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 research particularly significant for public health.
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 targeting cholesterol-transporting lipoproteins that contribute to heart attacks, strokes, and other major adverse cardiovascular events.
The company is expanding its feasibility study protocol based on insights from pre-clinical in vitro studies to quantify lipoprotein reduction resulting from Sigyn Therapy administration. This expansion could lead to a groundbreaking approach to reduce major adverse cardiovascular events in vulnerable patient populations.
The technology operates similarly to lipoprotein apheresis, an established FDA-approved treatment that has demonstrated 55% to 98% reductions in major adverse cardiovascular events in clinical studies. However, while lipoprotein apheresis is 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, potentially making treatment more accessible to patients.
Jim Joyce, Sigyn Therapeutics' CEO and co-inventor of Sigyn Therapy, stated that targeting the bloodstream reduction of Lp(a) and LDL-C while simultaneously suppressing dialysis-induced endotoxemia and inflammation introduces a broad-spectrum strategy to extend end-stage renal disease patient lives by addressing multiple core drivers of cardiovascular disease.
The potential impact extends beyond patient health outcomes to significant economic considerations. The U.S. dialysis industry generates approximately $34 billion in annual revenues from administering approximately 85 million dialysis treatments to more than 550,000 individuals with end-stage renal disease. Since most ESRD patients die from cardiovascular disease in the absence of effective therapeutic intervention, extending patient lives by just one month could increase top-line industry revenues by approximately $2.8 billion annually.
Primary beneficiaries of such revenue increases would include Fresenius Medical Care and Davita, Inc., which control 75% of the U.S. dialysis market according to public financial filings. The successful completion of the Sigyn feasibility study would set the stage for a pivotal efficacy study necessary to pursue potential market clearance for this innovative treatment approach.
For more information about the company's technology, visit https://www.SigynTherapeutics.com. Additional details about the press release can be found at https://www.newmediawire.com.
