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Nick: ‍This is Nick Tierney with RegenMed Circles. And I'm here with Michael Strøm, a shockwave specialist and sexologist out of Denmark.Michael: Yeah. I'm happy to be here today. I'm coming from manual therapy and started working with shockwave back in 2016. So, my daily work consists of shockwave for erectile dysfunction, Peyronie's disease, chronic pelvic pain and incontinence. So that is where I am today, and today I'm one of the leading shockwave guys in the world and in this field, participating in many conferences, doing keynote speeches and doing a lot of education. So that's also why tracking up data is becoming more and more important to me.Nick: So, we’re relatively new to shockwave ourselves. But in the short time we become aware of it, we do recognize there's a lot of evidence for shockwave, and a growing body of evidence in the literature. So why is there a need for data if there's already a lot of publications? Michael:We have Storz, we have MTS, we have Richard Wolf, we have Inceler, we have StimWave™, we have Medispec, we have so many different devices utilizing the three ways of generating the shock wave. And when we look at them in all the studies - it's different protocols - we can see everyone is having an effect, with the different devices and in different areas. But if we want to, as we’re wanting, an expert group I’m a part of in Europe, with different urologists, cure pain leaders, which is men's health shockwave, if we want to try to do a common protocol of getting a better sense of what is the right way to do, then we need to track every specific device on how many pulses and we actually need to go down to what kind of applicator is. So, if I take the Storz device, the electromagnetic, there are two different applicators. If we take the Richard Wolf, Elvation®, there are five different applicators, and we take the MTS - and that's electrohydraulic - they have three different hand pieces. So, all the things we need to track and incorporate to see how we're getting the best effect. For me, when I have all the equipment inside, I'm going to randomize every time I'm getting a client in, I say "Okay, for this indication I will believe this device will be the best. So, then I need to do my notes, I need to put in how many pulses, what kind of energy, how many sessions and what hand pieces they use because then we can start getting some really valuable data for us as clinicians but also for the companies to see where they need to go with the development of the devices. Nick: Very interesting. So, you’ve launched some Circles which are focused on these four indications that you commonly treat. Talk us a little bit through those Circles. How did you design them? What are their main objectives and missions? Etc.Michael: For erectile dysfunction, we are tracking the erectile function - how much is the improvement with tracking a life quality, so here you can really get a good hold on your clients to track them over time and get them in again because our patient is already reoccurring, coming in back again and again, that is easier to getting a new client. For Peyronie's disease we are tracking different aspects with tracking pain, function, how much the symptom is bothering them, quality of life and erectile function. So, here we can distinguish from what is coming from the curvature, what is from the erection, and with these kinds of very sensitive, you can really ‘hold them in the hand’ for a long while because this is a long game, this is a 12 to 24 months progress you're gonna stop. With pelvic pain, which is quite interesting, we're looking at erectile function that is normally away when they have pelvic pain, we're looking at the intensity of the pain, where it's located, how is it going to progress and how the quality of life is going to turn out. So, this is also something that's reassuring the client that we have access to take care of it because we normally been met and then forgotten the traditional system. For incontinence we're looking into quality of life, we're looking into how much leakage there is, how many times a day and how I said the function of the pelvic floor. The issue is that I've been having these questions from clients for years: “How do you track your outcomes?”, “What do you do?” and I’ve always been saying: “Well, I'm just meaning it - what you see is what you get. So, I'm also the secretary, I’m also the IT guy, I’m the marketing guy, and I'm doing the treatment as well. So, I didn’t have the capacity with the high amount of clients. I had to call everyone or write them an email, setting up this complex system. So, in that way the system with RegenMed is really making that easy for me, that's cheating a bit.Nick: It sounds like you also work with colleagues quite a bit and help give them guidance, and instruction, and standards that are emerging within this exciting field. How does the Circle play a role in that? Is there an opportunity for other - either new or even experienced shockwave practitioners - to benefit from joining into your study or Circle, and participating? And if so, what are the benefits for that?Michael: The key point is really that you are going to join my Circle, I’ve already been doing the hard work, so you can just log in, then you're going to start tracking the data, you’re going to have all these easy things handed directly to you. The second thing is that you’re going to have a big care for your clients. Every time they submit a new data point, you can engage them so they can either come back in or you can say “okay, I can see it's going good”. So, we just let it go for two more months or three months. And you're going to have this reoccurrence of the clients. You are going to have a different bond with them. The third thing is that with all the data you get, you are going to be comparing yourself to me and all the other guys in the Circles. So, you know how you're doing, you can benchmark yourself and have a lot of access to knowledge. You can see how I'm progressing. And in that way, you're going to lead your clients to a better state. So please join the Circle. It will help all of us to create better protocols for the different areas. And we need to have better protocols so we can attend to the care of our clients in the best possible matter.‍

Ozempic™, Wegovy™ and similar “GLP-1” drugs have underscored the importance of peptides. There are over 7,000 known peptides in thehuman body, each with its own characteristics and potential benefits and side effects.The medical literature describes the benefits of peptides for such major health categories as anti-aging, muscle growth and repair, wound healing, anti-inflammatory effects, antimicrobial properties, metabolic regulation,cardiovascular health, immune system modulation, pain management, and weight loss. [1]RegenMed’s Circles regularly support the development of real-world evidence for specific peptides physicians believe may represent promising therapeutic pathways. Such evidence may comprise post-market surveillance for approved drugs, or more structured datasets for other classes of peptides.RegenMed has recently assisted a U.S.-based physician and his co-investigator develop a study protocol and obtain IRB approval for a peptide known as BPC-157 (Body Protective Compound-157). Potential medical uses include sport medicine, gastrointestinal health, and musculoskeletal repair. Through their BPC-157 Circle, RegenMed will also assist with investigator and patient recruitment, ongoing IRB communications, regular investigator reports and collaboration, publication and dataset licensing. In the broad field of healthcare and wellness, there are many dozens if not hundreds of opportunities for disrupting the current expensive, complex and inequitable approach to clinical research. Each of those opportunities is large. Every day, RegenMed is exploiting them with new proprietary and valuable datasets.

RegenMed is now enabling independent clinicians to earn supplemental revenue and increase practice equity value through Physicians-Owned Circles. POCs are based on a simple premise – manufacturers, payers, self-insured employer groups and other healthcare constituencies regularly license high-quality healthcare datasets. This demand will only accelerate with the growth of AI learning models, where the error rate in healthcare must be close to zero. Independent practitioners are often in the best position to generate the real-world evidence datasets most valued by licensees. Through POCs, they can do so with minimal interruption to normal clinical flow. POC Members, including the Principal Investigator, receive 85% of all license fees generated by those Circles. Each month, RegenMed will publish and organize Physician-Owned Circles across the dozens of pathologies and treatment protocols representing the most valuable datasets in medicine. More information can be found here.

Reapplix, an international wound care company, has recently launched a RegenMed Private Circle aggregating clinical and long-term outcomes data on its personalized diabetic foot ulcer product. The diabetic foot ulcer market value is estimated at $5.2 billion. About 60% of all patients experience a wound that does not heal. If the severity of a wound progresses to grade 4 or 5, the cost of treatment is eight times higher than a grade 1 or 2 wound. For about 20% of patients, treatment ends in amputation within one year.The Reapplix Circle will help the company, its clinical customers, and their patients further support the safety and efficacy of its products.

TABLE OF CONTENTS THE REALITY ABOUT PROPER OUTCOMES CAPTURE 3 PROPER OUTCOMES CAPTURE IS RARE 3 FORMS OF OUTCOMES TRACKING 3 Anecdotal 3 Outcomes Only 3 Poor Transparency/Integrity 3 Clinically Irrelevant 3 Biosensors 3 THE UNFORTUNATE CONSEQUENCES 3 Evidence-Based Medicine? 3 Standards of Care? 4 Value-Based Care? 4 Health Equity? 4 WHY TRACK OUTCOMES 4 CLINICAL DECISION-MAKING 4 REIMBURSEMENT 4 PROFESSIONAL FULFILLMENT 5 REGULATORY/LEGAL COMPLIANCE 5 DEMOCRATIZING RESEARCH 5 PATIENT ENGAGEMENT 5 FINANCIAL AND REPUTATIONAL VALUE 5 HOW TO TRACK OUTCOMES 6 GOOD CLINICAL PRACTICE 6 ASK THE RIGHT QUESTIONS 6 COLLABORATE 6 TRANSPARENT AND ACCESSIBLE PUBLICATION 6 OTHER CONSIDERATIONS 6 VALUE TO THE CLINICIAN 6 Data Ownership 6 Data Monetization 7 MINIMAL CLINICAL BURDEN 7 TOTAL COST 7 ENDNOTES 7 THE REALITY ABOUT PROPER OUTCOMES CAPTURE Proper Outcomes Capture is Rare The large majority of clinicians do not track outcomes. Even in large academic medical centers, meaningful outcomes capture is limited. Given the intrinsic importance of outcomes monitoring, this failure is surprising. There are multiple reasons explaining healthcare’s poor record of clinically significant outcome capture. These include cost, lack of incentives, insufficient time, administrative burden, perceived complexity, and poor patient compliance. Forms of Outcomes Tracking Patients and physicians frequently see reference to “clinically proven”, “long-term efficacy” and similar claims implying validated GCP outcomes capture. These claims rarely withstand scrutiny. The reality of claims allegedly based on outcomes can be summarized as follows. Anecdotal Some claims are in essence based on word-of-mouth (including among providers), online case histories, testimonials, or similar forms of anecdotal “evidence”. Outcomes Only “ePROs” and other forms of surveys are easily available. However, their use by clinicians is infrequent, and patient compliance is poor. Moreover, these are poorly correlated (if at all) with the specific clinical interventions and patient populations needed to derive useful causal relationships. Poor Transparency/Integrity Healthcare is awash with data. Registries, journal articles, clinical trials, meta-studies, research files, etc. Most of these, however, suffer from limited accessibility, incompleteness, and the inability to validate/audit the underlying data. Clinically Irrelevant EMR platforms are principally dedicated to CPT codes and similar reimbursement schema. Patient quality surveys reflect subjective satisfaction. Re-admission rates, RVUs, facility utilization may provide some information on the “value” part of value-based care, but in practice do little to support everyday clinical-decision-making. Biosensors Apple watches, Pelotons and similar health outcome sources are already widely used by consumers/patients. More clinically sophisticated biosensors will soon become commonplace. These represent valuable outcomes datasets, but they are only rarely anchored to diagnoses, treatment protocols or well-structured clinical/scientific hypotheses. The Unfortunate Consequences Evidence-Based Medicine? For over a century, “evidence-based medicine” has been — in principle — a central tenet of medical education and care. By definition, evidence-based medicine should be grounded on standardized patient outcomes closely correlated to a specific condition and treatment protocol. However, in reality, genuine GCP outcomes tracking is typically relegated to premarketing approvals for medical products or other highly limited contexts. Standards of Care? Many of today’s “standards of care” are backed by poor levels of evidence. Moreover, in an era of personalized medicine one-size-fits-all standards of care are inapplicable to most situations. They fail to account for co-morbidities, differences among patient population groups, new medical science, facilities access, a patient’s ability to pay, and other considerations. Value-Based Care? VBC has been a goal of payers, providers, and patients for decades. The “care” in VBC refers to quality care personalized to the patient’s condition and objectives. The “value” can, in theory, be whatever the patient and provider wish. At its most impactful, however, value should equal superior and predictable long-term outcomes compared with clinical baselines. To date, genuine “value-based care” and “health equity” largely remain laudable goals rather than reality. Health Equity? Access to health care varies widely by location, income, education, and other factors. Prevalence of conditions, and outcomes for a given treatment protocol, can vary widely according to gender, race, age, and other factors. Health equity and social determinants of health are major objectives in modern healthcare delivery. However, without outcomes tracking specific to particular population groups, those objectives cannot realistically be achieved. WHY TRACK OUTCOMES Clinical Decision-Making Proper outcomes capture allows a clinician to make better evidence-based decisions regarding a patient’s care. That decision-making is not limited to a single visit or intervention; it can continue throughout the outcomes reporting period. It allows the clinician to identify potential adverse events, suggest supplemental procedures where appropriate, and maintain patient engagement in a meaningful way. Reimbursement Inevitably, healthcare’s fee-for-service revenue model will be replaced by value-based care. VBC can take many forms. Today, it is based principally on readmission rates, broadly defined population panel metrics, and even patient quality surveys. Increasingly, however, reimbursement rates will be determined by validated long-term outcomes measures This is already happening at the payer level. For example, CMS is tying IQR reimbursement to patient reported outcomes in the context of total knee and hip arthroscopies. This government payer focus on patient outcomes will certainly be extended in the near future to other specialties and conditions. Professional Fulfillment “Burnout”, depression, and other forms of professional dissatisfaction are well reported among physicians. A root cause is loss of clinical autonomy. A practitioner can regain a strong sense of professional independence and growth by posing thoughtful clinical questions, and monitoring standardized patient outcomes to develop causal correlations for his particular patient panel. Regulatory/Legal Compliance Providers have always operated in a complex legal and regulatory environment. That environment will only become more challenging in the years to come. Whether a sole practitioner or a large academic medical center, proper outcomes capture is an important tenet of good clinical practice. As such, it can provide key documentary support for regulatory compliance, marketing claims and litigation defense. Democratizing Research Impactful medical research depends on posing clinically relevant hypotheses, and developing validatable datasets generating statistically significant correlations. Longitudinal and standardized outcomes measures are a key element of those correlations. It is the busy clinician who can pose the most clinically relevant questions. Similarly, it is her patients who are best able to provide validated long-term outcomes corresponding to those questions. If cost and administrative burden can be minimized, then those datasets – often called real-world evidence – can democratize medical research for the benefit of all healthcare constituencies. Patient Engagement Patients are increasingly educated about their providers, treatment protocols and other healthcare options. They want to be involved in their healthcare decisions. They also want to monitor their outcomes, with or without the support of their physician. Financial and Reputational Value Monitoring outcomes not only reduces legal/regulatory risk (and therefore costs), but creates multiple value categories. These include materials for conference presentations and articles, as well as proprietary datasets supporting investigator fees, intellectual property, and licensing revenues. HOW TO TRACK OUTCOMES Good Clinical Practice Usable healthcare outcomes capture is not a matter of sending out perioding surveys. It requires appropriate and consistent assessment scores, regular and high patient compliance over at least a year, auditable correlations between clinical/scientific questions and the outcomes, and statistical significance. Ask The Right Questions Outcomes unrelated to specific clinical/scientific hypotheses are of little value. In the words of the FDA, they are not “fit-for-purpose”. Collaborate The most powerful statistical significance is based on a large “n” dataset comprising coherent and longitudinal data. Moreover, to have real clinical impact, those data should be collected across – and be capable of being parsed among – several patient population groups. This requires the efficient collaboration of multiple investigators in multiple locations. Transparent and Accessible Publication Properly structured outcomes datasets represent important information for practitioners and patients around the world. They deserve to be communicated promptly and widely allowing those practitioners to improve care for their patients. Moreover, because such datasets have been generated on the basis of good clinical practice, the authors’ data can be thoroughly validated. OTHER CONSIDERATIONS There are several approaches to track outcomes in a GCP and impactful manner. However, there are certain factors to be considered in choosing among those approaches. Value To The Clinician Data Ownership Who owns the aggregated datasets representing longitudinal outcomes is an important but often ignored question. It should be the clinician, but often is not. Data Monetization Ownership is important because outcomes datasets have value. They are copyrightable and licensable in their own right. They may contain the foundation of monetizable intellectual property. In the fast-advancing world of generative artificial intelligence, those datasets represent valuable sources for training large language models and other AI applications. Minimal Clinical Burden To have value, outcomes datasets must be based on good clinical practice. However, GCP can interrupt clinical flow, and represent substantial administrative burden. This need not be the case. Total Cost EMRs and other health data systems are already too expensive for many provider groups. (Hospital bankruptcies attributed to EMR installations are not uncommon.) As indicated, outcomes datasets can represent substantial value for provider groups. For them to represent a profit center however, the total cost should be taken into account. That cost includes initial and ongoing financial charges, as well as necessary support personnel, interrupted clinical flow and similar factors.