Sequana Medical NV (Euronext Brussels: SEQUA), a commercial stage medical device company focused on the development of innovative treatment solutions for the management of liver disease, heart failure, malignant ascites and other fluid imbalance disorders, today announces that the alfapump has been included in the DGVS (“German Society of Gastroenterology Digestive and Metabolic Diseases”) guidelines for complications of liver cirrhosis. These guidelines provide evidence-based key recommendations for diagnosis and therapy of complications of liver cirrhosis and upgrade the 2011 version. An interdisciplinary team of medical experts and patient support groups developed the guidelines following the recommendations by the Association of Scientific Medical Societies for evidence-based consensus guidelines.

Sequana Medical’s alfapump is currently commercialised in Europe for the treatment of refractory liver ascites, which is a key complication of liver cirrhosis with limited treatment options and severely impacting patients’ quality of life. The potential of the alfapump to address this unmet medical need has been demonstrated in multiple clinical studies showing a significant reduction in the need for large volume paracentesis (LVP), the current standard of care, and a significant improvement in patients’ quality of life.

The DGVS guidelines position the alfapump as a good and safe alternative to repeated LVP and states that the alfapump may also be considered in patients contraindicated for use of a transjugular intrahepatic portosystemic shunt (TIPS). There are numerous complications with TIPS, including hepatic encephalopathy and heart failure. Reference is made to the improvement in clinical outcomes through extensive clinical experience with the alfapump, as well as to the improvement in patient’s quality of life and nutritional benefit demonstrated in clinical studies.

Prof. Dr. Thomas Berg, Head of Hepatology at the University of Leipzig, commented: “I welcome the inclusion of the alfapump in the DGVS guidelines which are considered the reference treatment guidelines in Germany for patients suffering from complications of liver cirrhosis. There is a clear need for treatment alternatives for this underserved patient group. The increasing body of clinical evidence and real-world experience demonstrate the benefits of using the alfapump when performed in experienced centres and well-selected patients with refractory liver ascites.”

Ian Crosbie, Chief Executive Officer at Sequana Medical, added: “The inclusion of the alfapump in the DGVS guidelines is further proof of the increasing independent support and acceptance for alfapump use. We look forward to starting our North American POSEIDON pivotal study in recurrent or refractory liver ascites, expected in the second half of 2019, to support approval of the alfapump in the U.S. and Canada. The forecast growth in cirrhosis and refractory ascites as a result of non-alcoholic steatohepatitis (NASH) is a key health concern in the U.S. and makes the need for a modern and convenient treatment option all the more important.”