Sequana Medical’s new alfapump technology improves the care of patients with challenging refractory ascites Zurich, SWITZERLAND – 1 December 2014. Technological advances in Sequana Medical’s alfapump system will allow patients and their doctors to better manage the distressing symptoms of refractory ascites, a condition in which fluid builds up in the patient’s abdomen as a result of late-stage liver disease or cancer. With enhanced communications enabled by the new DirectLink Technology, clinicians will now be able to monitor the alfapump remotely. Patients with late stage liver disease or cancer require intensive treatment. Management of key symptoms such as ascites is critically important for patients, many of whom are waiting for a liver transplant. The build-up of ascitic fluid in their abdomens can be painful, preventing them from eating well or exercising and often causing painful hernias. Sequana Medical, a Swiss-based medical devices company, has pioneered the alfapump, the first and only internal pump system providing automatic and continual removal of ascites, now with DirectLink technology to improve patient management. Prior to the alfapump, the only therapy available for most patients with refractory ascites was large volume paracentesis, a lengthy, invasive procedure which can require weekly visits to the hospital for removal of the many litres of fluid from the abdomen. The process can be distressing for patients as it involves the use of large bore needles, sometimes inserted many times to access and remove the ascites. Michael Beckett, 50, from Portsmouth, UK had serious liver problems. He explains, “Before I had my alfapump implanted I had a huge belly with tiny arms and legs. I wasn’t eating and I was tired all of the time. I had to go to the Queen Alexandra Hospital in Portsmouth to have the fluid drained – sometimes I had 14 litres, that’s 14 kilos of extra weight around my belly.” Michael is now remarkably fit and his liver function is back to normal thanks to the care of his physicians and the alfapump therapy which allowed him to eat well and exercise. Michael believes the new alfapump system will make a big difference for people who are in the situation he was in two years ago. He had to travel a long distance to the Royal Free Hospital in London for his specialist liver care and he thinks that the new DirectLink upgrades will reduce the need for travel and hospital visits. He welcomes the added reassurance that the new developments offer patients, “Early proactive notice of any pump changes has got to be good news.” Dr Anne McCune, consultant hepatologist in the department of Medicine and Surgery at University Hospitals Bristol, leads the clinical trial team participating in a randomised controlled trial investigating alfapump technology vs. regular paracentesis in patients with liver cirrhosis and refractory large volume ascites. Dr McCune explains, “When patients have cirrhosis, the liver and kidneys stop working properly and patients can accumulate litres and litres of fluid in their abdomens which can be very painful. They might need to come to hospital fortnightly to have up to 15 litres drained from their tummy. The alfapump can avoid this by draining about 15 millilitres every 15 minutes. It means they'll pass a little bit more urine but we can program the pump to switch off at night for comfort. The new DirectLink Technology, which allows the alfapump to be monitored remotely, will ensure that the programmed therapy has been accurately delivered. The pump has the potential to improve quality of life for our liver patients and keep them out of hospital for longer periods. The study is ongoing and will evaluate both the clinical and cost-effectiveness of this exciting device.” Noel Johnson, the CEO of Sequana Medical explains, “We are very pleased with the improvement in clinical outcomes and patient quality of life seen with the alfapump therapy as ascites patients live free from repeat large volume paracentesis, avoiding the risk of current therapeutic options. Now with the remote monitoring enabled by the DirectLink Technology we expect to see increased efficiencies for healthcare professionals and an increased feeling of security for the patient.” The full launch of the new alfapump system will take place in December 2014 to the main European markets (Germany, Austria, Switzerland, France, UK, Denmark, Sweden, Norway), expanding to other countries in 2015 with some restrictions regarding the SIM card activation. Download the full press release at www.sequanamedical.com. ENDS Notes to Editors: About Sequana Medical Founded in 2006, Sequana Medical AG is a Swiss medical device company backed by NeoMed Management, VI Partners, Biomed Invest, Capricorn Venture Partners, Entrepreneurs Fund and Life Science Partners, and is dedicated to improving patient lives through innovative technologies to manage fluid overload in patients suffering from liver disease, cancer and congestive heart failure. For more information please visit www.sequanamedical.com. About alfapump and DirectLink technology The alfapump device, which is implanted beneath the skin of the abdomen, is smaller than two matchboxes, and works by pumping fluid from the abdomen into the bladder, where it is removed from the body naturally through urination. From December 2014, the alfapump system will be delivered in the European market with new and redefined features. A key new feature, DirectLink Technology, allows remote monitoring of pump activity. Pump data is collected daily by the Smart Charger and transferred via the mobile phone network to Sequana Medical secure servers where it is stored and analysed. The Company will be able to provide physicians with a periodic overview of alfapump system activity. Should an alfapump system parameter, such as battery level, fall outside of a defined range, Sequana Medical can alert the physician, who can take the appropriate action. Identifying changes in pump activity or patient requirements early enhances pump safety. Addressing issues early can save physician time and hospital resources thereby increasing efficiency for healthcare professionals. Patient management becomes much easier for doctors and medical teams, as they automatically receive analysed log data in their inbox, rather than having to download logfiles and manually send them to Sequana Medical for analysis. In addition, it should give patients a greater feeling of confidence with the knowledge that their alfapump system is being automatically and constantly monitored. This key feature supports scalability for Sequana Medical by automating a significant portion of the pump data analysis process. In addition to the DirectLink Technology feature, enhancements have been made to the performance of the alfapump and the design of the Smart Charger. The new generation alfapump system with DirectLink Technology allows ascites patients to live free from the need for repeat large volume paracentesis, achieving better quality of life by reducing the number of visits to the hospital and avoiding the risk of current therapeutic options. For more information please visit www.alfapump.com. About refractory ascites In patients with refractory ascites, up to 15 litres of fluid can gather around the abdominal organs and it is impossible for this fluid to be removed from the body through medication. Ascites can make patients look pregnant, as well as being painful and taking away the appetite, making patients weak and leading to malnutrition. These patients may have to make weekly or monthly trips to the hospital in order to have the fluid drained from their abdomen by paracentesis. The alfapump provides a simple solution to ascites and experts hope it could even help the liver regenerate. Contact Sequana Medical Emily Woodward Director of Marketing [email protected] Phone +41 44 403 55 21 www.sequanamedical.com www.alfapump.com
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