Sequana Medical - PMA application submitted to FDA for alfapump
Sequana Medical announced in late December that it has submitted a Premarket Approval (PMA) application to the US FDA regarding its alfapump device for use in patients with recurrent and refractory ascites (RRA), meeting its guidance for a submission in Q423. This marks a critical milestone for the company and we expect an FDA decision in H224. Given robust primary efficacy data from the POSEIDON North American pivotal study, as well as favourable safety and efficacy trends maintained at 12 months post-implantation, we are confident that there is a high likelihood of a positive outcome and commercial approval of the product. We believe US approval would mark a pivotal shift in Sequana’s commercial profile, given the strong market need for improved treatments for RRA that can boost patient quality-of-life (QoL), particularly in light of rising prevalence of non-alcoholic steatohepatitis.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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