Evidence Vault

RegenMed’s Physicians-Owned Circles (POCs) offer an innovative solution to some of the most significant challenges in rare disease research. Rare diseases — of which there are approximately 7,000 — affect 350 million people globally, including 25 million Americans. Shockingly, 95% of these conditions have no approved treatments, and one-third of the 15 million U.S. children affected will not live past age five. The financial burden is equally staggering, with costs estimated at 15 times those of more common diseases.POCs are physician-led collaborations focused on indication- and treatment-specific observational studies. Each POC operates under an Observational Protocol (OP) tailored to a specific anatomy, pathology, and treatment, with longitudinal outcomes tracked over time. All data generated are compliant with HIPAA, GDPR, and FDA Part 11 standards, ensuring the highest levels of quality, security, and clinical relevance.For physicians, POCs offer the opportunity to collaborate globally with peers, achieve earlier and more accurate diagnoses, follow evidence-based protocols, and engage patients more deeply. Members also share 85% of licensing revenues generated from the data, while gaining professional opportunities for publishing research and presenting at conferences.Industry stakeholders — such as pharmaceutical companies, clinical researchers, and value-based care organizations — also benefit. POCs provide access to validatable, clinically relevant datasets at a fraction of traditional costs. The data supports regulatory submissions, enables adaptive trial designs without placebo arms, and enhances post-market surveillance, all while minimizing risks like data gaps and ownership disputes that are common in “big data” solutions.By enabling multi-center, global collaboration with clear clinical hypotheses and real-world outcomes, RegenMed’s POCs are poised to accelerate innovation, improve patient outcomes, and transform the economics of rare disease research.

Executive SummaryFertility medicine is at the forefront of clinical innovation, offering patients an expanding array of treatment options. Yet many clinics struggle to measure outcomes, track long-term success, or collaborate with peers in real-time. RegenMed Circles changes that by giving fertility physicians the tools to collect structured, standardized, and compliant real-world data (RWD) from everyday clinical care. The result? Better insights, improved protocols, and enhanced outcomes — for every patient.While revenue potential through data licensing is a key feature, the primary mission of RegenMed Circles is to create physician-led communities focused on accelerating treatment advancement and clinical excellence. Through Circle participation, clinicians improve patient care while gaining access to rich benchmarking tools, peer collaboration, and professional growth opportunities.IntroductionThe fertility landscape is rapidly evolving. From IVF and IUI to cryopreservation and emerging regenerative therapies like PRP, clinics are offering more options than ever before. But despite technological and clinical advancements, most practices lack the infrastructure to collect meaningful, comparative outcome data across these treatments.This limits a clinic’s ability to improve protocols, benchmark against peers, or contribute to broader research. RegenMed Circles was built to close this gap — giving fertility providers a seamless way to track and analyze outcomes at scale.The Opportunity: Closing the Outcomes GapFertility care is outcome-driven, but few clinics have access to real-time, structured insights about their own performance — let alone how it compares to others. Clinics often struggle to:Standardize outcome tracking across providers and protocolsAnalyze trends over time or across treatment typesShare knowledge or collaborate on clinical advancementsAs patients become more outcome-aware and payers demand more data, the need for structured, real-world evidence is becoming essential — not optional.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 CareRegenMed Circles are secure, collaborative networks that enable clinics to:Collect and structure real-world treatment outcomes with zero workflow disruptionCompare anonymized results with national benchmarksCollaborate with peers on protocols, research, and publicationsKeep full ownership and control of their patient dataEach Circle focuses on a specific treatment domain or outcome type, examples include:IVF cycle success and implantation ratesIUI outcomes and ovulation induction effectivenessEgg and embryo freezing protocolsPRP for ovarian and endometrial supportMale fertility treatment response and trendsPhysicians can join existing Circles or propose new ones based on their areas of interest.Real-world evidence is becoming essential — not optional.Improving Patient Outcomes Through Real-World EvidenceBy collecting outcomes data in a structured, longitudinal format, clinics gain powerful tools to improve care:Identify top-performing protocols and refine treatment plansEnhance cycle prep strategies and optimize timingShare de-identified insights across clinical teamsTrack long-term patient success—not just short-term metricsCircle members receive interactive dashboards, cohort-level reports, and access to collaborative datasets. These tools empower fertility providers to continuously improve outcomes — without hiring new staff or disrupting care delivery. See below for some examples of what the platform looks like and how it can be used to assess patient outcomes.Patient PortalInvestigator PortalMonetizing Your Real-World DataIn addition to improving care, RegenMed Circles create sustainable revenue through compliant, de-identified data licensing. Clinics can:License aggregate datasets to pharma, device, or digital health partnersEarn up to 85% of licensing revenueParticipate in studies that shape future treatment developmentRevenue is just the beginning. Circle participation supports scientific publications, conference presentations, and national recognition for clinical leadership.Call to ActionCircles give fertility clinics a powerful way to elevate care and lead innovation. Whether you're optimizing IVF protocols, testing regenerative approaches like PRP, or working to better understand male fertility — Circles make your outcomes work for you.Join a growing network of physician-led innovators who are shaping the future of fertility care with real-world evidence.Visit www.rgnmed.com/circles or contact us to learn how to join or launch your own Circle.Contact UsRegenMed | www.rgnmed.comcircles@rgnmed.com