SciBase AB has initiated its pivotal study for final clinical verification

The pivotal study will be performed at 23 clinical institutions in Europe and the US, and will be the final clinical verification of the methods accuracy.

When the pivotal study is finalized and the results are made available, market introduction in Europe and Australia is to be initiated, which is expected during 2011. The study data is also to be used as basis for the regulatory PMA process in US, and IDE approval from FDA is already in place for the study.