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Physicians-Owned Circles in the large and dynamic physical therapy market are examples of RegenMed’s accelerating market traction. In the U.S. alone, this market is valued at about $50 bn, and is expected to grow by at least 18% over the next decade. The demand for physical therapy is fueled by a rise in chronic diseases, an expanding aging population, increased healthcare spending, and an increase demand for rehabilitation therapists to meet the needs of these populations. Also, private insurers and government health programs are increasingly turning to low-cost/high-quality outpatient providers such as physical therapists. Innovations in orthopedic treatments practices are also leading to post-surgery PT services. As one illustration, Paul Hobrough is the Principal Investigator for a Physicians-Owned Circle covering the use of hydrogels – itself a $47 billion market – in the context of shockwave therapies. Paul, based in the United Kingdom, is an internationally recognized speaker and teacher in the field. Through his broad network of additional investigators, the POC will rapidly generate multiple licensable real-world datasets advancing the field, while financially benefiting all POC members. There are an estimated 320,000 licensed physical therapists in the U.S., with an even larger number on a per capita basis in many European countries. Each of these is a potential member of one or more PT-related Physicians-Owned Circles. As such, they will generate validated and clinically significant real world datasets of high value to product manufacturers, employers, payers, and other healthcare constituencies. This is the clinical and financial power of Physicians-Owned Circles.

The healthcare data analytics market is worth $64 billion, with a forecasted 21% annual growth 1. At the same time, there is a strong focus on the importance of real-world data. Through its patented Circles platform, RegenMed is well positioned to exploit both of these powerful trends on an enterprise level. Everyday physician-patient interactions — correlated to long-term outcomes — are the largest and best source of real world data. In the US alone, over 1 billion such interactions take place each year at 7,400 hospitals, 9,600 ambulatory surgery centers and 340,000 physician group practices 2. Larger hospital systems are now monetizing their traditional electronic medical record data. However, they are investing heavily to do so. Moreover, the ownership, clinical significance, and reliability of EMR datasets are open to question. In contrast, Circles represent a clinical grade, low cost and highly efficient method to develop and monetize real-world datasets. Circles datasets are generated through a patented and minimally burdensome closed system. This enable the generation of healthcare datasets which are regularly updated, clinically significant, “hallucination” free, and protected from third-party claims of ownership.Hospitals and other provider groups are facing strong financial headwinds. Reimbursement rates are declining while costs are increasing. EMR and other IT costs are failing to deliver the promised patient care or economic returns. Circles generate a new and accumulating revenue source at a small fraction of typical IT expenditures. Moreover, Circles datasets lead to genuine value-based care, health equity, and deeper engagement with physicians and patients. For RegenMed, proprietary and monetizable Circles datasets are the foundation of accelerating enterprise sales.

Our December 16, 2024 Investors Webinar – Expectations 2025 – was well attended and well received. We thank and welcome all of our new investors, including our first fund. During the webinar, Michael Tierney, the Company’s co-founder and CEO, covered the planned 2025 acceleration of its 2024 market traction. As he explained, the demand for Circles real-world evidence datasets is likely to expand significantly in the coming years As a “Zero-To-One” company with growing recurring revenues, RegenMed is focused on rapid scaling within its large markets. While not specifying current Company valuations, Mr. Tierney discussed the rapid growth in recurring revenues and corresponding market value of several other SaaS companies. Mr. Tierney also identified strategic exits of relevant healthcare data companies at large valuations. These included CorEvitas, acquired by Thermo Fisher for $913 million in cash in 2023. Like RegenMed, CorEvitas focuses on real-world evidence. Mr. Tierney reviewed as an example of the Company’s progress the enthusiastic adoption of Physicians-Owned Circles commencing in the fourth quarter of 2024. The Company is preparing a series of YouTube videos covering major topics presented during the December 16 webinar. Once published, these will also be available on the Company’s Investors Page, with links also provided in future StartEngine campaign page updates.

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.‍

Type image caption here (optional)Michael Strøm is an international speaker, educator and men’s health shockwave specialist. He is the clinical director of The Academy of Shockwave Excellence, and starting in 2024, will be regularly conducting his own courses for international practitioners interested in learning about the use of shockwave for men’s health. Michael has designed several Circles to:1) help generate real-world data and outcomes against his specialized men’s health shockwave protocols and 2) enable other shockwave users to remotely contribute and benchmark their results from their home clinics. These aggregated real-world data will be the building blocks for real-world evidence, and that evidence is poised to help standardize protocols for shockwave users and their real-world patients. We are proud to work with evidence-based teachers and practitioners like Michael Strøm. Learn more about Michael Strøm's Circles below:Erectile Dysfunction CirclePeyronie’s Disease CircleChronic Pelvic Pain CircleIncontinence CircleContact us to learn more.