End-stage renal disease patients undergoing dialysis face cardiovascular mortality rates up to 20 times higher than the general population, according to a recent review article published in Nature that examined cardioprotection challenges in hemodialysis. The article, accessible at https://www.nature.com/articles/s41581-025-01035-z, reported that conventional cardiovascular drugs have failed to improve survival or reduce cardiovascular events in this vulnerable patient population. This medical crisis affects approximately 550,000 ESRD patients in the United States who receive about 85 million dialysis treatments annually, with cardiovascular disease accounting for 67% of ESRD patient deaths.
The Nature review authors suggested future research should focus on inflammatory pathways activated when blood interacts with dialysis membranes, a phenomenon Sigyn Therapeutics refers to as dialysis-induced inflammation. Sigyn's CardioDialysis technology represents a direct response to this scientific consensus, though it diverges from the review's pharmaceutical focus by employing a medical device approach. Instead of targeting single inflammatory molecules as suggested by the Nature authors, CardioDialysis aims to address 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 builds upon the established precedent of Lipoprotein Apheresis, an FDA-approved blood purification therapy that has demonstrated MACE reduction of 59% to 95% across multiple studies. However, Lipoprotein Apheresis suffers from limited clinical adoption with fewer than 60 specialized centers in the United States. CardioDialysis overcomes this infrastructure limitation by leveraging the existing global network of approximately 150,000 dialysis machines located in more than 7,500 kidney dialysis clinics in the U.S. alone. This deployment strategy could transform current kidney dialysis clinics into combined Renal and CardioDialysis treatment centers without requiring significant new infrastructure investment.
The technology addresses unique cardiovascular challenges specific to dialysis patients, including elevated lipoprotein(a) levels that are two to four times higher than in the general population and limited clinical benefit from LDL-C reducing statins. Additionally, dialysis treatments themselves induce inflammatory responses that further contribute to cardiovascular disease progression through elevated endotoxin and inflammatory cytokine levels. CardioDialysis provides a strategy to reduce circulating LDL-C and lipoprotein(a) levels while controlling dialysis-induced inflammation, all administered during patients' regularly scheduled dialysis sessions.
Beyond patient health implications, successful implementation of CardioDialysis could generate substantial economic value for 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, based on average dialysis revenues of $400 per treatment. Furthermore, the industry could increase top-line revenues by approximately $2.8 billion for each month that patient lives are extended. This represents a significant opportunity in a market where MACE-reducing therapies already exceed $100 billion annually.
The clinical advantages of focusing on ESRD patients include established blood access and the convenience of integrating CardioDialysis during regularly scheduled dialysis sessions. This patient population represents a medically urgent starting point for a technology that could eventually address cardiovascular disease in the broader population. The Nature review's emphasis on inflammatory targeting validates the scientific rationale behind Sigyn's approach, though the company's device-based strategy represents a departure from traditional pharmaceutical interventions that have proven inadequate for dialysis patients.
