Sigyn Therapeutics Highlights CardioDialysis Device as Potential Breakthrough for Cardiovascular Disease Treatment

Sigyn Therapeutics, Inc. has released a note highlighting the emergence of blood purification devices to treat cardiovascular disease, with particular focus on its CardioDialysis technology. The note emphasizes that while cardiovascular disease remains the leading cause of death in the United States, current drug therapies have inherent limitations in addressing the multiple circulating factors that fuel disease progression.

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 significant efficacy variance provides compelling evidence supporting the clinical advancement of CardioDialysis, which addresses a wider range of cardiovascular disease targets than existing blood purification technologies.

CardioDialysis demonstrates strategic advantages through its deployment on existing dialysis infrastructure. While Lipoprotein Apheresis is limited to specialized apheresis centers, CardioDialysis can be used on dialysis machines already located in hospitals and clinics worldwide. The United States has more than 7,500 dialysis clinics compared to fewer than 60 apheresis center locations, while globally there are approximately 50,000 dialysis clinics versus less than 800 apheresis centers. This distribution advantage is significant as the global market for Lipoprotein Apheresis continues to grow from $300 million in 2024 to a projected $650 million in 2033.

The technology offers particular promise for end-stage renal disease patients, who represent a population with significant unmet medical needs. More than four million ESRD patients worldwide receive approximately 640 million dialysis treatments annually, with cardiovascular disease accounting for approximately 67% of their deaths. Drug therapies have not been found to improve survival or reduce cardiovascular events in this patient population, creating a critical treatment gap that CardioDialysis could address during regularly scheduled dialysis sessions.

Beyond patient benefits, CardioDialysis could substantially impact dialysis industry economics. In the United States alone, extending the lives of approximately 550,000 ESRD patients on dialysis by just one month would increase industry revenues by approximately $2.8 billion. The market potential is substantial considering that the $300 million Lipoprotein Apheresis market in 2024 treated only about 5,500 individuals worldwide, equivalent to just 1% of the U.S. dialysis patient population.

Sigyn Therapeutics' clinical plan to initially treat cardiovascular disease in ESRD patients represents more than a niche opportunity, given that approximately two-thirds of these patients suffer from cardiovascular disease and current drug therapies provide minimal benefit. The company's broader development pipeline includes additional dialysis-like therapies such as ImmunePrep to optimize immunotherapeutic antibody delivery for cancer treatment, ChemoPrep to enhance targeted chemotherapy delivery, and ChemoPure to reduce chemotherapy toxicity. More information about the company's technologies is available at https://www.SigynTherapeutics.com.