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Ozempic™, Wegovy™ and similar “GLP-1” drugs have underscored the importance of peptides. There are over 7,000 known peptides in thehuman body, each with its own characteristics and potential benefits and side effects.The medical literature describes the benefits of peptides for such major health categories as anti-aging, muscle growth and repair, wound healing, anti-inflammatory effects, antimicrobial properties, metabolic regulation,cardiovascular health, immune system modulation, pain management, and weight loss. [1]RegenMed’s Circles regularly support the development of real-world evidence for specific peptides physicians believe may represent promising therapeutic pathways. Such evidence may comprise post-market surveillance for approved drugs, or more structured datasets for other classes of peptides.RegenMed has recently assisted a U.S.-based physician and his co-investigator develop a study protocol and obtain IRB approval for a peptide known as BPC-157 (Body Protective Compound-157). Potential medical uses include sport medicine, gastrointestinal health, and musculoskeletal repair. Through their BPC-157 Circle, RegenMed will also assist with investigator and patient recruitment, ongoing IRB communications, regular investigator reports and collaboration, publication and dataset licensing. In the broad field of healthcare and wellness, there are many dozens if not hundreds of opportunities for disrupting the current expensive, complex and inequitable approach to clinical research. Each of those opportunities is large. Every day, RegenMed is exploiting them with new proprietary and valuable datasets.

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.