Addressing a Broad-Spectrum of Inflammatory Targets
We designed Sigyn Therapy to overcome the limitations of previous drugs and devices to treat life-threatening inflammatory conditions. In our quest to save lives, we recognized that Sigyn Therapy would require the capability to deplete a broad-spectrum of inflammatory targets from the bloodstream. These targets include inflammatory cytokines, cytokine aggregates, endotoxin and larger CytoVesicles that transport cytokines and other inflammatory cargos.
What Is Cytokine Storm Syndrome?
Cytokine Storm Syndrome (CSS) is a life-threatening immune response that can be precipitated by a wide range of infectious and non-infectious conditions. The hallmark of CSS is an excessive or uncontrolled release of pro-inflammatory cytokines. The annual market opportunity for a therapeutic strategy to prevent or mitigate CSS is reported to exceed $20 billion.
An Expansive Treatment Pipeline
Our potential treatment indications include, but are not limited to sepsis, virus induced Cytokine Storm (VICS), bacteria induced Cytokine Storm (BICS), acute respiratory distress syndrome (ARDS) and acute forms of liver failure, including hepatic encephalopathy. We also believe there is an opportunity for Sigyn Therapy to stabilize or extend the life of patients waiting for the identification of a matched liver for transplantation. In such a scenario, Sigyn Therapy would serve as a bridge to liver transplant. Cytokine Storm Syndrome may also result from trauma, severe burns, acute pancreatitis, adverse drug reactions, cancer immunotherapies, cancer cachexia, acute kidney injury (AKI) and severe pneumonia.
An Innovative Mechanism of Action
Sigyn Therapy introduces an innovative mechanism to simultaneously deplete the presence of pro-inflammatory cytokines, cytokine aggregates and endotoxin from the bloodstream. Additionally, we designed Sigyn Therapy to address inflammatory cargos that are transported within or on the surface of circulating proteins that we define as CytoVesicles.
Incorporated within Sigyn Therapy is a cocktail of adsorbent components to maximize the depletion of inflammatory targets from the bloodstream. To optimize safety and performance, Sigyn Therapy isolates inflammatory targets from essential blood cells, which minimize biocompatibility issues and enhance target interaction with our adsorbent cocktail in a low-shear force environment.
To support the potential for widespread implementation, Sigyn Therapy is a single-use (blood-in-blood-out) disposable device designed for use on the established infrastructure of hemodialysis and continuous renal replacement therapy (CRRT) machines already located in hospitals and clinics worldwide. Sigyn Therapy does not require additional pumps or separation cartridges, yet is compatible for use with industry-standard connectors and blood tubing sets. To optimize scalability and control manufacturing costs, Sigyn Therapy is comprised of components whose supply is readily available from established industry vendors.