Sigyn Therapeutics, Inc. (OTCQB: SIGY) has released a detailed note from CEO Jim Joyce outlining the potential of its CardioDialysis technology to reduce major adverse cardiovascular events (MACE). Cardiovascular disease remains the leading cause of death globally, and current therapies, such as LDL-C reducing statins, lower MACE by only about 25%. In contrast, lipoprotein apheresis devices can reduce MACE by 75-95%, according to the American Heart Association, but their complexity and limited availability have hindered widespread adoption.
CardioDialysis addresses these limitations by integrating plasma separation and therapeutic adsorption within a single device that can be deployed on dialysis machines already present in over 5,000 hospitals and 7,500 dialysis clinics in the United States alone. This contrasts sharply with existing technologies like the Kaneka LIPOSORBER, which requires a complex multi-component system—including a plasma separation column, two cartridges, custom tubing, a blood warmer, multiple fluids, and several pumps—limiting its use to fewer than 60 specialized apheresis centers in the U.S.
Joyce emphasized that CardioDialysis processes the bloodstream with greater efficiency and targets a broader range of cardiovascular disease targets without needing replacement fluids or additional pumps. The technology enables continuous broad-spectrum clearance of inflammatory and pathogenic molecules from the entire bloodstream, which could simultaneously reduce inflammatory mediators fueling cardiovascular disease and lower cholesterol-transporting lipoproteins that contribute to heart attacks, strokes, and other MACE.
Given that 15-20% of MACE result in death, the successful clinical advancement of CardioDialysis could save thousands of lives each year. The company also notes that CardioDialysis is the first therapy in the emerging field of subtractive medicine to integrate plasma separation and adsorption in a single device, with potential therapeutic opportunities beyond cardiovascular disease, including sepsis, life-threatening viral infections, and neuroinflammatory disorders.
Sigyn Therapeutics’ development pipeline also includes ImmunePrep to optimize immunotherapeutic antibody delivery for cancer, ChemoPrep to enhance targeted chemotherapy delivery, and ChemoPure to reduce chemotherapy toxicity. The company’s forward-looking statements caution that actual results may differ materially from expectations due to risks associated with clinical advancement, manufacturing, and capital resources.
