Cardiovascular disease remains the leading cause of death in the United States, with current drug therapies offering limited benefit against the multitude of circulating factors that fuel disease progression. According to a note from Sigyn Therapeutics, blood purification devices like Lipoprotein Apheresis have demonstrated 75-95% reductions in major adverse cardiovascular events compared to the 25% average reduction achieved by statin drugs like Lipitor and Crestor.
The company's CardioDialysis device represents a significant advancement beyond existing blood purification technologies. While Lipoprotein Apheresis targets LDL-cholesterol and Lipoprotein(a), CardioDialysis addresses a wider range of cardiovascular disease targets, including inflammatory factors implicated in disease progression. In vitro studies have demonstrated the device's broad-spectrum capabilities against these circulating factors.
Perhaps most significantly, CardioDialysis leverages existing global dialysis infrastructure for deployment. The device can be used on dialysis machines already located in hospitals and clinics worldwide, while Lipoprotein Apheresis requires specialized plasma separation machines available at fewer than 60 apheresis centers in the United States. Globally, approximately 50,000 dialysis clinics exist compared to less than 800 apheresis center locations, creating a substantial distribution advantage for CardioDialysis.
This infrastructure advantage creates an immediate clinical opportunity to address cardiovascular disease in end-stage renal disease patients who rely on kidney dialysis for survival. More than four million ESRD patients globally receive approximately 640 million dialysis treatments annually, with cardiovascular disease accounting for approximately 67% of deaths in this population. Current drug therapies have not been found to improve survival or reduce cardiovascular events in ESRD patients, creating what the company describes as "a significant unmet need in global health."
CardioDialysis can be conveniently administered during regularly scheduled dialysis treatments, potentially extending patient lives while generating significant economic impact. In the United States alone, extending the lives of 550,000 ESRD dialysis patients by just one month would boost top-line dialysis industry revenues by approximately $2.8 billion. The global market for Lipoprotein Apheresis was estimated at $300 million in 2024 and is projected to reach $650 million by 2033, according to market data available at https://www.newmediawire.com.
Despite growing demand, Lipoprotein Apheresis treatment reached only approximately 5,500 individuals worldwide in 2024, equivalent to just 1% of the U.S. dialysis patient population. With approximately two-thirds of ESRD dialysis patients suffering from cardiovascular disease and current drug therapies providing minimal benefit, CardioDialysis represents a potentially transformative approach to addressing one of medicine's most persistent challenges.
