Sequana Medical NV Announces Positive Data from Non- Randomized Cohort in US Phase 1/2a MOJAVE Study of DSR® 2.0 for Treatment of Heart Failure

Sequana Medical NV announced that all three patients from the non-randomized cohort of the MOJAVE study were successfully treated with DSR 2.0. Data from the third patient show similar beneficial effects of DSR therapy as reported previously in the first two patients. Positive data from non-randomized cohort of MOJAVE study: All three patients treated in the non-randomized cohort of the MOJAVE study had heart failure with preserved ejection fraction (HFpEF) and severe diuretic resistance at baseline (mean furosemide equivalent dose of 1,227 mg per day). At the start of the study treatment period, loop diuretics were withheld, and patients were treated with DSR 2.0 up to daily for four weeks.

During the four-week DSR treatment period, all three patients maintained euvolemia without the need of loop diuretics and showed improved cardiorenal status post-treatment. Their diuretic responseiii nearly normalized with a mean increase of 324% in their six-hour urinary sodium excretion post-treatment vs baseline. These interim data also show a broad improvement in their kidney function with a mean improvement in eGFRiv of 47% and blood urea nitrogenv of 57% post-treatment vs baseline.

Since patients had HFpEF, their NT-proBNPvi levels were within normal ranges at baseline and were maintained post-treatment, indicating that their stable cardiovascular status was preserved. The need for loop diuretics was dramatically reduced or even completely eliminated following completion of the four-week DSR treatment period, which the Company believes is a demonstration of the durable improvement in cardio-renal health of the patient and supports DSR?s mechanism of action as breaking the vicious cycle of cardiorenal syndrome. In addition, none of the patients needed to be hospitalized for congestion since the start of the study.

To date, no clinically relevant changes in serum sodium levels or progressive hyponatremia were observed and no serious adverse events occurred, indicating that DSR 2.0 was safe and well tolerated in these first three US patients.