Breakthrough Device Offers Hope for Dialysis Patients at High Cardiac Risk

A new treatment for cardiovascular disease could soon be available for patients with end-stage renal disease. Sigyn Therapeutics has developed CardioDialysis, a device designed to address the high mortality rates in this vulnerable group. Unlike current therapies, it targets multiple risk factors at once and works alongside existing dialysis machines.

Patients with end-stage renal disease face a grim outlook, with cardiovascular disease causing around 67% of deaths. Once on dialysis, their median survival is just three to five years. Current drug treatments have failed to improve survival or reduce cardiovascular events, leaving a critical gap in care.

CardioDialysis aims to fill this gap by tackling a broader range of cardiovascular risks than existing therapies. While lipoprotein apheresis—used by 5,000 to 6,000 patients globally in 2023—focuses mainly on Lipoprotein(a), CardioDialysis also targets LDL-cholesterol and inflammatory factors. This wider approach could make it more effective for patients who currently have few options.

One of its key advantages is compatibility with standard dialysis equipment. With over 50,000 dialysis clinics worldwide—7,500 in the U.S. alone—the device can be integrated into routine treatments without needing specialized centers. By contrast, lipoprotein apheresis requires fewer than 800 dedicated facilities globally, limiting access.

The market for blood purification therapies is expanding rapidly. Valued at $300 million in 2024, it is expected to more than double to $650 million by 2033. Sigyn's initial focus is on the four million end-stage renal disease patients who undergo around 640 million dialysis sessions each year. If successful, CardioDialysis could extend lives while also increasing revenue for dialysis providers.

CardioDialysis offers a potential lifeline for millions of dialysis-dependent patients at high risk of cardiovascular death. Its ability to integrate with existing machines and treat multiple risk factors sets it apart from current options. The device's rollout could reshape treatment for a group with few alternatives and a pressing need for better care.