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Cardiovascular disease remains the world's leading cause of death, claiming more than 17.9 million lives annually according to the World Health Organization. Despite decades of medical advances, existing treatments often fall short for the highest-risk patients, particularly those with end-stage renal disease who face a 10-to-30-fold increased risk of cardiovascular events. As healthcare systems worldwide grapple with rising CVD treatment costs and limited access to specialized care, a new category of blood purification therapy is emerging that could fundamentally change how we approach cardiovascular disease treatment.

Industry Leaders Position for Growth in Cardiovascular Care

Major healthcare companies continue to invest heavily in %Cardiovascular and renal care markets.

%DaVita Inc. (NYSE: $DVA ) recently announced construction of a new state-of-the-art dialysis facility in partnership with Lutheran Home in Arlington Heights, Illinois, scheduled to open January 1, 2026, bringing treatment directly to patients in residential care settings.

Rockwell Medical, Inc. (NASDAQ: RMTI) exemplifies the innovation occurring within the dialysis supply chain. The company recently added a 510(k) approved single-use bicarbonate cartridge to its hemodialysis concentrates portfolio and has been recognized as a Great Place to Work® for three consecutive years. With 2025 guidance calling for net sales of $65-70 million and expectations to achieve positive adjusted EBITDA, Rockwell demonstrates the commercial viability of specialized dialysis products.

%FreseniusMedical Care (NYSE: $FMS ), experts in kidney care, disease, and dialysis, has demonstrated strong performance with organic revenue growth and double-digit operating income growth in the second quarter of 2025, while continuing to advance its "FME Reignite" strategy focused on enhanced profitability. Fresenius recently launched an ambitious share repurchase program, with the initial share buyback up to EUR 1 billion over two years.

Meanwhile, %Pfizer Inc. (NYSE: $PFE ) maintains its strong presence in cardiovascular therapeutics with multiple drugs addressing heart disease and stroke prevention. The drug juggernaut has multiple shots on goal to help people with CVD. Pfizer offers CVD treatments like Vyndaqel/Vyndamax (tafamidis) for transthyretin amyloid cardiomyopathy, and historically marketed Lipitor (atorvastatin calcium) and Caduet (amlodipine/atorvastatin) for cholesterol management and coronary heart disease risk. Additionally, Pfizer has ongoing research and development in cardiovascular areas, including its acquisition of Arena Pharmaceuticals, which brought in potential treatments for microvascular obstruction and decompensated heart failure, and licensing agreements for new discovery efforts in vascular inflammation and endothelial dysfunction.

Sigyn Therapeutics: Pioneering Next-Generation Cardiovascular Treatment

Against this backdrop, %SigynTherapeutics, Inc. (OTC: $SIGY ) has announced plans to enter the multi-billion dollar cardiovascular disease treatment market with a potentially groundbreaking approach. The company's upcoming multi-site clinical feasibility study represents a significant expansion of its %BloodPurification platform into one of healthcare's largest therapeutic areas.

Sigyn Therapy™ is designed as a first-in-class whole-blood adsorption therapy that can be deployed on the approximately 7,500 dialysis clinics and 5,000 hospitals throughout the United States. This infrastructure advantage could prove crucial for market penetration, as traditional lipoprotein apheresis treatment for cardiovascular disease is currently limited to fewer than 60 specialized centers nationwide. The company's approach targets both inflammatory molecules that promote CVD progression and cholesterol-transporting lipoproteins that contribute to heart attacks, strokes, and other major adverse cardiovascular events.

The clinical rationale is compelling. Published studies of %Lipoprotein apheresis have demonstrated 55% to 98% reductions in major adverse cardiovascular events in patients with progressive cardiovascular disease. However, access remains severely limited due to specialized equipment requirements. Sigyn Therapy™ aims to democratize access to similar treatment benefits by leveraging existing dialysis infrastructure.

Targeting the Highest-Risk Patient Population

Sigyn's initial clinical strategy focuses on dialysis-dependent ESRD patients, a population with extraordinarily high cardiovascular risk. These patients experience chronic inflammation due to dialysis treatments themselves, which increases LDL-C and lipoprotein(a) production while compromising the body's ability to clear these dangerous lipoproteins. Circulating levels of lipoprotein(a), which have no approved drug treatment, are 2 to 4 times higher in ESRD patients compared to the general population.

The company's clinical feasibility study will measure the reduction of lipoprotein(a) and LDL-C (the basis of FDA-approved lipoprotein apheresis) as well as the elimination of endotoxin and inflammatory cytokines that result from dialysis administration. This dual approach of targeting both lipoproteins and inflammatory mediators represents a novel strategy addressing multiple cardiovascular disease pathways simultaneously.

"Beyond offering the dialysis industry a potential new revenue channel and pathway to treat cardiovascular disease, the value of extending ESRD patient lives should not be overlooked," stated Jim Joyce, CEO of Sigyn Therapeutics and co-inventor of Sigyn Therapy™.

The Quantifiable Economics of Life Extension

The business case for effective cardiovascular treatment in the dialysis population is substantial. The U.S. dialysis industry generates approximately $34 billion in annual revenues from 85 million dialysis treatments administered to more than 550,000 individuals with ESRD. Based on these figures, each month of extended ESRD patient life could increase industry revenues by approximately $2.8 billion, with primary beneficiaries being Fresenius Medical Care and DaVita, who control 75% of the U.S. dialysis market.

Visionary Leadership Driving Innovation

Sigyn Therapeutics is led by CEO James "Jim" Joyce, a healthcare entrepreneur with over 30 years of public market experience and a track record of navigating breakthrough medical technologies from startup to market success. Before founding Sigyn, Joyce built Aethlon Medical from a single-shareholder startup to a NASDAQ-traded company with over 8,000 shareholders.

Under Joyce's leadership at Aethlon, the Hemopurifier® became the first therapeutic candidate to receive two FDA "Breakthrough Device" designations and the first device to receive Emergency Use Authorization from the FDA, Health Canada, and Germany to treat Ebola virus. Time Magazine recognized the Hemopurifier® as one of the "11 Most Remarkable Advances in Healthcare" and included it in their "Top 25 Best Inventions" list.

Joyce's experience extends beyond medical devices to biomarker discovery. As founder and former Executive Chairman of Exosome Sciences, he pioneered research into exosomal tau protein as a blood-based diagnostic for chronic traumatic encephalopathy (CTE) and Alzheimer's disease. The company's collaboration with Boston University's CTE Center revealed exosomal tau levels to be approximately 9 times higher in former NFL players, research published in the Journal of Alzheimer's Disease.

Market Transformation Potential

If successfully developed, %SigynTherapy could transform dialysis clinics into comprehensive renal and cardiovascular treatment centers. The company estimates that approximately 210,000 dialysis machines are available for use at U.S. healthcare facilities, representing a massive installed base for potential deployment.

The simultaneous ability to reduce cholesterol-transporting lipoproteins, endotoxin, and inflammatory cytokines during routine dialysis treatments represents a paradigm shift in cardiovascular care. Rather than requiring patients to travel to specialized centers for lipoprotein apheresis (today's standard of care), treatment could become as routine and accessible as dialysis itself.

For investors seeking exposure to the convergence of cardiovascular disease treatment and blood purification technology, Sigyn Therapeutics represents a compelling opportunity at the intersection of massive market need and potentially transformative innovation.

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