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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

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.

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.

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.

Executive SummaryReal-world evidence (RWE) is arguably the most important healthcare data category of the 21st century. For academic medical institutions (AMCs), a well-structured RWE Program can be foundational to several strategic initiatives:Better clinical decision-making and evidence-based standards of care.Better-funded, more diverse, and more impactful research.Value-based care and health equity/SDOH programs.Meaningful engagement with employed physicians, as well as external medical practices.Proprietary highly correlated datasets available for licensing and other monetization opportunities.Lower-cost and more sustained IP development.Ethical industry funding.Deeper and sustained patient engagement A Real-World Evidence Program based on Circles adds value to each department of an AMC, clinical or research. It imposes minimal clinical burden, is low-cost and modular, and represents a profit not a cost center.About Real-World EvidenceWhat It IsIn principle, RWE can be developed from a variety of sources – EMRs, retrospective studies, and registries for example. In practice, the most valuable RWE by far is based on validated everyday clinical interventions, closely correlated to standardized long-term outcomes.ImportancePolicymakers, regulators, payers and private sector experts have all emphasized the importance of RWE for value-based care, clinical decision-making, efficient and impactful medical research and greater health equity. [1]Institutional Value CategoriesValue-Based CareValue-based care is heavily dependent on RWE – standardized outcomes assessments closely correlated with specific relevant clinical data. This is what the FDA calls “fit-for-purpose” data. ResearchAn RWE Program makes high quality, impactful research opportunities accessible to younger and the busiest of clinicians. It allows publishable and statistically significant research to be democratized. [2]Industry FundingAs indicated, recent FDA guidance supports the use of RWE in regulatory decision-making. Most major device and pharmaceutical companies support investigator-initiated studies. A Circles-based RWE Program enables substantial expansion of IIS and similar industry-sponsored studies. Dataset LicensingAn RWE Program continuously generates validated, longitudinal, and proprietary datasets directly relevant to a specific clinical and/or scientific healthcare issue. These datasets are both clinically and statistically significant, thus representing deep value to product manufacturers, AI training models and other licensees. [3] Collaboration With External Provider GroupsOutpatient procedures across all specialties will continue to move to ASCs. There is likely to be a resurgence in regional physician-owned hospitals. Governmental and patient pressure to “bend the healthcare cost curve” will only intensify. IP DevelopmentThe busy clinician is simultaneously a key source of RWE and intellectual property. A well-designed RWE Program will educate and incentivize each physician regarding IP potential of their everyday cases, as well as provide him/her the tools to capture the relevant data to support such IP without interrupting clinical flow.Health Equity/SDOH“Health equity” and “Social Determinants of Health” are increasingly important components of value-based payments. [4] An RWE Program develops datasets supporting standards of care for under-represented patient cohorts, “orphan” indications and other groups which often fall outside of quality, mainstream healthcare. Expanded Access/Compassionate UseMany newer treatment protocols and products are first administered to patients in the context of expanded access programs. [5] These are typically delivered in the context of clinical trials. Circles combine technical robustness with low cost and efficiency, allowing AMCs to undertake many more EAP interventions. Patient Engagement A successful RWE Program drives high patient compliance in long-term outcomes reporting. Benchmarc™ delivers excellent patient UX, including educational materials, data-driven reports and other communications.This positive patient engagement redounds to an AMC’s overall branding value.RWE Program ElementsClinical Grade Technical PlatformA Circles-based RWE Program is founded on the patented inCytes™ (clinician-facing) and Benchmarc™ platforms. [6] It supports HIPAA, GDPR and Part 11 compliance. Its open API allows HL7 and other integrations. As an encrypted cloud-based system, inCytes™ is customizable, scalable, multilingual, available in many languages, and accessible on any device 24/7. Clinical User ExperienceUninterrupted Clinical FlowCircles processes ensure efficient RWE generation while eliminating clinical and administrative burden. Physicians and researchers focus on what matters most to them – study design, generating causal correlations, and improving evidence-based patient care.CollaborationCircles break down the barriers among specialties, and between the laboratory and the clinic. They enable sustained and meaningful collaboration across institutional and national borders. Education and TrainingWhat are the clinically important data to capture for a particular indication? How best do I measure outcomes for this procedure and patient? How can I validate product claims? How do I measure my patients’ outcomes against those of my peers? How do I develop an evidence-based standard of care for a particular patient cohort?Asking and answering these and similar questions are at the heart of medicine, and of an RWE Program. Clinician SupportSupport for conference presentations, publication, statistical analysis, IRB submissions, grant proposals, and clinical/scientific mentorship is an important part of a Circles-based RWE Program.Sustained Clinician EngagementCircle Academies are an example of regular communication channels inherent in an RWE Program enabling researchers and clinicians to discuss study designs, results, observations, and best practices. Profit Center, Not A Cost CenterCost-EfficiencyA Circles-based RWE Program is low cost and modular. SaaS pricing ensures complete control over expenditures, no commitments, full transparency, and the ability to scale as KPIs are met. MonetizationAn RWE Program will materially improve the quality and number of research and other grant proposals. Also, as indicated, RWE datasets represent significant value for product manufacturers, payers, and other healthcare constituencies. Properly designed and executed, an RWE Program will represent a substantial financial, clinical, and scientific return on investment for an AMC.Partner, Not A VendorRegenMed works as a long-term partner in the structuring and execution of an RWE Program. It provides the ongoing support needed to minimize clinical burden. At the same time, it works with AMC leadership to ensure that the Program meets pre-agreed KPIs.‍To find out more, please contact us.Endnotes1 See for example FDA, Real World Evidence, FDA, Post-Market Surveillance Programs; The 21st Century Cures Act; NIH Grants Program For Real-World Studies; Expect To See More RWE-Based Regulatory Decisions, Robert Califf, FDA Commissioner; Use Of Real-World Evidence In Regulatory DecisionMaking, EuropeanMedicines Agency. Registries for Evaluating Patient Outcomes: A User'sGuide: 4th Edition, Agency for Healthcare and Qualityand Research, U.S. Department of Health and Human Services. Deloitte 2022 Study: RWE’s Evolution Into A TrueEnd-To-End Capability. McKinsey: Creating Value FromNext-Generation Real-World Evidence.2 See Rediscovering andRe-Imagining Medical Research.3 See Healthcare Data: Ownership, Publication and Monetization. Getting Ready For TheGenerative AI Training Data Licensing Boom. 4 See for example SocialDeterminants of Health, https://health.gov/healthypeople/priority-areas/social-determinants-health; FDA Office Of Minority Health and HealthEquity, https://www.fda.gov/about-fda/office-commissioner/office-minority-health-and-health-equity;CMS Value Based Care, https://www.cms.gov/priorities/innovation/key-concepts/value-based-care.5 FDA Expanded Access, https://www.fda.gov/news-events/public-health-focus/expanded-access. Overview of FDA’s Expanded Access Programfor Investigational Drugs, Jarow et al., https://www.ncbi.nlm.nih.gov/pmc/articles/PMC5443564/pdf/nihms863256.pdf.CliicalTrials.gov data submissions for EAPs. https://prsinfo.clinicaltrials.gov/expanded_access_definitions.html. 6 U.S. Patent No. 11720567, Method and System For Processing LargeAmounts of Real-World Evidence.‍