To address infectious disease disorders that are not treatable with drugs, we designed Sigyn Therapy^TM to extract deadly pathogens and toxins from a patient’s bloodstream, while simultaneously providing a mechanism to dampen down excessive immune responses that are associated with life-threatening infections. Sigyn Therapy^TM has been validated to extract viral pathogens, bacterial toxins (including endotoxin), hepatic toxins and inflammatory cytokines from human blood plasma. These expansive capabilities establish Sigyn Therapy^TM as a novel strategy to address several unmet needs in global health:

1. Untreatable viral pathogens (most human viruses are not addressed with an antiviral drug)
2. Antibiotic-resistant bacterial infections (an increasingly prevalent global health threat)
3. Endotoxemia (bacterial toxin whose bloodstream presence commonly induces sepsis)
4. Sepsis (leading cause of hospital deaths in the United States)

We have significant experience in developing blood purification technologies to treat infectious disease disorders.  Most members of our team worked alongside our CEO in overseeing development of the first medical device to receive FDA “Emergency Use Authorization” approval to treat an infectious viral pathogen (Ebola) and the first to receive two “Breakthrough Device” designations from FDA.  As a result of these achievements, TIME Magazine named the device to its list of “Top Inventions” and “Top Medical Breakthroughs.”

First-in-human clinical studies of Sigyn Therapy^TM plan to enroll end-stage renal disease (ESRD) subjects with endotoxemia and concurrent inflammation, which are prevalent, yet untreatable conditions that shorten the lives of dialysis patients. Approximately 550,000 individuals suffer from ESRD in the United States.  A therapeutic strategy that helped to extend the lives of ESRD patients may have quantifiable value to the dialysis industry, which is dominated by Fresenius Medical Care and DaVita, Inc. in North America. Based on the number of ESRD patients treated in their networks, every month of extended life would equate to approximately $1 billion in added revenues for each company.

Beyond the post-exposure treatment of infectious disease disorders, we envision a need for Sigyn Therapy^TM in xenotransplantation, an emerging field related to the transplantation of an organ from a donor animal species into a human recipient. The advancement of xenotransplantation is being fueled by a global shortage of transplantable human organs and the recent emergence of gene-editing technologies that have increased the compatibility of porcine-derived (pig) kidneys for human transplantation. In the United States, approximately 90,000 individuals are on the waitlist for a kidney transplant, yet fewer than 30,000 kidney transplants are performed each year.

To optimize xenotransplantation outcomes, Sigyn Therapy^TM is proposed for administration to:

1. Gene-edited donor pigs to reduce pathogen accumulation in donor kidneys prior to their extraction for human transplantation. The feasibility of Sigyn Therapy^TM administration has been demonstrated in eight (8) porcine subjects to date.
2. Human transplant recipients during and after transplantation to reduce the bloodstream presence of pathogen, inflammatory and other circulating factors that may cause severe illness or induce the rejection of a transplanted organ, whose source may be either a human or animal donor.

This use of Sigyn Therapy^TM in these applications corresponds with published FDA guidance on the need for strategies to mitigate the risk of a known or unknown pathogen being transmitted from a porcine-derived organ to a human transplant recipient.