The Emergence of Blood Purification Devices to Treat Cardiovascular Disease
January 6, 2026
The following note was authored by Jim Joyce, inventor CEO at Sigyn Therapeutics
Dear Readers,
For more than a century, cardiovascular disease has been the leading cause of death in the United States.
While single-target drugs have been a therapeutic focal point, cardiovascular disease is fueled by a multitude of circulating factors, including inflammatory and cholesterol targets that are not addressed with drug therapies.
While not broadly recognized, multi-target blood purification devices to lower LDL-cholesterol (LDL-C) and Lipoprotein(a) levels, otherwise known as Lipoprotein Apheresis, can reduce major adverse cardiovascular events (MACE) by 75-95% (American Heart Association). Whereas, LDL-C lowering statins, (e.g., Lipitor, Crestor), the leading class of drugs to treat cardiovascular disease, are limited to average MACE reductions of 25%.
When considering this variance between device and drug treatment benefit, Lipoprotein Apheresis provides compelling efficacy evidence that supports the clinical advancement of CardioDialysis.
As compared to Lipoprotein Apheresis, CardioDialysis addresses a wider range of cardiovascular disease targets and is supported by a vastly larger global delivery infrastructure.
In additional to targeting LDL-C and Lipoprotein(a), in vitro studies of CardioDialysis have demonstrated its ability to address a broad-spectrum of inflammatory factors that are also implicated in cardiovascular disease progression.
In regard to global delivery infrastructure, CardioDialysis is deployed for use on dialysis machines already located in hospitals and clinics around the world. This is an important strategic advantage as the delivery of Lipoprotein Apheresis is limited to plasma separation machines located in specialized apheresis centers.
To provide some perspective, there are more than 7,500 dialysis clinics in the United States, while geographical access to Lipoprotein Apheresis is limited to fewer than 60 apheresis center locations. Globally, there are approximately 50,000 dialysis clinics, yet less than 800 apheresis center locations.
Regardless of distribution constraint, the demand for Lipoprotein Apheresis continues to grow. The global market for the therapy was estimated at $300 million in 2024 and is projected to reach $650 million in 2033. Thus, further supporting our rationale to clinically advance CardioDialysis.
Beyond our strategic distribution advantage, the deployment of CardioDialysis on dialysis machines provides an early clinical opportunity to address cardiovascular disease in end-stage renal disease (ESRD) patients who rely on kidney dialysis for survival.
Globally, more than four million ESRD patients receive ~640 million dialysis treatments each year. Once on dialysis, their median length of survival is 3-5 years. Cardiovascular disease accounts for ~67% of ESRD patient deaths.
Unfortunately, drug therapies have not been found to improve survival or reduce cardiovascular events in this patient population. As a result, the treatment of cardiovascular disease in ESRD patients remains a significant unmet need in global health.
Unlike Lipoprotein Apheresis, CardioDialysis can be conveniently administered during regularly scheduled dialysis treatments to combat cardiovascular disease progression. Beyond providing potential patient benefit, CardioDialysis could have a significant impact on dialysis industry revenues. In the United States, there is an estimated 550,00 ESRD patients on dialysis. Extending the lives of these patients by just one month would boost top-line U.S. dialysis industry revenues by ~$2.8 billion. What if the lives of ESRD patients could be extended by years?
Our clinical plan to initially treat cardiovascular disease in ESRD patients is far more than a niche market opportunity. Consider that the $300 million market for Lipoprotein Apheresis in 2024 was based on the treatment of approximately 5,500 individuals worldwide. That number is the equivalent of just 1% of the U.S. dialysis patient population and slightly more than 1/10th of one percent of the global population of ESRD patients on dialysis.
Now consider that a vast majority of ESRD dialysis patients suffer from cardiovascular disease; approximately two thirds will die from the condition; and drug therapies provide little if any benefit. Thus, further reinforcing the potential value of CardioDialysis.
Thank you for reading my note.
Sincerely, Jim