UK NICE recommends use of the alfapump® for the treatment of refractory ascites caused by cirrhosis under special arrangements
Ghent, BELGIUM – November 15, 2018 – 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 UK National Institute for Health and Care Excellence (“NICE”) has published updated Interventional Procedures Guidance (“IPG”) supporting the use of the alfapump® for the treatment of refractory ascites caused by cirrhosis. The updated IPG recommends use of the alfapump® under “special arrangements for clinical governance, consent, and audit or research” and replaces the previous guidance of February 2014 recommending the alfapump® for “research use only”. The updated guidance is a result of the additional safety, efficacy and quality of life data published for the alfapump®.
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 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 for refractory ascites 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. Clinical studies have demonstrated 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.
The new IPG recommends patient selection for the alfapump® to be done in specialist centers, by clinicians experienced in managing liver disease and in the various options available for managing ascites.
“Refractory ascites has a huge effect on a patient’s quality of life” commented Judi Rhys, Chief Executive of the British Liver Trust. “Those affected report feelings of isolation and depression as they cannot do their daily activities. The updated NICE guidance for the use of the alfapump® in patients suffering from this debilitating complication of liver disease is an important step forward for the patient community and their caregivers. We are enthused by the possible reduced hospital admissions and improved quality of life this new treatment option may offer.”
“The NICE guidance reinforces our strong conviction that the alfapump® has the potential to dramatically improve the lives of patients suffering from refractory ascites” said Ian Crosbie, Chief Executive Officer at Sequana Medical. “We are strongly committed to making the alfapump® available to those patients in need of a better alternative treatment that gives them and their family the chance of living a normal life again. The forecast growth in cirrhosis and refractory ascites as a result of NASH makes the need for a modern and convenient treatment option all the more important.”
KBC Securities and Kempen & Co are acting as Joint Global Coordinators and Joint Bookrunners. Mirabaud has been appointed as Lead Manager.
Subject to the approval of the prospectus by the Belgian Financial Services and Markets Authority ("FSMA") and market conditions, it is expected that the price range, as well as other details of the Offering will be published when the Offering period is expected to commence. After its approval, the prospectus is expected to be made available at the Company's registered office and on the websites of Sequana Medical (www.sequanamedical.com) and KBC Securities NV/SA (www.kbc.be/sequana, www.bolero.be/nl/sequana and www.kbcsecurities.com.)
The Offering is expected to consist of (i) a public offering in Belgium and (ii) private placements to institutional and other qualified investors in Belgium and elsewhere outside the United States. In the United States, only qualified institutional buyers are expected to be eligible, in accordance with an exemption from the registration requirements of the United States Securities Act of 1933, as amended.