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Sequana Medical Receives CE Mark Approval for the ALFApump™ System and Adds Key Executive to Team
Date:7/12/2011

ation. The ALFApump is recharged wirelessly and can be programmed to meet the unique needs of each patient.

Refractory ascites occurs when patients with ascites no longer respond to medical therapy. This condition affects over 100,000 patients in Europe and the US every year. The number of patients suffering from ascites is growing at approximately 10% a year due to the accelerating incidence of hepatitis- and obesity-related liver disease. The primary treatment for ascites is paracentesis, a procedure in which a large bore needle is inserted into the patient's abdomen to remove between 5-10 liters of ascites that has accumulated over a period of a week or two. The cumulative cost of ascites-related care for these patients often exceeds $50,000 each year.

"The benefits of the ALFApump System are entirely aligned with the goals of patients, physicians and payers," commented Dan Rose, VP of Commercial Operations. "The system is designed to offer patients better clinical outcomes and quality of life while eliminating the requirement for repeated expensive and burdensome invasive procedures. The performance of the ALFApump System in the PIONEER Clinical Study has surpassed our expectations and indicates a bright future for our technology as a new treatment option. We look forward to partnering with leading hepatology centers as we launch the ALFApump System in Europe."

In May, Sequana Medical completed full enrollment of its 40-patient PIONEER Study, a prospective, multi-center, open label study of patients with refractory ascites due to liver cirrhosis. The PIONEER Study was designed to evaluate the safety and performance of the ALFApump System in obviating the need for paracentesis, the standard therapy for patients with refractory ascites. The Study was completed in 9 centers across 4 European countries.  Dr. Jose Such, the principle investigator of the Pioneer Study, stated that, "The ALFApump System CE Marking is great news for both Sequan
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SOURCE Sequana Medical AG
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