Sigyn Therapeutics Advances CardioDialysis™ to Address Cardiovascular Disease in Dialysis Patients
Sigyn Therapeutics is developing CardioDialysis™, a medical device that leverages existing dialysis infrastructure to treat cardiovascular disease in end-stage renal disease patients, who face a 67% mortality rate from heart conditions and limited benefit from traditional drug therapies.
Sigyn Therapeutics is advancing CardioDialysis™, a medical device designed to treat cardiovascular disease through a broad-spectrum mechanism that addresses multiple therapeutic pathways simultaneously. The technology aims to reduce circulating inflammatory molecules while lowering levels of cholesterol-transporting lipoproteins that contribute to heart attacks, strokes, and other Major Adverse Cardiovascular Events (MACE). This approach offers to overcome the inherent limitations of single-target pharmaceutical drugs in a market for MACE-reducing therapies that exceeds $100 billion annually.
The company's initial clinical focus targets end-stage renal disease (ESRD) patients undergoing dialysis, where cardiovascular disease accounts for 67% of deaths according to the U.S. Renal Data System. This patient population faces unique challenges, including limited clinical benefit from LDL-C reducing statins and elevated levels of cholesterol-transporting lipoprotein(a) that are two to four times higher than in the general population. Additionally, dialysis treatments themselves induce inflammatory responses that further contribute to cardiovascular disease progression.
CardioDialysis™ builds upon the precedent of Lipoprotein Apheresis, an FDA-approved medical device that demonstrates blood purification can significantly reduce MACE. In a review article published by the American Heart Association available at https://www.ahajournals.org, Lipoprotein Apheresis was reported to lower MACE incidence by 59% to 95% across multiple studies. However, this therapy has been constrained by limited delivery infrastructure, with fewer than 60 specialized apheresis centers in the United States.
The strategic advantage of CardioDialysis™ lies in its deployment capability on existing dialysis machines located in more than 7,500 kidney dialysis clinics across the United States. This infrastructure leverage could transform current kidney dialysis clinics into combined Renal and CardioDialysis™ treatment centers. The company's regulatory strategy involves conducting both feasibility and pivotal efficacy studies within dialysis clinic settings, where ESRD patients already have blood access and can receive treatment during regularly scheduled dialysis sessions.
Beyond clinical benefits, CardioDialysis™ offers substantial economic value to the dialysis industry. 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. Additional information about the company's development pipeline can be found at https://www.SigynTherapeutics.com.
The company is currently editing its Investigational Device Exemption submission to clearly define its intent to treat cardiovascular disease, moving forward with regulatory steps required for FDA approval. This development represents a significant opportunity to address the substantial cardiovascular disease burden in dialysis patients while leveraging existing healthcare infrastructure for broader population impact.