Situation
iuvo’s client was in the early stages of developing a novel wound healing / infection treatment device and required support, including developing novel testing methods, to demonstrate efficacy, both in vitro and in vivo.
Background
iuvo’s Microbiology team initially worked collaboratively with the sponsor to develop an appropriate in vitro testing model to help show proof of concept and to demonstrate the effectiveness of the device. As the project evolved to a stage where in vivo testing was required in an animal model, our Toxicology team got involved and worked closely with the client on developing an appropriate in vivo test to demonstrate the efficacy of the device, as well as to lay out the biocompatibility strategy for the product. Both the in vitro and in vivo portions of the testing program required development of new methods and techniques, and a very close collaboration between iuvo and the sponsor.
Outcome
The combined project team was able to deliver key data to help finalize the design of the device, demonstrate efficacy in both in vitro and in vivo models, and provide key data to the sponsor on the overall program. Work continues on development of an exciting new product as it continues on its path toward approval.
