Sigyn Therapeutics has introduced CardioDialysis, a medical device designed to reduce major adverse cardiovascular events through continuous blood purification. The technology addresses cardiovascular disease, which remains the leading cause of death worldwide, by clearing inflammatory and pathogenic molecules from the bloodstream.
Current treatments for cardiovascular disease include LDL-C reducing statins, which reduce major adverse cardiovascular events by approximately 25%. More effective lipoprotein apheresis devices that filter LDL-C and Lipoprotein(a) from the bloodstream can reduce these events by 75-95%, according to the American Heart Association. However, these technologies have seen limited adoption due to complex, multi-component designs and insufficient delivery infrastructure.
CardioDialysis represents a significant advancement in subtractive medicine as the first technology to fully integrate plasma separation and therapeutic adsorption within a single device. This integration allows deployment on existing dialysis machines already located in hospitals and clinics, potentially expanding access dramatically. The device enables continuous broad-spectrum clearance of both inflammatory and pathogenic molecules from the entire bloodstream.
The limitations of current apheresis technology are illustrated by the Kaneka LIPOSORBER, an FDA-approved lipoprotein apheresis procedure with approximately 600,000 treatments administered to more than 6,000 patients worldwide. The LIPOSORBER procedure requires a plasma separation column, two LIPOSORBER cartridges, custom blood tubing sets, a blood warmer, multiple bags of replacement fluids, multiple bags of regeneration fluids, four waste bags, plus multiple pumps. This complexity limits access to fewer than 60 specialized apheresis centers in the United States.
In contrast, CardioDialysis is a fully integrated single-component device deployable on dialysis machines already located in more than 5,000 hospitals and 7,500 dialysis clinics in the United States alone. Compared to the LIPOSORBER, CardioDialysis addresses a broader range of cardiovascular disease targets, processes the bloodstream with greater efficiency, and does not require replacement fluids, additional pumps, or other auxiliary components.
The potential impact of this technology is substantial given that 15-20% of major adverse cardiovascular events result in death. Successful clinical advancement of CardioDialysis could save thousands of lives annually by reducing the circulating presence of inflammatory mediators that fuel cardiovascular disease progression while simultaneously lowering levels of cholesterol-transporting lipoproteins that contribute to heart attacks, strokes, and other major adverse cardiovascular events.
Sigyn Therapeutics' development pipeline includes additional technologies such as ImmunePrep to optimize immunotherapeutic antibody delivery for cancer treatment, ChemoPrep to enhance targeted chemotherapy delivery, and ChemoPure to reduce chemotherapy toxicity. More information about the company is available at https://www.SigynTherapeutics.com.
