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Welcome Real-world evidence (RWE) is at the heart of value-based care, and arguably the most important category of health data in the 21st century.Circles harness the power of RWE to create proprietary and statistically significant datasets in the context of any medical specialty, and representing value to all healthcare constituencies. In the Select Client Activities section of this newsletter, we summarize Real-World Evidence Programs recently launched by provider groups, product manufacturers, and distributors. In Select Company Activities, we highlight several major use case categories.Please contact us to discuss how Real-World Evidence Programs can advance your clinical, scientific, and commercial objectives.Select Client Activities ROSM Real-World Evidence ProgramWith eight locations in the Washington D.C. area, ROSM is one of the largest non-surgical orthopedic practices in the country. ROSM has always selected its diverse protocols in an evidence-based manner. It will now broaden that effort by applying focused, real-world evidence strategies against every ROSM clinical intervention.By deploying no fewer than seven Circles, ROSM will own, and generate sustainable value from, many rich, statistically significant, and tightly integrated datasets. Dr. Imran Siddiqui, Director of Clinical Operations at ROSM, says:“RegenMed shared our strategic vision, and with its turnkey platforms and deep regenerative medicine experience, was the natural partner to help us design and expand this broad initiative.”For more information, including how to join ROSM’s Circles, see here.EmCyte™ Real-World Evidence ProgramEmCyte Corporation is a world leader in the design, manufacture, and distribution of integrated systems for platelet rich plasma, bone marrow cell concentrate, adipose concentrate, bone marrow harvesting, and PRP analysis. EmCyte also supports Gulf Coast Biologics, led by Peter A. Everts, PhD, FRSM. GCB is a separate entity dedicated to the education and training of doctors from around the world in the evidence-based clinical use of biologics-based therapies.EmCyte and GCB have long been using the Circles platform to develop clinically and statistically significant datasets supporting various biologics treatments for knee and shoulder pathologies. (These have included patients presenting with bi-lateral conditions.)Dr. Everts says: “I have been working with RegenMed for almost two years on our “GCB Circles Program” successfully. I believe they have more to offer than any other company with regard to technological tools, costs, and flexibility.The platform has accommodated our highly specific research objectives. Customer engagement and feedback have been overwhelmingly positive. We have already generated valuable, statistically significant data for up to one year.” For more information on the EmCyte and Gulf Coast Biologics Real World Evidence Program, see here.Summus Medical Laser Real-World Evidence ProgramSummus Medical Laser® has partnered with RegenMed to establish a comprehensive Real-World Evidence Program. The program will support thousands of providers around the world by developing and sharing best practices for improving patient recovery and care. The RWE Program will expand Summus Laser's Class IV Laser Therapy research to generate validated and statistically significant datasets that will be used to enhance patient care, outcomes, and to further product innovations. Pete Cousins, the COO of Summus Medical Laser, says: "We look forward to unlocking new frontiers of innovation and patient care through the RWE Program. Collaborating with RegenMed presents an invaluable opportunity to accelerate and push the limits of laser therapy and its capabilities, ultimately advancing medical science and enhancing patient outcomes."For more information, including how to join the Summus Medical Laser Circles, see here. Breakthrough Regenerative Orthopedics Launches SI Joint CircleTimothy Mazzola, M.D practices non-operative orthopedic medicine at Breakthrough Regenerative Orthopedics. For patients presenting with pain and dysfunction in the lower back, hip, and knee regions, he focuses on instability of the sacroiliac (SI) ligament and its myofascial attachments. Dr. Mazzola’s Circle will evaluate the efficacy of ultrasound guided PRP and MFAT injections for such patients. Baseline and longitudinal outcomes measures will incorporate his proprietary physical examination measurement, “Millimeters of Motion,” to quantify SI ligamentous laxity. Dr. Mazzola says:“Breakthrough Regenerative Orthopedics is proud to partner with RegenMed to collect real world evidence on treating SI dysfunction and ligamentous laxity. RegenMed has become our go-to partner for clinical data collection based on their commitment to user-friendly, customer-focused data collection solutions for busy clinicians like ourselves.”Dr. Mazzola will also be delivering the keynote address at the upcoming C3 Annual Summit: Treatment Strategies for Lumbopelvic Pain and Dysfunction.More details on Dr. Mazzola’s Circle, as well as the opportunity to participate, can be found here.ISNS Launches Consumer-Facing Real-World Evidence Program For NutraceuticalsThe International Science and Nutrition Society is an international organization comprising physicians, scientists, and other experts in complementary and integrative medicine. Its advances science-based knowledge in nutrition, nutraceuticals, phytology, and ecology. ISNS works closely with RootBrands in preparing and distributing nutraceuticals and other health/wellness products throughout North America and Europe.ISNS and RootBrands have launched a Real-World Evidence Program to track long-term outcomes against customer reported baselines. The Circles design and data analyses will involve ISNS clinicians and scientists. Outcomes assessments include BMI, SF-12 Mental, SF-36 Emotional, SF-12 Physical, and SF-36 Energy/Fatigue.For more information on the ISNS Circles, see here.Select Company ActivitiesCo-Marketing ProgramsCircles create proprietary and statistically significant datasets representing value to all healthcare constituencies. Categories of value include clinical decision-making, product development, regulatory approvals, monetization, competitive differentiation, and patient and HCP engagement.Circles Co-Marketing Programs accelerate that value for both provider and industry Clients. Program elements include:Regular Client ReportsCircle AcademiesCircle Member RecruitmentPublicationContinuity of CareThird-Party SupportDataset MonetizationTo find out more about Circles Co-Marketing Programs, see here.Types of Real-World Evidence ProgramsReal-World Evidence Programs deliver clinical, scientific, and financial value for all healthcare constituencies. Recent articles published by RegenMed and covering various use cases include: CREATING LICENSABLE REAL-WORLD EVIDENCE DATASETS CIRCLES FOR OTC PRODUCT MANUFACTURERS CIRCLES FOR INDEPENDENT PROVIDER GROUPS CIRCLES FOR SUSTAINED MENTORING BY CLINICAL LEADERS REAL-WORLD EVIDENCE PROGRAMS FOR ACADEMIC MEDICAL INSTITUTIONS REDISCOVERING AND RE-IMAGINING MEDICAL RESEARCH CIRCLES FOR ASSESSMENT OF COGNITIVE IMPAIRMENTCopyright © 2024 Regenerative Medicine LLC

Timothy Mazzola, M.D., a triple-board certified physician, practices non-operative orthopedic and regenerative medicine at Breakthrough Regenerative Orthopedics in Boulder, Colorado. Many of his patients present with pain and dysfunction in the lower back, hip, and knee regions. He has recognized that treatment of the secondary symptomatic areas fails to address the primary root cause -- instability of the sacroiliac (SI) ligament and its myofascial attachments. Dr. Mazzola’s has therefore designed a Circle-based study to “Evaluate Efficacy of US-Guided PRP and MFAT Injections for Patients with Abnormal SI Ligamentous Laxity”. Baseline and longitudinal outcomes measures in this Circle will incorporate a unique physical examination objective measurement, “Millimeters of Motion,” to quantify SI ligamentous laxity. More details on Dr. Mazzola’s Circle, as well as the opportunity to participate, can be found here. Dr. Mazzola will also be delivering the keynote address at the upcoming C3 Annual Summit: Treatment Strategies for Lumbopelvic Pain and Dysfunction. In addition to Dr. Mazzola’s SI Joint Circle, topics at the conference will include:  Labral tears, hip pain and SIJ dysfunction – what do these problems have in common and which one came first.  How to stabilize hypermobile patients and train the core appropriately.  How does one assess stretch/flexibility without destabilizing ligaments, decreasing fascial integrity, or weakening muscle.  How to treat fascia of the lumbopelvic girdle to enhance whole body movement.  Which regenerative treatments and targets can more effectively stabilize and strengthen the lumbopelvic girdle. Each of these questions deserves answers based on real-world evidence. As he is doing with his Abnormal SI Ligamentous Laxity study, Dr. Mazzola and other musculoskeletal practitioners around the world are likely to collect that evidence through Circles in the coming months. For more information regarding Dr. Mazzola’s SI Joint Circle, the C3 Summit, or to undertake your own Circle, please contact us.

Summus Medical Laser® has partnered with RegenMed to establish a comprehensive Real-World Evidence Program. The program will support thousands of providers around the world by developing and sharing best practices for improving patient recovery and care. The RWE Program will expand Summus Laser's Class IV Laser Therapy research to generate validated and statistically significant datasets that will be used to enhance patient care, outcomes, and to further product innovations. Summus' RWE Program builds upon recent FDA guidance on the use of RWE to support regulatory decision-making for medical devices. The program is based on Circles, RegenMed's patented, technical platform and turnkey process for generating clinical, scientific, and financial value from real-world evidence. The program's initial Circles will collect and analyze real-world evidence on peripheral neuropathy from dozens of providers in the U.S. In the coming months, the program will grow to include additional pathologies and providers outside of the U.S. Dr. Phil Harrington, an internationally recognized expert in laser therapies, will be instrumental in developing the program's clinical surveys and outcomes assessments. Dr. Harrington says, "I am excited to be working with RegenMed in executing the RWE Program. This will help to expand Summus' clinical and scientific correlations and reach a broader team of providers to collect valuable data." Pete Cousins, the COO of Summus Medical Laser, adds: "We look forward to unlocking new frontiers of innovation and patient care through the RWE Program. Collaborating with RegenMed presents an invaluable opportunity to accelerate and push the limits of laser therapy and its capabilities, ultimately advancing medical science and enhancing patient outcomes." About Summus Medical Laser: Summus Medical Laser is a renowned leader in the laser therapy industry, providing laser products to over 51 countries that have resulted in millions of treatments performed worldwide. With a strong commitment to continued innovation, reliable stateside customer service, and growing brand awareness, Summus Medical Laser is devoted to empowering healthcare professionals to provide optimal patient care through the use of advanced laser therapy. To learn more, visit https://www.summuslaser.com. About RegenMed: RegenMed is the category leader in developing and executing Real-World Evidence Programs for provider groups, medical societies, and medical product manufacturers around the world. Those RWE Programs are redefining and democratizing impactful medical research. More information can be found at https://www.rgnmed.com/. Click here to review the initial Peripheral Neuropathy Circle SOURCE Summus Medical Laser

Academic medical and other large hospital systems (AMCs) are, in principle, major sources of one of the most critical assets for all healthcare constituencies – real world evidence (RWE). However, they often fail to develop it, and as a result are foregoing important research, clinical and financial value. A well-structured RWE Program can be foundational to several strategic initiatives. These include not only more accurate and targeted clinical decision-making, but also impactful research, proprietary and monetizable datasets, lower-cost and more remunerative IP development, and new funding sources. Moreover, an RWE Program can make a material difference in driving value-based care and health equity/SDOH initiatives. It adds value to each clinical and research department of an AMC, while imposing minimal clinical burden.

Unlocking The Value Of Circles Circles create proprietary and statistically significant datasets representing value to all healthcare constituencies. Categories of value include clinical decision-making, product development, regulatory approvals, monetization, competitive differentiation, and patient and HCP engagement. Circles Co-Marketing Programs accelerate that value for both provider and industry Clients. They convert Circles into a profit center.Illustrative ProgramsClient ReportsThese regularly distributed reports cover Case numbers, cases per investigator, compliance rates, select trends against end points, clinical observations, and other quantitative and qualitive content. Client Reports also include hand-outs with verbal and graphical content for patient communications.Circle AcademiesEach Circle Academy is a secure digital venue for licensed healthcare practitioners to present, discuss and benefit from real-world evidence relating to a specific clinical theme. A Circle Academy may be thought of as a secure “always-on” medical conference, available at any time from any location and any device. Circle Member RecruitmentMost clinical Circle founders wish to attract peers to improve the statistical significance of their datasets, and discuss best practices regarding specific indications and patient populations. Most industry Circle founders wish to extend the frequency and substance of their engagement with existing and potential product users. RegenMed supports these goals through press releases, website content, social media posts, conference attendance, and other channels.PublicationThe rich and validated Circles datasets are natural centerpieces for journal articles, conferences presentations, abstracts, and professional education/training materials. RegenMed partners with Circle Founders and Members to prepare foundational materials, develop video and other derivative assets, moderate conference panel discussions, and otherwise drive maximum exposure. Continuity Of CareCircles functionality supports sustained collaboration with — and information sharing among — referring and referee clinicians, post-procedure therapists, laboratory personnel and other professionals involved in a patient’s care.The referring clinician, the specialist, and the patient all benefit from the ability to contribute to and regularly review coordinated clinical care and longitudinal outcomes measurements. The multilingual capabilities of Circles allow, for example, referring clinicians in one country to monitor their patients before and after a clinical intervention in another country.Third Party SupportRegenMed helps Circle Founders incorporate scientific experts, medical statisticians, and other third parties into their studies. Similarly, it helps coordinate work with IRBs, MECs, and other bodies required for Good Clinical Practice. Dataset MonetizationCircles datasets have substantial value due to their large n-value, long-term outcomes capture, validated data, and clinically significant causal correlations.Those datasets therefore have significant value in the context of product development, new indications, regulatory submissions, and generative AI learning models.RegenMed works closely with its Clients to help maximize the value-producing elements of their Circles, as well as identify and pursue monetization opportunities.Learn MoreClient use cases involving Circles Co-Marketing Programs can be found here, here, and here. To discuss how such programs can help advanceyour specific objectives, please contact us.