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.

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— Sigyn Therapeutics, Inc.
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Sigyn Therapy0% Single-use extracorporeal blood purification device designed to remove pathogens, toxins, and cytokines.
ChemoPrep0% Cancer-treatment adjunct intended to reduce circulating exosomes before chemotherapy administration.
ChemoPure0% Post-chemotherapy blood purification concept designed to remove off-target chemotherapy from blood.
Research and development100% Pre-clinical studies, device design, and regulatory advancement for future commercialization.

The company is developing products for hospitals, dialysis providers, and clinical centers that treat severe infectious...

  • Hospitals and acute care centersprimary

    Would use Sigyn Therapy for severe infectious disease and inflammatory conditions if cleared.

  • Dialysis and CRRT providersprimary

    Would deploy the device on existing renal replacement machines for blood purification use cases.

  • Oncology treatment centerssecondary

    Potential users of ChemoPrep and ChemoPure to improve chemotherapy delivery and reduce toxicity.

  • Clinical research institutionssecondary

    Support pre-clinical validation and first-in-human studies for the company’s device pipeline.

  • Strategic distribution partnersemerging

    Would help commercialize cleared products through established healthcare channels.

Sigyn Therapeutics is headquartered in San Diego, California and is organized as a Delaware corporation...

  • •Headquartered in San Diego, California
  • •Incorporated as a Delaware corporation
  • •Primary development activity is U.S.-based
  • •Future use cases are framed for global hospital and dialysis infrastructure

The company’s strategy is to advance Sigyn Therapy through pre-clinical and clinical development toward FDA clearance,...

01
Regulatory advancement of Sigyn Therapyshort-term

FDA clearance is required before commercialization of the lead device.

02
Clinical validation of oncology platformsmedium-term

ChemoPrep and ChemoPure need evidence to support future adoption in cancer care.

03
Manufacturing readinessshort-term

Commercialization depends on cGMP-compliant production and reliable suppliers.

04
Strategic channel partnershipsmedium-term

Established distribution channels could accelerate market access after clearance.

Sigyn is exposed to the risks typical of early-stage medical device developers: regulatory uncertainty, clinical trial...

critical

FDA regulatory failure or delay

Sigyn Therapy is a Class III device requiring PMA approval before market clearance.

Scope
Lead product candidate
Materiality
high
critical

Financing risk

The company states it needs additional capital and has no assurance financing will be available.

Scope
Corporate continuity
Materiality
high
high

Clinical development failure

Pre-clinical and first-in-human results may not support efficacy or safety claims.

Scope
Sigyn Therapy, ChemoPrep, ChemoPure
Materiality
high
high

Supplier and CMO dependency

Manufacturing relies on third-party vendors and contract manufacturers for components and cGMP output.

Scope
Development and future commercialization
Materiality
medium
medium

Market adoption risk

Even if cleared, hospitals and dialysis providers must adopt a new extracorporeal therapy.

Scope
Commercial launch
Materiality
medium
Warrant fair value measurement
Affects reported non-cash expense and balance sheet valuation
Use of estimates
Can materially affect operating expenses and reported losses
Research and development cost allocation
Changes the presentation of R&D versus G&A
Future device commercialization accounting
Could materially change reported revenue timing and margins

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: 29/04/2026