Executive Summary

Cystic fibrosis (CF) is a complex, multisystem condition driven by mutations in the CFTR gene.  While CFTR modulators have transformed care for many, a significant subset of patients — particularly those with rare or unresponsive mutations — remain underserved.  Even for those benefiting from new therapies, the ability to measure long-term effectiveness, collaborate across sites, and adapt protocols based on real-world outcomes remains limited.

RegenMed Circles addresses these challenges by enabling CF physicians to collect structured, standardized, and HIPAA-compliant real-world data (RWD) directly from clinical care.  This data fuels continuous improvement in treatment, supports innovation in research, and enables new revenue through data licensing.  The result? Better insights, better care, and faster progress — for every person with CF.

Introduction

The CF care landscape is undergoing rapid change.  With the widespread use of CFTR modulators and expanding pipelines in gene and mRNA therapy, care teams have more options than ever.  Yet most CF clinics lack infrastructure to track outcomes across time, measure treatment durability, or collaborate on emerging therapies in real time.

RegenMed Circles was built to close that gap — giving CF clinicians a scalable, seamless way to collect, benchmark, and act on clinical outcome data, while also participating in studies that help advance future treatments.

The Opportunity: Closing The Outcomes Gap

CF is increasingly outcome-driven, but many clinicians still face key barriers to turning clinical observations into actionable data:

• Inconsistent tracking of outcomes like FEV1 change, exacerbation frequency, nutritional status, or mental health indicators
• Limited ability to benchmark patient trajectories against peers nationally or globally
• Minimal infrastructure for contributing to collaborative research or post-market surveillance

As patient needs evolve and research accelerates, structured RWD is no longer optional —it’s essential to unlocking the next phase of CF innovation.  Here at RegenMed, we can build your Circle based on your preference of outcomes measurements through the creation of Scoring Formulas, like the ones pictured below, to help you identify treatment outcome trends.

Regenmed Circles: A Platform For Collaborative Care

RegenMed Circles offer secure, physician-led networks designed to:

• Capture and structure longitudinal CF data with zero disruption to workflow
• Benchmark individual patient outcomes against broader cohorts
• Support collaboration across clinics on emerging therapies, protocols, and real-world validation
• Maintain full data ownership for clinicians and their institutions

Each Circle centers around a specific CF treatment focus or outcome type.  Examples include:

• Longitudinal tracking of CFTR modulator effectiveness by mutation group
• Nutritional outcomes (BMI, weight gain) in pediatric and adult CF
• Use of gene or mRNA therapies in patients with rare genotypes
• Frequency and severity of pulmonary exacerbations
• Mental health and quality-of-life tracking in chronic CF care

Physicians can join existing Circles or propose new ones tailored to the populations they serve or therapies they wish to explore.

Improving Patient Outcomes Through Real-World Evidence

With structured RWD, CF care teams can:

• Refine protocols based on mutation-specific response patterns
• Detect early signs of treatment decline or breakthrough infection
• Adapt care delivery based on long-term patient trends
• Identify subgroups most likely to benefit from emerging therapies
• Collaborate with peers to publish findings and influence standards of care

Circle members receive cohort-level reports, dashboards, and access to de-identified collaborative datasets.  No additional staff or technical infrastructure is required — just better insights from the care you’re already providing.

Monetizing Your Real-World Data

In addition to supporting clinical excellence, RegenMed Circles offer sustainable, physician-led revenue models:

• License de-identified datasets to pharma, biotech, and digital health partners
• Earn up to 85% of data licensing revenue
• Participate in industry-sponsored studies and registry collaborations
• Use funds to reinvest in research, care delivery, or new technologies

Participation also builds a foundation for peer-reviewed publications, conference abstracts, and clinical leadership in the rare disease space.

Call To Action

Cystic Fibrosis care is evolving — and your data can help lead the way.  Whether you're evaluating CFTR modulators, preparing for gene therapy trials, or simply working to understand long-term outcomes in your patients, RegenMed Circles empowers you to track, collaborate, and innovate.

Join a physician-led network that's redefining how we measure success in cystic fibrosis — one dataset at a time.

Visit www.rgnmed.com/circles or contact us to learn how to join or launch your own Circle.

Related white paper: Accelerating Clinical, Research and Financial Innovation In CF Care

Related one sheet: POCs_For_Cystic Fibrosis