory decisions — a meaningful shift for sponsors who have long been locked out of this data.

Note: The December 2025 guidance applies to medical devices. FDA has indicated it intends to consider parallel updates for drugs and biologics.

This isn't a data shortage.

It's an infrastructure problem — and the regulatory environment is beginning to reflect that.

How It Works

Each hospital keeps its data.
Only results travel.

NexusRWE uses a federated query architecture: analyses run behind each hospital's firewall, on their own hardware, under their own governance. The goal is that nothing leaves the institution except encrypted, de-identified summary results.

01

Query Dispatch

Pre-approved, audited queries are sent to participating hospital nodes. Each query is reviewed by the institution's governance team before running.

02

Local Execution

Analysis runs entirely behind the hospital's own firewall. Patient records never leave the institution. Hospitals deploy a lightweight containerized node with no data egress required.

03

Encrypted Results

Only de-identified, encrypted summary results return to the coordination server. No patient-level data, no records, no identifiers.

04

FDA-Ready Package

A tamper-proof audit trail and submission package auto-assemble, structured for FDA, EMA, and PMDA requirements.

Who It's For

Two sides of the same network.

Regulatory-grade evidence.
A fraction of the timeline.

Traditional centralized data licensing takes six to twelve months and still leaves exposure around data provenance and patient consent. NexusRWE generates the same quality of evidence, with a cleaner legal footprint and a built-in audit trail formatted for submission.

"The evidence you need is already in hospital systems. We help you use it — without asking hospitals to hand it over." — Sandy Estremera-Zink, Founder & CEO

Where NexusRWE Creates Value
Post-market safety surveillance — continuous monitoring across a live hospital network, without waiting for periodic data pulls or registry updates.
External control arms — generate a comparison population from real-world data to support device submissions where a randomized trial is impractical.
AI/ML model validation — validate algorithms against geographically distributed patient populations without centralizing any data.
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Contribute to research.
Keep your data.

Patient data never leaves your institution. NexusRWE deploys as a lightweight containerized node behind your firewall. Your governance team approves every query before it runs, and you retain full control.

  • Patient records remain on your infrastructure at all times
  • Governance approval is required for every query, with no automatic execution
  • Lightweight containerized deployment, minimal IT footprint
  • Compensation is based on computing resources used, structured to align with anti-kickback and Stark law requirements
  • De-identified summary outputs only, with no patient-level data transmitted
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The Team

Built by people who've done this before.

Sandy Estremera-Zink
Sandy Estremera-Zink, JD
Founder & CEO
15+ years in FDA-regulated industries

15+ years inside FDA-regulated companies, including Abeona Therapeutics, Corcept Therapeutics, and Atara Biotherapeutics. CIPP/US certified privacy professional. Two provisional patent applications filed February 2026, with Sandy as sole inventor. Stanford Law AI Strategy certificate (in progress), with deep working familiarity with FDA submission requirements and the regulatory frameworks NexusRWE is built around.

Rob Wynden
Rob Wynden, PhD
Co-Founder & CTO
20+ years in healthcare data infrastructure

Six years at UCSF as an NIH-funded principal investigator, building federated data networks across 100+ hospitals with 50+ published studies. He founded Aloha Health, a federated query engine deployed across 50+ trial sites with 10,000+ studies processed. He was previously VP Engineering at goBalto (acquired by Oracle), where he scaled engineering from 3 to 40 and reduced study startup time by 60%.

Why NexusRWE

What makes NexusRWE different.

⚖️

Patent-Pending Architecture

Two provisional patent applications covering the core query and aggregation architecture are currently pending, with Sandy Estremera-Zink, JD as sole inventor.

🏛️

Active Regulatory Engagement

NexusRWE has engaged with FDA staff focused on real-world evidence, rare diseases, and AI/ML, which informs how we think about submission architecture and compliance.

🚀

First-Mover Infrastructure

The December 2025 FDA guidance formalized a new category of privacy-preserving evidence infrastructure. NexusRWE is among the first platforms designed specifically for this emerging category.

🏥

Proven Federated Network Experience

Our CTO has deployed federated query infrastructure across 100+ hospitals and 50+ clinical trial sites, an architecture proven in production at UCSF and at Aloha Health.

Get In Touch

Ready to talk?

Whether you are evaluating evidence generation, exploring network participation, or considering an investment, we would like to hear from you.

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