The alfapump® system is currently not approved in the United States or Canada. In the United States and Canada, the alfapump® system is currently under clinical investigation (POSEIDON Study) and is being studied in adult patients with refractory or recurrent ascites due to cirrhosis. DSR® therapy is still in development and it should be noted that any statements regarding safety and efficacy arise from ongoing pre-clinical and clinical investigations which have yet to be completed. There is no link between the DSR® therapy and ongoing investigations with the alfapump® system in Europe, the United States or Canada.

Sequana Medical announces inclusion of alfapump® in EASL Clinical Practice Guidelines and presentation of study demonstrating physical component of QOL is predictor of mortality in refractory ascites.

Zurich, SWITZERLAND – 16. May 2018 — Sequana Medical AG (“Sequana Medical”), a commercial stage medical device company and an innovator in the management of liver disease & malignant ascites, announces two important developments at the recent EASL (European Association for the Study of the Liver) International Liver Congress 2018. First, the inclusion of alfapump® in the EASL Clinical Practice Guidelines for the management of patients with decompensated cirrhosis was announced, and secondly, the study by Macdonald et al reported that the physical component of health-related quality of life (“QoL”) is an independent predictor of mortality in refractory ascites patients.

The EASL clinical practice guidelines refer to two alfapump® multicentre safety and efficacy studies demonstrating a significant reduction of the number and volume of paracentesis in patients with advanced cirrhosis and refractory ascites by alfapump®. In addition, a multicentre randomised controlled trial in patients with refractory ascites is cited, showing a reduction in the median number of paracentesis per month by 85 % with respect to large volume paracentesis . Nutritional parameters and quality of life were also significantly improved in patients treated with the alfapump® system in this study.

The importance of quality of life for patients with severe ascites was demonstrated in a study by Stewart Macdonald et al. The analysis of data of 405 cirrhotic patients with severe ascites that were enrolled in a randomized controlled trial show that the physical component of the health-related quality of life is an independent predictor of mortality in these patients. According to this study, a poor physical component of quality of life in patients with severe ascites is associated with increased mortality.

The multicentre, randomized controlled trial (published in the Journal of Hepatology and Quality of Life Research) and the MOSAIC study (presented at the Annual Meeting of the American Association for the Study of Liver Diseases Annual Meeting 2017) both reported that the alfapump® demonstrated a clinically meaningful improvement of health-related quality of life in patient with refractory ascites.

“It is exciting to see the scientific community has been evaluating the growing clinical evidence that is currently available for the alfapump®. The collaboration with many clinicians to demonstrate the benefits of the alfapump® in multiple studies with different designs (from randomized controlled trials to “real world” post-market studies) has been a strong focus for us during the last years” said Gijs Klarenbeek, Consulting Chief Medical Officer of Sequana Medical. “It is very rewarding to see this is now leading to the alfapump® now being included in the EASL clinical practice guidelines.”

“We are delighted that the alfapump® is included in the EASL clinical practice guidelines. This important step for the alfapump® and Sequana Medical is a clear recognition of the extensive work that has been done in partnership with our partners in the clinical community to demonstrate the benefits that the alfapump® brings to this important patient group” said Ian Crosbie, Chief Executive Officer of Sequana Medical. “The publication by Macdonald et al is exciting as it demonstrates the link between physical component of quality of life and mortality in cirrhotic patients with severe ascites. We have repeatedly demonstrated that the alfapump® improves quality of life, one of the key clinical objectives in the management of these patients.”

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