Nanoflex® Technology Aggregate Toxicology

21 Day Toleration Study

  • Individual components of the Nanoparticle Aggregate Material were evaluated in a porcine model with no dermal irritation
    • Hydrogel material
    • Stabilizing surfactant
    • Suspension medium
  • TNF-α levels were evaluated in a porcine model
    • TNF-α levels with nanoparticle aggregate were not elevated over control.

28 Day Toleration and Migration Study - Injected     

  • Study Design
    • Nanoparticle Suspensions were injected sub cutaneously in mice and allowed to form aggregates
    • Material was removed after 28 days
    • Lung, liver spleen and draining lymph nodes were excised and sectioned.
  • Results
    • Nanoparticle aggregate mass was conserved and material did not migrate
    • Lung, liver, spleen and draining lymph nodes showed no particles in cells or tissue.

28 Day Injectible Aggregate Study     

  • No loss in aggregate mass over 28 days
  • Limited capsule formation around aggregate

28 Day Study     

Particles not found in liver, lung or spleen

28 Day Toleration and Migration Study - Implanted     

  • Study Design
    • Nanoparticle Aggregates were implanted sub cutaneously in mice
    • Material was removed after 90 days
    • Lung, liver spleen and draining lymph nodes were excised and sectioned.
  • Results
    • Nanoparticle aggregate mass was conserved and material did not migrate
    • Lung, liver, spleen and draining lymph nodes showed no particles in cells or tissue.

90 day toleration study - Limited Capsule formation

No loss of implanted aggregate mass

90 day toleration study - Limited Capsule formation


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