Nature Review Reinforces Sigyn Therapeutics' CardioDialysis Approach to Cardiovascular Disease in Dialysis Patients

A recent publication in the scientific journal Nature has reinforced the clinical strategy behind Sigyn Therapeutics' CardioDialysis technology, which aims to address cardiovascular disease in end-stage renal disease patients. The Nature review article, accessible at https://www.nature.com/articles/s41581-025-01035-z, reported that ESRD dialysis patients face up to a 20-fold greater risk of death from cardiovascular disease compared to the general population. This staggering statistic is compounded by the finding that existing cardiovascular drugs have not improved survival or reduced cardiovascular events in this patient population.

The Nature authors suggested future research should focus on targeting inflammatory pathways activated when blood interacts with dialysis membranes, a phenomenon Sigyn refers to as dialysis-induced inflammation. While Sigyn agrees with this focus, the company's CardioDialysis technology diverges by employing a broad-spectrum approach rather than targeting single inflammatory molecules. CardioDialysis aims to reduce circulating inflammatory molecules that fuel cardiovascular disease progression while simultaneously lowering cholesterol-transporting lipoproteins that contribute to heart attacks, strokes, and other Major Adverse Cardiovascular Events.

CardioDialysis represents a non-pharmacological option for patients unresponsive to cholesterol-lowering drugs and establishes an adjunct strategy to enhance cardiovascular drug benefits without adding further drug toxicity. The technology's initial clinical focus targets ESRD patients, 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., this represents a substantial market opportunity. CardioDialysis can be administered during regularly scheduled dialysis treatments, potentially transforming current kidney dialysis clinics into future Renal and CardioDialysis treatment centers.

The technology builds upon the medical precedent of Lipoprotein Apheresis, an FDA-approved blood purification method that has demonstrated significant MACE reduction. A review published by the American Heart Association observed Lipoprotein Apheresis lowered MACE incidence by 59% to 95% across studies, compared to pharmaceutical statins that reduce MACE by 20% to 45%. However, Lipoprotein Apheresis has been constrained by limited delivery infrastructure, with fewer than 60 specialized centers in the United States. CardioDialysis overcomes this limitation by leveraging existing dialysis infrastructure, with approximately 150,000 dialysis machines already located in more than 7,500 U.S. kidney dialysis clinics.

ESRD patients face unique cardiovascular challenges beyond drug therapy reach, including circulating lipoprotein(a) levels two to four times higher than the general population and inflammatory responses induced by dialysis treatments themselves. Currently, no market-cleared pharmaceutical products address lipoprotein(a), endotoxemia, or the broad-spectrum of inflammatory cytokines elevated in dialysis patients. CardioDialysis provides a strategy to reduce circulating LDL-C and lipoprotein(a) levels while controlling dialysis-induced inflammation.

Beyond potential patient benefits, successful CardioDialysis advancement could provide substantial value to the dialysis industry. 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. The annual market for MACE-reducing therapies exceeds $100 billion, positioning CardioDialysis to address a significant unmet medical need while creating new revenue streams within existing healthcare infrastructure.