Ghent, Belgium – 16 June 2023 – Sequana Medical NV (Euronext Brussels: SEQUA) (the “Company” or “Sequana Medical“), a pioneer in the treatment of fluid overload in liver disease, heart failure and cancer, today announces that its alfapump has won the ‘Best Technology’ Award at the European Mediscience Awards in London last night.
The European Mediscience Awards event is the largest annual gathering of private and publicly quoted healthcare, biotech and life sciences companies in Europe. Bringing together the best of European mediscience companies to celebrate achievement and recognise success, its awards are hotly contested.
Ian Crosbie, Chief Executive Officer of Sequana Medical, commented: “We developed the alfapump to transform the lives of patients with recurrent or refractory ascites due to liver cirrhosis – a rapidly growing patient population due to NASH / NAFLD epidemic. Our objective is to replace the standard of care that has changed little in over 2,000 years and deliver improved clinical outcomes, quality of life and cost savings. The recognition of this work by our industry peers is a tremendous accolade for the Sequana team and celebrates all the hard work that has gone into developing this transformational device.”
About the alfapump
Sequana Medical’s alfapump is a fully implantable, wirelessly charged device which continuously collects ascites as it forms in the abdominal cavity and moves it into the bladder, where it is naturally passed from the body through urination. In Europe, the alfapump has received CE mark-approval for the treatment of refractory ascites due to liver cirrhosis and malignant ascites and has been included in key European treatment guidelines. In the US, the Company’s key growth market, the alfapump has been granted breakthrough device designation by the Food and Drug Administration (FDA) for the treatment of recurrent or refractory ascites due to liver cirrhosis. The POSEIDON study, intended to support the approval of the alfapump in North America, reported strong top-line results meeting all primary efficacy endpoints with statistical significance and safety in line with expectations. Filing of the Pre-Market Approval (PMA) application with the US FDA is planned for H2 2023. Sequana Medical plans to commercialize the alfapump directly in the US, using a specialized in-house sales force targeting 90 liver transplant centers (covering 95% of adult liver transplants). The North American market for the alfapump is forecast to grow at a Compound Annual Growth Rate (CAGR) of 6-7%, from over 75,000 patients in 2025, reaching a market opportunity of over $2.5 billion by 2035, with NASH being the major driver of growth.
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About Sequana Medical
Sequana Medical NV is a pioneer in treating fluid overload, a serious and frequent clinical complication in patients with liver disease, heart failure and cancer. These patients can have up to 15 liters of extra fluid in their bodies, causing major medical issues including increased mortality, repeated hospitalizations, severe pain, difficulty breathing and restricted mobility that severely impacts daily life. Although diuretics are standard of care, the problem is that in many patients they are no longer effective and / or tolerable. There are limited effective treatment options for these patients, resulting in poor clinical outcomes, high costs and a major impact on their quality of life. Sequana Medical is seeking to provide innovative treatment options for this large and growing “diuretic-resistant” patient population.
alfapump® and DSR® are Sequana Medical’s proprietary platforms that work with the body to treat diuretic-resistant fluid overload, delivering major clinical and quality of life benefits for patients and reducing costs for healthcare systems. The Company has reported positive primary endpoint data from the North American pivotal POSEIDON trial of the alfapump in recurrent or refractory ascites due to liver cirrhosis, enabling the filing of a Pre-Market Approval (PMA) application with the FDA, planned for H2 2023. Having delivered clinical proof-of-concept for DSR as a disease-modifying drug program for the treatment of heart failure, the Company has commenced MOJAVE, a US randomized controlled multi-center Phase 1/2a clinical trial of DSR 2.0, with initial data expected in Q4 2023.
Sequana Medical is listed on Euronext Brussels (Ticker: SEQUA.BR) and headquartered in Ghent, Belgium. For further information, please visit www.sequanamedical.com.
Important Regulatory Disclaimers
The alfapump® system is currently not approved in the United States or Canada. In the United States and Canada, the alfapump system is currently under clinical investigation (POSEIDON Trial) and is being studied in adult patients with refractory or recurrent ascites due to cirrhosis. DSR® therapy is still in development and it should be noted that any statements regarding safety and efficacy arise from ongoing pre-clinical and clinical investigations which have yet to be completed. There is no link between DSR therapy and ongoing investigations with the alfapump system in Europe, the United States or Canada.
Note: alfapump® and DSR® are registered trademarks.
Such forward-looking statements are not guarantees of future performance. These forward-looking statements represent the current judgment of Sequana Medical on what the future holds, and are subject to risks and uncertainties that could cause actual results to differ materially. Sequana Medical expressly disclaims any obligation or undertaking to release any updates or revisions to any forward-looking statements in this press release, except if specifically required to do so by law or regulation. You should not place undue reliance on forward-looking statements, which reflect the opinions of Sequana Medical only as of the date of this press release.