SAN DIEGO, CA - December 11, 2025 - Sigyn Therapeutics, Inc. (OTCQB: SIGY) released a CEO note authored by Jim Joyce detailing the first-in-industry attributes of its CardioDialysis therapy for cardiovascular disease, the leading cause of death worldwide. The therapy aims to reduce Major Adverse Cardiovascular Events (MACE) by leveraging existing dialysis infrastructure and targeting a broad spectrum of inflammatory molecules.
According to Joyce, statins like Lipitor, Crestor, and Zocor are associated with only 25% reductions in MACE, as reported in a study published on PubMed Central. In contrast, the American Heart Association (AHA) reported that blood purification via lipoprotein apheresis is associated with 75% to 95% reductions in MACE, as detailed in an AHA journal article at ahajournals.org. However, lipoprotein apheresis is limited to about 60 specialized centers in the U.S. CardioDialysis overcomes this barrier by being deployable on dialysis machines at over 7,500 kidney dialysis clinics nationwide.
The therapy offers broad-spectrum clearance of cardiovascular disease targets. In vitro studies have demonstrated the ability to clear twelve therapeutic targets from human blood plasma, including inflammatory molecules not addressed by approved drugs. Animal studies at the University of Michigan found CardioDialysis to be safe and well tolerated.
Sigyn sees an early clinical and commercialization opportunity in end-stage renal disease (ESRD) patients, who suffer from cardiovascular disease at rates up to 20 times higher than the general population, with cardiovascular disease accounting for 67% of ESRD deaths. As noted in the journal Nature, drugs have not reduced cardiovascular events in dialysis patients. Additionally, lipoprotein(a) levels, which are not addressed by approved drugs, are 2-4 times higher in ESRD patients. With an estimated 550,000 ESRD patients receiving about 85 million dialysis treatments annually in the U.S., this represents a substantial market opportunity.
The clinical strategy is designed for efficiency: enrolling ESRD patients for studies conducted at their dialysis clinics, with CardioDialysis administered during regular treatments. This approach reduces time and cost for both feasibility and pivotal efficacy studies required for market approval.
Strategically, reducing MACE in ESRD patients could extend their lives. Based on average annual per-patient revenues of $65,000, each month of extended life for U.S. dialysis patients could add $2.8 billion in top-line industry revenues. CardioDialysis also offers a pathway for the dialysis industry to treat cardiovascular disease in the general population, potentially transforming kidney dialysis clinics into renal and cardio-dialysis treatment centers.
