Sequana Medical NV (“Sequana Medical”, the “Company”), 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, announces today that the U.S. Food and Drug Administration (FDA) has granted Breakthrough Device designation for the alfapump® for the treatment of liver recurrent or refractory ascites.

The FDA’s Breakthrough Devices Program is designed to facilitate the development and expedite the review of devices that provide more effective treatment or diagnosis of life-threatening or irreversibly debilitating diseases or conditions, and to provide patients and healthcare providers with timely access to these medical devices. Devices that receive this designation are eligible for more frequent interactions with the FDA’s experts to identify areas of agreement in a timely way and are eligible for prioritized review of the submission package to obtain regulatory approval in the U.S.

Ascites, a key complication of liver cirrhosis, is the accumulation of ascitic fluid in the abdomen. Patients may accumulate as much as 10 to 15 litres of ascitic fluid within the abdomen every 15 days. Patients suffering from liver recurrent or refractory ascites have limited treatment options and often have severely impacted quality of life due to the severe swelling of the abdomen, resulting in pain, difficulty breathing, moving, sleeping and eating, severe nausea and constipation. Existing treatment options carry the risk of significant or life-threatening side effects, provide only short-term symptomatic relief or have very limited availability.

The alfapump® is a fully-implanted, programmable, wireless, CE-marked system that automatically pumps ascites from the peritoneal cavity into the bladder, where the body eliminates the ascites naturally through urination. The potential of the alfapump® to address this unmet medical need in patients with liver recurrent or refractory ascites has been demonstrated in multiple clinical studies showing a significant reduction in the need for large volume paracentesis, which is paracentesis where at least 5 litres of fluid is removed (i.e., the current standard of care), and a significant improvement in patients’ quality of life.

A feasibility study in North America in patients with liver refractory or recurrent ascites has been completed and results were presented at the AASLD (American Association for the Study of Liver Diseases) annual meetings in October 2017 and November 2018. Preparations are underway to start a North American pivotal study in the second half of this year for approval of the alfapump® in North America.

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