Friday February 5th 2021

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Sequana Medical NV, an innovator in the treatment of diuretic-resistant fluid overload in liver disease, malignant ascites and heart failure, announces the granting of key patents for the alfapump DSR (Direct Sodium Removal) programme in the U.S. and European Union.

U.S. patent number 10,898,631 B2 and EU patent number EP 3 612 246 B1 are both entitled “Direct sodium removal method, solution and apparatus to reduce fluid overload in heart failure patients” and cover the alfapump DSR and its method of operation. Specifically, it covers the use of a no or low sodium infusate that is administered to a patient’s peritoneal cavity to directly remove sodium, and thereby fluid from the body to alleviate fluid overload in heart failure patients with residual renal

Ian Crosbie, Chief Executive Officer at Sequana Medical, commented: “We are very pleased with the granting of these patents in our key territories, which we believe provides significant protection for our alfapump DSR programme. We are excited for the prospect of this breakthrough approach to the potential treatment of diuretic-resistant fluid overload in heart failure – an enormous burden on patients, clinicians and payers. The strong interim results from the RED DESERT study that we announced in October 2020 suggest that not only can alfapump DSR therapy potentially manage the fluid and sodium balance of these patients without the need of diuretics but also restore their diuretic responsiveness, enabling a gentler and more effective management of this enormous problem. Following these very promising data, we intend to explore the use of alfapump DSR therapy in fluid overload related to haemodialysis and pre-dialysis renal failure. We look forward to reporting the top-line data from the RED DESERT study in up to 10 patients by the end of H1 2021 and initiating SAHARA DESERT, our dose-ranging study of alfapump DSR in decompensated heart failure patients.”