Sigyn Therapeutics has announced the prioritization of CardioDialysis™, a medical device designed to treat cardiovascular disease through blood purification technology. The company plans to leverage existing dialysis infrastructure, with more than 7,500 dialysis clinics in the United States containing approximately 150,000 dialysis machines that could potentially deploy the CardioDialysis™ technology.

Cardiovascular disease represents the leading cause of death globally and poses particularly severe challenges for end-stage renal disease patients. According to the U.S. Renal Data System, cardiovascular disease accounts for 67% of ESRD patient deaths, with cardiovascular disease incidence rates 20 times higher in dialysis patients compared to the general population. The median survival for dialysis-dependent ESRD patients typically ranges from three to five years.

The CardioDialysis™ technology targets multiple therapeutic pathways simultaneously, addressing what the company describes as inherent limitations of single-target pharmaceutical drugs. The 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.

Sigyn Therapeutics points to Lipoprotein Apheresis as an FDA-approved precedent demonstrating that blood purification can significantly reduce Major Adverse Cardiovascular Events. A review article published by the American Heart Association reported that Lipoprotein Apheresis lowered MACE incidence by 59% to 95% across 11 studies involving 1,387 treated patients. This compares to pharmaceutical statins, which typically reduce MACE by 20% to 45%.

The company's initial clinical focus will target ESRD dialysis patients, who face unique cardiovascular challenges not adequately addressed by current drug therapies. Clinical studies reveal that ESRD patients receive limited, if any, clinical benefit from LDL-C reducing statins, the leading class of drugs to treat cardiovascular disease. Additionally, circulating levels of cholesterol-transporting lipoprotein(a) are reported to be two to four times higher in ESRD dialysis patients.

Dialysis treatments themselves contribute to the problem by inducing inflammatory responses that further drive cardiovascular disease progression. Circulating levels of endotoxin and inflammatory cytokines often elevate in response to dialysis treatment. Currently, no market-cleared pharmaceutical products address Lipoprotein(a), endotoxemia, or the broad spectrum of inflammatory cytokines elevated in dialysis patients.

The potential economic impact of successful CardioDialysis™ implementation could be substantial for the dialysis industry. 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 lives.

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 blood access, and CardioDialysis™ can be administered during regularly scheduled dialysis sessions. Dialysis clinic staff have extensive experience administering extracorporeal blood purification therapies and can readily identify candidate enrollment subjects among patients they treat regularly.

The company has previously collaborated with the clinical research division of a leading dialysis company to design a clinical feasibility study protocol. This protocol was incorporated into an Investigational Device Exemption drafted for FDA submission. The company is currently editing its IDE submission to clearly define its intent to treat cardiovascular disease, moving closer to initiating human studies.

For more information about Sigyn Therapeutics, visit https://www.SigynTherapeutics.com.

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