Sequana Medical NV announced that it has completed implanting patients in POSEIDON, the North American pivotal study to support regulatory approval of the alfapump system in the U.S. and Canada, for the treatment of recurrent or refractory ascites due to liver cirrhosis. Of the 71 patients enrolled in the Pivotal Cohort, 40 patients have been implanted with the alfapump. Pivotal patients completing the six-months post-implantation period will be included in the primary efficacy endpoint analysis, and reporting of these data is planned for the fourth quarter of 2022.

A further 29 patients from the Roll-In Cohort were also implanted with the alfapump and will be included in the overall safety analysis. Importantly, a preliminary interim analysis of patient survival following alfapump implantation in the Roll-In Cohort indicated a mean survival probability of 70% at 12 months. This compares favourably with the published literature reporting a survival rate for refractory ascites patients of only 50% at 12 months.