Sigyn Therapeutics Highlights CardioDialysis Potential to Transform Cardiovascular Disease Treatment

Sigyn Therapeutics is advancing CardioDialysis to extend the lives of individuals with cardiovascular disease, the leading cause of death worldwide. A primary objective of cardiovascular disease therapies is to reduce the incidence of heart attacks, strokes, and other Major Adverse Cardiovascular Events (MACE). LDL-C reducing statins, the leading class of drugs to treat cardiovascular disease, are associated with 25% reductions in MACE according to a source publication at https://pmc.ncbi.nlm.nih.gov/articles/PMC12359277/. In contrast, the American Heart Association recently reported that blood purification to reduce LDL-C and Lipoprotein(a) levels (lipoprotein apheresis) is associated with 75% to 95% reductions in MACE, as detailed in https://www.ahajournals.org/doi/10.1161/ATV.0000000000000177. CardioDialysis could expand the use of blood purification to treat cardiovascular disease and potentially improve upon these MACE reductions.

Overcoming a major barrier for treatment adoption is a key attribute. While lipoprotein apheresis is FDA-approved and proven to reduce MACE, its broad adoption is constrained by delivery infrastructure, with treatments limited to approximately 60 specialized apheresis centers in the United States. CardioDialysis is not constrained by this limitation as it is deployed for use on dialysis machines already located at more than 7,500 kidney dialysis clinics in the U.S. alone. Lipoprotein apheresis devices do not operate on dialysis machines.

CardioDialysis offers broad-spectrum clearance of cardiovascular disease targets. In vitro blood purification studies have validated its ability to address a broad spectrum of therapeutic targets, including inflammatory molecules that contribute to cardiovascular disease progression, yet are not addressed with market-approved therapies. The clearance of twelve therapeutic targets from human blood plasma has been demonstrated, and CardioDialysis has been observed to be safe and well tolerated in porcine animal studies conducted at the University of Michigan.

An early clinical and commercialization opportunity exists in dialysis patients. CardioDialysis can be conveniently administered during regularly scheduled dialysis treatments for end-stage renal disease (ESRD) patients. The U.S. Renal Data System reports that cardiovascular disease accounts for 67% of ESRD patient deaths and its incidence is up to 20 times higher in ESRD patients compared to the general population. As recently reported in the Journal Nature, drugs to treat cardiovascular disease have not reduced cardiovascular events in dialysis patients. Additionally, circulating levels of cholesterol-transporting lipoprotein(a), which is not addressed with an approved drug, are 2-4 times higher in ESRD dialysis patients. Beyond high mortality rates, cardiovascular disease represents a substantial initial market opportunity, given an estimated 550,000 ESRD patients receive approximately 85 million dialysis treatments in the U.S. each year.

The clinical strategy is executable and efficient. The plan is to enroll ESRD patients to participate in a study conducted at their kidney dialysis clinic, with administration of CardioDialysis occurring during their regularly scheduled dialysis treatments. This strategy applies to both human feasibility (safety) and pivotal efficacy studies required for market approval consideration, potentially reducing the time and cost to conduct these studies compared to traditional ICU-based trials for life-threatening conditions.

CardioDialysis offers strategic value to the dialysis industry. Since cardiovascular disease is the leading cause of ESRD deaths, a reduction in MACE would be expected to extend ESRD patient lives. Based on average annual per-patient revenues of $65,000, top-line dialysis industry revenues could be increased by $2.8 billion for each month that the lives of U.S. dialysis patients are extended. CardioDialysis also introduces a potential pathway for the dialysis industry to treat cardiovascular disease in the general population, which is the commercial focus of lipoprotein apheresis. This could transform current kidney dialysis clinics into future renal and CardioDialysis treatment centers.