Sigyn Therapeutics Expands Cardiovascular Disease Study to Target Lipoprotein Reduction

Sigyn Therapeutics, Inc. has announced plans to expand its multi-site clinical feasibility study of Sigyn Therapy™ to include quantification of lipoprotein reduction in high-risk cardiovascular disease subjects. This development comes as cardiovascular disease remains the leading cause of death globally according to the World Health Organization, making advancements in treatment particularly significant for public health.

The expanded study protocol builds upon pre-clinical in vitro studies and aims to measure reductions in lipoprotein(a) and low-density lipoprotein cholesterol, both known contributors to heart attacks, strokes, and other major adverse cardiovascular events. Sigyn Therapy™ represents a first-in-class whole-blood adsorption technology designed for deployment on existing dialysis machines, potentially offering broader accessibility compared to current treatment options.

Current FDA-approved lipoprotein apheresis treatment, while clinically proven to reduce major adverse cardiovascular events by 55% to 98%, is limited to fewer than 60 specialized centers in the United States. In contrast, Sigyn Therapy™ could potentially be administered through approximately 7,500 U.S. dialysis clinics, significantly expanding treatment access for patients suffering from cardiovascular complications.

The technology's dual approach targets both inflammatory molecules that promote cardiovascular disease progression and cholesterol-transporting lipoproteins simultaneously. This broad-spectrum strategy could prove particularly valuable for end-stage renal disease patients, who typically undergo regular dialysis treatments and face cardiovascular disease as their leading cause of mortality.

According to company statements, the successful completion of the feasibility study would pave the way for a pivotal efficacy study necessary to pursue potential market clearance. The implications extend beyond patient health outcomes to substantial economic considerations within the dialysis industry, which generates approximately $34 billion annually from administering roughly 85 million treatments to more than 550,000 end-stage renal disease patients in the United States.

Industry analysis suggests that extending the lives of end-stage renal disease patients by just one month could increase top-line industry revenues by approximately $2.8 billion, with primary beneficiaries being market leaders Fresenius Medical Care and Davita, Inc., who control 75% of the U.S. dialysis market. The potential commercialization of Sigyn Therapy™ represents not only a medical advancement but also a significant economic opportunity within the healthcare sector.

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