Sigyn Therapeutics, Inc. (OTCQB: SIGY) announced today a strategic note from CEO and inventor Jim Joyce, emphasizing the potential of its CardioDialysis technology to reduce major adverse cardiovascular events (MACE). Cardiovascular disease remains the leading cause of death worldwide, and current therapies, including statins, reduce MACE by approximately 25%. In contrast, Lipoprotein Apheresis devices that filter LDL-C and Lipoprotein(a) from the bloodstream can reduce MACE by 75-95%, according to the American Heart Association. However, these devices have complex, multi-component designs that limit their widespread adoption.
CardioDialysis is designed to overcome these limitations. It is the first technology to fully integrate plasma separation and therapeutic adsorption within a single device, which can be deployed on dialysis machines already located in hospitals and clinics. This integration enables continuous broad-spectrum clearance of inflammatory and pathogenic molecules from the entire bloodstream, addressing a broader range of cardiovascular disease targets more efficiently than existing systems like the Kaneka LIPOSORBER.
The Kaneka LIPOSORBER, an FDA-approved procedure, has administered approximately 600,000 treatments to over 6,000 patients worldwide. However, its setup requires a plasma separation column, two LIPOSORBER cartridges, custom blood tubing sets, a blood warmer, multiple bags of replacement and regeneration fluids, four waste bags, and multiple pumps. This complexity limits its availability to fewer than 60 specialized apheresis centers in the United States.
In contrast, CardioDialysis is a fully integrated single-component device that can be deployed on dialysis machines in more than 5,000 hospitals and 7,500 dialysis clinics in the U.S. alone. It processes the bloodstream with greater efficiency and does not require replacement fluids, additional pumps, or other auxiliary components. According to Joyce, considering that 15-20% of major adverse cardiovascular events result in death, the successful clinical advancement of CardioDialysis could save thousands of lives each year.
Sigyn Therapeutics is focused on advancing CardioDialysis through clinical studies required for market clearance. The company also has a development pipeline that includes ImmunePrep to optimize delivery of immunotherapeutic antibodies for cancer, ChemoPrep to enhance targeted chemotherapy delivery, and ChemoPure to reduce chemotherapy toxicity. For more information, visit www.SigynTherapeutics.com.
