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

Sigyn Therapeutics has announced the advancement of CardioDialysis™, a medical device designed to treat cardiovascular disease by leveraging the existing global infrastructure of dialysis machines. The company's initial clinical focus targets end-stage renal disease patients undergoing dialysis, a population where cardiovascular disease accounts for 67% of deaths according to the U.S. Renal Data System.

CardioDialysis™ operates through a broad-spectrum mechanism that simultaneously reduces inflammatory molecules fueling cardiovascular disease progression and lowers levels of cholesterol-transporting lipoproteins associated with heart attacks, strokes, and other Major Adverse Cardiovascular Events. This approach aims to overcome limitations of single-target pharmaceutical drugs in a market for MACE-reducing therapies exceeding $100 billion annually.

The technology builds upon the precedent of Lipoprotein Apheresis, an FDA-approved medical device that has demonstrated MACE reduction rates of 59% to 95% across multiple studies. However, Lipoprotein Apheresis remains constrained by limited delivery infrastructure, with fewer than 60 specialized centers in the United States. In contrast, CardioDialysis™ can be deployed on approximately 150,000 dialysis machines located in more than 7,500 kidney dialysis clinics across the country alone.

This deployment strategy offers significant advantages for both clinical development and commercialization. The company plans to conduct FDA-required studies within dialysis clinics rather than hospital intensive care units, leveraging existing blood access points and regular treatment schedules of ESRD patients. This approach addresses historical challenges in enrolling ICU patients for clinical trials while utilizing staff experienced in extracorporeal blood purification therapies.

For the dialysis industry, successful implementation of CardioDialysis™ could transform current kidney dialysis clinics into Renal and CardioDialysis™ treatment centers. The technology addresses unique cardiovascular challenges faced by ESRD patients, including elevated lipoprotein(a) levels two to four times higher than the general population and limited clinical benefit from statin therapies. Additionally, dialysis treatments themselves induce inflammatory responses that contribute to cardiovascular disease progression.

The potential economic impact on the dialysis industry is substantial. Based on average dialysis revenues of $400 per treatment, the industry could recoup up to $654 million in lost revenues for each week of reduced ESRD patient hospitalizations. Furthermore, extending ESRD patient lives could generate approximately $2.8 billion in additional monthly revenues for the industry. The company's website at https://www.SigynTherapeutics.com provides additional information about their development pipeline.

Sigyn Therapeutics has drafted an Investigational Device Exemption for FDA submission that clearly defines cardiovascular disease as the intended treatment condition. The company previously collaborated with a leading dialysis company's clinical research division to design feasibility study protocols demonstrating safety in 12-15 ESRD subjects across three dialysis clinic locations.