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Sequana Medical NV, a pioneer in the treatment of fluid overload in liver disease, heart failure and cancer, announced data from its North American pivotal POSEIDON study of the alfapump demonstrating significantly improved quality of life focused on ascites symptoms and physical functions compared to baseline, which is not seen in refractory ascites patients enrolled contemporaneously in the prospective NACSELD3 (North American Consortium for Study of End-Stage Liver Disease) cohort.
The two cohorts were matched for Ascites-Q, age, sex and enrolment MELD-NA, which is a scoring system for assessing the severity of chronic liver disease. These data will be presented as an oral poster presentation on Friday, June 7, 2024 at 09.30am CEST at the EASL Congress 2024, Europe’s largest event in this domain, taking place in Milan, Italy.
Dr. Bajaj, Professor of Medicine at Virginia Commonwealth University and Richmond VA Medical Center commented: “A real-world, propensity-matched North American cohort of patients which was matched to the POSEIDON study showed significantly improved quality of life with the alfapump. This could help this unmet need in patients with cirrhosis and recurrent or refractory ascites.”
Dr. Gijs Klarenbeek, MD, chief medical officer at Sequana Medical, added: “This important study adds to the existing evidence from controlled studies and real world evidence. All data consistently shows the impact of the alfapump on quality of life for this patient population, underserved by current therapeutic options. At Sequana Medical, we are focused on bringing the alfapump to physicians, patients and their caregivers as they deserve modern and impactful care for this condition that has such a detrimental effect on how they live their lives.”
Matched cohort analysis of 37 patients from each study: This was a comparative analysis in which 37 patients from the North Americal pivotal alfapump study (POSEIDON) were matched 1:1 to patients from the NACSELD3 prospective cirrhosis cohort.
For the alfapump cohort, Quality of Life (as evaluated by Ascites-Q and SF-36 (Physical Component Score)) improved significantly at six months compared to baseline, but this benefit was not seen in the NACSELD3 cohort.
There was no statistically significant difference in mortality, hospitalisations or liver transplants between the two groups; the hospitalisations in the POSEIDON group were mainly observed in the post-implant period.
Recurrent or refractory ascites is a severe condition characterized by the accumulation of fluid in the abdomen. The current standard treatment involves therapeutic paracentesis, an invasive and burdensome procedure that drains ascites from the abdomen using a large needle over an extended period. If approved by the FDA, the alfapump could become the first active implantable medical device in the US that automatically and continuously removes ascites from the abdomen into the bladder, where it is naturally eliminated through urination.
The PMA application submitted to the US FDA was based on the successful execution of Sequana Medical’s pivotal POSEIDON study, a landmark study across 18 centers in the US and Canada with a total of 69 patients implanted with the alfapump. The primary effectiveness endpoints at six months post-implantation in the Pivotal Cohort exceeded the predefined thresholds with statistical significance, and primary safety endpoint data was in line with expectations. Data at 12 months post-implantation continued to show a strong and durable clinical profile, virtually eliminating the need for therapeutic paracentesis and delivering a clinically meaningful improvement in patients’ quality of life.
Data from the patient preference study and a matched cohort analysis of the NACSELD-III registry with the POSEIDON Pivotal Cohort indicated that US patients have a strong preference for the alfapump vs standard paracentesis procedures and that the safety profile of the alfapump is comparable to standard of care.
The North American market of recurrent and refractory ascites due to liver cirrhosis is forecast to grow on average 9% per year, from approximately 78,000 patients in 2025 reaching 147,000 patients by 2032, primarily driven by the increasing prevalence of NASH. The total market opportunity for alfapump is estimated at $2.4 billion in 2025, including approximately $600 million from the Company’s initial priority market targeting patients requiring at least 12 paracenteses per year. To date, over 1,000 alfapump systems have been implanted.
Sequana Medical NV is a pioneer in treating fluid overload, a serious and frequent clinical complication in patients with liver disease, heart failure and cancer.
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