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.
We are utilizing our proprietary alfapump® and DSR® (Direct Sodium Removal) technologies to develop innovative treatments for fluid overload in liver disease, heart failure and cancer when diuretics are no longer effective.
The alfapump® is a unique, fully implanted, wirelessly charged device that automatically pumps fluid from the abdominal cavity into the bladder, where it is naturally eliminated through urination.
The alfapump® has received CE mark in Europe. In the US, the alfapump® has received Breakthrough Device status from the FDA and the Premarket Approval application has been submitted to the FDA in December 2023.
Over 1000 devices have been implanted to date.
Direct Sodium Removal or DSR has the potential to break the negative feedback cycle of cardiorenal syndrome, through effective control of the volume status for an extended period of time and thereby avoiding the negative consequences of loop diuretics.
Ascites has a dramatic impact on the quality of life of patients. Patients suffering from ascites are immobile and very restricted in their daily activities, and often report feelings of isolation and depression.
When we interviewed patients that had the alfapump® implanted, they all reported a substantial improvement in their daily life.
Through our ongoing development work and close collaboration with clinicians, we continue to grow the body of evidence for our alfapump® and DSR technologies, as shown by the multiple peer-reviewed journal publications.