The alfapump® system is not currently 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. For more information regarding the POSEIDON clinical study see www.poseidonstudy.com. The 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.


Inside information
REGULATED INFORMATION – INSIDE INFORMATION alfapump pivotal study for treatment of recurrent or refractory ascites due to liver cirrhosis Optimised clinical trial design of up to 50 patients implanted with alfapump in study cohort and shorter follow-up time for primary endpoint analysis Planned U.S. launch of alfapump moved forward to H1 2022 Proposed rule of...
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REGULATED INFORMATION – INSIDE INFORMATION First-in-human single dose DSR study meets primary and secondary endpoints Direct Sodium Removal (DSR) was safe & well-tolerated Substantially higher sodium removal with DSR vs standard Peritoneal Dialysis (PD) solution Consistent results between treated patients First clinical study of repeated dose DSR with alfapump® (alfapump DSR) planned to commence in...
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