Sigyn Therapeutics Advances CardioDialysis™ to Address Cardiovascular Disease in Dialysis Patients

Sigyn Therapeutics is advancing CardioDialysis™ to treat cardiovascular disease, the leading cause of death globally. The medical device aims to reduce circulating inflammatory molecules that fuel cardiovascular disease progression while simultaneously lowering levels of cholesterol-transporting lipoproteins that contribute to heart attacks, strokes, and other Major Adverse Cardiovascular Events. Based on its broad-spectrum mechanism, CardioDialysis™ offers to reduce the incidence of MACE by overcoming the inherent limitations of single-target drugs in a market exceeding $100 billion annually.

The initial clinical and commercialization focus of CardioDialysis™ targets end-stage renal disease patients, where cardiovascular disease accounts for 67% of deaths according to the U.S. Renal Data System. With approximately 550,000 ESRD patients receiving about 85 million dialysis treatments annually in the U.S., this represents a substantial market opportunity. CardioDialysis™ can be conveniently integrated with regularly scheduled dialysis treatments, optimizing market penetration within the dialysis industry.

CardioDialysis™ builds upon the precedent of Lipoprotein Apheresis, an FDA-approved medical device that demonstrates the ability of blood purification to significantly reduce Major Adverse Cardiovascular Events. In a review published by the American Heart Association, Lipoprotein Apheresis was reported to lower MACE incidence by 59% to 95% across 11 studies involving 1,387 patients. This contrasts with pharmaceutical statins like Lipitor, Crestor, and Zocor, which typically reduce MACE by 20% to 45%. However, Lipoprotein Apheresis has limited clinical adoption due to infrastructure constraints, with fewer than 60 specialized apheresis centers in the United States.

The strategic advantage of CardioDialysis™ lies in its deployment capability on existing dialysis infrastructure. An estimated 150,000 dialysis machines are located in more than 7,500 kidney dialysis clinics across the United States alone. This infrastructure leverage enables the potential transformation of current kidney dialysis clinics into Renal and CardioDialysis™ treatment centers without requiring significant additional capital investment.

End-stage renal disease patients face unique cardiovascular challenges that conventional drug therapies fail to address adequately. Clinical studies reveal that ESRD patients receive limited, if any, clinical benefit from LDL-C reducing statins, the leading class of cardiovascular drugs. Additionally, circulating levels of cholesterol-transporting lipoprotein(a) are two to four times higher in ESRD dialysis patients. Compounding these challenges, dialysis treatments themselves induce inflammatory responses that contribute to cardiovascular disease progression through elevated endotoxin and inflammatory cytokine levels.

From a clinical development perspective, enrolling ESRD patients in dialysis clinics offers significant advantages over hospital intensive care unit settings required for previous treatment indications. ESRD patients already have established blood access, and CardioDialysis™ can be administered during regularly scheduled dialysis sessions. The staff at dialysis clinics have extensive experience in administering extracorporeal blood purification therapies and can readily identify suitable clinical study candidates among patients they regularly treat.

The successful advancement of CardioDialysis™ could provide substantial value to the dialysis industry beyond introducing new revenue streams. When ESRD patients are hospitalized, dialysis companies lose revenues as treatments shift to out-of-network facilities. Based on average dialysis revenues of $400 per treatment, the U.S. dialysis industry could recoup up to $654 million in lost revenues for each week of reduced ESRD patient hospitalizations. The industry could also increase top-line revenues by approximately $2.8 billion for each month of extended ESRD patient survival.

Sigyn Therapeutics is currently editing its Investigational Device Exemption submission to clearly define the intent to treat cardiovascular disease, having previously collaborated with a leading dialysis company's clinical research division to design a clinical feasibility study protocol. The protocol aims to demonstrate safety in 12-15 ESRD subjects across three dialysis clinic sites, incorporating the Company's technology into the established dialysis treatment framework.