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The New Role of Real-World Evidence (RWE)Real-World Evidence (RWE) has emerged as a cornerstone of modern healthcare innovation, regulatory science, and payer strategy. Once considered supplementary, RWE now informs pivotal regulatory decisions, market access strategies, and post-market evaluations. The U.S. Food and Drug Administration (FDA), through the 21st Century Cures Act and subsequent guidance, has formally embraced RWE — defined as clinical evidence derived from real-world data (RWD) such as electronic health records (EHRs), insurance claims, and patient-generated information.RWE’s legitimacy has been reinforced by landmark regulatory approvals, including Medtronic’s CRT-D device and label expansions for drugs like Ibrance and Tecentriq, all supported by high-quality RWD. Industry and payers alike are accelerating investment in RWE strategies. A 2023 Deloitte survey revealed that 92% of life sciences firms have RWE strategies, with two-thirds planning increased investments. Likewise, payers such as UnitedHealthcare and Aetna are leveraging RWE to drive value-based care.The Imperative for Primary, Validated RWDDespite the growing utility of retrospective datasets, the RegenMed’s recent White Paper argues for the superiority of purpose-collected, prospective RWD. These data sources — gathered directly from clinicians and patients — offer several compelling advantages over administrative or passively collected data:Fit-for-Purpose DesignEMR and claims data, collected primarily for billing, often lack the precision and completeness required for rigorous research. Purpose-built datasets enable the use of validated instruments, structured formats, and contextually relevant clinical endpoints.Clinical NuanceStructured physician reporting captures nuanced clinical insights, including treatment rationale, staging, and intent — data points typically obscured in EMRs.Patient-Reported OutcomesProspective data collection engages patients directly, capturing metrics like pain, functionality, and satisfaction — offering a fuller picture of treatment efficacy than retrospective proxies.Agility and TimelinessReal-time data collection enables swift adaptation to emergent clinical trends, whereas retrospective data sources lag by months or years.Data IntegrityPurpose-collected data allows immediate validation at the point of entry. Structured electronic case report forms (eCRFs) and integrated logic checks dramatically reduce error rates.Regulatory CredibilityHigh internal validity and transparent provenance make prospectively collected RWD more persuasive in regulatory and payer contexts.Circles: RegenMed’s Response to the RWE ChallengeTo meet the demand for validated RWD, RegenMed regularly publishes and executes “Circles” — an ecosystem of statistically robust, domain-specific datasets focused on discrete pathologies, anatomical regions, and standardized outcomes. These datasets are:Built from physician-generated, real-world clinical data.Structured to answer specific scientific or clinical questions.Fully de-identified and HIPAA/GDPR compliant.Designed for flexibility in observational protocol (OP) development.Circles empower clinicians to contribute cases while sharing in dataset monetization, aligning incentives and driving long-term data growth. Importantly, Circles data typically do not require IRB review, as they are gathered during routine care for quality improvement purposes rather than interventional experimentation.Real-World Application: TKA and THA DatasetsThe White Paper includes illustrative Circles reports on Total Knee Arthroplasty (TKA) and Total Hip Arthroplasty (THA), demonstrating Circles’ potential for granular, verifiable insights. These reports exemplify how customized observational protocols, rich clinical detail, and long-term patient-reported outcomes converge to support practice-changing analytics and licensing opportunities.ConclusionValidated real-world data, collected directly from clinicians and patients with rigor and intent, is no longer optional — it is essential. As regulatory bodies, payers, and innovators continue to demand more actionable, credible, and agile evidence, RegenMed’s Circles platform positions itself as a next-generation solution. By aligning clinical insight, scientific design, and economic incentives, Circles transforms real-world data into real-world impact.

BackgroundOn May 16, 2025, the Centers for Medicare & Medicaid Services (CMS) and the Office of the National Coordinator for Health Information Technology (ASTP/ONC) issued a Request for Information (RFI) on the Health Technology Ecosystem. The RFI is gathering input from all healthcare stakeholders on how to modernize the digital health ecosystem for Medicare beneficiaries, focusing on improved patient empowerment, interoperability, and value-based care (VBC). CMS and ASTP/ONC are especially interested in practical ideas, evidence-based suggestions, and real-world examples to guide potential policy updates, future rulemaking, and digital health innovation that is patient-centered, cost-effective, and outcome-driven. Key CMS objectives include:Reduce provider and patient burden related to data access, reporting, and administrative workflows.Encourage development and widespread adoption of real-time, personalized, and secure digital tools.Improve access for patients and caregivers to their health data. Develop secure digital identity credentials for such access.Eliminate barriers to using digital tools in clinical workflows. Standardize and automate documentation and quality measurement. Develop strategies for supporting small/rural practices.Simplify data exchange between providers and payers.Align technology with Alternative Payment Model requirements. Promote adoption of digital tools measuring and improving outcomes. Support VBC organizations with scalable, interoperable infrastructure.This RFI marks a pivotal step in shaping how digital tools and real-world data can transform U.S. healthcare. CMS and ASTP/ONC emphasize transparency, patient empowerment, ecosystem-wide participation, and practical policy refinements to make digital health technology work better — for everyone. These are precisely the goals and capabilities of RegenMed’s technical platforms and associated processes.RegenMed Summary ResponseThe Company’s flagship solution, Circles, is a digital platform designed to collect, structure, and analyze longitudinal health data in a secure and patient-centric way. Key capabilities include:Low-cost, clinically relevant data collection with minimal burden on providers.Supports value-based care by correlating treatments with long-term patient outcomes.Allows patients to access and compare their personal outcomes with similar cohorts.Provides cloud-based, real-time access to longitudinal datasets from any device.Incorporates both conventional and Complementary and Alternative Medicine (CAM) practices, addressing gaps in traditional clinical trial data. See this Article.Empowers clinicians — especially in non-academic settings — to engage in high-quality, outcomes-driven research.Avoids shortcomings of “big data” systems such as clinical irrelevance, poor interoperability, algorithmic opacity, and data ownership disputes. See this Article.Clinically and statistically significant datasets based on verifiable physician-patient interactions, structured around specific anatomical regions, pathologies, treatment protocols, and standardized outcomes assessments.Enabling faster, lower-cost and more impactful medical innovation, especially critical today due to declining public research funding and bias concerns in peer-reviewed literature.Provide high-quality, verifiable data for training reliable AI healthcare models.Supports SODH and health equity through use by any sized provider group, any specialty, in any location.Supports deep and sustained collaboration on any clinical topic among providers and medical scientists across institutional and regional borders.Innovative patient health tokens for highly secure digital access to, and control over, individual longitudinal health records. (See this White Paper.)Ethical, clinical, reputational, and financial motivation to providers to generate clinically and statistically significant real-world evidence. (Physicians-Owned Circles.)This summary captures RegenMed’s overarching position: that real-world, patient- and provider-validated data, structured around long-term outcomes and specific clinical contexts, is the foundation for effective digital health transformation. Their Circles platform is proposed as a model framework for CMS and stakeholders to achieve these goals at scale. RegenMed’s detailed Response can be found in the Federal Register here.

Big Data RWE often relies on fragmented, manipulated sources, with gaps, limited clinical relevance, and unclear ownership. It's costly, opaque, and often disconnected from real-world clinical insights.Solution:Circles Data offers a transparent, verifiable, and clinically relevant approach by sourcing directly from primary sources — physicians, patients, labs — within a secure, closed platform. It captures complete, longitudinal, and context-specific data, ensuring high integrity and meaningful insights.Key Advantages:‍Data Integrity and Verifiability: Direct, timestamped, unmanipulated data from trusted sources‍Completeness: Long-term, correlated patient cases with comprehensive outcomes‍Clinical Relevance: Focused, protocol-specific datasets aligned with real-world practice‍Strong Data Governance: Clear ownership, GCP compliance, and trusted collection methods‍Cost-Effective: Lower costs with minimal burden on clinicians and patients‍Equitable and Profitable: Physicians retain up to 80% of licensing value, boosting revenue & ownership‍Robust Reporting: Unlimited, included reports for deeper insightsChoose quality, transparency, and ownership. Choose Circles:

Peptides are revolutionizing clinical diagnosis and treatment with their high selectivity and favorable side effect profiles. Here are some key insights:Regulatory Approvals: Over 11% of new pharmaceutical entities approved by the FDA between 2016 and 2024 were synthetic peptides. In 2023 alone, peptides accounted for 16.3% of novel therapeutics.Safety and Efficacy: While peptides offer significant benefits, challenges like immunogenicity and off-target effects need careful consideration. Metabolic Disorders: GLP-1 RAs like liraglutide, semaglutide, and tirzepatide are effective in managing type 2 diabetes and obesity, with additional cardiovascular benefits.Oncology: Peptide–drug conjugates (PDCs) and peptide vaccines are innovative approaches in cancer therapy, offering targeted treatment options. Cardiovascular and Neurological Diseases: Peptides show promise in managing heart failure and neurodegenerative diseases like Alzheimer's.Other Applications: Peptides are used in cosmetics for anti-aging effects and as antimicrobial agents to combat antibiotic resistance.

RegenMed is proud to announce that Dr. Dimitrios Tsoukas will act as Principal Investigator for a series of major Physicians-Owned Circles in the fast-evolving field of orthobioligics. These will be the first POCs in Greece. The initial POC Observational Protocol designed by Dr. Tsoukas will generate clinically and statistically significant datasets comparing safety and efficacy of PRP, ADSCs, and BMAC in knee osteoarthritis. His clinical surveys will not only track dosage, injection sites and other key treatment protocol information, but specific products used and delivery approaches. The resulting well-correlated datasets will thus represent substantial value to product manufacturers, payers, researchers, AI models and other licensees. Physician investigators participating in Dr. Tsoukas’s POCs will share 85% of all such license fees. In addition to senior positions in several orthopedic organizations such as ESSKA and ISAKOS, Dr. Tsoukas is the founder of IARMES, which includes other leading orthopedic practitioners in Europe and North America. Moreover, Dr. Tsoukas also teaches and practices in several countries outside of Greece, including Switzerland, Qatar, and the UAE. He is also an Adjunct Professor at the University of Nebraska, Lincoln. As such, RegenMed and Dr. Tsoukas expect to significantly expand international physician participation in his Circles.