Sigyn Therapeutics, Inc. has released a note highlighting the potential of blood purification devices to treat cardiovascular disease, with particular focus on the company's CardioDialysis technology. The note, authored by inventor and CEO Jim Joyce, emphasizes how multi-target blood purification approaches differ fundamentally from traditional drug therapies in addressing the complex nature of cardiovascular conditions.
Cardiovascular disease has remained the leading cause of death in the United States for more than a century. While single-target drugs have been the primary therapeutic approach, cardiovascular disease involves multiple circulating factors including inflammatory and cholesterol targets that drug therapies often fail to address comprehensively. According to the American Heart Association, multi-target blood purification devices that lower LDL-cholesterol and Lipoprotein(a) levels, known as Lipoprotein Apheresis, can reduce major adverse cardiovascular events by 75-95%. In contrast, LDL-C lowering statins like Lipitor and Crestor typically achieve average MACE reductions of only 25%.
CardioDialysis represents a significant advancement beyond existing blood purification technologies. While Lipoprotein Apheresis targets specific cholesterol components, CardioDialysis addresses a wider range of cardiovascular disease targets. In vitro studies have demonstrated the device's ability to target a broad spectrum of inflammatory factors implicated in cardiovascular disease progression. This multi-target approach could potentially overcome the limitations of single-target drug therapies that have dominated cardiovascular treatment for decades.
The global delivery infrastructure provides CardioDialysis with a substantial strategic advantage. The device is designed for deployment on dialysis machines already located in hospitals and clinics worldwide. This contrasts sharply with Lipoprotein Apheresis, which requires specialized plasma separation machines available only in limited apheresis centers. The United States has more than 7,500 dialysis clinics compared to fewer than 60 apheresis center locations. Globally, approximately 50,000 dialysis clinics exist versus less than 800 apheresis centers. This distribution disparity creates significant accessibility challenges for current blood purification therapies.
Despite distribution constraints, demand for blood purification therapies continues to grow. The global market for Lipoprotein Apheresis was estimated at $300 million in 2024 and is projected to reach $650 million by 2033, according to the company's analysis. This market growth further supports the rationale for advancing CardioDialysis technology clinically.
The deployment of CardioDialysis on existing dialysis machines creates a unique clinical opportunity to address cardiovascular disease in end-stage renal disease patients. Globally, more than four million ESRD patients receive approximately 640 million dialysis treatments annually. Once on dialysis, their median survival is only 3-5 years, with cardiovascular disease accounting for approximately 67% of ESRD patient deaths. Drug therapies have not demonstrated significant improvement in survival or cardiovascular event reduction in this patient population, creating what the company describes as a significant unmet need in global health.
Unlike Lipoprotein Apheresis, CardioDialysis can be conveniently administered during regularly scheduled dialysis treatments. Beyond potential patient benefits, the technology could significantly impact dialysis industry revenues. In the United States alone, approximately 550,000 ESRD patients receive dialysis. Extending these patients' lives by just one month could increase top-line U.S. dialysis industry revenues by approximately $2.8 billion annually.
The company's clinical plan to initially treat cardiovascular disease in ESRD patients represents more than a niche market opportunity. The $300 million market for Lipoprotein Apheresis in 2024 was based on treating approximately 5,500 individuals worldwide. This number represents just 1% of the U.S. dialysis patient population and slightly more than one-tenth of one percent of the global ESRD patient population on dialysis. Given that approximately two-thirds of ESRD dialysis patients suffer from cardiovascular disease and drug therapies provide limited benefit, CardioDialysis could address a substantial medical need while creating significant economic value.
More information about Sigyn Therapeutics is available at https://www.SigynTherapeutics.com. The original press release can be viewed at https://www.newmediawire.com.
