Sequana Medical AG (Sequana Medical), a commercial stage medical device company and an innovator in the management of liver disease, today announced that Prof. Florence Wong, University of Toronto, presented the findings of the MOSAIC study data at the Annual Meeting of the American Association for the Study of Liver Diseases (AASLD) Annual Meeting (The Liver Meeting®), held in Washington, DC.
This North American prospective, open label, single arm, multi-centre study comprised 30 cirrhotic patients with recurrent large ascites, and not eligible for TIPS. Lead investigators of the study, Professor Florence Wong from University of Toronto, Toronto, ON, Canada and Professor Patrick Kamath from Mayo Clinic College of Medicine and Science, Rochester, MN concluded: “alfapump implantation resulted in a clinically significant improvement in mean quality of life, as measured by CLDQ and AscitesQ (two validated questionnaires), and elimination of LVP requirement in 70% of patients at 3 months. Study patients had greater than expected overall survival compared with prior publications. Reinterventions, explants and adverse events related to AKI and infection remain as concerns. Further studies should include revised catheter design and procedural and post-procedure care algorithms.”
Ian Crosbie, Chief Executive Officer of Sequana Medical added, “We are very pleased to see that in the MOSAIC study the alfapump® delivers clear benefits to this important patient group in terms of quality of life improvement and dramatic reduction in the burden of large volume paracenteses. In addition, the increased survival of these patients compared to what is expected in a population of patients with refractory ascites is very exciting. The growth of NAFLD and NASH makes the need for an innovative and effective treatment option for refractory ascites all the more important. Through our ongoing development work and close collaboration with clinicians, we continue to further improve the performance of the alfapump®, resulting in lower rates of adverse events, and even greater reductions in paracentesis frequency in our more recent patient implants.”
About Refractory Ascites (RA)
Accumulation of ascites is a common complication of cirrhosis and one of the leading reasons for hospital admission. The number of patients with cirrhosis is predicted to grow significantly, with much of the growth due to the increasing prevalence of non-alcoholic fatty liver disease (NAFLD) and non-alcoholic steatohepatitis (NASH).
Approximately 60% of cirrhotic patients develop ascites within 10 years of diagnosis. An estimated 10% of patients with ascites develop refractory ascites, where the ascites cannot be treated with diuretics and restriction of dietary sodium. The most frequent treatment for RA patients is paracentesis, a lengthy, invasive and painful procedure that can require weekly hospital visits for drainage of excess fluid and is associated with poor quality-of-life. This often involves the drainage of over 5 litres of fluid and is termed large volume paracentesis.
About the alfapump®
Sequana Medical’s alfapump® is a fully implantable, programmable, transcutaneously-charged, battery-powered pump for the management of refractory ascites. By moving ascites to the bladder, the body can eliminate it naturally through urination. The alfapump® prevents fluid build-up and its’ possible complications, improving patient quality of life and nutrition, and potentially reducing hospital visits and healthcare costs. The alfapump® DirectLink Technology allows clinicians to receive pump performance information and more effectively manage patients treated by the alfapump®.
Over 600 alfapump® systems have been implanted and the product is currently commercially available in Europe.
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Note to Editors
About Sequana Medical:
Sequana Medical is a commercial stage medical device company and an innovator in the management of liver disease.
The first product, alfapump®, is a fully implantable, programmable, transcutaneously-charged, battery-powered pump for the management of refractory ascites (chronic fluid build-up in the abdomen) due to i) liver cirrhosis, or ii) malignant ascites with a life expectancy of 6 months or less. The alfapump® is one of the first real alternatives to large-volume paracentesis, a lengthy, invasive and painful procedure that can require weekly hospital visits for drainage of excess fluid. By moving ascites to the bladder, where the body can eliminate it naturally through urination, the alfapump® prevents fluid build-up and its possible complications, improving patient quality of life and nutrition, and potentially reducing hospital visits and healthcare costs. The alfapump® DirectLink Technology allows clinicians to receive pump performance information and more effectively manage patients treated by the alfapump®. The alfapump® has received the CE Mark and is commercially available in 14 countries. The alfapump® is currently under evaluation in the US under an IDE study.
Through the experience gained from the design, development, manufacture and commercialisation of the alfapump®, together with an extensive intellectual property portfolio, Sequana Medical has established an enabling platform for fully implantable fluid-imbalance therapies.
The Company is headquartered in Zurich, Switzerland and our investors include NeoMed Management, VI Partners, Biomed Invest, Capricorn Health Tech, Entrepreneur’s Fund, Quest for Growth, Salus Partners and Life Science Partners. For further information, please visit www.sequanamedical.com.