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Are you a provider specializing in Women's Health Shockwave therapy? Want to elevate your clinical practice, own your data, and unlock new financial and research opportunities — all while collaborating within a dedicated community? RegenMed is proud to introduce our Women’s Health Shockwave Circles, a high-quality, low-cost, turnkey solution designed specifically for physicians like you. Led by Principle Investigator Amy Vander Linden, this community offers a unique platform to share insights, accelerate innovation, and generate real-world evidence to advance women’s health treatments. Join a network of forward-thinking physicians committed to improving patient outcomes and shaping the future of women’s health interventions. As part of the Circle, you'll gain access to: Proprietary data ownership and controlRobust clinical and financial insightsCollaborative opportunities with leading expertsA supportive community dedicated to advancing women's health Together, we can drive impactful change in Women's Health Shockwave therapy. Elevate your practice, contribute to groundbreaking research, and be part of a movement that puts physicians at the center of innovation. Learn more about Dr. Amy Vander Linden’s Circles below: Female Reproductive System/Clitoral Enhancement/Shockwave/FSFI Pelvis/Pelvic Floor Dysfunction/Shockwave/PUF+ICIQ-UI+BPI Female Reproductive System/Endometriosis/Shockwave/SF-12+FSFI+BPI Female Reproductive System/Polycystic Ovarian Syndrome (PCOS)/Shockwave/SF-12+FSFI+BPI

Physician Group Sponsors — now you can easily establish a clinically-impactful and revenue-producing library of proprietary data registries. A Circles Registry Program will materially advance clinical excellence, ethically generate new funding, and add real value to member physicians.What Sets Circles Apart?Clinically Relevant and Peer-Reviewed: Observational Protocols tailored to real-world practice, covering specific anatomical regions, pathologies, and outcomes.Top-Tier Data Quality: Comparable to traditional clinical trials — compliant with HIPAA, GDPR, and more — fully validated, and continuously refreshed with new data.Proprietary & Valuable: No data ownership conflicts — highly licenseable datasets that drive innovation and revenue.Financial & Strategic BenefitsTap into the $60B healthcare data analytics market, growing at 20% annually.License quality datasets to manufacturers, insurers, AI developers, and research centers — 85% of license fees go directly to your physician group.Enhance standards of care, expand service lines, and boost your valuation for future exits.Strengthen negotiating power with payers, improve CMS compliance, and unlock new contracting opportunities.Minimal Effort, Maximum ImpactEasy setup with patented platforms (#inCytes™ & #Benchmarc™).Quick, cost-effective data collection — just $5 per case, $35/month subscription.Engage physicians with minimal burden while fostering collaboration and professional growth.Offer patients personalized feedback, improving engagement and satisfaction.Learn more in our one sheet: "Circles Registries For ASCs, IPGs, and IPAs"

Please join our CEO and Co-Founder for a presentation on our $100 bn addressable markets, ongoing market traction, and financial and per share projections. We look forward to engaging with our current investors in this exciting “Zero-to-One” company, and those who may be interested in joining them. Visit our Investors page for more details.

While the $60 billion healthcare data analytics industry expands rapidly, ASCs are failing to exploit their most valuable asset while others do so. This RegenMed video explains how any ASC can generate new revenue streams and asset value by capturing and monetizing real-world evidence (RWE) from routine patient care. Key sections of the video, with time codes, are:The Opportunity [0:18 – 1:14]Real-World Evidence — structured datasets generated from routine patient care — is in high demand across industry and research. The $60 billion healthcare data analytics industry is growing at a rate of over 20% annually. ASCs are not only uniquely positioned to contribute to this market, but to benefit from it financially. RWE licensors include product manufacturers, insurers, research centers, and AI models. Use cases for licenses include competitive intelligence, regulatory submissions, product innovation, legal compliance, value based care, social determinants of health, and health equity. ASCs Can Participate [1:15 – 2:26]ASCs already regularly enter EMR and other real-world data, and pay to do so. However, that data is being aggregated, manipulated, and licensed by others. However, and despite their high cost, RWE datasets synthesizing EMRs, prescription, insurance claim and other disparate sources are incomplete, unverifiable and generally clinically irrelevant. Using RegenMed’s patented Circles technology and processes, ASCs can now structure, aggregate, own and monetize that RWD themselves — without burdening staff or altering clinical workflows. Primary and well correlated datasets which are verifiably sourced from daily patient care – against a prospectively designed Observational Protocol – are far more clinically relevant and “fit-for-purpose” than current RWE offerings. They are therefore far more valuable.What Do Circles Datasets Look Like [2:27–3:40]This section shows two separate illustrative reports. One compares four different knee implant products over twelve months against KOOS Jr. scores in the context of total knee arthroplasty. The second compares two separate surgical techniques over 27 months against a VAS score in the context of total hip arthroplasty.Although these are orthopedics examples, Circles can be and are used to generate clinically and statistically significant datasets for any anatomical region, pathology, treatment protocol, and standardized or custom outcomes score – regardless of medical specialty. EBITDA and New Asset Potential For An Average ASC [3:40 – 6:04]Based on the stated assumptions, which of course will depend on the specific circumstances of each ASC, five Circles datasets generated by ten physicians can produce new annual EBITDA of $850,000 for a total cost of only $31,000 — a return on investment of 14x. Moreover, these five 6-month longitudinal Circles datasets represent asset value of $2.6 million on the stated assumptions. Finally, an ASC can continue to increase these income streams and asset value through continued outcomes capture, additional Observational Protocols relevant to its practice mix, and combining internal and external Circles datasets.ConclusionTo discuss your specific situation, please contact us. RegenMed is not a mere solutions vendor. It works with each Client as a long-term partner to develop meaningful clinical and financial returns on investment.Contact usRegenMed | www.rgnmed.comcircles@rgnmed.com

The New Role of Real-World Evidence (RWE)Real-World Evidence (RWE) has emerged as a cornerstone of modern healthcare innovation, regulatory science, and payer strategy. Once considered supplementary, RWE now informs pivotal regulatory decisions, market access strategies, and post-market evaluations. The U.S. Food and Drug Administration (FDA), through the 21st Century Cures Act and subsequent guidance, has formally embraced RWE — defined as clinical evidence derived from real-world data (RWD) such as electronic health records (EHRs), insurance claims, and patient-generated information.RWE’s legitimacy has been reinforced by landmark regulatory approvals, including Medtronic’s CRT-D device and label expansions for drugs like Ibrance and Tecentriq, all supported by high-quality RWD. Industry and payers alike are accelerating investment in RWE strategies. A 2023 Deloitte survey revealed that 92% of life sciences firms have RWE strategies, with two-thirds planning increased investments. Likewise, payers such as UnitedHealthcare and Aetna are leveraging RWE to drive value-based care.The Imperative for Primary, Validated RWDDespite the growing utility of retrospective datasets, the RegenMed’s recent White Paper argues for the superiority of purpose-collected, prospective RWD. These data sources — gathered directly from clinicians and patients — offer several compelling advantages over administrative or passively collected data:Fit-for-Purpose DesignEMR and claims data, collected primarily for billing, often lack the precision and completeness required for rigorous research. Purpose-built datasets enable the use of validated instruments, structured formats, and contextually relevant clinical endpoints.Clinical NuanceStructured physician reporting captures nuanced clinical insights, including treatment rationale, staging, and intent — data points typically obscured in EMRs.Patient-Reported OutcomesProspective data collection engages patients directly, capturing metrics like pain, functionality, and satisfaction — offering a fuller picture of treatment efficacy than retrospective proxies.Agility and TimelinessReal-time data collection enables swift adaptation to emergent clinical trends, whereas retrospective data sources lag by months or years.Data IntegrityPurpose-collected data allows immediate validation at the point of entry. Structured electronic case report forms (eCRFs) and integrated logic checks dramatically reduce error rates.Regulatory CredibilityHigh internal validity and transparent provenance make prospectively collected RWD more persuasive in regulatory and payer contexts.Circles: RegenMed’s Response to the RWE ChallengeTo meet the demand for validated RWD, RegenMed regularly publishes and executes “Circles” — an ecosystem of statistically robust, domain-specific datasets focused on discrete pathologies, anatomical regions, and standardized outcomes. These datasets are:Built from physician-generated, real-world clinical data.Structured to answer specific scientific or clinical questions.Fully de-identified and HIPAA/GDPR compliant.Designed for flexibility in observational protocol (OP) development.Circles empower clinicians to contribute cases while sharing in dataset monetization, aligning incentives and driving long-term data growth. Importantly, Circles data typically do not require IRB review, as they are gathered during routine care for quality improvement purposes rather than interventional experimentation.Real-World Application: TKA and THA DatasetsThe White Paper includes illustrative Circles reports on Total Knee Arthroplasty (TKA) and Total Hip Arthroplasty (THA), demonstrating Circles’ potential for granular, verifiable insights. These reports exemplify how customized observational protocols, rich clinical detail, and long-term patient-reported outcomes converge to support practice-changing analytics and licensing opportunities.ConclusionValidated real-world data, collected directly from clinicians and patients with rigor and intent, is no longer optional — it is essential. As regulatory bodies, payers, and innovators continue to demand more actionable, credible, and agile evidence, RegenMed’s Circles platform positions itself as a next-generation solution. By aligning clinical insight, scientific design, and economic incentives, Circles transforms real-world data into real-world impact.