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 accounts for 67% of mortality among end-stage renal disease patients according to the U.S. Renal Data System. The company's initial clinical focus will target ESRD dialysis patients, who face unique cardiovascular challenges including 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 contribute to cardiovascular disease progression.
The CardioDialysis™ mechanism operates on a broad-spectrum approach, targeting multiple therapeutic pathways simultaneously. The device 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. This approach offers potential advantages over single-target pharmaceutical drugs, which have shown limited effectiveness in ESRD patients.
Sigyn Therapeutics points to Lipoprotein Apheresis as an FDA-approved precedent demonstrating that blood purification can significantly reduce Major Adverse Cardiovascular Events. According to 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 11 studies involving 1,387 patients. This compares favorably to pharmaceutical statins, which typically reduce MACE by 20% to 45%.
The clinical adoption strategy represents a significant departure from traditional approaches. By conducting studies in dialysis clinics rather than hospital intensive care units, the company anticipates more efficient patient enrollment and treatment. ESRD patients already have established blood access, and CardioDialysis™ can be administered during regularly scheduled dialysis sessions. This contrasts with the challenges of enrolling ICU patients, which has historically proven difficult for blood purification therapies.
The potential economic impact on the dialysis industry could be substantial. The U.S. dialysis industry stands to recoup up to $654 million in lost revenues for each week of reduced ESRD patient hospitalizations, based on average dialysis revenues of $400 per treatment. Additionally, the industry could increase top-line revenues by approximately $2.8 billion for each month of extended ESRD patient survival.
Sigyn Therapeutics has drafted an Investigational Device Exemption for FDA submission, with the protocol developed in collaboration with the clinical research division of a leading dialysis company. The company's regulatory strategy now clearly defines cardiovascular disease as the intended treatment condition. The successful advancement of CardioDialysis™ could transform current kidney dialysis clinics into Renal and CardioDialysis™ treatment centers, creating new revenue streams while addressing a critical unmet medical need in a patient population with limited treatment options.
