Sigyn Therapeutics is a pre-revenue medical device development company focused on extracorporeal blood purification — devices that circulate a patient's blood outside the body through an adsorbent column to remove harmful substances before returning cleaned plasma to the bloodstream. Sigyn's lead candidate, Sigyn Therapy, targets life-threatening infectious disease conditions including sepsis, endotoxemia, antibiotic-resistant bacterial infections, and untreatable viral pathogens — conditions with no adequate drug-based solutions. The device is designed to run on existing hemodialysis and CRRT machines already deployed in hospitals, lowering the barrier to adoption. Sigyn Therapy has completed pre-clinical in vitro and animal studies, and the company has drafted an Investigational Device Exemption application for FDA submission to begin first-in-human feasibility studies, though no human trials have been conducted. Sigyn is also developing three earlier-stage cancer devices: ImmunePrep, which clears "decoy" molecules before immunotherapy infusion; ChemoPrep, which removes tumor-derived exosomes that interfere with chemotherapy; and ChemoPure, which extracts residual off-target chemotherapy to reduce toxicity. None of these cancer devices have entered animal or human studies. Sigyn's commercial model, if it achieves FDA Pre-Market Approval, would center on selling single-use disposable devices to hospitals and dialysis centers on a per-treatment basis. Sigyn has indicated it may pursue partnerships with established dialysis operators rather than building its own distribution infrastructure. The company currently has four employees and is funded through equity capital.