Sequana Medical - POSEIDON results de-risk alfapump programme
Positive results from POSEIDON, Sequana Medical’s North American pivotal study of its implantable alfapump device in patients with recurrent and refractory ascites (RRA), should pave the way for the company to file a US premarket approval application (PMA) with the FDA in H223. The study convincingly met the primary efficacy endpoints and, given that no unanticipated adverse device effects (UADE) were observed, we believe that these results should de-risk the likelihood of US market approval and commercialisation. We are raising our US commercial probability of success (PoS) estimate to 80% (55% previously), resulting in an increase to our rNPV valuation to €345.0m (previously €273.8m).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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