Sigyn Therapeutics to launch multi-site trial of novel blood-filtering therapy in high-risk patients

Sigyn Therapeutics, Inc. has announced plans to initiate a multi-site clinical feasibility study evaluating its breakthrough Sigyn Therapy™ in patients with high-risk cardiovascular disease, the world’s leading cause of death, according to the World Health Organization. CEO Jim Joyce told Proactive that Sigyn Therapy is a first-in-class whole-blood adsorption technology designed to be deployed on existing dialysis machines already found in hospitals and clinics worldwide. Unlike conventional approaches, the therapy is engineered to address multiple drivers of cardiovascular disease progression in a single treatment. Specific to CVD, Sigyn Therapy has been shown to reduce circulating inflammatory molecules that accelerate disease progression, while simultaneously targeting cholesterol-transporting lipoproteins that are responsible for heart attacks, strokes, and other major adverse cardiovascular events. Building on encouraging results from pre-clinical in vitro studies, the company is expanding its feasibility study protocol to include the measurement of lipoprotein reduction during therapy. This will allow investigators to quantify the dual-action benefit of Sigyn Therapy in reducing both inflammation and lipid-related risks. The upcoming feasibility study will be a critical step toward the company’s long-term goal: advancing to a pivotal efficacy study required for potential regulatory clearance and commercialization. If successful, Sigyn Therapy could represent a transformative advancement in the treatment of cardiovascular disease by integrating seamlessly into existing hospital infrastructure while addressing some of the most urgent unmet needs in cardiac care. Joyce added that the company is in the process of modifying its Investigational Device Exemption (IDE) for submission to the FDA, to formally include Ldl-c and Lp(a) reduction as observational endpoints. #proactiveinvestors #sigyntherapeuticsinc #otcqb #sigy #CardiovascularDisease #Dialysis #SigynTherapeutics #MedicalDevices #BloodPurification #ClinicalTrials #Lipoproteins #StatinAlternative #EndStageRenalDisease #FDAReview