Sigyn Therapeutics has detailed the potential of its CardioDialysis device as a treatment for cardiovascular disease, emphasizing its advantages over existing therapies and its specific relevance for end-stage renal disease patients. Cardiovascular disease remains the leading cause of death in the United States, with drug therapies addressing only single targets and achieving limited reductions in major adverse cardiovascular events. The company's note points to Lipoprotein Apheresis, a blood purification technology that can reduce major adverse cardiovascular events by 75-95% according to the American Heart Association, compared to statin drugs that achieve average reductions of just 25%. This efficacy gap supports the clinical advancement of CardioDialysis, which addresses a wider range of cardiovascular disease targets than Lipoprotein Apheresis while leveraging existing global dialysis infrastructure.
CardioDialysis targets not only LDL-cholesterol and Lipoprotein(a) but also a broad spectrum of inflammatory factors implicated in cardiovascular disease progression, as demonstrated in in vitro studies. The device's deployment on existing dialysis machines provides a significant strategic advantage, with more than 7,500 dialysis clinics in the United States compared to fewer than 60 specialized apheresis centers. Globally, approximately 50,000 dialysis clinics exist versus less than 800 apheresis center locations. The global market for Lipoprotein Apheresis was estimated at $300 million in 2024 and is projected to reach $650 million by 2033, indicating growing demand for blood purification therapies.
Sigyn's clinical plan focuses initially on treating cardiovascular disease in end-stage renal disease patients, who represent a population of more than four million globally receiving approximately 640 million dialysis treatments annually. Cardiovascular disease accounts for approximately 67% of deaths among end-stage renal disease patients, who have a median survival of 3-5 years once on dialysis. Drug therapies have not been found to improve survival or reduce cardiovascular events in this patient population, creating what the company describes as a significant unmet need in global health. Unlike Lipoprotein Apheresis, CardioDialysis can be administered during regularly scheduled dialysis treatments, potentially extending patient lives while boosting dialysis industry revenues.
The company notes that extending the lives of the estimated 550,000 U.S. dialysis patients by just one month would increase top-line industry revenues by approximately $2.8 billion. The initial focus on end-stage renal disease patients represents more than a niche market opportunity, as the 2024 Lipoprotein Apheresis market of $300 million was based on treating approximately 5,500 individuals worldwide—equivalent to just 1% of the U.S. dialysis patient population. With approximately two-thirds of end-stage renal disease patients suffering from cardiovascular disease and drug therapies providing minimal benefit, the company sees substantial potential for CardioDialysis to address this critical healthcare challenge.
