Sigyn Therapeutics is advancing CardioDialysis, a medical device designed to treat cardiovascular disease through blood purification technology that could be administered during regular dialysis treatments. The development comes as cardiovascular disease remains the leading cause of death worldwide, with current treatments showing limitations in effectiveness, particularly for end-stage renal disease patients.
The significance of CardioDialysis lies in its potential to overcome infrastructure barriers that have limited the adoption of similar blood purification treatments. While lipoprotein apheresis, an FDA-approved blood purification method, has demonstrated 75% to 95% reductions in Major Adverse Cardiovascular Events according to an American Heart Association report, its use is constrained to approximately 60 specialized centers in the United States. CardioDialysis could be deployed on existing dialysis machines at more than 7,500 kidney dialysis clinics nationwide, potentially expanding access to this treatment approach.
CardioDialysis offers broad-spectrum clearance of cardiovascular disease targets, addressing not only cholesterol-transporting lipoproteins but also inflammatory molecules that contribute to disease progression. In vitro studies have validated the device's ability to clear twelve therapeutic targets from human blood plasma, all below 200nm in diameter. Animal studies conducted at the University of Michigan have shown the therapy to be safe and well tolerated.
The immediate clinical opportunity exists in treating cardiovascular disease in end-stage renal disease patients, who represent a population with particularly high cardiovascular risk. According to U.S. Renal Data System reports, cardiovascular disease accounts for 67% of ESRD patient deaths, with incidence up to 20 times higher than in the general population. A source publication notes that traditional cardiovascular drugs have not reduced cardiovascular events in dialysis patients, creating an urgent need for alternative treatments.
Sigyn's clinical strategy represents another innovative aspect of their approach. Rather than conducting studies in intensive care units, the company plans to enroll ESRD patients at their regular dialysis clinics, administering CardioDialysis during scheduled treatments. This strategy could significantly reduce the time and cost of clinical studies while providing a more realistic treatment setting.
The commercial implications are substantial, with approximately 550,000 ESRD patients receiving about 85 million dialysis treatments annually in the United States. Cardiovascular disease reduction could extend patient lives, potentially increasing dialysis industry revenues by $2.8 billion for each month of extended life, based on average annual per-patient revenues of $65,000. Beyond the ESRD population, CardioDialysis introduces a pathway for dialysis clinics to treat cardiovascular disease in the general population, potentially transforming kidney dialysis centers into combined renal and cardiovascular treatment facilities.
This development matters because it addresses multiple healthcare challenges simultaneously: improving cardiovascular outcomes for high-risk patients, leveraging existing medical infrastructure to increase treatment accessibility, and creating potential revenue streams for the dialysis industry. The technology's broad-spectrum approach to blood purification could overcome limitations of single-target drugs while providing treatment options for patients who have not responded to conventional therapies.
