Sigyn Therapeutics Expands Clinical Study of Novel Cardiovascular Treatment for High-Risk Patients

Sigyn Therapeutics has announced plans to commence a multi-site clinical feasibility study of Sigyn Therapy in high-risk cardiovascular disease subjects. Cardiovascular disease remains the leading cause of death globally according to the World Health Organization, making this development particularly significant for patient care. The company is expanding its feasibility study protocol to quantify lipoprotein reduction based on insights from pre-clinical in vitro studies. Sigyn Therapy represents a first-in-class whole-blood adsorption technology designed for use on dialysis machines located in hospitals and clinics worldwide.

The technology reduces circulating inflammatory molecules that promote cardiovascular disease progression while simultaneously targeting cholesterol-transporting lipoproteins that contribute to heart attacks, strokes, and other major adverse cardiovascular events. Unlike existing lipoprotein apheresis treatments that are limited to fewer than 60 specialized centers in the United States, Sigyn Therapy can be deployed on dialysis machines located in approximately 7,500 U.S. dialysis clinics. This broader accessibility could revolutionize treatment availability for cardiovascular disease patients. The technology can be conveniently administered to end-stage renal disease patients during their regularly scheduled dialysis treatments, addressing multiple core drivers of cardiovascular disease simultaneously.

The clinical benefit of lipoprotein reduction is well-established, with published studies reporting 55% to 98% reductions in major adverse cardiovascular events in treated patients. Jim Joyce, Sigyn Therapeutics' CEO and co-inventor of Sigyn Therapy, emphasized that targeting bloodstream reduction of Lp(a) and LDL-C while suppressing dialysis-induced endotoxemia and inflammation introduces a broad-spectrum strategy to extend ESRD patient lives. The potential impact on patient outcomes is substantial, as cardiovascular disease is the leading cause of death among end-stage renal disease patients.

The successful completion of the Sigyn feasibility study would set the stage for a pivotal efficacy study necessary to pursue potential market clearance. For more information about the company's technology, visit https://www.SigynTherapeutics.com. This development comes at a critical time when the dialysis industry generates approximately $34 billion in annual revenues from administering roughly 85 million treatments to more than 550,000 individuals with end-stage renal disease. Extending the lives of these patients by addressing cardiovascular complications could have significant implications for both patient care and healthcare economics.