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 in Europe at the EASL meeting in 2012.

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.

In January 2019, the U.S. 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 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 [source]. 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 [source]. 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 [source].
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 favorable 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.
In December 2024, the alfapump® system received PMA approval from the US FDA.

DSR® therapy is still in development and is currently not approved in the United States or Canada. Any statements regarding safety and efficacy arise from ongoing pre-clinical and clinical investigations which have yet to be completed. Sequana Medical makes no claims of safety or effectiveness of the DSR® therapy in the U.S. or Canada.