A Treatment Candidate to Address Bloodstream Pathogens, Deadly Toxins and Inflammatory Disease Targets

August 10, 2021

Sigyn Therapeutics was founded on the belief that a properly designed medical device could address sepsis and other life-threatening inflammatory conditions that remain beyond the reach of drug therapies.

This belief is reflected through our development of Sigyn Therapy.  Since December 2020, we reported results from a series of studies that have demonstrated first-in-industry capabilities of Sigyn Therapy to address pathogen sources of inflammation, deadly toxins and relevant inflammatory mediators. 

Among the therapeutic targets validated were viral pathogens (including COVID-19), bacterial endotoxin, relevant inflammatory cytokines (IL-6, IL-1b, TNF-a) and hepatic toxins (ammonia, bilirubin, and bile acid).  We also completed a study that modeled our ability to capture CytoVesicles that transport inflammatory cargos throughout the bloodstream.  

Contributing to these expansive capabilities is a formulation of adsorbent components that are incorporated within Sigyn Therapy.  Our adsorbent formulation provides more than 170,000 square meters of surface area on which to adsorb and remove bloodstream targets. This equates to more than 40 acres of surface adsorption area in each adult version of Sigyn Therapy.

Conversely, consider that the ~$340 million market value of our closest public comparable is driven by an adsorption device (market cleared to treat life-threatening inflammatory conditions outside the U.S.) with approximately one fourth of our surface area capacity and based on an adsorbent bead component whose maximum pore size to eliminate inflammatory targets is reported to be 5 nanometers.  Sigyn Therapy has been demonstrated to addresses inflammatory targets as well as pathogen sources of inflammation whose molecular size can exceed 100 nanometers in size. 

Beyond our broad-spectrum capacity to remove bloodstream targets, we disclosed on July 29th, the completion of our first-in-mammal pilot study that demonstrated the safe administration of Sigyn Therapy during six-hour treatment exposures.  In the coming months, we will continue to collect animal safety data, which will be included in an Investigational Device Exemption (IDE) that we are drafting for submission to The United States Food and Drug Administration (FDA) to support the initiation of human clinical studies.

Sincerely, Jim