Sigyn Therapeutics Expands Cardiovascular Disease Study to Target Lipoprotein Reduction

Sigyn Therapeutics, Inc. has announced plans to commence a multi-site clinical feasibility study of Sigyn Therapy in high-risk cardiovascular disease subjects. Cardiovascular disease remains the number one cause of death globally according to the World Health Organization, making this development particularly significant for patients at elevated risk.

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 specifically targets cardiovascular disease by reducing circulating inflammatory molecules that promote disease progression while simultaneously addressing cholesterol-transporting lipoproteins that contribute to heart attacks, strokes, and other major adverse cardiovascular events.

The company had previously reported that its clinical feasibility study protocol would enroll dialysis-dependent end-stage renal disease patients with endotoxemia and concurrent inflammation. These conditions are known to promote cardiovascular disease, which represents the leading cause of death among ESRD patients. Based on insights from pre-clinical in vitro studies, the company is now expanding its feasibility study protocol to quantify lipoprotein reduction resulting from Sigyn Therapy administration.

The use of extracorporeal devices to reduce lipoprotein(a) and low-density lipoprotein cholesterol from the bloodstream is commercially known as lipoprotein apheresis, an established FDA-approved treatment precedent for cardiovascular disease. Published clinical studies of lipoprotein apheresis have reported 55% to 98% reductions in major adverse cardiovascular events in treated patients. However, treatment access in the United States remains limited to fewer than 60 specialized apheresis centers.

Sigyn Therapy's potential advantage lies in its deployment on dialysis machines located in approximately 7,500 U.S. dialysis clinics, offering significantly broader accessibility. Beyond its commercialization potential, the therapy can be conveniently administered to ESRD patients during their regularly scheduled dialysis treatments without requiring additional specialized facilities.

The successful completion of the Sigyn feasibility study would establish the foundation for a pivotal efficacy study necessary to pursue potential market clearance. This development could have substantial implications for the approximately 550,000 individuals with end-stage renal disease in the United States who receive approximately 85 million dialysis treatments annually, generating industry revenues of approximately $34 billion.

Cardiovascular disease represents the primary cause of mortality among ESRD patients in the absence of effective therapeutic interventions. Extending the lives of these patients by just one month could potentially increase top-line industry revenues by approximately $2.8 billion annually, with primary revenue beneficiaries including Fresenius Medical Care and Davita, Inc., who control 75% of the U.S. dialysis market according to public financial filings.

For additional information about the company's technology and development programs, visit https://www.SigynTherapeutics.com. The original press release containing this announcement can be viewed at https://www.newmediawire.com.