Pain Points

  • Aseptic manufacturing is costly
  • Material not compatible with traditional

     sterilization modalities

  • EO supply chain is increasingly uncertain


  • Deepest penetrating modality
  • Double layered final packaging
  • Met performance and residual requirements for FDA submission
  • Entire cycle times measured in hours

Core Value

  • FDA cleared devices
  • Over 500,000 surgeries have been completed using

biomaterials processed with NovaSterilis’ scCO2 process

SAR Story

XX Story

  • Biomaterials company had product that didn’t work with traditional sterilization methods
  • NovaSterilis (NS) moved them from proof-of-concept through development, sterilization validation and regulatory review
  • Within 18 months of engagement with NS, the 510k clearance was received

Explore Why NovaSterilis

Achieve Sterility Assurance Level 10-6

Environmentally Friendly Alternative to EO