Sequana Medical NV is a commercial stage medical device company developing the alfapump® platform for the treatment of fluid overload in liver disease, malignant ascites and heart failure where diuretics are no longer effective. Fluid overload is a fast growing complication of advanced liver disease driven by NASH (non-alcoholic steatohepatitis) related cirrhosis and a common complication in heart failure with diuretic resistance being widespread in both of these indications.
Both indications leverage Sequana Medical’s alfapump, a unique, fully implanted wireless device that automatically pumps fluid from the abdomen into the bladder, where it is naturally eliminated through urination.
The alfapump has been granted FDA breakthrough device designation for recurrent and refractory ascites due to liver cirrhosis with a pivotal study in the U.S. and Canada (POSEIDON) underway, and is approved in Europe for refractory ascites due to liver cirrhosis and malignant ascites.
Over 800 alfapump systems have been implanted to date. The alfapump DSR® (Direct Sodium Removal) builds on this experience and is in development as a potential chronic therapy for fluid overload in heart failure.
Clinical proof-of-concept was achieved and strong interim results have been published from an ongoing repeated dose alfapump DSR study (RED DESERT) in diuretic-resistant heart failure patients.
Sequana Medical is headquartered in Ghent, Belgium. For further information, please visit: