Sigyn Therapeutics, Inc. (OTCQB: SIGY), developer of CardioDialysis, has released a note from CEO Jim Joyce detailing the potential of the technology to reduce major adverse cardiovascular events (MACE). Cardiovascular disease remains the leading cause of death worldwide, and current therapies like statins reduce MACE by approximately 25%. In contrast, lipoprotein apheresis devices that filter LDL-C and Lipoprotein(a) from the bloodstream have demonstrated a 75-95% reduction in MACE, according to the American Heart Association. However, widespread adoption of these devices has been limited by their complex, multi-component designs and lack of global delivery infrastructure.
CardioDialysis overcomes these limitations by integrating plasma separation and therapeutic adsorption within a single device that can be deployed on dialysis machines already located in hospitals and clinics. The technology enables continuous broad-spectrum clearance of inflammatory and pathogenic molecules from the entire bloodstream. For context, the Kaneka LIPOSORBER, an FDA-approved lipoprotein apheresis procedure, has administered approximately 600,000 treatments to over 6,000 patients worldwide. The LIPOSORBER procedure involves a plasma separation column, two LIPOSORBER cartridges, custom blood tubing sets, a blood warmer, multiple bags of replacement fluids and regeneration fluids, four waste bags, plus multiple pumps. Due to its complexity, access to LIPOSORBER treatment is limited 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 located in more than 5,000 hospitals and 7,500 dialysis clinics in the United States alone. Compared to 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. Given that 15-20% of MACE result in death, the successful clinical advancement of CardioDialysis could save thousands of lives each year.
Sigyn Therapeutics is focused on subtractive medicine, with CardioDialysis being the first therapy to integrate plasma separation and therapeutic adsorption within a single device. Therapeutic opportunities include sepsis, life-threatening viral infections, neuroinflammatory disorders, and cardiovascular disease. In cardiovascular disease, CardioDialysis aims to reduce inflammatory mediators that fuel disease progression while lowering cholesterol-transporting lipoproteins that contribute to heart attacks and strokes, overcoming the limitations of single-target drugs. The company's development pipeline also includes ImmunePrep, ChemoPrep, and ChemoPure technologies. More information is available at www.SigynTherapeutics.com.
