Pre-clinical Work
NovoSkin optimised its BTM using in vitro cell culture and numerous large and small animal studies:
- NovoSorb TM biocompatibility and safety (rats x120)
- BTM Mark I Vs Integra (sheep x2, 4weeks) (published in JBCR, July/August 2009)
- BTM Mark I Vs BTM (pig x2, 4 surgical wounds 8cm x 8cm full thickness per animal, 6 months)
- BTM immediate and delayed split skin graft (pig x6, 4 surgical wounds 8cm x 8cm full thickness per animal 4 weeks) (presented at the 43rd ABA meeting, 2011)
- BTM with membrane (pig x2, 4 surgical wounds 8cm x 8cm full thickness per animal 4 weeks)
- BTM Vs Integra (pig x6, 4 surgical wounds 8cm x 8cm full thickness per animal 4 weeks)
The key requirements for BTM, an implantable device, are safety and efficacy. The following safety studies under ISO10993 have been successfully conducted:
- Growth Inhibition (Cytotoxicity)
- Intracutaneous reactivity
- Sensitisation
- Genotoxicity (mouse Lymphoma)
- Implantation sub chronic systemic toxicity 90 days
- Implantation sub chronic systemic toxicity 180 days
- Subcutaneous implantation
- Pyrogenicity