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Sequana Medical - POSEIDON pivotal study meets primary endpoint

Sequana Medical reported that the POSEIDON North American pivotal study of its implantable alfapump device in patients with recurrent and refractory ascites (RRA) due to liver cirrhosis met the primary efficacy endpoint, and that safety results were in line with expectations. These positive results should pave the way for the company to file a US premarket approval application with the FDA in H223, in line with prior guidance, which we estimate can lead to US market launch in mid-2024. The alfapump device was shown to lead to significant reductions in the need for RRA patients to undergo burdensome therapeutic paracentesis (TP) procedures, which should lead to improved patient independence and quality of life, given the limitations of current treatments as discussed in our Outlook report. We expect the rising prevalence of non-alcoholic steatohepatitis will result in the target market for RRA patients in North America increasing at an upper single-digit CAGR over the next decade, providing a robust commercialisation opportunity for alfapump in RRA.