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RegenMed is now enabling independent clinicians to earn supplemental revenue and increase practice equity value through Physicians-Owned Circles. POCs are based on a simple premise – manufacturers, payers, self-insured employer groups and other healthcare constituencies regularly license high-quality healthcare datasets. This demand will only accelerate with the growth of AI learning models, where the error rate in healthcare must be close to zero. Independent practitioners are often in the best position to generate the real-world evidence datasets most valued by licensees. Through POCs, they can do so with minimal interruption to normal clinical flow. POC Members, including the Principal Investigator, receive 85% of all license fees generated by those Circles. Each month, RegenMed will publish and organize Physician-Owned Circles across the dozens of pathologies and treatment protocols representing the most valuable datasets in medicine. More information can be found here.

Reapplix, an international wound care company, has recently launched a RegenMed Private Circle aggregating clinical and long-term outcomes data on its personalized diabetic foot ulcer product. The diabetic foot ulcer market value is estimated at $5.2 billion. About 60% of all patients experience a wound that does not heal. If the severity of a wound progresses to grade 4 or 5, the cost of treatment is eight times higher than a grade 1 or 2 wound. For about 20% of patients, treatment ends in amputation within one year.The Reapplix Circle will help the company, its clinical customers, and their patients further support the safety and efficacy of its products.

Less Costly. More Efficient. More Impactful.Clinical Research Is BrokenIt fails to deliver better outcomes. It is expensive and cumbersome. Only the largest of corporations can afford to bring products to market. Supporting data exclude most patient types. Most everyday clinical interventions have no or poor levels of evidentiary support. Social media anecdotes and DTC advertisements have replaced physician-led patient education. The proliferation of medical journals and articles masks a sharp deterioration in the quality of data and reliability of conclusions. Bias, confounding variables, contradictions, and lack of data transparency are common. The consequence is higher healthcare expenditures each year for worse health outcomes.There Is A Better WayReturn to the origins of evidence-based medicine. Clinical/scientific hypotheses based on better care. Meaningful outcomes capture. A sense of health equity. Question, doubt, test. Listen to the data, do not manipulate them. Independence and courage in the face of “experts”. Be alive to unexpected correlations. Establish causation, not association. Collaborate, teach, learn.As simple as possible, but no simpler. Reduce unnecessary costs and complexity. Do the most good for the most patients. Clinical research should not be the right of only the well-funded few. It should not be episodic. It should be the right, the professional responsibility, of each healthcare practitioner. Clinical research is integral to the everyday practice of medicine.Real-World Evidence ProgramsThe most important clinical/scientific data are to be found in everyday physician/patient interactions. Identify them, capture them, analyze them. Relate standardized outcomes measures to specific hypotheses and proposed endpoints. Include all patients; planned as well as unexpected correlations will emerge. Observe good clinical practice. Ensure full data integrity and auditability. Collaborate efficiently with peers, scientists and experts. Analyze, question, present, publish, improve, refine, expand. Do not interrupt normal clinical flow; harness it. For your benefit, for the benefit of your patients, for the advancement of medicine.Let Us HelpJoin an existingCircle. (A Circle is an indication-and/or procedure-specific research protocol.) Or work with us to create your own.We will handle practice customization, case creation, patient enrollment and follow-up, report generation, onboarding fellow investigators, and other administrative tasks.Collaborate with peers andexperts around the world.HIPAA, GDPR, Part 11 compliant. Multilingual. Aggregated data and reports accessible anytime from any device.Own and control yourdata. Present, publish, share, license,develop funding.Fully scalable from small studies to large multi-center trials.‍Copyright© 2024 Regenerative Medicine LLC‍

CMS Mandate Total hip and knee arthroplasties are the most common procedures for degenerative joint disease -- about 1.3 million annually in the U.S. These procedures are therefore a major component of healthcare payer reimbursements. In order better to control those reimbursements, the U.S. CMS will now include in its Hospital Inpatient Quality Reporting Program the “Total Hip Arthroplasty/Total Knee Arthroplasty Outcome-Based Performance Measure” (THA/TKA PRO-PM). Key elements of the mandate highlighted by the CMS include:  The THA/TKA PRO-PM was developed for the hospital setting to promote collaboration and shared decision-making between patients and providers across the full spectrum of care.  CMS seeks to advance patient-centered measurement with as little burden as possible to both providers and patients. The THA/TKA PRO-PM is the first PRO-PM of its kind that incorporates the patient’s self-assessment of their pain and function directly in the measure outcome. Hospitals failing to achieve the necessary THA/TKA PRO-PM thresholds will see substantial reductions in CMS reimbursement rates. Those thresholds include:  All Medicare Fee-for service (FFS) patients aged 65 years or older with eligible inpatient elective, primary THA/TKA procedures.  Collecting and submitting complete data on at least 50 percent of eligible THA/TKA patients. Voluntary THA/TKA PRO-PM data submissions to CMS began in October 2023. Mandatory data submissions will begin September 30, 2026. Important Considerations Systems Hospital systems are often poorly equipped properly to track and monitor long-term outcomes in a manner compliant with the CMS requirements. Their IT platforms are usually designed for fee-for-service reimbursement, revenue management, marketing and other objectives unrelated to clinical outcomes monitoring. Outcomes capture, if it occurs at all, is limited to patient satisfaction, research studies and other episodic contexts. Cost Failure to meet the new CMS TKA/THA rules can result in significant reductions in payments to hospitals. However, the cost of compliance can also be expensive – both in initial investment and ongoing expense. Interrupting Clinical Flow The responsibility of long-term outcomes is likely to fall on already over-burdened clinicians and their staff. This may lead to interruption of other clinical responsibilities, worsening professional morale, and unlikely attainment of the minimum CMS guidelines. Patient Engagement Long-term outcomes capture and analysis represent an opportunity for deeper patient engagement and early detection of possible adverse events. They can also drive a culture of more informed clinical decision-making. Publication When correlated with relevant clinical intervention data, long-term outcomes are the basis of statistically significant journal articles, conference presentations and educational materials. Dataset Monetization Longitudinal datasets complying with Good Clinical Practice and 21 CFR Part 11 will represent substantial intellectual property value, as well as licensing and other monetization opportunities. Future Payer Requirements Healthcare is steadily moving from fee-for-service to “value-based”. The CMS THA/TKA mandate represents a focus on outcomes-driven reimbursement which will soon affect all medical specialties and procedures. A hospital will be prudent to establish an outcomes capture system which not only accommodates TKAs and THAs today, but can do so for all other procedures. Moreover, as indicated properly implemented those longitudinal datasets can represent a profit center. A Compliant Program RegenMed regularly works with provider groups to establish Real-World Evidence Programs which are tailor-made to meet CMS’s THA/TKA PRO-PM mandate. Key elements include:Robust, patented technical platform and associated processes competitive with much more expensive solutions.HIPAA, GDPR and Part 11 Compliant.Outcomes capture representing excellent clinician and patient user experience. Does not interrupt clinical flow.Low cost, flexible and highly scalable. Supports GCP data collection. Powerful reporting features. Generate statistically and clinically significant longitudinal datasets ready for publication, presentations and monetization. Processes include onboarding of clinicians and staff. Patient enrollment. Inherently supports collaboration among healthcare professionals, laboratory technicians, and others. All datasets are owned by client, and accessible 24/7 from any device. Ability to accommodate any standardized or custom outcomes assessment score. Open APIs support integration with other systems. To find out more, please visit rgnmed.com or contact us.

General GCP stems from the work of the International Council for Harmonisation of Technical Requirements for Pharmaceuticals for Human Use (“ICH”). Section 6 of the ICH Efficacy Guidelines deals with GCP, and can be found here. These guidelines have been adopted in virtually all developed countries, including the U.S. GCP concepts are self-evident, and consistent with the manner in which all good physicians behave. They can be summarized as follows:“All clinical trials should be conducted in accordance with ethical principles, sound scientific evidence and clear detailed protocols. The benefits of conducting trials should outweigh the risks. he rights, safety and well-being of trial participants are of paramount importance and these should be preserved by obtaining informed consent and maintaining confidentiality. The care must be given by appropriately qualified personnel with adequate experience. Records should be easily accessible and retrievable for accurate reporting, verification, and interpretation. Investigational products should be manufactured according to Good Manufacturing Practice.” (See here.) GCP And Real-World Evidence GCP is relevant to real-world evidence studies. In its December 2019 guidance on the use of RWE for regulatory decision- making, the FDA explicitly stated:“Many of the considerations and best practices for generating RWE are derived from the same principles that govern generation of clinical evidence from traditional clinical studies, which are generally referred to as good clinical practice (GCP).” GCP CertificatesA study sponsor depends on GCP compliance. They typically require that each investigator (or his/her organization) holds a GCP certificate. GCP certificates are issued by independent parties. The CITI Program is commonly used. Programs are available for organizations as well as individuals. The current cost is about $130 per person, and the course requires about 4 hours of time.GCP certificates provide value for independent physicians. They support the ability to participate in industry-sponsored studies. They offer legal protection. They give comfort to patients. They satisfy typical IRB requirements. They provide a useful checklist for study protocols. A clinician will want to refer to GCP in the context of any article, post or conference presentation based on a study design and/or results.InCytes™, Circles And GCPMuch of GCP depends on proper, auditable record-keeping. This and other GCP elements are accommodated by inCytes™ and associated processes.‍Reference Materials https://www.ncbi.nlm.nih.gov/pmc/articles/PMC3097692/pdf/biij-04- e5.pdf. (Historyof GCP.)https://www.fda.gov/media/174819/download. (FDADecember 2023 Draft Guidance on real-world evidence studies.)https://www.ich.org/page/efficacy-guidelineshttps://www.youtube.com/watch?v=6pAtb4X1UPU (FDA presentation on data integrity.)https://www.fda.gov/about- fda/center-drug-evaluation-and- research-cder/good-clinical-practicehttps://www.fda.gov/science-research/clinical-trials-and-human-subject-protection/regulations-good- clinical-practice-and-clinical-trialshttps://www.fda.gov/science-research/clinical-trials-and-human-subject-protection/good-clinical-practice-gcp-inspection-collaboration-international-regulators-drug-development