Sigyn Therapeutics' CardioDialysis™ Device Targets Cardiovascular Mortality in Dialysis Patients

Sigyn Therapeutics is advancing CardioDialysis™, a medical device designed to treat cardiovascular disease, which remains the leading cause of death globally. The therapy specifically targets end-stage renal disease patients undergoing dialysis, a population facing particularly high cardiovascular mortality rates. According to the U.S. Renal Data System, cardiovascular disease accounts for 67% of deaths among ESRD patients, with incidence rates 20 times higher than in the general population.

CardioDialysis™ operates through a broad-spectrum mechanism that simultaneously reduces inflammatory molecules fueling cardiovascular disease progression and lowers levels of cholesterol-transporting lipoproteins linked to heart attacks, strokes, and other Major Adverse Cardiovascular Events. This approach aims to overcome limitations of single-target pharmaceutical drugs in the cardiovascular treatment market, which exceeds $100 billion annually. The device builds upon the precedent of Lipoprotein Apheresis, an FDA-approved therapy that demonstrated 59% to 95% reductions in MACE across multiple studies, significantly outperforming statin drugs that typically reduce MACE by 20% to 45%.

The strategic advantage of CardioDialysis™ lies in its deployment capability through existing dialysis infrastructure. With approximately 150,000 dialysis machines located in more than 7,500 clinics across the United States, the therapy can be integrated into regularly scheduled dialysis treatments without requiring specialized delivery centers. This accessibility contrasts sharply with Lipoprotein Apheresis, which remains limited to fewer than 60 specialized centers nationwide. The company envisions transforming current kidney dialysis clinics into combined Renal and CardioDialysis™ treatment centers.

ESRD patients present unique cardiovascular challenges that conventional drug therapies often fail to address. Clinical studies show these patients receive limited benefit from LDL-C reducing statins, while circulating levels of lipoprotein(a) are typically two to four times higher than in the general population. Compounding these issues, dialysis treatments themselves induce inflammatory responses that further contribute to cardiovascular disease progression. Currently, no market-cleared pharmaceutical products address lipoprotein(a), endotoxemia, or the broad spectrum of inflammatory cytokines elevated in dialysis patients.

From a clinical development perspective, focusing on ESRD patients offers significant advantages for FDA approval pathways. The company can conduct both feasibility and pivotal efficacy studies within dialysis clinics rather than hospital intensive care units, where patient enrollment has historically proven challenging. ESRD patients already have established blood access, and CardioDialysis™ can be administered during their regular dialysis sessions. The stable condition of these patients compared to ICU-admitted subjects reduces potential complications in clinical studies.

The economic implications for the dialysis industry are substantial. Successful implementation of CardioDialysis™ could help 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. Additionally, extending ESRD patient lives could generate approximately $2.8 billion in additional top-line revenues for each month of extended survival. The company has previously collaborated with a leading dialysis company to design clinical feasibility study protocols and is currently editing its Investigational Device Exemption submission to clearly define cardiovascular disease as the intended treatment indication.