Sequana Medical NV (Euronext Brussels: SEQUA, the “Company”), an innovator in the treatment of diuretic-resistant fluid overload in liver disease, malignant ascites and heart failure, today announces its business highlights and financial results for the six-month period ending 30 June 2021 and its outlook for the remainder of the year and beyond.

Ian Crosbie, Chief Executive Officer at Sequana Medical, commented: “We have continued to deliver outstanding clinical results in H1 2021 with promising data from our POSEIDON and RED DESERT studies demonstrating the potential of our two technology platforms, alfapump and Direct Sodium Removal (DSR).

“We believe that the strong interim results from the POSEIDON Roll-In Cohort significantly de-risk our North American liver programme and demonstrate the potential of the alfapump to provide a safe and efficacious treatment that can dramatically improve the quality of life for patients with recurrent or refractory liver ascites. While we have made strong progress in POSEIDON patient recruitment, we continue to work with the FDA on expanding the number of patients to be enrolled and look forward to updating the market on timing. The delay in planned submission of the PMA due to subcomponent shortages is frustrating but reflects the growing issues facing many high-tech companies in sourcing complex electronic components and we are working tirelessly with our long-term suppliers to further minimise the delay on alfapump PMA submission in the U.S.

“RED DESERT demonstrated that alfapump DSR could not only replace high doses of loop diuretics but also improve the diuretic response and cardio-renal status in patients with diuretic-resistant heart failure. These results indicate the unique capabilities of DSR, which we are further evaluating in the SAHARA DESERT study in decompensated heart failure patients. We expect to report interim results from this trial before the end of the year.

“The continued growth of the NASH-related ascites and decompensated heart failure markets validates our focus on delivering innovative treatments for when diuretics are no longer an effective option in these patients.”

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