Sequana Medical - Additional POSEIDON data confirm benefits
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.Sequana Medical NV. Sequana Medical NV is a Belgium-based company, which manufactures medical devices. The Company focuses mainly on the development of treatment solutions for the management of liver disease, heart failure, malignant ascites and other fluid imbalance disorders. Sequana Medical NV provides alfapump, which is an implantable, programmable, wireless-charged and battery-powered system that is CE-marking for the management of refractory ascites due to liver cirrhosis and malignant ascites. Over 650 alfapump systems have been implanted. Apart from the Alfapump, the Company also aims to develop a direct sodium removal (DSR) therapy, which is a propriety approach to the treatment of volume overload in heart failure.
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