Sequana Medical - New data further support alfapump approval
Sequana Medical announced: 1/ 12-months data from POSEIDON showing sustained safety and efficacy, 2/ results from a patient preference study showing strong preference for alfapump vs. standard of care and 3/ results from a matched interim analysis of NACSELD registry and POSEIDON patients indicating comparable safety profile vs. standard of care. PMA is on track to be submitted by year-end. Again, a set of positive results, further supporting the benefits of the alfapump and reinforcing our confidence in its potential to replace current standard of care. As a reminder, based on the positive top-line data published in October 2022, weSequana 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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