Sigyn Therapeutics, Inc. (OTCQB: SIGY) has announced the development of CardioDialysis, a medical device designed to reduce major adverse cardiovascular events (MACE) through continuous broad-spectrum clearance of inflammatory and pathogenic molecules from the bloodstream. The technology, described in a letter by CEO and inventor Jim Joyce, aims to address the limitations of current therapies for cardiovascular disease, the leading cause of death worldwide.
Current standard-of-care treatments, such as LDL-C reducing statins, lower MACE by approximately 25%. In contrast, lipoprotein apheresis devices that filter LDL-C and Lipoprotein(a) from the bloodstream can reduce MACE by 75-95%, according to the American Heart Association. However, these devices have complex, multi-component designs that restrict their use to specialized centers. For example, the FDA-approved Kaneka LIPOSORBER procedure requires multiple columns, cartridges, tubing sets, pumps, and fluids, limiting access to fewer than 60 apheresis centers in the United States, despite having administered approximately 600,000 treatments to over 6,000 patients worldwide.
CardioDialysis overcomes these barriers by integrating plasma separation and therapeutic adsorption into a single device that can be deployed on dialysis machines already present in more than 5,000 hospitals and 7,500 dialysis clinics in the United States alone. This design eliminates the need for replacement fluids, additional pumps, or other auxiliary components, simplifying the procedure and broadening access. According to the company, CardioDialysis addresses a broader range of cardiovascular disease targets and processes the bloodstream with greater efficiency compared to existing apheresis systems.
The implications of this announcement are significant. With 15-20% of MACE resulting in death, the successful clinical advancement of CardioDialysis could potentially save thousands of lives annually. The technology also holds therapeutic promise for other conditions, including sepsis, life-threatening viral infections, and neuroinflammatory disorders, as it enables continuous removal of inflammatory mediators and pathogenic molecules.
Sigyn Therapeutics' pipeline also includes ImmunePrep, ChemoPrep, and ChemoPure technologies aimed at optimizing cancer therapies. For more information, visit the company's website at www.SigynTherapeutics.com.
The press release includes forward-looking statements regarding the company's ability to clinically advance CardioDialysis, manufacture the device, and raise capital, among other risks detailed in its SEC filings.
