Evidence Vault

Executive SummaryOsteogenesis imperfecta (OI) presents lifelong clinical challenges for patients and physicians alike — from managing fracture risk to navigating bisphosphonate therapy and surgical interventions. Yet few providers have access to longitudinal, structured outcome data to guide treatment decisions or assess long-term effectiveness.RegenMed Circles changes that by giving physicians the tools to collect compliant, real-world data (RWD) directly from clinical care — without disrupting workflows. With Circles, OI specialists gain insights that lead to better protocols, stronger patient outcomes, and evidence-based care pathways tailored to rare bone disease.While Circles support revenue generation through data licensing, the core mission remains clinical: empowering communities of providers to advance care through shared data, shared insights, and shared impact.IntroductionOsteogenesis imperfecta (OI) is a rare genetic disorder characterized by increased bone fragility, which often requires a lifetime of complex care. Patients with OI may receive bisphosphonate infusions to improve bone density, undergo corrective surgeries to manage fractures or deformities, or benefit from physical therapy and emerging regenerative approaches. However, despite advancements in medical treatments, clinicians continue to face significant uncertainty in managing OI.Questions persist about which patients respond best to bisphosphonates over time, how fracture frequency may change with growth or puberty, and what the long-term functional outcomes are of early orthopedic interventions. These critical issues are difficult to answer with certainty, and many providers must rely on fragmented notes, anecdotal recall, or small, siloed studies to inform their high-stakes decisions. In a field where treatment protocols and patient care are still evolving, it’s clear that the need for better, more structured data has never been greater.The Opportunity: Closing The Outcomes GapOI care spans years, disciplines, and interventions — but structured outcome tracking is virtually nonexistent. Physicians often struggle to:Standardize assessments of pain, function, and quality of lifeTrack treatment response across growth stagesAnalyze long-term effects of pharmacologic and surgical interventionsShare data or collaborate with peers on new protocolsThis creates missed opportunities to learn from real-world outcomes and improve care at scale. As precision medicine advances and regulators seek more real-world evidence, longitudinal, de-identified datasets are becoming critical — not optional.‍Regenmed Circles: A Platform For Collaborative CareRegenMed Circles are secure, physician-led networks built to collect, analyze, and share structured outcome data — designed specifically for rare and complex conditions like OI.Through Circles, OI providers can:Capture patient-reported outcomes and clinical events across visitsTrack response to bisphosphonate therapy, surgeries, and rehab over timeCompare anonymized data against aggregate benchmarksPropose or join disease-specific registries and research cohortsEach Circle is tailored to clinical priorities — like fracture incidence, mobility scores, or growth metrics — and can incorporate custom scoring formulas and patient-reported outcome measures (PROMs) built in collaboration with care teams.Physicians 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 plansMonitor long-term changes in mobility, function, and painDetect adverse events early and respond proactivelyShare findings with peers, researchers, and familiesCircle members receive interactive dashboards, cohort-level reports, and access to collaborative datasets.These tools empower 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.‍Monetizing 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 ActionWhether you specialize in pediatric bone health, genetic orthopedics, or multidisciplinary rare disease care, RegenMed Circles can help you turn everyday care into evidence-based advancement.Visit www.rgnmed.com/circles or contact us to learn how to launch or join an OI Circle tailored to your clinical priorities.‍

Executive SummarySMA treatment is rapidly evolving, providing patients with increasing therapeutic options. However, challenges remain in consistently measuring treatment outcomes and facilitating real-time collaboration among clinicians. RegenMed Circles offer SMA specialists a platform to collect standardized, compliant real-world data (RWD) from routine clinical practice. The goal is to generate deeper insights, refine treatment strategies, and ultimately improve outcomes for every individual with SMA.While potential for data sharing exists, the central aim of RegenMed Circles is to foster clinician-led communities dedicated to accelerating advancements in SMA treatment and promoting clinical excellence. By participating, clinicians can enhance patient care while benefiting from comprehensive benchmarking tools, peer collaboration, and opportunities for professional development.IntroductionThe spinal muscular atrophy (SMA) treatment landscape has been revolutionized in recent years. From gene therapies and antisense oligonucleotides to small molecule SMN protein enhancers, clinicians now have more therapeutic options available than ever before. However, despite these significant clinical advancements, the infrastructure to systematically collect meaningful, comparative outcome data across these diverse treatments often lags behind.This limitation hinders the ability of clinicians and researchers to optimize treatment protocols, benchmark effectiveness across different interventions, and contribute robust data to the broader understanding of long-term outcomes in SMA. RegenMed Circles was established to address this critical need — providing a platform for the SMA community to seamlessly track and analyze patient outcomes at scale.The Opportunity: Closing The Outcomes GapSMA care is increasingly outcome-focused, yet few treatment centers possess real-time, structured insights into their own performance, much less how it compares to others. SMA care teams often face challenges in:Standardize outcome tracking across providers and protocolsAnalyze trends over time or across treatment typesFacilitating knowledge sharing and collaboration on clinical advancements within the SMA communityAs individuals with SMA and their families become more informed about outcomes and as payers increasingly require robust data, the necessity for structured, real-world evidence is becoming fundamental — 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 in SMA.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. Physicians 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 SMA 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.Monetizing 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 doctors treating Spinal Muscular Atrophy a powerful way to elevate care and lead innovation. Whether you're optimizing supportive care protocols, or working with disease-modifying therapies — Circles make your outcomes work for you.Join a growing network of physician-led innovators who are shaping the future of SMA care with real-world evidence.Visit www.rgnmed.com/circles or contact us to learn how to join or launch your own Circle.

Executive SummaryCystic 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.IntroductionThe 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 GapCF 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 indicatorsLimited ability to benchmark patient trajectories against peers nationally or globallyMinimal infrastructure for contributing to collaborative research or post-market surveillanceAs 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 CareRegenMed Circles offer secure, physician-led networks designed to:Capture and structure longitudinal CF data with zero disruption to workflowBenchmark individual patient outcomes against broader cohortsSupport collaboration across clinics on emerging therapies, protocols, and real-world validationMaintain full data ownership for clinicians and their institutionsEach Circle centers around a specific CF treatment focus or outcome type. Examples include:Longitudinal tracking of CFTR modulator effectiveness by mutation groupNutritional outcomes (BMI, weight gain) in pediatric and adult CFUse of gene or mRNA therapies in patients with rare genotypesFrequency and severity of pulmonary exacerbationsMental health and quality-of-life tracking in chronic CF carePhysicians 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 EvidenceWith structured RWD, CF care teams can:Refine protocols based on mutation-specific response patternsDetect early signs of treatment decline or breakthrough infectionAdapt care delivery based on long-term patient trendsIdentify subgroups most likely to benefit from emerging therapiesCollaborate with peers to publish findings and influence standards of careCircle 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 DataIn addition to supporting clinical excellence, RegenMed Circles offer sustainable, physician-led revenue models:License de-identified datasets to pharma, biotech, and digital health partnersEarn up to 85% of data licensing revenueParticipate in industry-sponsored studies and registry collaborationsUse funds to reinvest in research, care delivery, or new technologiesParticipation also builds a foundation for peer-reviewed publications, conference abstracts, and clinical leadership in the rare disease space.Call To ActionCystic 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.

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