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It has been our pleasure to know and work with Jimmy Sung, MD, JD, FACS, for over five years. In 2018, the concept of Tribeca Aesthetics was a mere dream. Within three years, however, Dr. Sung had acquired premium property in strategically located lower Manhattan, converted it into fully certified first-class medical space (including a surgical suite), and built a thriving evidence-based plastic surgery and aesthetic practice. The photograph below shows one of RegenMed’s C/SAB members, John Kennedy, MD, FRCS, and Lisa Fortier, DVM, Ph.D. with Dr. Sung looking over his plans for the new center.Tribeca Aesthetics also houses a dedicated teaching area, as well as the Futrell laboratory, named in honor of one of Dr. Sung’s mentors at the University of Pittsburgh Medical Center, J. William Futrell, M.D., FACS.In addition to his independent practice, Dr. Sung serves as a faculty member of Plastic and Reconstructive Surgery at Weill Cornell Medical College. He also actively supports the population surrounding Tribeca Aesthetics, by serving as a member of the New York City Manhattan Community Board 1.RegenMed continues to support Dr. Sung through Circles in developing Tribeca Aesthetics as a national center of excellence in the field of evidence-based plastic surgery and aesthetics. We have no doubt that Dr. Sung’s work will be increasingly impactful for his patients and colleagues.

Dr. José Miguel Catalán was in excellent company when he presented his intraosseous PRP protocols and 1yr+ Circle data at the recent Sociedad Española de Traumatología del Deporte (SETRADE) 15th biennial congress.Our friendship and partnership with Dr. Catalán dates back to 2015. He was a young doctor offering innovative regenerative medicine treatments to locals of Palma Mallorca, Spain, and we were a young company with a vision to expand and simplify real-world data collection and use. As our very first Circle member, he invested time, feedback and everyday clinical cases to help us adapt and improve. In turn, we supported his efforts in conducting real-world research, obtaining Industry support and preparing for a growing number of conference presentations.From the day we first met, Dr. Catalán has dreamed of sharing his protocols on a global stage. Today, those dreams have become realities, as he travels the world to present his techniques and real-world results with esteemed colleagues. (Catch him next at the 14th annual TOBI: The Orthobiologic Institute conference in Las Vegas, June 8th - 10th.)We applaud Dr. Catalán's vision, work ethic, and persistence, and are proud to be a partner in his journey.

TABLE OF CONTENTS‍ILLUSTRATIVE MULTICENTER STUDY USE CASES Improved Standards Of Care Clinical Decision Making Reimbursement Testing A Clinical/Scientific Hypothesis Registries Sustained Involvement Of Teaching Hospital Residents And Fellows Extend Best Practices Of Sports Medicine KOL’sFUNDINGCIRCLES AS A COMPREHENSIVE SOLUTION General Identifying Peers And Experts IRB And Other Approvals Data Collection, Aggregation, Correlations Patient Compliance And User Experience Ongoing Collaboration Publication And InfluenceCONCLUSIONCONTACT USFOOTNOTES Abstract“Impactful and professionally rewarding multicenter studies arewell within reach for all clinicians.”Illustrative Multicenter Study Use CasesThe efficiency with which multicenter studies can be designed and executed opens up a range of use cases. As but a few examples:Improved Standards of CareAn orthopedic surgeon wishes to substantiate that his specific approach to minimally invasive shoulder reconstruction is superior in safety and efficacy to the standard approach currently utilized in his hospital.Clinical Decision MakingA pain medicine doctor wishes to improve her ability to develop different treatment plans for a diverse patient population presenting with lower back pain. She wants to be able to segment her lower back pain patient panel in an evidence-based manner.Reimbursement An ambulatory surgery center wishes to support reimbursement for a particular procedure for which patients currently pay out-of-pocket. Reimbursement may come from traditional payers, or in the context of a narrow network established by the ASC with select partners.Testing A Clinical/Scientific HypothesisA clinician, intrigued by peer-reviewed literature suggesting the value of certain biologics for a specific segment of her patient panel, wishes to validate their safety and efficacy for that segment.RegistriesA regional medical society wishes to establish a registry which adds value to its members, attracts new members, attracts new industry funding in a product-agnostic manner, and simultaneously advances the mission of the society.Sustained Involvement of Teaching Hospital Residents and FellowsThe maxillofacial department of a major hospital wishes to establish a research/clinical program which not only attracts promising fellows and residents, but maintains a relationship with them throughout their careers.Extend Best Practices of Sports Medicine KOL’sA sports medicine thought leader establishes and encourages best practices among college level soccer trainers in the context of concussion protocols, by involving those trainers in his study.‍FundingTraditional studies are long, expensive and involve limited patient populations. Such studies will of course always have their place. However, as indicated above in footnote 1, there are equally legitimate, far less costly and often more impactful alternatives. Their modest budgets and clinical efficiency make funding much more accessible.In larger hospitals and clinical groups, study funding is often available from research, education, training and even marketing budgets. Another approach is Investigator-Initiated Trials. These studies are financially supported by industry, but explicitly leave to the clinician/investigator all control over study design and execution. [1] Circles As A Comprehensive SolutionGeneralCircles represent an integrated approach to multi-center studies. A successful Circle comprises two closely integrated components:inCytes™ , the technical foundation for value-added registries, studies, trials and other forms of clinical data collection.Circle Academies, which enable the collaboration, education, discussion, publication, and the “network effect” needed to realize the full potential of correlations developed through inCytes™.Circles thus represent a turnkey solution with excellent user experiences – and motivation – for clinicians, patients,and other users. The burden on providers is minimal.Identifying Peers and Experts RegenMed plays an active role in identifying – and supporting collaboration among – practitioners sharing a common clinical/scientific interest. Those “Circle Members” can be found in the same hospital department, in study-relevant medical societies, as authors of articles and conference presentations, and among RegenMed’s network.Circle Members often include scientific and clinical domain experts who can assist with study design,education and training. They also help identify and analyze useful correlations generated through aggregated datasets. A statistician can also be a valuable member of a Circle.IRB and Other ApprovalsAs mentioned, many forms of clinically- and statistically significant studies do not require the involvement of an IRB. Examples are “observational” and “quality improvement” studies. [2]Data Collection, Aggregation, CorrelationsThe statistic power and clinical value of most multicenter studies derive from their large population sizes. This also is the foundation for uncovering “serendipitous” correlations, as well as those envisioned in the original study design. The time needed to achieve that “n” is also significantly accelerated when multicenter studies are efficiently executed.Circles enable the economical and efficient collection of real-world data within the clinical setting of each Circle Member. At the same time, Circle functionality aggregates those data in real time from all Circle Members, wherever located.That aggregated data is then available - also in real-time and at any time - to all Circle Members.Importantly, aggregated is available through a powerful Report Builder allowing any Circle Member to:filter Circle data according to any study question, and compare it to patient report outcomes or other assessment scores established as part of the Study;compare his data against those of all Circle Members;compare a particular patient’s data against those of her broader patient panel;compare outcomes of two or more patient cohorts against the same outcomes score;export raw data; andmore.Circles accommodate variations in protocols and legal/regulatory environments across various practices, while preserving the “canonicity” of all data relevant to verifiable and useful correlations in the multi-center study’s dataset. They also provide full multilingual functionality, allowing participation among like-minded members in any country. [3]Patient Compliance And User ExperiencePatient enrollment, and timely capture of their longitudinal outcomes against a standardized scoring algorithm, are essential to a successful study. The Benchmarc™ patient user experience drives consistently high compliance rates. In addition, RegenMed offers a cost-effective Service Provider Agreement, pursuant to which it handles enrollment and outcomes reporting follow-up on behalf of clinicians.Ongoing CollaborationFor many clinicians, the opportunity to collaborate with peers in other institutions and countries is an attractive aspect of multicenter studies. Ideally that collaboration is meaningful and sustained throughout the full course of the study - from the initial design through the joint generation of correlations. Circle Academies provide the secure, always-on environment allowing them to do so.Publication and InfluenceClinicians and other healthcare constituencies around the world will be interested in one or more elements of multicenter studies – hypotheses, indications involved, study protocol, tentative correlations, methods of efficient execution. These elements are compelling data-driven content for conference presentations, articles, blog posts, training/education programs and patient materials. [4]RegenMed works closely with Circle Members to develop the appropriate content, formats and distribution channels reflecting their work. [5] ConclusionMost clinicians are capable of designing and/or participating in a multicenter study. Doing so need not be expensiveor burdensome. Properly executed, such studies are professionally rewarding, and result in genuine clinical and professional value.‍Contact UsIf you have any questions about how multicenter Circles may benefit you or your institution, please contact us.Footnotes1 See our Article of Investigator-Initiated Trials here.2 A good example is the extensive AAOS Registries. See here.3 While English is common to most clinicians around the world, most are more comfortable in their native language. More importantly, patient-reported outcomes reporting and other patient-engagement elements are essential to a successful study. That engagement should be in the patient’s native language.4 Indeed, a common criticism of traditional trials is the secrecy with which they are conducted. It is often many years, if ever, before their methodologies and conclusions are published.5 See here for more information.Copyright © 2023 Regenerative Medicine LLC

Statistical Significance and Clinical Relevance are two important concepts in the field of medicine, and particularly in clinical research.Being a bit more specific, statistical significance refers to the likelihood that a result is not due to chance. In other words, it is the probability that an observed effect (for example, a clinical effect resulting from a given treatment) is real and not just due to chance. A statistically significant result is considered meaningful in general terms when the p-value is less than 0.05, meaning that there is less than a 5% chance that the observed effect is due to chance.Clinical relevance refers to the practical importance of any effect (after a treatment) on a patient’s everyday life (i.e. less pain, higher survival rate or better quality of life). Any result can be considered clinically relevant when it has a meaningful impact on patient outcomes, for example using a patient reported outcome measure (PROM).These two concepts are related but not equivalent. For many reasons, a given result may be statistically significant but not clinically relevant, or vice versa. For example, a treatment may have a large clinical effect but fail to reach statistically significance due to a small population size or other factors, such as data dispersion or variability.‍In summary, statistical significance and clinical relevance are both important for clinical research, the first providing unbiased evidence of a relationship or effect, while the latter represents the practical implications of results obtained in terms of patient care and decision making.The ideal situation is having a result that is both statistically significant and clinically relevant. One of the best ways to achieve this in clinical trials, is deriving research data from a large number of a homogeneous group of enrolled patients (restricted by inclusion and exclusion criteria). However, in a real world scenario there is high variability and many factors affecting any clinical outcome (disease severity, age, sex, comorbidities, etc).There is also one more aspect that affects clinical relevance for any real patient population, and is called generalizability, the degree to which you can apply the results of any clinical study to a broader patient population. One good example is that many clinical trials might offer statistical significance and clinical relevance in a restricted study population, but not generalizability.The use of Real-World Data obtained from daily clinical practice could overcome the previous limitations by allowing clinicians to easily collaborate and aggregate de-identified data. This could lead to the generation of Real-World Evidence that can be considered statistically significant, clinically relevant and generalizable to different patient populations.RegenMed Circles have been developed with this goal in mind, facilitating data sharing among healthcare practitioners and their industry partners, and putting the patient at the center of their care to advance and progress in any field of medicine and healthcare.If you want to know more about Circles or how our solutions could help you in different ways, contact us.

Real-world evidence (RWE) is valuable not only for regulatory compliance, clinical decision-making and tracking adverse events. It can also drive patient engagement, profitability and professional advancement.The highest quality RWE reflects scientific rigor, long-term outcomes capture and statistical significance. For many, these parameters suggest expense and clinical burden. This need not be the case, especially in the context of Circles. An interesting use case for the efficient development of RWE, and subsequent value creation, is the recent work done by BioXcellerator (Biox) in Colombia.Biox treats patients from throughout North America, often coordinating with physicians in the U.S. and other countries. In 2022, Biox developed an observational study protocol comprising key pre-, peri- and post clinical datapoints. Outcomes are measured utilizing the Impairment Scale for traumatic spinal cord injury developed by the American Spinal Injury Association. Patients are also assessed using the Barthel Index For Activities of Daily Living.Biox has now collected real-world data against their protocol for more than 380 cases. Its preliminary reports and analysis are summarized in the charts below. These are already providing value to treating physicians, referring physicians, existing patients as well as those considering therapeutic alternatives for spinal indications.Moreover, such real-world observational studies are now standard for BIOX physicians and their patients. This will result in transparent evidence-based standards of care specific to a variety of indications and patient-cohorts.Although this use case involves biologics for degenerative spine disease, systematic collection and analysis of real-world evidence are valuable in the context of any indication or clinical setting. The generation by practitioners in any specialty of scientifically valid real-world evidence need not be burdensome or expensive. Moreover, it adds substantial benefits not only in clinical decision support, but practice growth, professional advancement, collaboration, product improvement and influence among peers.Contact us to find out more.