Sequana Medical announces inclusion of alfapump® in German treatment guidelines (DGVS) for complications of liver cirrhosis

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Sequana Medical’s pump 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 pump 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 pump as a good and safe alternative to repeated LVP and states that the pump 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 pump, as well as to the improvement in patient’s quality of life and nutritional benefit demonstrated in clinical studies.

Sequana Medical's technology is based on its proprietary pump® platform, a fully implantable, programmable, wirelessly-charged, battery-powered system for automatic and continuous removal of fluid from the abdomen, which is applicable across multiple life-threatening disorders. The pump is being commercialised in Europe for the management of refractory ascites (chronic fluid build-up in the abdomen) due to liver cirrhosis and malignant ascites. The number of patients with refractory liver ascites is forecast to increase dramatically due to the growing prevalence of NASH (Non-alcoholic Steatohepatitis).

Over 700 pump systems have been implanted to date and since April 2018, the pump has been included in the EASL (European Association for the Study of the Liver) clinical practice guidelines for decompensated cirrhosis. In January 2019, the FDA has granted Breakthrough Device designation for the pump for the treatment of recurrent or refractory liver ascites. The pump has not yet received regulatory approval in the U.S. and Canada and the Company expects to start POSEIDON, the North American pivotal study in in the second half of 2019 to support approval of the pump in recurrent or refractory liver ascites.

The pump is one of the first safe and effective, long-term alternatives to large-volume paracentesis (LVP) for the management of ascites, offering major advantages to patients, clinicians and healthcare systems. By automatically and continuously moving ascites to the bladder, where the body eliminates it naturally through urination, the pump prevents fluid build-up and its possible complications, improving patient quality of life and nutrition, and potentially reducing hospital visits and healthcare costs. The pump DirectLink technology allows clinicians to receive pump performance information and more effectively manage patients treated by the pump.

Sequana Medical has leveraged its pump experience and is developing pump DSR to deliver a convenient and fully implanted system for DSR therapy, its novel and proprietary approach for the management of volume overload in heart failure. Data from animal studies presented at EuroPCR 2018 and HFSA 2018 indicate that DSR therapy is effective and safe. The first-in-human single dose DSR proof-of-concept study has been conducted by Dr. Testani at Yale University in the U.S. and results are scheduled to be presented at Heart Failure 2019 on 27 May 2019. The repeated dose DSR proof-of-concept study is expected to start in the second half of 2019.

Sequana Medical is headquartered in Ghent, Belgium. For further information, please visit .

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Globe Newswire: 06:00 GMT Wednesday 15th May 2019

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