Sequana Medical - MOJAVE early efficacy validates DSR 2.0
Sequana Medical recently announced positive interim data, from the non-randomised cohort of the Phase I/IIa MOJAVE study, in patients with chronic heart failure (CHF) and severe diuretic resistance treated with Direct Sodium Removal (DSR) 2.0. Data from the first two patients demonstrated that DSR 2.0 is safe and well tolerated and that it exhibits robust initial signs of efficacy, confirming the efficacy signals seen with the first-generation product (DSR 1.0) in the SAHARA and RED DESERT studies and highlighting potential of a disease-modifying treatment. Sequana also reported favourable developments with its recurrent and refractory ascites (RRA) programme for the alfapump, including positive efficacy and safety in 12-month data from the POSEIDON pivotal study, a patient preference study showing positive potential demand among the US RRA population, and a comparable safety profile to standard-of-care (SoC) following a matched interim analysis between POSEIDON and the NACSELD registry. Importantly, the company remains on track to submit a PMA application in Q423, which could lead to US approval in H224.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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