Sigyn Therapeutics Unveils CardioDialysis™ Technology with Potential to Transform Cardiovascular Disease Treatment

Sigyn Therapeutics, Inc. has detailed the first-in-industry attributes of its CardioDialysis™ technology, a medical device designed to treat cardiovascular disease through blood purification. The company's approach aims to address the limitations of current therapies and expand treatment access by utilizing existing dialysis infrastructure.

Cardiovascular disease remains the leading cause of death worldwide, with current standard treatments including LDL-C reducing statins like Lipitor, Crestor, and Zocor. According to a source publication at https://pmc.ncbi.nlm.nih.gov/articles/PMC12359277/, these drugs are associated with 25% reductions in Major Adverse Cardiovascular Events (MACE), which include heart attacks and strokes. In contrast, the American Heart Association has reported that blood purification methods to reduce LDL-C and Lipoprotein(a) levels, known as lipoprotein apheresis, are associated with 75% to 95% reductions in MACE, as detailed in a publication at https://www.ahajournals.org/doi/10.1161/ATV.0000000000000177.

Despite the effectiveness of lipoprotein apheresis, its adoption is limited by delivery infrastructure, with treatments available at only about 60 specialized centers in the United States. CardioDialysis™ overcomes this barrier by being designed for deployment on standard dialysis machines already present at more than 7,500 kidney dialysis clinics across the country. This infrastructure advantage could significantly expand patient access to blood purification treatments for cardiovascular disease.

The technology offers broad-spectrum clearance of cardiovascular disease targets. In vitro studies have validated its ability to remove twelve different therapeutic targets from human blood plasma, all below 200nm in diameter. These targets include inflammatory molecules that contribute to disease progression but are not addressed by currently approved therapies. Preliminary animal studies conducted at the University of Michigan have indicated that CardioDialysis™ is safe and well tolerated.

Sigyn has identified an early clinical and commercialization opportunity in treating end-stage renal disease (ESRD) patients who undergo regular dialysis. Cardiovascular disease accounts for 67% of deaths among ESRD patients, with incidence rates up to 20 times higher than in the general population. The U.S. Renal Data System reports that approximately 550,000 ESRD patients receive about 85 million dialysis treatments annually in the U.S., representing a substantial initial market. Furthermore, drugs to treat cardiovascular disease have not reduced cardiovascular events in dialysis patients, and levels of cholesterol-transporting lipoprotein(a) are 2-4 times higher in this population.

The company's clinical strategy involves enrolling ESRD patients for studies conducted at their regular dialysis clinics, with CardioDialysis™ administered during scheduled treatments. This approach avoids the challenges of recruiting subjects in intensive care unit settings and is expected to reduce both the time and cost required for clinical studies needed for FDA market approval through the Center for Devices and Radiological Health.

Beyond patient benefits, CardioDialysis™ offers strategic value to the dialysis industry. Reducing MACE could extend the lives of ESRD patients, potentially increasing dialysis industry revenues by approximately $2.8 billion for each month of extended patient life, based on average annual per-patient revenues of $65,000. The technology also creates a pathway for dialysis clinics to expand their services to treat cardiovascular disease in the general population, potentially transforming current kidney dialysis centers into future renal and CardioDialysis treatment centers.