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ROSM Launches Innovative Real World Evidence Program with RegenMed

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April 8, 2024
Clinical interactions generate valuable real-world data, analyzed with digital health tech, leading to recognized evidence by FDA and payers. ROSM enhances non-surgical protocols with real-world evidence strategies, collaborating with RegenMed to advance regenerative medicine standards.
Research is changing. Everyday clinical interactions generate volumes of unique and valuable real-world data. With the help of digital health technologies, those data can now be properly stored, linked and analyzed in a way typically only reserved for expensive studies. This leads to real-world evidence which is fast becoming recognized by the FDA [1], payers [2] and many other stakeholders for its substantial cost and other advantages compared to traditional trials. Regenerative Orthopedics and Sports Medicine “ROSM” has always selected and tested its diverse non-surgical protocols in an evidence-based manner. With the help of RegenMed, ROSM will now broaden that effort by applying focused, real-world evidence strategies against every protocol, patient and physician within its multiple locations in the greater Washington D.C. area. Dr. Imran Siddiqui, Director of Clinical Operations at ROSM, says this about the new initiative:“The field of regenerative medicine remains growing, both in size and in need for evidence-based standards. ROSM has long been a pioneer of non-surgical treatment options, and that leadership will now extend to the generation and dissemination of real-world evidence across a growing number of protocols, products and patient populations. 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.” ROSM’s real-evidence program will focus on deploying Circles, turnkey real-world data registries, against key anatomical treatment areas. Each Circle will capture and integrate relevant real-world data, including outcomes, interventional variables, and where relevant, biological assays, and help generate comparative real-world evidence against a wide range of products and protocols. Furthermore, ROSM will invite fellow regenerative practitioners and industry partners to collaborate within the Circles, helping to generate large, multi-centric databases which advance the field forward. Nicolas Tierney, Chief Operating Officer for RegenMed, adds:“The growing field of real-world evidence, much like regenerative medicine, is in need of standardization. By volume, ROSM is one of the leading private providers of regenerative medicine therapies within the U.S.. Those case volumes, coupled with the traditional research discipline of its expert physicians, are the necessary ingredients to generate real-world evidence which is clinically and statistically significant. We are proud to support ROSM in their efforts to innovate and improve both clinical care and research.” You can learn more about ROSMs’ new Circle library by clicking the below links. Please address all inquiries to info@rgnmed.com. Knees,Hips and Pelvis,Shoulders, Elbows, Hand and Wrist,Lumbar Spine,Neck and Cervical Spine, Foot and Ankle
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EmCyte’s Circles-Based Real-World Evidence Program Delivers Clinically and Statistically Significant Results

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April 1, 2024
EmCyte 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 PeterA. Everts, PhD, FRSM.
EmCyte 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.For well over a year, EmCyte and GCB have 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.)The Circles program has involved 10 clinical investigators in North America, collected detailed clinical interventional data and long-term outcomes up to one year. At the recent annual meeting of the Interventional Orthobiologics Foundation, Imran Siddiqui, M.D. of ROSM delivered a presentation reflecting statistical as well as clinical significance based on the real-world data collected by GCB Knee Circle.As the EmCyte Circles program continues to expand, many more clinicians in North America and Europe will have access to, and be able to participate in, efficient yet powerful studies which will lead to clinical decision support and new standards of care for a variety of musculoskeletal pathologies.
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Summus Medical Laser Launches Circles-Based Real-World Evidence Program

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April 1, 2024
RegenMed partners with Summus Medical Laser to establish a real-world evidence program. Summus, a U.S. corporation, has distributed thousands of Class IV laser systems globally, used by healthcare professionals in various fields.
RegenMed is partnering with Summus Medical Laser to establish a comprehensive real-world evidence program. Summus, a U.S. corporation, has distributed thousands of its Class IV laser systems to over fifty countries. Those systems have been used to deliver millions of treatments for a variety of indications. Summus lasers are used by physicians, chiropractors, veterinarians, and dental professionals.The initial Circle designed by Summus, in conjunction with its clinical thought-leaders, will collect and analyze real-world evidence on peripheral neuropathy from dozens of practitioners in the U.S. Each practitioner will be able to customize clinical surveys to match the realities of his/her practice, without compromising the overall clinical and statistical significance of the aggregated datasets. For example, both bi-lateral and unilateral presentations of peripheral neuropathy will be accommodated. A key part of the Summus Real-World Evidence Program will be regular reports to its clinical customers regarding trends, observations, best practices, and other correlations. These reports will be supplemented by livestreamed sessions among Circle members to review learnings, comments, and questions. In addition, RegenMed will regularly provide to Summus separate reports on patient compliance, clinical customer metrics, correlations suggesting new indications, potential product improvements, and other data-driven observations. In parallel with the growth of the peripheral neuropathy Circle, the Summus Real-World Evidence Program will expand to offer additional Circles across a variety of indications and international regions.
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ISNS Launches Consumer-Facing Real-World Evidence Program For Nutraceuticals

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April 1, 2024
The International Science and Nutrition Society is an international organization which brings together physicians, scientists, and other experts in complementary and integrative medicine. Its mission is to advance science-based knowledge in nutrition, nutraceuticals, phytology, and ecology.
The International Science and Nutrition Society is an international organization which brings together physicians, scientists, and other experts in complementary and integrative medicine. Its mission is to advance science-based knowledge in nutrition, nutraceuticals, phytology, and ecology. Its podcasts are listened to by thousands in North America and Europe. ISNS also works closely with RootBrands in preparing and distributing nutraceuticals and other health/wellness products.RegenMed is partnering with ISNS and RootBrands to enroll its customers in Circles which will track outcomes against their individually reported baselines. The Circles design and data analyses will involve ISNS clinicians and scientists. Long-term outcomes will be tracked utilizing a number of standardized assessments, including BMI (both metric and imperial), SF-12 Mental, SF-36 Emotional, SF-12 Physical, and SF-36 Energy/Fatigue.Initial Circles surveys will be delivered in English. To accommodate the many ISNS and RootBrands customers in countries with other primary languages, Circles will also be implemented in those languages, without compromising the integrity of the aggregated datasets wherever generated.ISNS and RootBrands keep in regular touch with their customers through newsletters and other communications. Those communications will now include reports and observations based on Circles aggregated datasets.
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RegenMed Migrates 5,000 Arthrex SOS Cases Onto Circles For The Mackay Clinic

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April 1, 2024
Prof. Gordon Mackay is a renowned orthopedic surgeon specializing in ligament and tendon repair, working with elite athletes globally. He is the inventor of the InternalBrace and actively collaborates with orthopedic experts to advance its clinical applications.
Prof. Gordon Mackay is an internationally respected orthopedic surgeon specializing in ligament and tendon repair. He works extensively with high-level athletes in Europe and other parts of the world, and served as the official doctor for the 2014 Ryder Cup at Gleneagles and for the 2014 Commonwealth Games in Glasgow.Prof. Mackay maintains an active practice in the United Kingdom, and is the inventor of the InternalBrace, with the support of Arthrex. Although a busy clinician, he is committed to evidence-based medical research. This includes ongoing collaboration with eighteen leading orthopedic surgeons and consultants around the world to advance the evidence-based clinical applications for the InternalBrace. Prof. Mackay was an early and active user of Arthrex’s Surgical Outcomes System, collecting clinical and long-term outcomes data on over 5,000 patients across six separate SOS modules. When Arthrex decided to sunset SOS in August of 2023, Prof. Mackay chose Circles as his new data collection and analysis platform. RegenMed efficiently migrated onto Circles over 5,000 of his SOS cases, maintaining full data validity conforming to the original SOS modules. Through Circles, Prof. Mackay’s office maintains strong patient engagement for continuing long-term outcomes capture. His office also uses Circles for new cases.
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