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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.

The fast-growing shockwave market is already valued at $3 billion. Manufacturers around the world are investing in new devices and applicators to address the rising demand for non-surgical therapeutic options. They need clinical evidence to support those new technologies. Increasingly, that evidence will not come from clinical trials, but your everyday clinical data and outcomes.Physicians-Owned Circles (POCs) streamline the capture, aggregation and licensure of high-quality, real-world shockwave data. Qualifying Principal Investigators receive 10% of resulting license fees, and qualifying Investigators share 75%. Cost and time obligations are minimal, and the data is yours to use for various non-commercial purposes.

RegenMed was founded – and operates – on a fundamental financial principle: the most valuable company is that which can establish and then grow recurring revenues across a diverse client base. It is thus distinctive from many other forms of healthcare investments.The Challenges For Pre-Revenue Healthcare CompaniesHealthcare is obviously an enormous market – in the United States alone, it represents fully 17% of the country’s GDP. 1There are therefore thousands of investment opportunities, both with established and newer companies. Many of the latter tend to be bets on new products with any revenues far into the future. While some of these bets pay off, the great majority do not.Unfortunately, it is very difficult even for the largest drug companies to predict which of their clinical trials will prove successful. On average, 14% of drugs and vaccines that enter clinical trials receive regulatory approval. (Only 2% for oncology drugs.)The Financial ConsequencesOnly the best capitalized companies can withstand the financial implications of this reality. In 2023, biotech bankruptcies reached a 10-year high, with more companies filing for bankruptcy than any year since 2010. This trend continued into 2024, with 22 biotech companies shutting down. 2 Indeed, the broader healthcare industry also saw a surge in bankruptcies. In 2023, 79 healthcare companies with liabilities of at least $10 million filed for bankruptcy, more than triple the number in 2021. 3 In 2023, 17 out of 80 healthcare bankruptcies (21%) involved private equity-backed firms, marking a 112.5% increase over the past five years. 4How RegenMed Is DifferentRegenMed is selling shovels to gold miners – its patented product Circles is needed by any medical provider or product manufacturer which needs to conduct a clinical study. (As discussed in an earlier post, RegenMed also participates with its clients in the monetization of those studies.) RegenMed has established a strong product-market fit, with revenues earned from a broad variety of clients in North America, Europe and elsewhere. Those revenues are recurring and growing – the company’s business model is predicated on monthly subscriptions and small per Case charges. This low pricing is an important competitive moat in today’s far-too-expensive healthcare world. It also allows rapid scaling. RegenMed is led by an experienced management team with proven track records. They know that “slow and steady” wins the race. They focus on cash earnings, minimizing debt, and continuing to scale the Company’s established product-market fit in its large addressable markets.

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.‍