Sigyn CardioDialysis™ is a first-in-industry medical device to treat cardiovascular disease, the leading cause of death globally. CardioDialysis™ aims to reduce the circulating presence of inflammatory molecules that fuel cardiovascular disease progression while simultaneously lowing levels of cholesterol-transporting lipoproteins that contribute to heart attacks, strokes, and other Major Adverse Cardiovascular Events (MACE).

Based on its broad-spectrum mechanism, CardioDialysis™ offers to reduce the incidence of MACE by overcoming the inherent limitations of single-target drugs. The annual market for MACE-reducing therapies has been reported to exceed $100 billion.

Initial Clinical and Commercialization Focus 

Our initial clinical and commercialization focus is directed toward the treatment of cardiovascular disease in end-stage renal disease (ESRD) dialysis patients. According to the U.S. Renal Data System, cardiovascular disease is attributed to 67% of ESRD patient deaths and its incidence is 20 times higher in dialysis patients as compared to the general population. This is a well-defined, yet substantial initial market opportunity, given that an estimated 550,000 ESRD patients receive ~85 million dialysis treatments in the U.S. each year. To optimize our treatment of cardiovascular disease in ESRD patients, CardioDialysis™ can be conveniently integrated during their regularly scheduled dialysis treatments.

Medical Device Precedent to Treat Cardiovascular Disease 

CardioDialysis™ targets multiple key therapeutic pathways, including cholesterol-transporting lipoproteins that play a central role in the development and progression of cardiovascular disease.

Lipoprotein Apheresis (LA) is an FDA-approved precedent that demonstrates medical devices can reduce Major Adverse Cardiovascular Events (MACE) by lowering levels of lipoprotein(a) and low-density lipoprotein cholesterol (LDL-C) in the bloodstream. In a recent review article published by the American Heart Association, Lipoprotein Apheresis was reported to lower the incidence of MACE by 59% to 95% across 11 studies encompassing 1,387 treated patients. In contrast, statin drugs to reduce LDL-C levels are reported to reduce MACE by 20% to 40%.

To date, the clinical adoption of Lipoprotein Apheresis has been constrained by a limited delivery infrastructure, with fewer than 60 specialized apheresis centers able to provide access to the therapy in the United States.

Leveraging the Global Dialysis Machine Infrastructure

CardioDialysis™ is not constrained by delivery infrastructure as it can be deployed on dialysis machines located in hospitals and clinics around the world.  An estimated 150,000 dialysis machines are located at more than 7,500 kidney dialysis clinics in the United States alone.  By leveraging this infrastructure, we envision the possibility that today’s kidney dialysis clinics could be transformed into integrated Renal and CardioDialysis™ treatment centers in the future.

Potential Value of CardioDialysis™ to the Dialysis Industry 

If successfully advanced, CardioDialysis™ would offer a strategy to improve and extend the quality of life of ESRD patients who rely on dialysis for survival. Beyond introducing a potential new revenue source to the dialysis industry, CardioDialysis™ could establish a pathway to treat cardiovascular disease in the general population, which is the commercialization focus of Lipoprotein Apheresis.

Extending the lives of ESRD patients and reducing their hospitalizations would provide quantifiable value to the dialysis industry. When ESRD patients are hospitalized, dialysis companies lose revenues as in-clinic dialysis treatments are instead administered at out-of-network hospitals. Based on average dialysis revenues of $400 per treatment, the dialysis industry could recoup ~$654 million in lost revenues for each week of reduced U.S. ESRD patient hospitalizations. The dialysis industry could also increase top-line revenues by ~$2.8 billion for each month of extending U.S. ESRD patient lives.