Beyond the Reach of Drug Therapies
When we designed Sigyn TherapyTM, we envisioned the possibility of a blood purification technology that could extract pathogen sources of life-threatening inflammation and simultaneously dampen down the overproduction of inflammatory cytokines (the cytokine storm). The elevated presence of these bloodstream targets is associated with increased mortality in sepsis (leading cause of hospital deaths) and other pathogen-associated inflammatory disorders that are not addressed with drug therapies.
From a Conceptual Vision to Reality
As reflected by the results of recent invitro studies, our vision is transitioning towards reality. Sigyn TherapyTM has been validated to deplete a broad-spectrum of bacterial toxins, viral pathogens, and inflammatory cytokines from human blood plasma. Subsequently, animal safety studies of Sigyn TherapyTM have been completed at the University of Michigan.
We now plan to enroll end-stage renal disease (ESRD) patients with endotoxemia and concurrent inflammation in first-in-human studies of Sigyn TherapyTM. As per our study protocol, Sigyn TherapyTM will be administered in combination with the ESRD patient's regularly scheduled dialysis sessions to demonstrate treatment safety in a health compromised patient population.
Beyond evaluating safety, circulating levels of endotoxin, tumor necrosis factor-a (TNF-α), interleukin-1β (IL-1β), and interleukin-6 (IL-6) will be quantified before and after each administration of Sigyn TherapyTM. Circulating endotoxin and excess TNF-α, IL-1β, and IL-6 production are commonly associated with our non-ESRD treatment opportunities, including sepsis, community-acquired pneumonia, and drug-resistant bacterial and viral infections.
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Sigyn Therapy Highlights
- Sigyn Therapy is a single-use disposable device designed for deployment on the established infrastructure of hemodialysis and continuous renal replacement machines located in hospitals and clinics around the world.
- Sigyn Therapy has an immense capacity to extract bloodstream targets as it incorporates a formulation of adsorbent components that provide more than 200,000 square meters (~50 acres or 37 American football fields) of surface area on which to adsorb and remove bloodstream targets.
- Sigyn Therapy is also highly efficient, as a patient’s entire circulatory system can pass through the device more than 15-times during a four-hour treatment.
- Unlike devices that concentrate therapeutic targets in the blood-path, Sigyn Therapy isolates and extracts therapeutic targets from the bloodstream to eliminate continued blood cell interactions during treatment.