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Relevance Of OrthobiologicsOrthobiologics are increasingly used as alternatives to, or to defer, surgical interventions. Regenerative rehabilitation and “prehabilitation” underscore the importance of orthobiologics as adjunct therapies.The fast-growing orthobiologics market is valued in excess of $8 billion. Leading orthopedic medical centers such as Hospital For Special Surgery, Northwell, and Mayo Clinic operate dedicated orthobiologics centers of excellence.ClinicalTrials.gov lists hundreds of studies focusing on biologics and other regenerative medicine approaches for musculoskeletal indications. Smith & Nephew, Stryker, Arthrex and other orthopedic product manufacturers actively develop and market orthobiologics products. Journals and other medical literature focusing on orthobiologics are common. [1]The AAOS Biologics Initiative, AO Foundation Osteobiologics, and the Biologic Association represent but a few orthopedic society activities focusing on orthobiologics.The Relevance Of Real-World EvidenceSupporting research is a major objective of most medical societies. However, the cost, delay, and exclusionary criteria of traditional clinical trials have become serious obstacles to genuine clinical translation for most indications and patient populations. Pragmatic, “n of 1”, properly curated registries [2], and other modern study designs based on RWE provide critical support for, and often alternatives to, traditional RCTs. Recent FDA draft guidance states that RWE “may provide an efficient means of generating the necessary clinical evidence to support regulatory decisions”. [3]Three of the most important trends in healthcare are value-based care, health equity/SDOH, and controlling costs. RWE is an essential element of each of these. [4]RWE study designs are particularly important in the field of orthobiologics, which often involve autologous and/or systemic datapoints.Program ElementsA society can design a COP to be modest or comprehensive. It is modular, flexible, and scalable. A typical COP comprises the following sequence and elements: Development of two to three Circles targeting clinical/scientific endpoints with particular relevance to society members. Principal investigators are identified from among society leadership or member thought leaders.Recruitment of five or more society members as Circle co-investigators. Link to an actively promoted Join-A-Circle page to enhance recruitment of additional society members as co-investigators.Establishment of a dedicated society website research page, which is also actively promoted. This page describes Circles protocols, endpoints, principal and co-investigators, and developing real-world data.Communications through the society newsletter and other suitable communication channels of preliminary aggregated data and related observations. Use of Circle Academies to host periodic “Circle Hours” among society members. These private discussions among society members, moderated by principal investigators, cover learnings from ongoing Circle activities to date.Circle Academies also support secure 24/7 interaction among Circle members and, if desired, other society members.Engagement with industry and donor organizations to support investigator-initiated trials, training and education sessions, society meeting break-out sessions, and other society initiatives derived from the COP.Publication of select COP activities or results by the society and/or principal investigators through internal and external conferences, articles, and social media.Scaling of Circles to include provider groups and/or other societies outside of society membership. Design and implementation of additional Circles addressing specific member research or clinical interests.Development of COP monetization opportunities resulting from product development, conference sponsorship, data licensing and other pathways.Execution And PricingThe inCytes™ and Benchmarc™ platforms, and accompanying physician processes, ensure that RegenMed can handle all COP elements on a turnkey basis on behalf of a society.A COP can begin modestly, allowing members to join one or more of the dozens of orthobiologics Circles already available. The corresponding cost is only $5 per Case, and $35 per month per subscriber.As a society wishes to scale its COP, pricing remains low and flexible. Any COP program can be terminated at any time. [5]RegenMed engages with industry and donors to develop financial support for the COP. Properly designed and executed, a society COP can represent a significant source of revenues to support its mission.RegenMed works as a long-term partner to ensure that each COP is tailored to a society’s objectives, mission, and membership.Learn MoreLeadership History and Principles How Circles Work Circles Value Propositions Circle Academies Latest LinkedInPricing and Terms Contact UsEndnotes1 See for example, Biologic Orthopedics; MDPI Biologics (Open Access); Biologics In Orthopaedic Surgery; Science Direct, 2019; Orthobiologics A Comprehensive Review of the Current Evidence and Use in Orthopedic Subspecialties, ResearchGate, 2018; Orthobiologics: A Review, ResearchGate, 2023. 2 See AHRQ Registries Users Guide, cited above in footnote 1. 3 Use of Real-World Evidence to Support Regulatory Decision-Making For Medical Devices, FDA, December 2023, https://www.fda.gov/media/174819/download. 4 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. 5 Further information on pricing can be found here.‍Copyright © 2024 Regenerative Medicine LLC

Type image caption here (optional)The FDA has released draft guidance on the “Use of Real-World Evidence to Support Regulatory Decision-Making for Medical Devices”. The principles underlying this guidance have important – and advantageous – implications not only for device manufacturers but also for clinicians.The FDA states that real-world evidence (RWE) “may provide an efficient means of generating the necessary clinical evidence to support regulatory decisions”. However, the guidance also emphasizes that data quality, good clinical practice, proper study design, longitudinal outcomes data and other traditional methodological considerations remain critical.The FDA enumerates many potential sources of RWE. Nevertheless, it is clear from the guidance that only specific types of real-world data (RWD) surrounding a discrete category of clinical interventions, and causally correlated to longitudinal outcomes, will generate acceptable “study-specific derived dataset(s).”This means that busy clinicians and their patients are essential to developing the RWD which can be converted into RWE. It is those already over-worked clinicians who are best positioned to design, capture and analyze study-specific RWD. It is their patients who must report long-term outcomes against standardized assessment measures. The overriding question is: where is the time or incentive to do so?The technology and processes underlying each Circle is “fit-for-purpose”in the context of any RWE objective to comply with the FDA’s guidance. (Indeed, the U.S. patent underlying Circles is titled “Method and System For Processing Large Amounts of Real-World Evidence”.) Moreover, Circles eliminate administrative burden for clinicians in generating RWE, while developing accompanying ethical professional and financial incentives.Please contact us to find out more.

RegenMed’s December 2023 Newsletter may be found here. It summarizes many of the ways our clients around the world are generating clinical, scientific, and financial value through Circles. The Newsletter also covers select company developments.Value-based care, real-world evidence and health equity will remain forceful healthcare trends in 2024. Addressing and benefiting from these trends is the essence of our client partnerships. All of us at RegenMed wish a restful and joyful holiday season to the exemplary healthcare professionals with whom we have the pleasure of working. We look forward to expanding and deepening those partnerships in the New Year.

Type image caption here (optional)Institutional constraints can limit the ability of physicians and researchers to collect long-term outcomes, design and execute studies, develop value-based care models best suited to their patient panels, or publish. Obstacles include time and RVU pressures, funding, complex IRB processes, and access to laboratory time and scientific experts. ‍Circles address these challenges. They inherently support collaboration across institutional and national borders. Their patented functionality is clinical grade, but imposes virtually no administrative burden. Cost is minimal; indeed, RegenMed often sources investigator-initiated study funding for Circle Members.Circles thus represent a powerful yet efficient solution for observing, participating in, or even designing “external” real-world evidence initiatives.Moreover, simple “internal” Circles implementations – such as long-term capture of standardized outcomes measures – can provide substantial clinical value to employed physicians. At only $5 per Case, and with easy data import capability for institutional EMRs, the cost-benefit analysis is straightforward.

TABLE OF CONTENTS‍ INTRODUCTION USE CASES AND BENEFITS Sustained Collaboration With Mentees Medical Society Influence Support For Patient Groups Value-Based Care Registries Private Studies Health Equity and SDOH Expanded Access (Compassionate Use)EXECUTION Pilot Study Expansion User Experience FundingFOOTNOTESIntroductionPhysicians and researchers at academic medical centers can advance their professional objectives through real-world evidence. [1] However, structural barriers often hinder their ability to do so. Those barriers can include:RVU and other financial pressures.Funding constraints. Complex, lengthy IRB processes. Limited access to laboratory time, scientists, statisticians, andother experts.Inability to develop statistically significant population samples.Cumbersome or poorly suited internal IT platforms.Circles address these challenges. On the one hand, their features comply with the objectives – transparency, consents, investigator credentials, HIPAA, etc. – underlying institutional policies. On the other hand, they offer the flexibility and user experience necessary to support collaboration across institutional and national borders.Circles thus represent a powerful, efficient, and low-cost solution for designing and executing “external” yet impactful studies.‍Use Cases And BenefitsCircles use cases relevant to employed clinicians and researchers include the following.Sustained Collaboration With MenteesDepartment chairs and other mentors can continuemeaningful relationships with fellows, residents and other mentees who havemoved to other practice environments. They can build upon past work, as well asinitiate new areas of inquiry. Medical Society InfluenceInstitutional thought-leaders often serve as medical society board members or officers. These are excellent positions from which to develop research, registry,and other initiatives. Properly structured and executed, such initiatives will lead to evidence-based clinical translation of medical advances. They will also drive value for and retention of society members, and increase the society’s impact.Support For Patient GroupsAlliances, advocacy groups, athletic conferences, veterans’ organizations, and other groups coalesce strongly around specific medical conditions. Diabetes, traumatic brain injury, cognitive impairment, IVF, and PTSD are but a few examples. Institutional leaders can help such groups develop science-based recommendations for their constituencies. Value-Based Care RegistriesValue-based care is perhaps the dominant trend in 21st century healthcare delivery. Today, value means much more than lower readmission rates. Providers are expected to demonstrate long-term safety and efficacy for each category of clinical intervention. However, even the largest hospital groups rarely capture long term outcomes consistently. The clinical grade inCytes™ and Benchmarc™ platforms capture two years or more of outcomes at only $5 per Case. Those data can easily be integrated into existing EMR platforms, and thus represent a strong clinical and financial return on investment for medical centers of any size. Circles typically reflect compliance rates of 70% or higher for patient outcomes reporting. Private StudiesYounger physicians, as well as their more experienced colleagues, are often deterred from developing datasets which could support their clinical decision-making. A study need not be expensive, burdensome, or time-consuming to be impactful. Institutions often permit observational and quality control studies without undue complications. Moreover, an institution-employed physician is always free to observe – and often participate in – an existing Circle which may be relevant to them.Health Equity and SDOH”Health equity” and “Social Determinants of Health” are increasingly important components of value-based payments. [2] Circle Members can include rural providers, practical nurses, social workers or even caregivers collaborating closely with those in academic medical centers.Circle Observational Protocols can include social or other assessments and datasets in linked to more traditional clinical data.Expanded Access (Compassionate Use)Many newer treatment protocols and products are first administered to patients in the context of expanded access programs. [3] These are typically related to clinical trials. Institutional policies can make it difficult for physicians or their patients to participate in such trials. Circles enable them to do so in a transparent manner.‍ExecutionPilot StudyCircles are highly flexible. A Circles-based initiative can be implemented for minimal cost and in a short amount of time. It can also be terminated quickly. [4] This allows a Circle Founder to begin conservatively and with a minimal budget, while benefitting from the full functionality and power of Circles.ExpansionCircles are fully scalable in terms of complexity, dataset size, numbers of sites and investigators and other parameters. They can be rendered in a variety of languages without losing data integrity. Circles can accommodate – and integrate data from – clinicians, patients, laboratories, consulting clinicians and other parties.User ExperienceCircles UX for clinicians, researchers and patients is excellent. Moreover, RegenMed’s processes support sustained collaboration, investigator recruitment, patient enrollment, teaching, publication, and many other support elements. Circles protect clinicians’ data ownership. FundingThe real-world evidence generated by Circles is inherently valuable. RegenMed works closely with industry and physicians to develop investigator-initiated studies and associated compensation, honoraria and other reimbursement fairly reflecting that value.To find out more, please contact us.Footnotes1 See for example FDA, Real World Evidence; McKinsey, Creating Value FromNext-Generation Real-World Evidence; AHRQ (HHS), Registries For Evaluating Patient Outcomes, A User’s Guide.2 See for example Social Determinants of Health; FDA Office Of Minority Health and Health Equity; CMS Value Based Care.3 FDA Expanded Access. Overview of FDA’s Expanded Access Program for Investigational Drugs, Jarow et al.. ClinicalTrials.gov data submissions for EAPs.‍4 Summary pricing can be found at our What Is A Circle page. More detailed information on products, servicing and pricing can be found Product/Service Charges and Payment Terms. Copyright © 2023 Regenerative Medicine LLC