Sigyn Therapeutics, Inc.
Sigyn Therapeutics, Inc. is a U.S.-based development-stage medical device company focused on extracorporeal blood purification technologies. Its pipeline includes Sigyn Therapy for infectious disease disorders, along with ChemoPrep and ChemoPure for oncology applications, all designed to operate through hospital dialysis and CRRT infrastructure.
Fiscal year 2024 · change from previous year
Development 2019–2024
Business
Share of revenueSingle-use extracorporeal blood purification device designed to remove pathogens, toxins, and cytokines.
Cancer-treatment adjunct intended to reduce circulating exosomes before chemotherapy administration.
Post-chemotherapy blood purification concept designed to remove off-target chemotherapy from blood.
Pre-clinical studies, device design, and regulatory advancement for future commercialization.
Customers
The company is developing products for hospitals, dialysis providers, and clinical centers that treat severe infectious disease, sepsis, endotoxemia, and dialysis-related inflammation. Its oncology concepts are aimed at cancer treatment settings where chemotherapy delivery and toxicity management are important. At this stage, the direct customer base is not commercial buyers but rather clinical investigators, potential hospital users, and future distribution partners.
Would use Sigyn Therapy for severe infectious disease and inflammatory conditions if cleared.
Would deploy the device on existing renal replacement machines for blood purification use cases.
Potential users of ChemoPrep and ChemoPure to improve chemotherapy delivery and reduce toxicity.
Support pre-clinical validation and first-in-human studies for the company’s device pipeline.
Would help commercialize cleared products through established healthcare channels.
Strategy
The company’s strategy is to advance Sigyn Therapy through pre-clinical and clinical development toward FDA clearance, while continuing to build its oncology adjunct platform. It also plans to rely on contract manufacturers and component suppliers, and may pursue distribution relationships with healthcare organizations that already serve dialysis, hospital, and oncology markets.
FDA clearance is required before commercialization of the lead device.
ChemoPrep and ChemoPure need evidence to support future adoption in cancer care.
Commercialization depends on cGMP-compliant production and reliable suppliers.
Established distribution channels could accelerate market access after clearance.
Geography
Sigyn Therapeutics is headquartered in San Diego, California and is organized as a Delaware corporation. Its development and future commercialization plans are centered on the United States, while the company describes potential use of its therapies on global dialysis and hospital infrastructure if regulatory clearance is obtained.
Risks
Sigyn is exposed to the risks typical of early-stage medical device developers: regulatory uncertainty, clinical trial failure, and the need for substantial capital before any product revenue. Its business also depends on third-party manufacturers and suppliers, and any interruption in those relationships could delay development or commercialization.
The company states it needs additional capital and has no assurance financing will be available.
Exposure: Corporate continuity
Sigyn Therapy is a Class III device requiring PMA approval before market clearance.
Exposure: Lead product candidate
Pre-clinical and first-in-human results may not support efficacy or safety claims.
Manufacturing relies on third-party vendors and contract manufacturers for components and cGMP output.
Exposure: Development and future commercialization
Even if cleared, hospitals and dialysis providers must adopt a new extracorporeal therapy.
Exposure: Commercial launch
Accounting
Judgemental itemsBlack-Scholes inputs such as volatility and expected life can materially change expense and equity values.
Impact: Affects reported non-cash expense and balance sheet valuation
Management must estimate allocations and other uncertain items in a pre-revenue company.
Impact: Can materially affect operating expenses and reported losses
Payroll and development spending must be allocated between functions.
Impact: Changes the presentation of R&D versus G&A
Any future sales would require revenue recognition policies and possibly inventory accounting.
Impact: Could materially change reported revenue timing and margins
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Last updated: 24/09/2026