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Addressing Strategic ImperativesIntroduction OTC product demand is driven by perceived safety and efficacy among healthcare professionals and consumers. Moreover, legal/regulatory compliance is an increasingly important issue for manufacturers. [1]Well-structured datasets comprising real-world evidence(RWE) are foundational to meeting both categories of requirements.Through its HCP and consumer customers, an OTC product manufacturer can generate a large amount of RWE comprising substantial clinical, scientific, and commercial value. OTC category leaders recognize this value, and have established programs to achieve it. [2]Through Circles, RegenMed supports product manufacturers globally in developing RWE programs delivering demonstrable and sustained return on investment.Circles: Not A Cost Center, But A Strategic ImperativeRWE is a strategic imperative for OTC product manufacturers. [3] As an important signal of emerging trends, the FDA states that RWE “may provide an efficient means of generating the necessary clinical evidence to support regulatory decisions”.Thus, RWE can be an important element of value-based care, new product development, reimbursement, HCP and patient engagement, health equity and evidence-based support for marketing claims.However, the FDA also emphasizes that RWE must be “fit for purpose”. In other words, it must start with well-defined endpoints, be causally correlated to longitudinal outcomes, represent validated data, and otherwise conform to traditional parameters of properly designed and executed studies.Circles-based RWE programs meet these criteria. They are efficient, cost-effective, flexible and scalable. As such, they can advance one or more strategic objectives for any OTC product manufacturer, regardless of size and market position:Financial: New product development. Improvement of existing products. IP capture. Support for new indications. Reimbursement.Competitive Differentiation: Publication. Conference Presentations. Research. Deeper HCP and patient engagement.Brand Extension: Recruitment and collaboration among HCP influencers and their peers. Evidence-based content for patient groups.Legal/Regulatory Compliance: Regulatory submissions. Marketing claims. Adverse event reporting. Safety/efficacy reports for specific formulations.Critically, an OTC product manufacturer owns the Circles-based RWE which it and its customers generate. It therefore maintains control over the resultant product development, publication, and other value creation opportunities. See here and here for more information.Learn MoreWhat Is A CircleValue PropositionsJoin/Start A CircleProcesses For PhysiciansOwnership, Publication, MonetizationContact UsEndnotes1 See for example here, here, and here.2 See for example the sunscreen study materials disseminated by Johnson&Johnson.3 Real World Evidence, FDA, February 2023. Registries for Evaluating Patient Outcomes: A User’s Guide, HHS/AHRQ, September 2020. Creating Value From Next-Generation Real-World Evidence, McKinsey July 2020. Use of Real-World Evidence to Support Regulatory Decision-Making For Medical Devices, FDA, December2023.‍Copyright © 2024 Regenerative Medicine LLC

Addressing Strategic ImperativesIntroductionFor a number of reasons, the domination by large hospital systems of healthcare delivery may be slowing if not reversing.Conversely, physician owned hospitals, ambulatory surgery centers, and other independent clinical practices are assuming a greater role.This is not surprising given the desire of physicians for independence – not only financial but also in matters of clinical judgment. The growth of physician-controlled practices is also driven by the preference of patients for personalized care, the national focus on value-based care, and governmental policy initiatives.There is however a fundamental challenge for independent practices – they are by definition owned by physicians. Physicians are trained – and want – to provide patient care, not deal with business issues.Most of the strategic issues for independent provider groups are the same as for other businesses: financial stability, recruitment of qualified personnel, competitive differentiation, growth, predicting the future, and preparing for it. Circles: Not A Cost Center, But A Strategic ImperativeIn healthcare, more than most other industries, data are fundamental. They are at the center of reimbursement, product development, value-based care, and legal/regulatory compliance.However, meaningful use, CPT codes, RVUs, and similar data requirements have imposed large costs and administrative burdens on providers. Paradoxically, these data-driven initiatives have often reduced compensation to clinicians. They also reduce the time clinicians can spend on patient care.Meanwhile, real-world evidence is emerging as the most important healthcare data category in the 21st century. [1] Critically, the most valuable sources of real- world evidence arise from everyday clinical interventions and correlated long-term outcomes. Independent provider groups are in a position to capture, own and monetize that real-world evidence.As emphasized by the FDA, however, real-world evidence depends on aggregated real-world datasets which are validated, well-structured, “fit-for-purpose”, and statistically significant. The technical platform and processes underlying each Circle ensure that these parameters are met – with minimum burden for the busy clinician.Moreover, independent provider groups own and control the real-world data and evidence generated by Circles. That ownership and control can advance several strategic objectives:Financial: Database licensing revenues. Clinical study fees. Internal product development and monetization. New service lines. Reimbursement.Competitive Differentiation: Publication. Conference Presentations. Research. Deeper patient engagement.Personnel: Recruitment/retention of physicians and researchers. Minimal burden for clinicians and office staff.Legal/Regulatory Compliance: Support expanded access, quality improvement, off-label, and other clinical initiatives.Brand Extension: Inherent collaboration with clinical peers and experts on clinical/scientific topics of common interest.‍Learn MoreWhat Is A CircleValue PropositionsJoin/Start A CircleProcesses For PhysiciansOwnership, Publication, MonetizationContact Us‍EndnotesReal World Evidence, FDA, February 2023. Registries for Evaluating Patient Outcomes: A User’sGuide, HHS/AHRQ, September 2020. Creating Value From Next-Generation Real-World Evidence, McKinsey July 2020. See Deloitte Insights, 2018.Copyright © 2024 Regenerative Medicine LLC

Type image caption here (optional)Michael Strøm is an international speaker, educator and men’s health shockwave specialist. He is the clinical director of The Academy of Shockwave Excellence, and starting in 2024, will be regularly conducting his own courses for international practitioners interested in learning about the use of shockwave for men’s health. Michael has designed several Circles to:1) help generate real-world data and outcomes against his specialized men’s health shockwave protocols and 2) enable other shockwave users to remotely contribute and benchmark their results from their home clinics. These aggregated real-world data will be the building blocks for real-world evidence, and that evidence is poised to help standardize protocols for shockwave users and their real-world patients. We are proud to work with evidence-based teachers and practitioners like Michael Strøm. Learn more about Michael Strøm's Circles below:Erectile Dysfunction CirclePeyronie’s Disease CircleChronic Pelvic Pain CircleIncontinence CircleContact us to learn more.

IntroductionRegenMed supports small clinical practices around the world in the design and execution of real-world data and evidence programs. Those programs result in clinically and statistically significant datasets. They are the basis of conference presentations, articles, industry support, licensing transactions, and other forms of monetization.Many small provider groups begin by joining Open Access Circles. These cost only $35 per month per subscriber, and $5 per Case (including outcomes capture for two years or more if desired).Open Access Circles are a highly economical way to observe and participate in the full functionality of one or many indication-specific studies. Eventually, however, most small provider groups decide to establish Private Circles.By doing so, they own and control their data. Such ownership and control are the foundation of sustained reputational and financial value for them.‍The Value of Real-World EvidenceReal-world evidence is widely recognized as critical to better clinical decision-making, streamlining regulatory approvals, and supporting marketing claims.RWE is an essential element of the most important trends in healthcare — value-based medicine, health equity, and cost reduction. It is the foundation of many public and private healthcare programs.Private Circles generate datasets which are well-structured, fit-for-purpose and fully validated. They generate valuable real-world evidence.‍Publication and Monetization Through Private CirclesPrivate Circles democratize the ability of clinicians to conduct high-quality and impactful research. They enable ownership of, and control over, the resulting valuable real-world evidence.However, smaller provider groups often do not have the resources or experience necessary to realize the full value of their real-world evidence. RegenMed provides the platforms and processes allowing them to do so.RegenMed works with clinicians to:Enroll regional and international peers into their Private Circles.Generate regular reports for themselves, their patients, regulators and others.Assist with conferences slides and other presentation materials.Help prepare evidence-based posts and newsletters for websites, social media and other channels.Attract funding and other forms of support from industry.In addition, RegenMed can assist Private Circle Founders pursue real-world evidence licensing, intellectual property and other monetization opportunities.‍Getting StartedA Private Circle costs only $500, plus $35 per subscriber month and $5 per Case. A small clinical group can be up and running in a matter of days, with minimal burden.RegenMed works closely and continually with each Private Circle Founder to ensure they obtain the reputational and financial value inherent in their ownership of the resulting real-world evidence.‍Learn MoreWhat Is A CircleHow Circles Work ‍Join/Start A CircleProcesses For Physicians ‍LatestContact UsCopyright © 2024 Regenerative Medicine LLC

Type image caption here (optional)The recent IOF MAX Experience, organized by the Interventional Orthobiologics Foundation, brought together some of the world’s foremost experts on orthobiologics to share their proprietary real-world data and real-world evidence. Many of those experts proudly included a growing number of Circle founders, including: ‍Peter A. Everts, PhD, FRSM opened the show with some nuanced hypotheses for "Where will the Field of Orthobiologics be in 2030?". Those same hypotheses informed his launch of the Gulf Coast Biologics Knee and Shoulder Circles over a year ago.Imran Siddiqui, Research Director at Regenerative Orthopedics & Sports Medicine, presented statistically significant 1 year results from those same Circles. Numerous IOF members joined Dr. Everts and Siddiqui as expert co-investigators, including: Luga Podesta, MD, Glenn M. Flanagan II, Alberto J. Panero D.O., Shounuck Patel, DO, Walter I. Sussman, Gayan Poovendran MD,CAQSM, and Ariana De Mers. Special thanks as well to Dr. Chris Brown Mahoney for her statistical analyses, which is a critical component for elevating real-world "data" into "evidence". Lastly, IOF members and sponsors continue to launch and grow their own real-world studies in 2024. We present their headshots and studies proudly, as their proprietary real-world evidence are bound to play a role in future curriculums, standards and regulatory decisions.Contact us to learn more about Circles.