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Nick Tierney: Hello! This is Nick Tierney with RegenMed Circles, and I'm joined by Dr. Grant Pagdin, who's a regenerative medicine and anti-aging expert located in Kelowna, British Columbia. Dr. Pagdin, thank you for your time.Grant Pagdin: Yeah, thanks, Nick. It's a pleasure to be here.‍Nick: Please tell us a little bit about yourself.Grant Pagdin: Well, I got involved with bioidentical hormone replacement back in around 2009, 2010, and I got certified through the American Academy of Anti-Aging Medicine with their board exams. So, I have expertise in bioidentical hormone replacement, and also in the regenerative procedures involving PRP and stem cells along the way. I also was involved with clinical research that was pharmaceutical, sponsored, and I have my name on about 39 research papers using pharmaceutical medications and trying to get those things to market. In 2019, Health Canada intervened in the stem cell space in Canada and insisted that if we were going to use stem cells to treat osteoarthritis, we had to register a clinical trial. So, I put my own trial together. It's sort of self-funded, self-initiated. I'm the sponsor and the investigator, and I stick handled all through the Health Canada regulations to put my clinical research trial as the pioneering trial in Canada using stem cells for osteoarthritis. So, I have a fairly extensive background in research as well as my background in bioidentical hormones and regenerative procedures.‍Nick: Excellent. And today's topic is going to be bioidentical hormones in particular. So, tell us a little bit about what those are, what they're used for, and a little bit more about some of the challenges and or misconceptions about them.Grant Pagdin: The big challenge in this field is that some of the drug companies are now producing bioidentical options so that you can get a pharmaceutical drug. That's a prescription, and it's available from any pharmacy, and it's standardized. It has a DIN number. It goes through your extended healthcare plan.But some of these products are not available, or not always suitable. So, we ask the compounding pharmacy to make up a special cream, or a lotion, or a recipe, according to the doctor's prescription, and they will use the exact hormone that would be normally present in the body. So, a bioidentical form, and it's formulated in some sort of a method of delivery. So, the challenge for us really is to show that these things are safe and effective, that they work as they ought to, and that they would provide important, meaningful clinical improvements on a par with what the standard prescription pharmaceutical versions might do. That evidence is really lacking in the marketplace right now.And some of the regulatory bodies or the oversight bodies, for instance, Women's Menopause Society, aren’t really coming out strongly in favor of these compounded hormones, because they're not really validated, and the standards of manufacturing are not necessarily uniform across the board. So, we do have some challenges when it comes to showing the safety and the efficacy of these compounded bioidenticals.‍Nick: So, in the field of stem cells, you mentioned that you self-organized a clinical trial which you brought to Health Canada, and are now conducting. Probably, the rare practitioner that can put all of those pieces together, and afford to be able to run a clinical trial. What are the other options for generating clinical evidence. How else can we start to collect data on BHRT?Grant Pagdin: As you've alluded there, Nick, putting together a registered clinical trial, is a very onerous proposition. But an emerging way of achieving some meaningful data is what's called real-world data collection. So, what we do is rather than having a registered clinical trial where patients are randomized either to receive a placebo or an active drug, what we do is we take a cadre of patients that have similar symptoms and similar presentation. We put them on some treatment, and we track their outcomes with patient-reported outcome tools. I don't have to register that as a clinical trial. I don't have to have ethics oversight. We just have to have the patient that consents to, first of all, the treatment with the hormones and participation in the data collection. ‍Nick: So, you're doing this real-world data collection already, it sounds like, and what are the types of patients that you're tracking after prescribing BHRT?Grant Pagdin: So, in my testosterone replacement Circle, these are males that are registering with us for the onset of testosterone replacement. They've been deemed to be suitable candidates based on their symptoms and their blood test results.They do a questionnaire at baseline that gives us an idea of some validated symptom scores that they are dealing with. Then we initiate testosterone replacement. It could be done either as an injectable pharmaceutical substance, or as a compounded topical transdermal substance. And so, I record that at the beginning of the Circle of which sort of approach we're using for hormones, and then the individual is prompted to repeat the symptom score 1 month, 3 months, and 6 months into the treatment. And that way we can track how well they're doing. ‍Nick: And on the clinical side, what is the type of data that you're really interested in entering and then correlating against those outcomes?Grant Pagdin: Sure. So, as the provider I'm going to be entering into the Circle the data around the severity of the symptoms, the nature of the prescribed treatment, whether it's going to be an injectable testosterone, and the exact dose or transdermal testosterone, and the dose as well as the baseline lab levels. You know the total testosterone, free bioavailable testosterone SHBG, some of the parameters that we want to track. So, it's the responsibility of the provider to enter some of that basic data information at the baseline and then again at follow up. If we have follow-up lab tests, I typically do my follow-up labs at 3 months and 6 months. So, I would have a little bit of data to enter at those time points. But it's not particularly onerous for the provider. There's just some basic information that we want to register in that data set.‍Nick: So, that's great, Dr. Pagdin. So, you're collecting a lot of great patient data. You're spending the time to enter in a lot of specific prescription and other data related to formulations. What are you doing it for? What will you be using the data for?Grant Pagdin: Well, there's really 3 benefits that are obvious that I can think of, Nick. The 1st is the benefit for the patient themselves to feel engaged in the program, to be able to track their progress and have some objective numbers that they can see that helps them to track their outcome.The 2nd is for the provider. So, I want to know, am I, you know, am I hitting the mark? Do I need to make some adjustments, you know? And how is this particular patient doing compared to the overall cohort? So, it helps me to refine my prescribing and optimize the treatment of the patient.And the 3rd is that these API suppliers that produce these ingredients to make the compounded hormones, they're very interested in the efficacy and the outcomes, and that data would be very valuable to them. So, if there's a way that we can monetize this in a licensing way to be able to make that data available to these manufacturers and suppliers, that would be just, you know, an extra bonus.‍Nick: And so, Dr. Pagdin, so far, you're describing something you've already started, are doing yourself have been doing for over a year now with us. Is there a way for other doctors to participate?Grant Pagdin: Yes, I've established these Circles for some time now, just a little over a year. In the Hormone Replacement Circle for men I have over 300 registered subjects. In my Bioidentical Hormone Replacement Circle for women, I have over 250. So, what I would do is - I would invite other providers that are working in this field to contribute their cases to these Circles, so that we can have even more data available. So, for instance, if I had 10 providers, all contributing 100 patients each over the next 6 months to my Circle, well, we'd have, you know, thousands of patients in the Circle, and that data just becomes so much more powerful when it gets to those kinds of numbers. Keep in mind that it's anonymized data. So, you don't get to see the names of the patients. But you get the power of this amalgamated data from a number of providers as a contributor. Then also the other benefit, if you are contributing as a provider, you would be able to avail yourself of some of the financial rewards that could come from the licensing of the data to the manufacturers and the pharmacies.So, if there are any colleagues out there working in this bioidentical field, you could join the team of providers contributing data to the Circle, have access to that data for your own patients, for your own purposes, and also have access to the potential for licensing this data.

Real-World Evidence Patent FamilyPatents can be difficult to understand; they are also difficult to receive. In the right contexts, however, they are highly valuable. Especially in large, fast-growing markets (like healthcare data), strong patents act as competitive moats, and long-term revenue sources.RegenMed is building a foundational patent family in the + $500 bn world of generating and analyzing real-world healthcare data. And, real-world evidence is at the heart of value-based care, better health outcomes for all patients, and less expensive but more impactful medical innovations. Our issued patent family already includes 20 distinct claims relating to the clinically efficient development of proprietary, highly valuable datasets. For example:Handling disparities in real-world data which might otherwise not be combinable, or which might originate from disparate or heterogeneous sources.Generating real-world data from the ground up . . . such that reliable canonical answers can be mined from large datasets and consistently provided in response to queries to the solution for an answer.Gathering and analyzing large amounts of RWD data from heterogeneous, multi-national, and unverifiable data sources, and provide canonical results that are constituently reliable and can expose, for example, clinically-significant correlations between medical products or treatments and outcomes.Again, this type of patent language may seem overly technical and abstract. But it underlies large parts of all healthcare data use cases in the 21st century. And it is not merely conceptual. These and other patent claims are reflected in the many RegenMed Circles deployed by hospitals, product manufacturers and other healthcare constituencies around the world.Proprietary, Copyrightable Healthcare Databases RegenMed’s Circles use a closed system for generating, aggregating, and analyzing healthcare data. They cover any anatomical region, pathology and/or treatment protocol. As such, they can establish hundreds of new and important correlations for clinicians, scientists, patients, product manufacturers and AI training models. Most healthcare data today derives from multiple sources. Moreover, they pass through many hands and are generally “cleaned” and otherwise manipulated. They rarely include outcomes data. All of this makes it difficult if not impossible to identify primary data sources and ownership. Moreover, it leads to a high degree of unreliability in most clinical contexts.Circles avoid all of these issues. Each datapoint is attributable not only to its primary source, but is also integrally tied to specific clinical contexts and long-term outcomes. Circles datasets are thus proprietary to those who create them, and copyrightable. This and their high quality lead to multiple data license opportunities across a broad variety of healthcare data users.This Reg CF offering is made available through StartEngine Primary LLC, member FINRA/SIPC. This investment is speculative, illiquid, and involves a high degree of risk, including the possible loss of your entire investment.

RegenMed is pleased to announce that Mr. Dolph Courchaine has joined the company as Chief Information Technology Officer. Dolph brings to the company 30 years of senior level IT experience with large hospital systems and health plan insurers. Dolph started his career as a software engineer for a Staff Model HMO and quickly progressed into leadership roles across many Health System owned Health Plans. He oversaw the IT division of a University owned managed care organization, subsequently sold to BlueCross/BlueShield of Michigan. He was the functional health plan CIO for a $3.5 billion integrated healthcare system. Dolph served as the CIO of WellMed Medical Management, a $1 billion dollar privately owned healthcare delivery and financial risk-bearing entity that was subsequently acquired by Optum. Dolph was responsible for all IT supporting the $3 billion group of the Geisinger health plans. Most recently, Dolph has served as a strategic consultant to regional based health systems that own health plans as well as with OptumCare, a major subsidiary of the United Health Group. He has a broad and deep set of experience in application engineering, technology management, health care insurance, and health care delivery As real world evidence and data licensing become more important to all hospitals and health insurance plans, Dolph’s expertise will be invaluable in helping RegenMed expand its patented technical platforms into enterprise wide deployments.

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.