Built for a Regulatory Moment That Just Arrived

After 15 years inside and outside FDA-regulated companies, the bottleneck was always the same. The evidence existed. The hospitals had it. But getting to it required months of legal negotiation, data use agreements, HIPAA business associate agreements, and patient data leaving institutions where it was generated. NexusRWE was built to remove that bottleneck.

Every part of the system is designed to eliminate the legal friction that has historically blocked real-world evidence generation. From query approval to result delivery, every step is governed, logged, and auditable from end to end. The audit trail is not an afterthought. It is the foundation, built specifically to give FDA the confidence it needs to rely on distributed real-world evidence in regulatory decisions. Sponsors get the evidence they need. Hospitals keep their data. Regulators get transparency they can trust.

In December 2025, the FDA issued final guidance enabling de-identified, distributed real-world evidence for device regulatory submissions. On December 15, FDA signaled the same shift is coming for drugs and biologics. NexusRWE is among the first platforms built specifically for this framework. The market is large, the timing is right, and the infrastructure did not exist until now.

The Opportunity

The RWE market is growing fast - Real-world evidence is increasingly required for regulatory submissions, post-market surveillance, and label expansions across devices, drugs, and biologics.
The regulatory window just opened - The December 2025 FDA guidance created a new category of compliant evidence infrastructure. Early platforms that meet this standard will define the market.
Hospitals want to participate but could not - Billions in potential RWE value sits locked inside hospital systems. NexusRWE unlocks it without asking hospitals to give anything up.

Why NexusRWE

Patent portfolio covering the core query and aggregation architecture, filed February 2026, with Sandy Estremera-Zink, JD as sole inventor
Active engagement with FDA staff on RWE, rare diseases, and AI/ML
Federated query architecture designed for production-scale deployment across hospital networks, with institutional governance built in from the ground up
First-mover infrastructure designed specifically for the new FDA framework
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