Sequana Medical NV products

The alfapump® system is a fully implantable pump system that collects ascites as it forms and moves it into the bladder, where it is passed naturally from the body through urination. The implantation procedure can be performed under local or general anaesthesia in less than one hour. Once implanted, patient interaction with the alfapump® system is minimal. The patient simply charges the alfapump® wirelessly through the skin by holding a hand-held charging device over the alfapump®. While charging, data from the alfapump® is transferred to this charger. This data can be accessed by the physician during follow-up visits and settings can be changed as appropriate.

Liver disease, a large and growing market globally. Cirrhosis is late-stage liver disease which occurs when scar tissue (fibrosis) replaces healthy tissue. Alcohol and viral hepatitis B and C are common causes of cirrhosis, although there are many other causes including non-alcoholic fatty liver disease (NAFLD) and non-alcoholic steatohepatis (NASH). The incidence of liver disease and liver cirrhosis is increasing driven by unhealthy lifestyles, obesity and ageing populations. Chronic liver disease and cirrhosis are one of the fastest growing leading causes of death in the U.S. Source.

Ascites is also a common complication of certain late-stage cancers due to fluid build-up in the peritoneal cavity from a number of causes including draining of the lymph system. While life expectancy for many cancer patients with malignant ascites is short (less than 3 months), ovarian and breast cancer patients often have longer life expectancies. In 2018, the incidence in the U.S. and EU5 is estimated to be about 500,000 for breast cancer and about 50,000 for ovarian cancer. Approximately 3% of the breast cancer patients and 37% of the ovarian cancer patients will develop malignant ascites.

Heart failure is a progressive disease that results in the heart being unable to pump enough blood and thereby supply oxygen to support other organs in the body. The American Heart Association estimates that 6.5 million adults in the United States age 20 and over are affected by heart failure and that number is expected to rise to 8.0 million adults by 2030. Causes of heart failure include coronary artery disease, heart attacks, high blood pressure and faulty heart valves. Heart failure can disturb the normal functioning of the kidney, weakening its ability to excrete sodium from the body and triggering mechanisms that cause water retention resulting in fluid overload. Patients with heart failure commonly experience shortness of breath, fatigue, difficulty exercising and swelling of the legs. The increase in fluid volume increases the burden on the weakened heart, further exacerbating the problem.