Sequana Medical - DSR 2.0 moving forward
Following sustained positive effects from the SAHARA I study in restoring diuretic response (DR) in heart failure (HF) patients with persistent congestion, Sequana will focus on advancing its Direct Sodium Removal (DSR) programme using its second-generation product (DSR 2.0) as applied through a peritoneal catheter (‘short-term DSR’). This should provide a more straightforward regulatory pathway than the alfapump DSR combination approach studied previously. 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 it plans to submit a US premarket approval (PMA) application in H223. We have reassessed the potential market opportunity for DSR 2.0, and revised our clinical development timeline assumptions, pushing back our potential DSR launch forecast from H226 to 2028. We now derive an equity valuation per basic share of €12.38 for Sequana Medical, versus €13.12 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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