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TABLE OF CONTENTSBACKGROUNDREAL-WORLD EVIDENCE AND CIRCLESRELEVANCE OF CIRCLES TO TRACK II HEALTHCARE DIALOGUECONCLUSIONFOR FURTHER INFORMATIONFOOTNOTESAbstractGeographic, linguistic, resource and even political constraints impede effective collaboration among US and Chinese healthcare professionals. This is an unfortunate situation for global healthcare, given the clinical and scientific leadership in each country. Recognizing this, senior representatives from both sides have identified foundational elements needed to improve healthcare conditions in China and the US. This article identifies a realistic path towards executing those elements.BackgroundThis past summer, the National Committee on US - China Relations and the National School of Development convened “Track II” discussions on healthcare [1]. Senior Chinese and US representatives from industry, academia and clinical practices met face-to-face for the first time in four years.The “Consensus Agreement” resulting from those discussions highlighted the following goals relevant to healthcare issues pertaining to both countries:Meaningful and sustained collaboration among Chinese and US healthcare professionals (“HCP’s”) on specific areas of mutual interest.Joint design and execution of traditional clinical trials, supported by real-world evidence.Use of modern electronic platforms for healthcare data capture, aggregation, analysis, and clinical decision-making.Developing standards of care for broader population samples, including the underserved.Integration of primary care protocols with those of specialty, social and community practices.Improving opportunities for, and methods of communications among, HCPs of both countries.Use of modern digital technology to improve patient understanding, engagement, and compliance.The following sections propose a cost-effective yet clinical-grade approach to achieving these objectives. Real-World Evidence and CirclesReal-world evidence (“RWE”) underlies many of the recommendations of the Consensus Agreement. RWE is essential to standards of care, better clinical decisions, value-based medicine, product improvement, patient engagement, and reimbursement. [2] It is relevant to any pathology, indication, medical product, or clinical/scientific interest.RegenMed is a product-agnostic company led by internationally recognized physicians and scientists. The Company’s sole focus is generating demonstrable and sustained clinical and scientific value from RWE on behalf of its Clients.RegenMed’s Circles integrate the technical platforms [3] and processes [4] which drive RWE value opportunities in a minimally burdensome manner. Circles are used around the world by providers, medical societies, industry, and other healthcare constituencies. [5] Relevance of Circles To Track II Healthcare DialogueTranslating broad Track II objectives into achievable reality is challenging. But modern technology and processes dedicated to supporting cross-border HCP collaboration allow concrete progress in an economical and minimally burdensome manner.Objective: Real-World StudiesCircles are used for registries and various forms of trials and studies [6], both on a stand-alone basis and to support more narrowly defined trials.Objective: Genuine HCP CollaborationCircles’ user-experience focuses on sustained collaboration. They inherently support multi-lingual/cultural work across institutional and national borders.Objective: Standards of Care For Underserved PopulationsThe Circles platform is low-cost, accessible 24/7 from any device by patients and clinicians, and easy to use. Its UX emphasizes patient engagement, compliance and comprehension of medical conditions and proposed treatment paths.Objective: Modern Digital TechnologyCircles are based on patented technical platforms. [7] These enable the efficient and economical collection, aggregation and analysis of real-world healthcare data, and the generation of clinical and scientific value from those data.Objective: Improve Amount and Quality Of CommunicationsCircle Reports, Circle Hours [8], Circle Academies, Join-A-Circle, Publication and similar functionality support meaningful, secure and sustained communications among Circle Members on any clinical/scientific topic of interest. ConclusionThe potential for world-wide healthcare advances achievable through meaningful collaboration among US and Chinese clinicians and scientists is enormous. This is the basic premise of the Track Healthcare II Dialogue between the two countries.Realizing that potential is ultimately up to day-to-day interactions among those clinicians and scientists. Circles are a cost-effective and “shovel-ready” solution to support that interaction. For Further Information US – China Track II Healthcare DialogueRgnMed.com/Circles/GeneralJoin/Start A Circle KnowledgeBaseLinkedInLatestContact UsFootnotes 1 Track II diplomacy or "backchannel diplomacy" is the practice of "non-governmental, informal and unofficial contacts and activities between private citizens or groups of individuals, sometimes called “non-state actors”. Wikipedia.2 See also Registries for Evaluating Patient Outcomes: A User's Guide: 4th Edition, AHRQ, U.S. Department of Health and Human Services.3 The patented clinician-facing inCytes™ and patient-facing Benchmarc™ technologies.4 Patient enrollment, post-procedure long-term outcomes capture, report generation, publication, ongoing collaboration support, publication, industry funding, IRB support and similar administrative elements can be handled by RegenMed.5 Circles use cases are further described on the company’s Latest and LinkedIn pages.6 Pragmatic, observational, quality improvement, regulatory, post-market surveillance, “n of 1”, investigator-initiated and other forms of studies and trials.7 U.S. patent number 11720567, Method and System For Processing Large Amounts of Real-World Evidence. RegenMed is developing a family of patents and other intellectual property relating to healthcare RWE. This includes generative AI.8 Livestreamed and recorded video conferences among Circle Members to discuss observations, correlations, best-practices, and other matters.Copyright © 2023 Regenerative Medicine LLC

BackgroundBHRT’s are estimated to account for one third of menopausal hormone therapy prescriptions. 1 Since the Women’s Health Initiative Hormone Therapy Trials, 2 the debate over relative safety and efficacy between conventional hormone therapeutic approaches and BHRT’s for women remains vibrant. Similar discussion surrounds BHRT’s andropause and other male-specific conditions. As stated by The American College of Obstetricians and Gynecologists 3: “Compounded preparations are not regulated by the FDA. Although technically all compounded prescription drug preparations could be considered unapproved new drugs, the FDA has adopted a policy of enforcement discretion, allowing legitimate preparation of compounded formulations to be regulated by state boards of pharmacy, with a provision of stepping in when dangerous practices must be addressed and when drug manufacturing occurs under the guise of compounding. There are currently no specific regulations by the FDA on what constitutes a legitimate claim for compounded drug preparations. In general, states regard compounding to be part of the practice of pharmacy. In addition, individual states’ pharmacy acts usually permit other licensed practitioners (e.g., physicians, nurse practitioners, and others with prescriptive authority) to engage in the practice of pharmacy compounding for their own patients.”BHRT’s are thus an important manifestation of a much broader healthcare trend -- personalized/precision medicine. 4 The Need For BHRT StudiesRWE studies and registries are needed to focus on many safety and efficacy issues specific to bio-identical hormone products and interventions. Examples include: Testosterone Replacement Therapy “TRT) for symptomatic hypogonadism.Other TRT claims such as beneficial effects on bone density, strength, muscle, cardioprotective effects. Potential TRT side-effects such as polycythemia, peripheral edema, cardiac and hepatic dysfunction.Comparison of bio-identical estradiol, estriol and progesterone with synthetic and animal derived versions.Specific compounding ingredients and proportions for a given product as used for a specific indication, and with reported long-term outcomes.Long-term outcome assessments capturing increased incidence of breast cancer, cardiovascular disease, venous thromboembolism, hirsutism, and other for specific dosages of specific products.Identification of outcomes, including adverse events, against various administration routes – subcutaneous pellets, injections, oral, other.Dosage measurement of key compounded ingredients in the context of specific indications and long-term outcomes assessments.Integrating longitudinal laboratory blood, saliva, and other analyses into the study protocol.Publications such as The Clinical Utility of Compounded Bioidentical Hormone Therapy: A Review, by the National Academies of Science, Engineering and Medicine suggest other important real-world study topics regarding BHRT. Practical Considerations The need for clinically significant datasets addressing many BHRT issues is evident. Patients, providers, and regulators will increasingly require such evidence. Equally clear is that such datasets will ultimately depend on busy clinicians designing and executing such studies. Those clinicians will also need to enroll their BHRT patients into their studies, and ensure maximum compliance with long-term outcomes reporting. These factors normally imply cost, time, administrative burden, and distraction from patient care. Circles eliminate these traditional obstacles. At the same time, they enable providers to support clinical decision making with relevant aggregated datasets. They provide the foundation for evidence-based communications with patients. Circles also allow compounding pharmacies and other manufacturers to develop auditable, statistically significant product and treatment registries to support marketing claims. Illustrative Use CaseDr. Grant Pagdin is utilizing two Circles – one for men and a second for women – to develop BHRT clinical decision support. Pre-treatment and long-term outcomes assessments include the Cervantes Short-Form Scale and the Aging Males’ Symptom Scale. Aggregated outcomes are explained and shared with patients, as described on the Outcomes Page on Dr. Pagdin’s website. Dr. Pagdin’s initial BHRT Circles and associated datasets will focus on standardized outcomes assessments and patient compliance. Subsequent Circles will also collect data on specific types, dosages and other characteristics of bio-identical product used. For Further InformationRgnMed.com / Circles / GeneralJoin/Start A CircleKnowledgeBaseLinkedInLatestContact Us‍1 Compounded Bioidentical Hormones: Myths and Realities. Santoro and Liss. Clin. Obstet. Gynecol. 2021 Dec1;64(4):793-802.2 See The Women’s Health Initiative Hormone Therapy Trials: Update and Overview of Health Outcomes During the Intervention and Post-Stopping Phases, Manson et al.3 Committee on Gynecologic Practice and the American Society for Reproductive Medicine Practice Committee. 4 See for example Personalized Medicine: A Biological Approach to Patient Treatment (FDA), and From Hype to Reality: Data Science Enabling Personalized Medicine, Froehlich et al.

RegenMed is proud to announce that Dr. Bert Mandelbaum has joined its Clinical/Scientific Advisory Board.Dr. Mandelbaum is an internationally recognized orthopedics thought leader. He serves on the Cedars-Sinai Kerlan-Jobe Institute board of directors, and is its co-chair of medical affairs. Dr. Mandelbaum has held governing positions at many major orthopedic medical societies. He also exercises senior medical responsibilities with U.S. major league soccer, USA Gymnastics, FIFA, and the US Men’s National Soccer Team (team physician), among others.RegenMed values highly the strategic support provided by Dr. Mandelbaum and his fellow C/SAB Members. It is particularly gratified by their shared belief in the clinical, professional and financial value inherent in real-world evidence, and the ability of Circles to deliver that value for healthcare providers and industry around the world.

RegenMed works with hospital systems, medical societies, and large medical product companies around the world. Circles help them generate clinical and financial value from real-world evidence in established as well as emerging medical specialties.We are also proud to work with independent clinicians such as Dr. Luis Gallego. Dr. Gallego practices in the historic city of Almeria, Spain, performing about 350 shoulder and knee surgeries annually. He would perform another 800 if he did not feel those patients would have better outcomes with alternative approaches. His data show that 80% of the patients he treats with biologics enjoy long-term improvement on standardized scores such as WOMAC.Real-world data are an essential part of any medical research – whether formal trials or clinical decision support. Those data remain a major untapped asset of most medical practices. Circles ensure that the cost and burden of developing real-world evidence are negligible, but that the returns are manifold and substantial.‍Contact us to learn more.‍

Dear Healthcare Professionals, Our August 2023 Newsletter summarizes:Recent provider and industry Circles use cases, including cognitive impairment and nutraceuticals.Migration to Circles of clinical clients’ data from Arthrex’s Surgical Outcomes System.The establishment of a dedicated Research Page, with pre-designed Circles, for a U.S. medical society.The issuance to RegenMed of a U.S. patent for Method and System For Processing Large Amounts of Real-World Evidence. The addition of Doctors Kenneth R. Zaslav and Bert R. Mandelbaum to our Clinical/Scientific Advisory Board. Cordially, RegenMed