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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 is proud to announce that Dr. Marcus Klingenberg will be acting as a Principal Investigator for four separate Physicians-Owned Circles in the field of micronized adipose tissue therapies for musculoskeletal indications. Dr. Klingenberg is an internationally recognized orthopedic surgeon; patients from throughout Europe travel to the BetaKlinik which he co-founded in 2008 in Bonn, Germany. The four separate Observational Protocols will cover MFAT treatment for unilateral knee cases, bilateral knee cases, unilateral hip cases, and bilateral hip cases. They will generate statistically and clinically significant longitudinal datasets, including specific devices utilized, within only a few months. Those proprietary data sets, and resulting license fees, will be owned 85% by participating POC members. RegenMed is already in preliminary discussions for pre-licensing arrangements with MFAT device manufacturers.Dr. Klingenberg’s Observational Protocols will be published shortly on RegenMed’s POC Library Page. Qualifying clinicians interested in joining one more of those POC’s are encouraged to apply.

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.

In the rapidly evolving landscape of healthcare, data has become the new currency. Physicians, as the frontline caregivers, hold a unique position to leverage this data for better patient outcomes and streamlined practices. But why is it crucial for physicians to own their patient data? 1. Enhanced Patient Care: Owning patient data allows physicians to have a comprehensive view of a patient's health history, enabling more accurate diagnoses and personalized treatment plans. 2. Improved Efficiency: With direct access to patient data, physicians can reduce administrative burdens, streamline workflows, and focus more on what matters most—patient care. 3. Data Security and Privacy: By owning the data, physicians can ensure it is stored securely and complies with privacy regulations, building trust with patients. 4. Innovation and Research: Access to robust data sets can fuel medical research and innovation, driving advancements in healthcare technologies and treatments. 5. Empowered Decision Making: Physicians can make data-driven decisions, leading to better outcomes and a more proactive approach to healthcare. At RegenMed, we believe in the power of data ownership. Our platform - Circles - empowers physicians to take control of their patient data, providing the tools and support needed to navigate the complexities of data management. Join Circles today and experience the future of healthcare data ownership:

INTRODUCTION The Circles platform is a patented system through which correlated, verifiable, and longitudinal healthcare datasets are generated. Because the system is turnkey and closed by design, the datasets which it generates are proprietary to the sources/authors of that data. The primary data sources are physicians, laboratories, and patients (including their remote monitoring devices). Healthcare data which is attributable to patients enjoys broad legal protection. Legal and ethical policy make clear that individuals are entitled to exclusive ownership of and control over their personal healthcare data. Such protected health information (PHI) can only be viewed and used by others after explicit and informed consent has been given by the patient. Typically, that consent is only given to healthcare providers for the sole purpose of patient care. Currently, various forms of anonymization and pseudonymization are used to create healthcare datasets which, in theory, are not attributable to individual patients. These so-called anonymized datasets are at the core of the $60+ billion healthcare data analytics market. However, the attempt to dissociate patients’ ownership rights from such a valuable datasets is vulnerable on several fronts:  Many forms of claimed anonymization and pseudonymization are weak. Similarly, databases containing individual healthcare information are regularly accessed by multiple and undisclosed parties, many with poor cybersecurity protection in place.  Medicine is becoming increasingly “personalized” and “precision”. An important part of an individual’s health record is her genomic, proteomic, microbiomics, and other “omics” data. Even if an individual’s name and other information traditionally defined as personal are removed from this data, omics data is by definition highly specific to an individual.  As in other fields, consumers are increasingly aware of the value of their data, whether or not it is anonymized. National policies, legislation, class action litigation, patient advocacy, and other trends will inevitably increase the awareness of individuals with respect to such personal healthcare data. Recognizing these trends, RegenMed is developing blockchain functionality on its Circles platform to provide patients with the option to use public-private key cryptography and distributable ledger technology to secure their PHI. It will further exploit this technology to reward patients with tokens, representing complete longitudinal patient datasets. Those tokens will represent value for their holders in a number of ways, including reduced insurance premiums, access to Circle databases, medical product discounts, etc. Circles will provide similar token issuance to physicians and other key sources of independent longitudinal healthcare datasets. CONCEPTUAL MODEL The idea is to create a token-based system where patients own tokens representing rights or interests in their anonymized health data. These tokens could be monetized, transferred, or managed by the patients themselves. Key Components  Private Blockchain: Ensures data security, integrity, and traceability.  Data Tokens: Digital representations of ownership or value derived from anonymized health data.  Smart Contracts: Automated contracts governing data usage rights, consent, and revenue-sharing mechanisms.  Patient Wallets: Secure interfaces where patients can hold and manage their tokens.  Data Marketplaces (optional): Platforms where patients can sell or license access to their tokens to authorized entities (e.g., researchers, insurers, providers, product manufacturers). Technical Implementation Blockchain Infrastructure Use a private blockchain (e.g., Hyperledger Fabric, Corda) for better control and security compared to public blockchains. Ensure scalability to handle large volumes of health data tokens. Token Design Non-Fungible Tokens (NFTs): Unique tokens representing specific datasets or patient profiles. Fungible Tokens: Tokens representing a general value derived from aggregated or anonymized data. Smart Contracts Automate consent management — ensuring patient consents are recorded and immutable. Enforce revenue-sharing mechanisms — automatically distributing financial rewards to patients when their data is licensed or sold. Provide revocation mechanisms — allowing patients to reclaim ownership or withdraw consent where legally applicable. Security and Privacy Protocols Use zero-knowledge proofs to verify data integrity without revealing the actual data. Implement end-to-end encryption for all transactions involving patient data. Ensure robust identity management to prevent unauthorized access. Legal Considerations Compliance with Illustrative Data Privacy Laws HIPAA (U.S.): Ensure that the initial de-identification process complies with HIPAA's de-identification standards. GDPR (EU): If European data is involved, even anonymized data may require consent if it can be reasonably re-identified. CCPA/CPRA (California): Ensure compliance with consumer rights to control, delete, or transfer their data. Establishing Legal Ownership Current laws do not clearly define patient ownership of de-identified data. The Circles platform will anticipate the inevitable movement towards recognizing such ownership through the following:  Contracts: Clearly define ownership rights and the value associated with tokens.  Data Trusts: Establish legal entities that hold data on behalf of patients and distribute revenues accordingly.  Tokenized Consent Agreements: Ensure that smart contracts are legally binding and enforceable. Ethical and Governance Considerations In dealing with patient healthcare data, ethical considerations are as important as legal ones. Circles functionality will address these considerations as follows:  Patient Empowerment and Consent. Ensure patients have full control over their tokens and can consent to or revoke data usage. Provide transparent reporting of how their data is being used and monetized.  Fair Compensation Models. Implement fair revenue-sharing structures that reward patients proportionally based on the value their data generates. Consider differential pricing where patients with rare conditions may earn more due to higher data demand.  Governance Models. Establish patient advisory boards or token-holder governance structures to ensure ethical use of data. Regularly audit systems and processes for transparency and fairness. CONCLUSION In the fast-evolving healthcare data world, adequate security and proof of ownership of -- and incentives for consent to use -- patient data are becoming pressing societal issues. The patented Circles platform has a strong technical foundation upon which to build efficient and scalable solutions.