Sigyn Therapeutics, Inc. (OTCQB: SIGY), the developer of CardioDialysis, a medical device designed to remove inflammatory and pathogenic molecules from the bloodstream, has released a note from CEO Jim Joyce outlining the technology's potential to reduce major adverse cardiovascular events (MACE). Cardiovascular disease remains the leading cause of death globally, and current therapies like statins reduce MACE by only about 25%. In contrast, lipoprotein apheresis devices that filter LDL-C and Lipoprotein(a) can reduce MACE by 75-95%, according to the American Heart Association. However, these devices have limited adoption due to their complex, multi-component designs.
CardioDialysis aims to overcome these barriers by being the first technology to fully integrate plasma separation and therapeutic adsorption within a single device. This design allows it to be deployed on dialysis machines already present in over 5,000 hospitals and 7,500 dialysis clinics in the United States alone. For comparison, the FDA-approved Kaneka LIPOSORBER procedure requires multiple components, including a plasma separation column, two cartridges, custom tubing sets, a blood warmer, and various pumps and fluids, limiting its use to fewer than 60 specialized apheresis centers nationwide. CardioDialysis, on the other hand, processes blood more efficiently, addresses a broader range of cardiovascular targets, and does not require replacement fluids or auxiliary pumps.
The device enables continuous broad-spectrum clearance of inflammatory and pathogenic molecules from the entire bloodstream. Since 15-20% of MACE result in death, the successful clinical advancement of CardioDialysis could save thousands of lives annually. Sigyn Therapeutics is developing CardioDialysis for multiple indications, including sepsis, viral infections, neuroinflammatory disorders, and cardiovascular disease. The company also has a pipeline that includes ImmunePrep for cancer immunotherapy, ChemoPrep for targeted chemotherapy delivery, and ChemoPure to reduce chemotherapy toxicity. More information is available at www.SigynTherapeutics.com.
