Pain Points
- Aseptic manufacturing is costly
- Material not compatible with traditional
sterilization modalities
- EO supply chain is increasingly uncertain
Solution
- 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
FDA Story
- Agency looking to broaden commercial use of EO alternative sterilization modalities
- Selected alongside of 3 others recipients all of which were billion plus companies
- Bimonthly meetings FDA to streamline the adoption rate of scCO2
