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
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
