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.

Our history

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 randomized 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 UK NICE interventional procedure guidance for treatment of refractory ascites caused by cirrhosis. In January 2019, the US FDA granted the alfapump® Breakthrough Device designation for the treatment of recurrent or refractory liver ascites. We submitted a Pre-Market Approval (PMA) application to the US FDA in December 2023 having reported positive primary and secondary endpoint data from the North American pivotal POSEIDON study of the alfapump® in recurrent or refractory ascites due to liver cirrhosis.

We started development of DSR® (Direct Sodium Removal) in 2017, a new breakthrough therapy for the treatment of fluid overload in congestive heart failure patients, in collaboration with Dr. Jeffrey Testani, Associate Professor at Yale University. Pre-clinical and clinical proof-of-concept data from single dose DSR® therapy were published in the high impact cardiovascular journal Circulation in 2020. Top-line data from RED DESERT, a proof-of-concept study of repeated dose DSR® therapy in diuretic-resistant heart failure patients, using our first-generation DSR® product (DSR 1.0), were reported in May 2021. Based on the success of RED DESERT, we initiated the SAHARA study in diuretic-resistant heart failure patients with persistent congestion, our target population, and positive top-line data were reported in November 2022.

In parallel, we developed a second-generation DSR® product (DSR® 2.0), a proprietary sodium-free dextrose / icodextrin solution expected to have an improved therapeutic and favourable safety profile and with a robust intellectual property protection. MOJAVE, a US randomized controlled multi-center Phase 1/2a clinical trial of DSR® 2.0 is currently ongoing, seeking to confirm the strong efficacy seen in the RED DESERT and SAHARA studies. All three patients from the non-randomized cohort have been successfully treated with DSR® 2.0, and the randomized cohort of up to a further 30 patients will start following approval of the alfapump® PMA application by the US FDA.