Ghent, Belgium – 23 January 2024– Sequana Medical NV (Euronext Brussels: SEQUA) (the “Company” or “SequanaMedical”), a pioneer in the treatment of fluid overload in liver disease, heart failure and cancer, today announces that an independent Data and Safety Monitoring Board (DSMB) approved the start of the randomized cohort in MOJAVE, the US Phase 1/2a study of DSR 2.0 for treatment of patients with diuretic-resistant heart failure, following review of the safety data reported from the non-randomized cohort.

Follow-up data from the three patients in the non-randomized cohort confirm the durable improvement in their cardio-renal health and support DSR’s mechanism of action as breaking the vicious cycle of cardiorenal syndrome.

The randomized controlled cohort will enrol up to 30 additional patients across different centers in the US, with up to 20 patients treated with DSR 2.0 on top of optimized usual care for congestive heart failure for up to four weeks, and up to ten control patients treated with intravenous loop diuretics as part of maximized usual care for congestive heart failure. After the last DSR treatment, patients will be followed for a three-month safety follow-up period. The first patient is expected to be enrolled in Q1 2024 and interim data are planned for H2 2024.