Sigyn Therapeutics (OTCQB: SIGY) has announced a significant advancement in cardiovascular disease treatment with its CardioDialysis technology, a medical device designed to continuously clear inflammatory and pathogenic molecules from the bloodstream. The device, which integrates plasma separation and therapeutic adsorption into a single unit, can be deployed on dialysis machines already present in hospitals and clinics, overcoming the logistical barriers that have limited the use of similar technologies like lipoprotein apheresis.
Cardiovascular disease remains the leading cause of death globally, with current statin therapies reducing major adverse cardiovascular events (MACE) by only about 25%. In contrast, lipoprotein apheresis devices, such as the Kaneka LIPOSORBER, have demonstrated a 75-95% reduction in MACE, according to the American Heart Association. However, the complexity of these systems—requiring multiple components, custom tubing, and specialized centers—has restricted their widespread use. The LIPOSORBER, for instance, has been administered to fewer than 6,000 patients worldwide and is only available at about 60 specialized centers in the United States.
CardioDialysis simplifies this process by offering a fully integrated, single-component device that can be used on dialysis machines in over 5,000 hospitals and 7,500 dialysis clinics nationwide. Unlike the LIPOSORBER, it does not require replacement fluids, additional pumps, or auxiliary components, and it processes blood more efficiently while targeting a broader range of cardiovascular disease targets. The device aims to reduce circulating inflammatory mediators that drive disease progression and lower cholesterol-transporting lipoproteins responsible for heart attacks and strokes.
Jim Joyce, CEO and inventor of CardioDialysis, emphasized that 15-20% of MACE result in death, and successful clinical advancement of this technology could save thousands of lives annually. The company plans to pursue clinical studies to gain regulatory clearance and bring the device to market.
Beyond cardiovascular disease, Sigyn Therapeutics is exploring CardioDialysis for sepsis, viral infections, and neuroinflammatory disorders, as well as developing complementary therapies like ImmunePrep, ChemoPrep, and ChemoPure. The company’s approach represents a shift in subtractive medicine, moving beyond single-target drugs to broad-spectrum blood purification.
For more information, visit SigynTherapeutics.com.
