Sequana Medical FDA approval for alfapump
Sequana receives a nice Christmas present this year as it obtained PMA approval from the FDA for its alfapump system in the treatment of r/r ascites due to liver cirrhosis, ahead of the guided 1Q25 timeline. We see the approval as an important derisking event for the company, which will enable the company to address a market opportunity of $ >2bn (mgmt. estimates) in the US. The commercialisation intends to specifically target 90 liver transplant centres and is expected to launch in 2H25. We note that Sequana's current cash runway extends into 1Q25. With approval in hand, the company could aim to attract additional capital in preparation for the launch. We reiterate our € 6 TP and Buy rating.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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