Sigyn Therapeutics' CardioDialysis Device Leverages Existing Infrastructure to Expand Cardiovascular Treatment Access

Sigyn Therapeutics is advancing CardioDialysis, a medical device designed to treat cardiovascular disease through blood purification, with first-in-industry attributes that could expand treatment access and potentially improve upon existing outcomes. The company's approach leverages existing dialysis infrastructure, addressing a major barrier that has limited the adoption of similar therapies. Cardiovascular disease remains the leading cause of death worldwide, with current therapies like LDL-C reducing statins associated with 25% reductions in Major Adverse Cardiovascular Events (MACE). In contrast, the American Heart Association has reported that blood purification to reduce LDL-C and Lipoprotein(a) levels, known as lipoprotein apheresis, is associated with 75% to 95% reductions in MACE according to research published at https://www.ahajournals.org/doi/10.1161/ATV.0000000000000177. However, lipoprotein apheresis treatments are limited to approximately 60 specialized centers in the United States due to delivery infrastructure constraints.

CardioDialysis overcomes this barrier by being deployable on dialysis machines already located at more than 7,500 kidney dialysis clinics in the U.S. alone. This represents a significant expansion potential compared to existing apheresis treatments. The device has demonstrated broad-spectrum clearance capabilities, addressing twelve therapeutic targets below 200nm in diameter from human blood plasma, including inflammatory molecules not addressed by market-approved therapies. The company has identified an early clinical and commercialization opportunity in end-stage renal disease (ESRD) patients, where cardiovascular disease accounts for 67% of deaths according to the U.S. Renal Data System. Cardiovascular disease incidence is up to 20 times higher in ESRD patients compared to the general population, and circulating levels of cholesterol-transporting lipoprotein(a) are 2-4 times higher in these patients. With approximately 550,000 ESRD patients receiving about 85 million dialysis treatments annually in the U.S., this represents a substantial initial market opportunity.

Sigyn's clinical strategy involves enrolling ESRD patients at their kidney dialysis clinics, with CardioDialysis administration occurring during regularly scheduled dialysis treatments. This approach is expected to significantly reduce the time and cost of clinical studies compared to traditional ICU-based trials for life-threatening conditions. The company's research includes studies published at https://pmc.ncbi.nlm.nih.gov/articles/PMC12359277/ that inform their development approach. Beyond patient benefits, CardioDialysis offers strategic value to the dialysis industry. With cardiovascular disease as the leading cause of ESRD deaths, reducing MACE could extend patient lives, potentially increasing top-line dialysis industry revenues by $2.8 billion for each month of extended life based on average annual per-patient revenues of $65,000. The technology also creates a potential pathway for dialysis clinics to treat cardiovascular disease in the general population, potentially transforming current kidney dialysis clinics into future renal and CardioDialysis treatment centers.