Sequana Medical - Update on FDA approval
Sequana Medical announced the outcome from the Day 100 meeting with the FDA. The positive news is that the FDA did not have any additional clinical questions, which partially de-risks the approval. Some non-clinical questions remain to be answered. Management indicates that those are manageable and should be completed by end of September 2024.The company will exclude its DirectLink software from the PMA submission for the time being. Instead of being sent automatically to the doctors, the alfapump data will hence be retrieved manually at first by people in the field. Hence no impact on adoption expected. All in all, FDASequana 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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