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.
The concept of the alfapump® dates back to 2000 when a physician was searching for a better way to manage his ascites patients.
The first prototypes were built in 2005 and the founders demonstrated the technical feasibility of the approach. The first patients were implanted with a device in 2008 and in 2011 we received the CE-mark for removal of refractory ascites due to liver cirrhosis following completion of the PIONEER clinical study. The alfapump® was commercially launched at the EASL meeting in 2012 and in the same year the CE-mark was received for removal of malignant ascites.
Since then we have continued to invest in the clinical, technical and commercial development of the alfapump®. This includes the completion of the MOSAIC IDE feasibility study in North America in patients with recurrent and refractory liver ascites and the publication of the results of the European randomised controlled trial and the initial results of the Post-Marketing Surveillance Registry in patients with refractory liver ascites.
Following these studies, the alfapump® has been endorsed by key independent third parties in Europe and has been included in the EASL (European Association for the Study of the Liver) clinical practice guidelines for decompensated cirrhosis, the German treatment guidelines (DGVS) for complications of liver cirrhosis and the U.K. NICE interventional procedure guidance for treatment of refractory ascites caused by cirrhosis. In January 2019, the U.S. FDA granted the alfapump® Breakthrough Device designation for the treatment of recurrent or refractory liver ascites. The North American pivotal POSEIDON study intended to support marketing approval and reimbursement of the alfapump® in the U.S. and Canada has reported positive top-line results, enabling us to file a Pre-Market Approval (PMA) application with the FDA, planned for H2 2023.
In 2017, we established DSR® (Direct Sodium Removal), a new breakthrough therapy in development for the treatment of fluid overload in patients suffering from heart failure, in collaboration with Dr. Jeffrey Testani, Associate Professor at Yale University. Pre-clinical and clinical proof-of-concept of DSR® was achieved and data from these studies have been published in the high impact clinical journal Circulation, indicating the potential of this therapeutic approach. RED DESERT was the first DSR® study in diuretic-resistant heart failure patients and demonstrated that repeated DSR® therapy is able to both manage the fluid and sodium balance of these patients as well as restore their diuretic response and improve their cardio-renal status.
Following the promising results in RED DESERT, we evaluated our DSR therapy in patients with decompensated diuretic-resistant heart failure in the SAHARA study and confirmed that DSR was able to i) safely, effectively and rapidly eliminate fluid overload in heart failure patients, ii) improve the health of the heart and preserve renal function, and iii) restore the ability of the kidney to manage the fluid and sodium naturally, resulting in a large and long-lasting reduction in the need for diuretic drugs.