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Strong Demand For ShovelsEvery drug, biologic and medical device company needs to conduct at least one clinical trial before it is allowed to market its product. Increasingly, most also need to collect long-term outcomes through “post-market surveillance”. As of April 15, 2024, there were over 491,000 clinical studies registered worldwide.1 This does not include the many thousands of other studies in medical fields conducted by research organizations, medical societies, and academic medical centers.Each of those studies requires data collection tools to capture, aggregate, report and analyze clinical and outcomes information. As value-based care and real-world evidence become more important in healthcare, the need for these tools will greatly expand. RegenMed’s Circles deliver to individual physicians -- as well as to sophisticated industry clients – a regulatorily compliant, low cost, and highly efficient platform for any type of clinical study.‍Plus, A Piece Of The GoldmineCritically, each Circle can generate a clinically and statistically significant dataset proprietary to Circle Members and to RegenMed. (See here for more details.) Such datasets represent significant and ongoing value for many potential healthcare constituencies. RegenMed is not only selling shovels to the healthcare data gold miners, it is also helping them monetize their efforts while participating in that monetization.‍

Fewer than half of Americans feel that the healthcare system is good enough. (Over 20% rate it as poor.) A large percentage of doctors question the healthcare system's effectiveness in meeting patients’ needs. Almost half of physicians report burnout -- emotional exhaustion, depersonalization, reduced sense of personal accomplishment. And as indicated, these trends are only worsening. RegenMed’s business model is firmly rooted in the primacy of healthcare professionals. It is they who – by virtue of education, experience and disposition -- are able to diagnose, treat, and engage with patients in a meaningful way. It is they who can identify the most important clinical issues, the most sensible and cost-effective approach to addressing those issues, and the areas where new products and treatment protocols will have the broadest impact. RegenMed’s Circles – especially its Physician-Owned Circles – empower the clinical independence of any healthcare professional. They do not interrupt normal clinical flow, but make it more meaningful for both clinicians and patients. And, critically, they return to physicians a large amount of the financial value which they deserve. There are over 1 million active physicians in the U.S., and almost 2 million in the European Union. Very few of them do not want to exercise their best clinical judgment on behalf of their patients. Very few of them do not want the tools, data, and ethical financial incentive which will allow them to do so. RegenMed’s strong monthly growth only confirms this strong demand among physicians all over the world. We are confident that this is only the beginning of “zero to one” business model which can have a profound and beneficial impact on healthcare.

“Zero to One” is a concept coined by Peter Thiel (PayPal, Palantir, Founders Fund). It denotes a company which not only identifies a new and large market, but also develops the ability to capture a good deal of that market’s value. The image to the left is a large expanse of sand with a small pocket of oil bubbling to the surface. From those two simple ingredients the petrochemical and semiconductor industries evolved. However, it was not enough to recognize the value of sand and viscous crude oil. It was also necessary to build the infrastructure and processes necessary to capture that value.RegenMed was founded — and operates — on the premise that real world data is to healthcare what sand was to semiconductors or crude to refined petrochemicals. It is the commonplace — but uncaptured and unrefined raw materials -- from which the most valuable healthcare innovations will emerge.The high-quality datasets which can be generated from real world data are of immense value to healthcare insurers, providers, product manufacturers, and of course patients. Physicians — closely collaborating with each other — are the key to identifying the most promised real-world data, capturing it, and helping unlock its value. RegenMed’s clients prove this every day.Healthcare in the U.S. is broken. There are a few more important problems for us to solve. The key is enabling and incentivizing physicians to generate the evidence based on real-world treatments and correlated patient outcomes. RegenMed has built the patented platforms and processes which do that on a regular basis. We and our clients welcome your investment so that we can rapidly expand upon this early zero to one success. The opportunities are enormous.

Register for our live-streamed Investors webinar this Tuesday, November 12 at 6:30 pm EST, GMT-5. Michael Tierney, our Chief Executive Officer and Co-Founder, will be covering our addressable markets, product market fit, recurring revenue growth, intellectual property, and use of proceeds. There will be ample time for questions and answers. A recording of the webinar will also be available afterwards.

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.