Sequana Medical - Approaching key inflection points
Sequana Medical reported H122 financials with expenditure mildly above our forecasts and confirmed previous guidance for its cash runway to last into Q323, including €10m in potential proceeds from its Kreos loan facility. Most importantly, it maintained guidance for key upcoming catalysts, namely its expectation to report top-line data for its North American POSEIDON study of alfapump in recurrent and refractory ascites (RRA) in Q422 and to submit a US premarket approval (PMA) application in H223, assuming positive data. Sequana also expects to commence enrolment in H123 for the MOJAVE Phase Ib/IIa US trial assessing DSR 2.0 as short-term direct sodium removal (DSR) therapy in chronic heart failure patients with persistent congestion.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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