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Quality Healthcare Does Not Have To Be So Expensive

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November 1, 2024
Americans pay more for healthcare than any other country, and yet are less healthy by many measures. Moreover, healthcare costs continue to rise faster than general inflation. How can this be? A major reason is the cost of clinical trials.
Americans pay more for healthcare than any other country, and yet are less healthy by many measures. Moreover, healthcare costs continue to rise faster than general inflation. How can this be? A major reason is the cost of clinical trials. Clinical trials are how we ensure that a drug, device or other medical product is safe and effective – obviously an important goal. However, the average clinical trial today can easily cost $60,000,000 and last over seven years. A typical number of patients in a trial is at least 500, who are asked to answer, for example, 300 or questions. That is $120,000 per patient, and $200,000 per question. This means that only the largest companies can afford clinical trials. That they will charge high prices for approved products. That their clinical trials will be narrowly focused on products which will give them the greatest profitability. That many medical products which could have a greater impact on more people, for less cost, will never see the light of day. Lower Costs Drive Higher Quality and More Accessibility The obvious solution is to reduce the cost required to establish the safety and efficacy of medical products. Lower cost does not mean lower quality. To the contrary, it often means better quality, more accessibility, and greater innovation. Henry Ford’s Model Ts were lower cost, better, faster and available to far more people than the cars of his competitors. Space X is committed to bringing down the cost per kilogram of a rocket launch from several thousands of dollars to $10. Why should medical products be more expensive and less accessible each year? A RegenMed Circle can generate a clinically and statistically significant dataset involving 500 patients and 300 questions for only $6,700. That is $13 per patient, and $22 per question. This is made possible by the technology and processes described in RegenMed’s patent, Method and System For Processing Large Amounts Of Real-World Evidence.In many cases, there will of course be additional costs beyond clinical trials in obtaining final regulatory approval for a particular product. But the ability to develop high-quality clinical datasets at a small fraction of current costs is a major step in bringing better, more useful and more accessible products to market. For more information on how RegenMed is supporting physicians and product manufacturers around the world deliver evidence-based care to more patients, at a lower cost, see our Latest page.This Reg CF offering is made available through StartEngine Primary, LLC. This investment is speculative, illiquid, and involves a high degree of risk, including the possible loss of your entire investment.
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Michael Strøm: Why I Collect Real-World Shockwave Data, And How You Can Join Me

Client News
October 25, 2024
In a recent interview with RegenMed Circles, Michael Strøm, a leading shockwave specialist and sexologist from Denmark, shares his experience and the importance of data in shockwave therapy.
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.‍
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What Does A Broken Healthcare Market Look Like?

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October 25, 2024
Healthcare data should be about making more people healthier, enabling them to live longer, and at less cost. In reality, it has become the opposite:
October 22, 2024 Healthcare data should be about making more people healthier, enabling them to live longer, and at less cost. In reality, it has become the opposite: Declining healthcare metrics for more people. Enormously expensive. Poor physician and patient satisfaction. Unverifiable, often misleading, claims. RegenMed has solutions – solutions already accepted by healthcare clients around the world. But, first, it is important to understand the magnitude of the problem. There is significant evidence connecting physician burnout to the use of Electronic Health Records. Multiple studies have shown that the extensive documentation requirements, usability issues, and the time burden of EHRs are major contributors to physician fatigue and burnout. A review highlighted that physicians often spend more time on documentation than direct patient care. The frustration is amplified the perception of being reduced to data-entry clerks, diminishing professional satisfaction. The former President of the American Medical Association, James L Madara, M.D., has said “Today we have really remarkable tools—robotic surgery, new forms of radiation treatment, targeted biologics; and we live in a time of rapid development in the digital world—telemedicine as an example . . . But appearing in disguise among these positive products are other digital so-called advancements that don't have an appropriate evidence base, or just don't work that well—or actually impede care, confuse patients and waste our time. . . . From ineffective electronic health records, to an explosion of direct-to-consumer digital health products, to apps of mixed quality – it's the digital snake oil of the early 21st century." “Hospital bankruptcies linked to the installation of electronic health record (EHR) systems have been a growing concern. . . . Southcoast Hospital and Lahey Health both experienced significant financial losses following their EHR installations. Southcoast had to reduce its workforce after the costs exceeded their budget, while Lahey Health lost $21 million and laid off 130 employees due to unplanned training expenses. . . . . Brigham and Women’s Hospital faced a $53 million shortfall following their $47 million Epic EHR implementation. The financial burden led to the elimination of several positions and forced the hospital to cut operating expenses by $50 million. MD Anderson Cancer Center also had to reduce administrative staff by nearly 900 positions after encountering significant financial difficulties related to its EHR implementation.” There is a growing recognition in the medical community that the promise of big data in healthcare has been hampered by significant challenges. These include poor data quality, lack of interoperability between datasets, insufficient expertise, and overhyped expectations. While big data holds potential for improving healthcare outcomes, many argue that it has yet to deliver on its transformative promises due to these structural and technological barriers. Yes, and RegenMed is implementing them every day. See the Latest page on our website for client use cases. And stay tuned for future updates here.
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Real-World Evidence For Select Peptides

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October 16, 2024
Ozempic™, Wegovy™ and similar “GLP-1” drugs have underscored the importance of peptides. There are over 7,000 known peptides in the human body, each with its own characteristics and potential benefits and side effects.
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.
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