Nature Review Bolsters Sigyn's CardioDialysis Approach to Cardiovascular Disease in Dialysis Patients

A recent review article in Nature has underscored the critical need for new approaches to cardiovascular disease in end-stage renal disease patients, providing scientific validation for Sigyn Therapeutics' CardioDialysis technology. The article, published on November 20, 2025, reported that ESRD dialysis patients face up to a 20-fold greater risk of death from cardiovascular disease compared to the general population, and that existing cardiovascular drugs have not improved survival or reduced cardiovascular events in this vulnerable group.

The Nature review, accessible at https://www.nature.com/articles/s41581-025-01035-z, aligns with Sigyn's clinical strategy by suggesting future research should focus on inflammatory pathways activated when blood interacts with dialysis membranes. This dialysis-induced inflammation is known to accelerate cardiovascular disease progression. However, while the review authors recommend targeting specific inflammatory molecules with drugs, Sigyn's CardioDialysis takes a different approach by addressing a broad spectrum of inflammatory molecules while simultaneously lowering cholesterol-transporting lipoproteins that contribute to heart attacks, strokes, and other Major Adverse Cardiovascular Events.

The importance of this development lies in addressing a population where cardiovascular disease accounts for 67% of deaths, according to the U.S. Renal Data System. With approximately 550,000 ESRD patients receiving about 85 million dialysis treatments annually in the U.S. alone, the potential impact is substantial. Unlike pharmaceutical approaches that have shown limited effectiveness in dialysis patients, CardioDialysis can be administered during regularly scheduled dialysis treatments, leveraging existing infrastructure rather than requiring specialized facilities.

This approach builds upon the precedent of Lipoprotein Apheresis, an FDA-approved blood purification method that has demonstrated significant MACE reduction but suffers from limited delivery infrastructure with fewer than 60 specialized centers in the United States. In contrast, CardioDialysis can be deployed on the estimated 150,000 dialysis machines already located in more than 7,500 kidney dialysis clinics across the U.S., potentially transforming current dialysis centers into combined Renal and CardioDialysis treatment facilities.

The commercial implications are significant for a dialysis industry dominated by DaVita and Fresenius Medical Care. Beyond introducing a new revenue source, successful implementation of CardioDialysis could help the industry recoup substantial lost revenues when ESRD patients are hospitalized and receive dialysis at out-of-network facilities. Based on average dialysis revenues of $400 per treatment, the U.S. dialysis industry could recoup up to $654 million in lost revenues for each week of reduced ESRD patient hospitalizations and increase top-line revenues by approximately $2.8 billion for each month patient lives are extended.

From a clinical perspective, the technology addresses unique challenges faced by dialysis patients, including elevated levels of cholesterol-transporting lipoprotein(a) that are two to four times higher than in the general population and the inflammatory responses induced by dialysis treatments themselves. With no market-cleared pharmaceutical products currently available to address Lipoprotein(a), endotoxemia, or the broad spectrum of inflammatory cytokines elevated in dialysis patients, CardioDialysis represents a potentially transformative approach to reducing mortality in a population with a median survival of just 3-5 years once dialysis-dependent.