Sequana Medical Announces Strong 24-Month Results from POSEIDON Study at AASLD The Liver Meeting® in San Diego; US PMA alfapump approval expected before end of Q1 2025

The poster, entitled “alfapump System in Refractory Ascites: Results from the POSEIDON Study at 24 months”2concerns the new 24-month results of the POSEIDON study3 which concluded that the alfapump system (AS) was very effective in control of ascites, virtually eliminating the need for large volume paracentesis (LVP) long term. Frequency of LVP requirement in the roll-in cohort decreased from pre-implantation to 3 months post-impant and persisted to 24 months by more than 50% (mean LVP/month 2.7±1.3 to 0.1±0.2). Ascites volume removed by LVP fell from 22.8 ±12.5L/month pre- to 2.6± 6 L/month 3 months post-alfapump system implant. Overall survival at 24 months in the alfapump pivotal cohort was 62%.

The poster was presented by Dr. H.E. Vargas, M.D., Professor of Medicine for the Mayo Clinic College of Medicine (Phoenix, Arizona, US), who commented: “The alfapump system was very effective in control of ascites, virtually eliminating the need for LVP long term, up to 24 months. However, close monitoring is needed for the development of AKI (Acute Kidney Injury) or infection, which must be treated promptly to prevent adverse outcomes. Data from the roll-in cohort provides evidence the alfapump can work well in circumstances close to clinical practice. For patients requiring refractory ascites management for more than 6 months, the alfapump is a safe and effective tool.”

Ian Crosbie, Chief Executive Officer of Sequana Medical NV, continued: "We are delighted with the two year results from the POSEIDON study confirming the long term benefits to alfapump patients, particularly the virtual elimination of large volume paracentesis, which has such a devastating impact on the life of these patients. Overall survival of over 60% at two years in the pivotal cohort compares very favourably to the published literature and we will continue to explore this further. The feedback we continue to receive from the clinical community confirms our assessment of the large and growing universe of US patients with recurrent and refractory ascites due to liver cirrhosis, driven by NASH / MASH and alcoholic liver disease, and the clear need for modern treatment options. We are pleased with the constructive and positive ongoing discussions with the FDA to address the remaining topics of our PMA application. We continue to plan for PMA approval before the end of Q1 2025 and US commercial launch in H2 2025, delivering a step change in the treatment options available to these patients”.

Sequana Medical management is attending The Liver Meeting and is available to meet.