Sigyn Therapeutics (OTC: SIGY) is a pre-revenue medical device development company focused on blood purification therapies for infectious disease, organ transplantation, and oncology applications. The company generates no product revenue and has no market-approved products as of its 10-K filed April 15, 2025. Operations are funded entirely through debt financing, including short-term convertible notes ($795,890 in proceeds for FY2024) and promissory notes ($157,000 in proceeds for FY2024). Core pipeline candidates include Sigyn Therapy, a blood purification platform targeting infectious disease and transplant applications; ImmunePrepTM, designed to enhance immunotherapeutic antibody performance; ChemoPrepTM, targeting chemotherapy delivery improvement; and ChemoPureTM, targeting extraction of off-target chemotherapy from the bloodstream. The company was founded in 2019 and is incorporated in Delaware. Jim Joyce serves as CEO and Interim CFO, with Craig Roberts as Co-founder and CTO. The company disclosed going-concern conditions, stating current working capital is insufficient to fund operations for at least the next twelve months (as of filing date April 15, 2025).

Revenue model

No revenue. The company is pre-commercial and funds operations through short-term convertible notes, promissory notes, and shareholder advances. Net cash from financing activities was $872,890 for FY2024 and $1,386,544 for FY2023.

Products and services

Pipeline medical devices include: Sigyn TherapyTM (blood purification for infectious disease and transplant infection prevention, including xenotransplantation applications); ImmunePrepTM (enhancing immunotherapeutic antibody performance in cancer treatment); ChemoPrepTM (improving chemotherapy delivery); ChemoPureTM (extracting off-target chemotherapy from the bloodstream to reduce toxicity). No products are market-approved as of the 10-K filed April 15, 2025.

Customers and end markets

No commercial customers. Target end markets include hospital and critical care settings for infectious disease treatment, organ transplant programs including xenotransplantation, and oncology treatment centers. No customer contracts or commercial agreements are disclosed in the filing.

Value-chain role

Early-stage medical device developer. The company designs extracorporeal blood purification devices and submits to FDA regulatory pathways including PMA. No manufacturing at commercial scale is disclosed. Co-founder Craig Roberts previously invented devices licensed to C.R. Bard and registered in 32 countries through prior ventures.

Geographic exposure

Incorporated in Delaware. No commercial geographic footprint disclosed in the filing.

Source: SEC 10-K, filed 2025-04-15

Industry: Surgical & Medical Instruments & Apparatus