Sigyn Therapeutics has released a note highlighting the potential of its CardioDialysis device as an emerging blood purification technology to address cardiovascular disease, the leading cause of death in the United States for over a century. The company's analysis contrasts current drug therapies with blood purification approaches, revealing significant differences in treatment efficacy and accessibility.
According to the American Heart Association, multi-target blood purification devices like Lipoprotein Apheresis can reduce major adverse cardiovascular events by 75-95%, while LDL-C lowering statins such as Lipitor and Crestor achieve average reductions of only 25%. This substantial variance in treatment benefit provides compelling evidence supporting the clinical advancement of CardioDialysis technology.
CardioDialysis addresses a wider range of cardiovascular disease targets than existing blood purification methods, including both cholesterol-transporting lipoproteins and inflammatory factors implicated in disease progression. In vitro studies have demonstrated the device's ability to target a broad spectrum of inflammatory molecules alongside LDL-cholesterol and Lipoprotein(a).
The technology's strategic advantage lies in its deployment on existing dialysis infrastructure. While Lipoprotein Apheresis is limited to approximately 60 specialized apheresis centers in the United States and fewer than 800 globally, CardioDialysis can be used on dialysis machines already located in more than 7,500 U.S. clinics and approximately 50,000 clinics worldwide. This accessibility gap represents a significant barrier to treatment adoption, despite growing market demand projected to reach $650 million by 2033 according to industry estimates available at https://www.newmediawire.com.
Sigyn's initial clinical focus targets end-stage renal disease patients who represent a critical unmet need in global health. More than four million ESRD patients receive approximately 640 million dialysis treatments annually, with cardiovascular disease accounting for approximately 67% of deaths in this population. Current drug therapies have not demonstrated improved survival or reduced cardiovascular events for these patients, creating a substantial treatment gap.
The company notes that CardioDialysis can be conveniently administered during regularly scheduled dialysis treatments, potentially extending patient lives while generating significant economic impact. Extending the lives of U.S. dialysis patients by just one month could increase dialysis industry revenues by approximately $2.8 billion, according to company projections.
Market analysis reveals the scale of this opportunity: the $300 million global market for Lipoprotein Apheresis in 2024 treated approximately 5,500 individuals worldwide, equivalent to just 1% of the U.S. dialysis patient population and slightly more than one-tenth of one percent of global ESRD patients on dialysis. With approximately two-thirds of ESRD dialysis patients suffering from cardiovascular disease and current drug therapies providing limited benefit, CardioDialysis represents more than a niche market opportunity.
Sigyn Therapeutics continues to develop its therapeutic pipeline, which includes additional dialysis-like therapies targeting cancer treatment optimization. More information about the company's development programs is available at https://www.SigynTherapeutics.com.
