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.
Ascites is also a common complication of certain late-stage cancers due to fluid build-up in the peritoneal cavity from a number of causes including draining of the lymph system. While life expectancy for many cancer patients with malignant ascites is short (less than 3 months), ovarian and breast cancer patients often have longer life expectancies.
In 2018, the incidence in the U.S. and EU5 is estimated to be about 500,000 for breast cancer and about 50,000 for ovarian cancer. Source
Approximately 3% of the breast cancer patients and 37% of the ovarian cancer patients will develop malignant ascites. Source
Similar to ascites caused by liver disease, paracentesis is used to remove the ascites that accumulates in the body when diuretics are not effective. Malignant ascites places a significant burden on the patient through regular hospital visits and impact on their daily life. It also reduces their ability to withstand anti-cancer therapies, potentially reducing survival.
The alfapump® offers patients suffering from malignant ascites with a completely new and much-needed treatment option for the management of their ascites. A further benefit of the alfapump® in malignant ascites is that the physician is able to conduct regular liquid biopsies through the analysis of urine samples. These will contain significant material direct from the peritoneal cavity, including cancer cells.