Nature Review Highlights Urgent Cardiovascular Crisis in Dialysis Patients, Points to New Therapeutic Approach

The scientific journal Nature recently published a review article that reinforces the urgent need to address cardiovascular disease in end-stage renal disease patients. The article, titled "Still Searching for the Right Target for Cardioprotection in Haemodialysis," reported that ESRD dialysis patients face up to a 20-fold greater risk of death from cardiovascular disease compared to the general population, while existing cardiovascular drugs have not improved survival or reduced cardiovascular events in this vulnerable population. This review article, accessible at https://www.nature.com/articles/s41581-025-01035-z, arrives as cardiovascular disease accounts for 67% of ESRD patient deaths according to the U.S. Renal Data System.

The median survival for dialysis-dependent ESRD patients is just 3-5 years, with clinical studies indicating they receive limited if any benefit from LDL-C reducing statins, the leading class of cardiovascular drugs. Additionally, circulating levels of cholesterol-transporting lipoprotein(a) are two to four times higher in ESRD dialysis patients compared to the general population. Consistent with Sigyn's clinical strategy for CardioDialysis, the Nature authors suggested future research should focus on targeting inflammatory pathways activated when blood interacts with dialysis membranes. This dialysis-induced inflammation is known to accelerate cardiovascular disease progression.

However, Sigyn's approach diverges from the article's drug-focused recommendations, as CardioDialysis performs functions beyond pharmaceutical reach 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. CardioDialysis establishes an adjunct strategy to enhance the benefit of cardiovascular drugs without adding further drug toxicity while providing a non-pharmacological option for patients unresponsive to cholesterol-lowering medications. The technology leverages the established precedent of Lipoprotein Apheresis, an FDA-approved blood purification method that has demonstrated the ability to reduce MACE by 59% to 95% across multiple studies, compared to pharmaceutical statins that reduce MACE by 20% to 45%.

Unlike Lipoprotein Apheresis, which is constrained by limited delivery infrastructure with fewer than 60 specialized centers in the United States, CardioDialysis can be deployed on existing dialysis machines already located in hospitals and clinics worldwide. An estimated 150,000 dialysis machines operate in more than 7,500 kidney dialysis clinics in the U.S. alone, potentially transforming current kidney dialysis clinics into future Renal and CardioDialysis treatment centers. The technology can be conveniently administered to ESRD patients during their regularly scheduled dialysis treatments, which number approximately 85 million annually in the U.S. among 550,000 ESRD patients.

Beyond addressing the unique cardiovascular challenges of dialysis patients, CardioDialysis could provide substantial value to the dialysis industry. Reducing ESRD patient hospitalizations could recoup up to $654 million in lost revenues for each week of reduced hospital stays, while extending patient lives could increase top-line revenues by approximately $2.8 billion for each month of extended survival. The annual market for MACE-reducing therapies exceeds $100 billion, positioning CardioDialysis as a potential new revenue source for the dialysis industry while addressing a critical unmet medical need in a population facing extraordinary cardiovascular risks.