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  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 injectable aggregate study
     
  28 Day Study  
 
  • Particles not found in liver, lung or spleen
 
28 day injectable aggregate study
     
  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
 
 
 
     
  90 day toleration study - Limited Capsule formation  
     
     
     
     
     
     
     
     
     

 

 

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Latest News
ULURU Inc. developed and commercializes Altrazeal™, a transforming powder dressing with proprietary Nanoflex™ technology, for the management of exuding wounds.
Visit
www.altrazeal.com
for clinical case studies, patient testimonials, application guidelines, and much more…