Challenges facing the Market
- Aseptic manufacturing is costly
- Material not compatible with traditional sterilization modalities
- EO supply chain is increasingly uncertain
- Biomaterials company had product that was not compatible with traditional sterilization methods
- NovaSterilis (NS) provided a turnkey solution moving them from proof-of-concept through development, sterilization validation, and regulatory review
- Within 18 months of engagement with NS, the 510k clearance was received
- Contract sterilization development services
- Equipment and software necessary to achieve FDA clearance
- Over 500,000 surgeries have been completed using biomaterials processed with NovaSterilis’ scCO2 process
Explore Why NovaSterilis
Environmentally Friendly Alternative to EO
Broader Compatibility Including Biologics
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