Sigyn Therapeutics, Inc. Business Summary

Company Overview

Sigyn Therapeutics, Inc. develops medical devices aimed at treating cancer and infectious disease disorders. The company specializes in extracorporeal blood purification technologies with a broad portfolio of therapeutic candidates designed to improve drug delivery and reduce treatment toxicities.

Core Technologies and Therapeutic Candidates

• Sigyn Therapy™: The lead therapeutic device targeting infectious disease disorders unaddressable by drugs. It extracts viruses, bacterial toxins (including endotoxins), hepatic toxins, and inflammatory cytokines from human blood plasma. It has shown success in pre-clinical and animal studies and is intended for FDA first-in-human feasibility studies.
• ImmunePrep™ platform: Enhances the performance of immunotherapeutic antibodies (such as monoclonal antibodies, checkpoint inhibitors) to improve targeted delivery to cancer sites.
• ChemoPrep™: Designed to improve chemotherapy delivery by reducing tumor-derived exosomes that disrupt drug targeting.
• ChemoPure™: Aims to reduce chemotherapy toxicity by extracting residual off-target chemotherapy from the bloodstream.

Unmet Needs Addressed

• Treating untreatable viral pathogens, including emerging pandemic viruses.
• Combating antibiotic-resistant bacterial infections.
• Managing endotoxemia and sepsis, which have high mortality rates globally and are particularly prevalent among end-stage renal disease (ESRD) patients.
• Potential application in xenotransplantation to reduce the transmission of pathogens from donor animals, particularly gene-edited pigs.

Clinical and Animal Studies

• Preclinical in vitro studies: Demonstrated the capability to reduce relevant pathogens, toxins, and cytokines from human blood plasma.
• Animal studies: Conducted with eight pig subjects using standard dialysis machines, showing feasibility and safety with no serious adverse events.
• Planned human studies: An Investigational Device Exemption (IDE) draft proposes enrolling 12-15 ESRD patients with endotoxemia and inflammation to demonstrate safety and monitor endotoxin/inflammation markers.

Market and Industry

• No current commercial products; the focus is on regulatory and clinical development.
• The therapies offer strategic value to pharmaceutical, dialysis, and organ transplant industries.
• Target markets include dialysis providers (e.g., Fresenius Medical Care, DaVita), transplant sectors, and global health initiatives.

Intellectual Property

• Pending patents covering extracorporeal therapies for xenotransplantation, enhancing antibody activity, improving chemotherapy delivery, and broad-spectrum cytokine reduction.
• U.S. and international patent applications are in progress.

Regulatory Status

• The company's devices are classified as Class III medical devices requiring extensive FDA approval via the PMA pathway.
• Past FDA interactions suggest potential for accelerated pathways using market-approved antibodies.
• The company is preparing an IDE for human feasibility studies; market approval is pending.

Corporate Details

• Employees: 4 salaried employees.
• Facilities: Located at 2468 Historic Decatur Road, Suite 140, San Diego, California.
• Regulatory filings: Files periodic SEC reports such as 10-K, 10-Q, and 8-K.

Revenue and Financials

• No specific information on revenue, sales, or income has been provided in the summary.

Note: The summary is based solely on the provided document and does not include any speculative or unreported financial data.