Disclaimer

The alfapump® system is currently not approved in the United States or Canada. In the United States and Canada, the alfapump® system is currently under clinical investigation (POSEIDON Study) and is being studied in adult patients with refractory or recurrent ascites due to cirrhosis. DSR® therapy is still in development and it should be noted that any statements regarding safety and efficacy arise from ongoing pre-clinical and clinical investigations which have yet to be completed. There is no link between the DSR® therapy and ongoing investigations with the alfapump® system in Europe, the United States or Canada.

Day

May 22, 2024
PRESS RELEASE REGULATED INFORMATION – INSIDE INFORMATION 22 MAY 2024, 07:00 CEST Positive and collaborative meeting with FDA PMA substantive review complete;  No further new questions on clinical or pre-clinical data FDA Advisory Panel no longer expected FDA Marketing Approval now anticipated in Q1 2025 Planned US commercial launch remains H2 2025 Ghent, Belgium –...
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