The company’s current investigational medical device, Sigyn Therapy, is a novel medical device that is being studied for addressing viral pathogens and bacterial toxins to avoid this massive inflammation onslaught and the potential of sepsis.
During the early days of the COVID-19 pandemic, some hospitalized patients with severe cases of the virus had their medical conditions deteriorate badly to the point it created massive inflammation and they experienced the cytokine storm.
When these patients began to suffer the effects of this overwhelming inflammation, they might succumb to it. Since the emergence of the COVID-19 related cytokine storm, clinicians have tried avoiding it and biotechnology companies have been trying to address it with therapies and medical devices.
San Diego-based Sigyn Therapeutics has developed its Sigyn Therapy, which is a novel blood purification technology, to address the viral pathogens and bacterial toxins of the cytokine storm in concert with the depletion of inflammatory cytokines from the bloodstream. Sigyn is looking to addressing the cytokine storm that underlies sepsis, especially as clinicians understand the gravity of sepsis because it remains the greatest cause of inpatient mortality.
Sigyn Therapy is a single-use (blood-in-blood-out) disposable device designed for use on the existing infrastructure of hemodialysis and continuous renal replacement therapy machines currently being deployed in care facilities. The device does not require additional infrastructure such as pumps or separation cartridges, and is compatible with industry-standard connectors and blood tubing sets.
Sigyn Therapeutics Co-founder and CEO Jim Joyce believes blood purification devices can either be designed to go beyond the reach of medications, or in some cases, augment the benefits of drug therapies.
Prior to starting his current company, Joyce founded another company in the field and has testified before Congress on issues related to Project BioShield legislation and the deployment of broad-spectrum blood devices as countermeasures against biological weapons. His efforts were instrumental in expanding the definition of treatment countermeasure in Project BioShield legislation to include medical devices.
Contagion spoke to Joyce who provided further insights about his company's medical device, results from their studies thus far, and his work on Project BioShield legislation.