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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.

Less Costly. More Efficient. More Impactful.Clinical Research Is BrokenIt fails to deliver better outcomes. It is expensive and cumbersome. Only the largest of corporations can afford to bring products to market. Supporting data exclude most patient types. Most everyday clinical interventions have no or poor levels of evidentiary support. Social media anecdotes and DTC advertisements have replaced physician-led patient education. The proliferation of medical journals and articles masks a sharp deterioration in the quality of data and reliability of conclusions. Bias, confounding variables, contradictions, and lack of data transparency are common. The consequence is higher healthcare expenditures each year for worse health outcomes.There Is A Better WayReturn to the origins of evidence-based medicine. Clinical/scientific hypotheses based on better care. Meaningful outcomes capture. A sense of health equity. Question, doubt, test. Listen to the data, do not manipulate them. Independence and courage in the face of “experts”. Be alive to unexpected correlations. Establish causation, not association. Collaborate, teach, learn.As simple as possible, but no simpler. Reduce unnecessary costs and complexity. Do the most good for the most patients. Clinical research should not be the right of only the well-funded few. It should not be episodic. It should be the right, the professional responsibility, of each healthcare practitioner. Clinical research is integral to the everyday practice of medicine.Real-World Evidence ProgramsThe most important clinical/scientific data are to be found in everyday physician/patient interactions. Identify them, capture them, analyze them. Relate standardized outcomes measures to specific hypotheses and proposed endpoints. Include all patients; planned as well as unexpected correlations will emerge. Observe good clinical practice. Ensure full data integrity and auditability. Collaborate efficiently with peers, scientists and experts. Analyze, question, present, publish, improve, refine, expand. Do not interrupt normal clinical flow; harness it. For your benefit, for the benefit of your patients, for the advancement of medicine.Let Us HelpJoin an existingCircle. (A Circle is an indication-and/or procedure-specific research protocol.) Or work with us to create your own.We will handle practice customization, case creation, patient enrollment and follow-up, report generation, onboarding fellow investigators, and other administrative tasks.Collaborate with peers andexperts around the world.HIPAA, GDPR, Part 11 compliant. Multilingual. Aggregated data and reports accessible anytime from any device.Own and control yourdata. Present, publish, share, license,develop funding.Fully scalable from small studies to large multi-center trials.‍Copyright© 2024 Regenerative Medicine LLC‍