Sequana Medical NV announced that the first patient has been enrolled in its MOJAVE study. MOJAVE, a randomized controlled Phase 1/2a study in the US, will evaluate the safety and efficacy of the Company's second-generation DSR product (DSR 2.0) in diuretic-resistant chronic heart failure patients with persistent congestion. The study will start with a non-randomized cohort of three patients treated with DSR 2.0. Progress to the randomized cohort of up to 30 additional patients depends on approval from the Data and Safety Monitoring Board (DSMB) following their review of the non-randomized cohort data, planned for fourth quarter 2023. The non-randomized cohort consists of three eligible patients who will be treated with DSR 2.0, administered via a peritoneal dialysis (PD) catheter, on top of optimized usual care for congestive heart failure for up to four weeks, followed by a three-month safety follow-up period. Following review and approval of the non-randomized cohort data by the DSMB, patients will be enrolled in the multi-center randomized cohort. The intention is for up to 20 randomized patients to be treated with DSR 2.0, administered via a PD catheter, on top of optimized usual care for congestive heart failure for up to four weeks
and for up to ten randomized patients treated with intravenous loop diuretics alone as part of maximized usual care for congestive heart failure. Following four weeks of treatment, there is a three-month safety follow-up period.