Edison Investment Research - Sequana Medical (SEQUA) Sequana Medical - Pushing back alfapump PMA to mid-2023

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Edison Investment Research

Sean Conroy

Sequana Medical - Pushing back alfapump PMA to mid-2023

Sequana Medical indicated that due to a worldwide shortage of electronic components, it now anticipates its US premarket approval (PMA) application for the alfapump will now be submitted in mid-2023, compared to prior guidance of Q422. We have pushed back our potential North American alfapump launch estimate in recurrent and refractory ascites (RRA) to mid-2024 (from H223 previously), while our projections for the Direct Sodium Removal (DSR) programmes in heart failure are unchanged. We now obtain a new pipeline rNPV of €219.8m (vs €248.2m, previously).

10/09/2021 1 EN

Underlying

Sequana Medical

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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BE0974340722 Euronext Brussels Belgium

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Edison Investment Research

Edison is an investment research and advisory company, with offices in North America, Europe, the Middle East and AsiaPac. The heart of Edison is our world renowned equity research platform and deep multi-sector expertise. At Edison Investment Research, our research is widely read by international investors, advisors and stakeholders. Edison Advisors leverages our core research platform to provide differentiated services including investor relations and strategic consulting.

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Analysts

Sean Conroy

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Sequana Medical - Pushing back alfapump PMA to mid-2023

Morning Notes : AGS BB, CMBT BB, FAGR BB, GREEN BB, SEQUA BB

Sequana Medical CMS proposes NTAP top up payment for the alfapump

Sequana Medical FIRST LOOK: Additional funding extends runway to YE25

Manx Financial Group - Termination of coverage

musicMagpie - Termination of coverage

Topps Tiles - Accelerating growth through Q125

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