Sequana Medical has reported additional data on safety, quality of life (QoL) and survival from the POSEIDON North American open-label pivotal study assessing the company’s implantable alfapump device in patients with recurrent and refractory ascites (RRA) due to liver cirrhosis. The company previously reported in Q422 that the study met the primary efficacy endpoint, and that the primary safety endpoints were in line with expectations. The additional data, reported at the EASL Congress 2023, show that alfapump was effective in controlling ascites, by virtually eliminating the need for needle paracentesis. Sequana also confirmed that the additional safety data were in line with expectations, while a clinically relevant and statistically significant improvement in patients’ QoL was also shown through validated and pre-specified health survey questionnaires. We believe that the additional data suggest a strong clinical and commercial profile, and support the likelihood of US alfapump approval.
