Nature Review Supports CardioDialysis Approach for Cardiovascular Disease in Dialysis Patients

The recent publication in Nature of a review article titled "Still Searching for the Right Target for Cardioprotection in Haemodialysis" has brought renewed attention to the critical challenge of cardiovascular disease in end-stage renal disease patients. The article confirms 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 failed to improve survival or reduce cardiovascular events in this vulnerable patient group. This scientific validation comes as Sigyn Therapeutics advances its CardioDialysis technology, which represents a novel approach to addressing this unmet medical need.

The Nature review, accessible at https://www.nature.com/articles/s41581-025-01035-z, emphasizes that future research should focus on inflammatory pathways activated when blood interacts with dialysis membranes, a phenomenon known as dialysis-induced inflammation. While the authors suggest targeting specific inflammatory molecules, Sigyn's CardioDialysis takes a broader approach by addressing multiple inflammatory molecules simultaneously while also reducing cholesterol-transporting lipoproteins that contribute to heart attacks, strokes, and other Major Adverse Cardiovascular Events. This dual mechanism positions CardioDialysis as a comprehensive solution that can be administered during regular dialysis treatments, offering practical advantages for ESRD patients who already require frequent medical intervention.

Cardiovascular disease accounts for approximately 67% of ESRD patient deaths according to U.S. Renal Data System statistics, creating a substantial market opportunity given that approximately 550,000 ESRD patients receive about 85 million dialysis treatments annually in the United States alone. The technology builds upon the established precedent of Lipoprotein Apheresis, an FDA-approved blood purification method that has demonstrated significant MACE reduction in clinical studies. However, unlike Lipoprotein Apheresis which is limited by infrastructure constraints with fewer than 60 specialized centers in the U.S., CardioDialysis can leverage the existing global network of approximately 150,000 dialysis machines already located in hospitals and clinics worldwide.

The economic implications are significant for the dialysis industry, which is dominated by DaVita and Fresenius Medical Care in the United States. Successful implementation of CardioDialysis could potentially recoup substantial lost revenues when ESRD patients are hospitalized, as dialysis organizations lose approximately $400 per treatment when patients receive care at out-of-network facilities. Beyond financial considerations, 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 currently available pharmaceutical products to address these specific issues, CardioDialysis represents a potentially transformative approach that could extend patient survival while improving quality of life for those dependent on dialysis for survival.