Sequana Medical - Guidance maintained for key programmes
Sequana reported its FY21 results on 12 April and confirmed its operating guidance for the coming months. The company continues to expect to report top-line data for its North American POSEIDON study of alfapump in recurrent and refractory ascites (RRA) in Q422 and submit a US premarket approval (PMA) application in mid-2023. It plans to report top-line data for its SAHARA DESERT alfapump DSR study in patients with decompensated heart failure (HF) in H222. The company plans to begin its first human study (MOJAVE DESERT) of its ‘standalone’ short-term DSR treatment in HF patients in H222. After increasing our R&D cost estimates following the FY21 results and reducing alfapump sales forecasts in Europe (which is not a prioritised RRA market for Sequana), we lower our equity value per basic share slightly to €13.12 (versus €13.55 previously).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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