Cardiovascular disease remains the leading cause of death worldwide, and current therapies, such as LDL-C reducing statins, only lower the risk of major adverse cardiovascular events (MACE) by about 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, their adoption has been limited by complex, multi-component designs that require specialized centers. Sigyn Therapeutics (OTCQB: SIGY) aims to address this gap with CardioDialysis, a next-generation blood purification technology that integrates plasma separation and therapeutic adsorption within a single device, deployable on dialysis machines already present in over 5,000 hospitals and 7,500 clinics in the United States alone.
In a note released today, CEO and inventor Jim Joyce highlighted the limitations of existing apheresis systems, such as the Kaneka LIPOSORBER, which has administered approximately 600,000 treatments to over 6,000 patients worldwide but is limited to fewer than 60 specialized apheresis centers in the U.S. due to its setup complexity. The LIPOSORBER procedure requires a plasma separation column, two cartridges, custom blood tubing sets, a blood warmer, multiple bags of replacement and regeneration fluids, four waste bags, and several pumps. In contrast, CardioDialysis is a fully integrated single-component device that processes the bloodstream with greater efficiency, does not require replacement fluids or additional pumps, and targets a broader range of cardiovascular disease targets.
Mechanistically, CardioDialysis enables continuous broad-spectrum clearance of inflammatory and pathogenic molecules from the entire bloodstream. This is significant because inflammation plays a key role in cardiovascular disease progression. By simultaneously reducing inflammatory mediators and cholesterol-transporting lipoproteins, CardioDialysis aims to overcome the limitations of single-target drugs. Given that 15-20% of MACE result in death, the successful clinical advancement of CardioDialysis could save thousands of lives each year, according to Joyce.
Beyond cardiovascular disease, Sigyn Therapeutics is exploring CardioDialysis for sepsis, life-threatening viral infections, and neuroinflammatory disorders. The company's pipeline also includes ImmunePrep to optimize immunotherapeutic antibody delivery for cancer, ChemoPrep to enhance targeted chemotherapy delivery, and ChemoPure to reduce chemotherapy toxicity. For more information, visit www.SigynTherapeutics.com.
