Regulated Information
Ghent, BELGIUM – 26 March 2019 (19:00 CET) – Sequana Medical NV [Euronext Brussels: SEQUA] (“Sequana Medical”, the “Company”) today invited the holders of securities issued by the Company to attend an extraordinary shareholders’ meeting before notary public on Thursday 25 April 2019.
The agenda items of the extraordinary shareholders’ meeting relate to a number of proposed technical amendments to the articles of association of the Company.
The extraordinary shareholders’ meeting will take place at the Company’s registered offices in Ghent and will start at 9:00 CET. The full convening notice with the agenda and proposed resolutions can be consulted on the website of Sequana Medical: www.sequanamedical.com/investors/shareholder-information/.
For more information, please contact:
Sequana Medical
Lies Vanneste
Director IR
Tel: +32 (0) 498 05 35 79
Email: IR@sequanamedical.com
Consilium Strategic Communications
Alexandra Harrison, Marieke Vermeersch, Sukaina Virji
Tel: +44 (0) 203 709 5000
Email: sequanamedical@consilium-comms.com
About Sequana Medical
Sequana Medical is 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.
Sequana Medical’s alfapump® is a fully implantable, programmable, wirelessly-charged, battery-powered system that is CE-marked for the management of i) refractory ascites (chronic fluid build-up in the abdomen) due to liver cirrhosis and ii) malignant ascites (with a life expectancy of six months or less). The number of patients with liver refractory ascites is forecast to increase dramatically due to the growing prevalence of NASH (Non-alcoholic Steatohepatitis).
Over 650 alfapump systems have been implanted and since April 2018, the alfapump has been included in the EASL (European Association for the Study of the Liver) clinical practice guidelines for decompensated cirrhosis. In January 2019, the FDA has granted Breakthrough Device designation for the alfapump for the treatment of liver recurrent or refractory ascites. The alfapump MOSAIC North American IDE feasibility study in patients with liver refractory or recurrent ascites has been completed and results were presented at the AASLD (American Association for the Study of Liver Diseases) annual meetings in October 2017 and November 2018. The alfapump has not yet received regulatory approval in the U.S.
The alfapump is one of the first safe and effective, long-term alternatives to large-volume paracentesis which is a lengthy, invasive and painful procedure, only providing short-term symptomatic relief, requiring hospital visits and placing a significant burden on the healthcare system and patient quality of life. By automatically and continuously moving ascites to the bladder, where the body eliminates it naturally through urination, the alfapump prevents fluid build-up and its possible complications, improving patient quality of life and nutrition, and potentially reducing hospital visits and healthcare costs. The alfapump DirectLink technology allows clinicians to receive pump performance information and more effectively manage patients treated by the alfapump.
Sequana Medical is developing the alfapump DSR, built upon the proven alfapump platform, to deliver a convenient and fully implanted system for Direct Sodium Removal (“DSR“) therapy, a novel and proprietary approach for the management of volume overload in heart failure. Data from animal studies presented at EuroPCR 2018 and HFSA 2018 indicate that DSR therapy is effective and safe. A first in human study for DSR therapy is ongoing. Treatment of volume overload in diuretic-resistant heart failure patients is a major clinical challenge. There are an estimated one million hospitalisations due to heart failure in the U.S. each year, of which 90% are due to symptoms of volume overload. The estimated cost of heart failure-related hospitalisations in the U.S. is $13 billion a year.
Sequana Medical is headquartered in Ghent, Belgium. For further information, please visit www.sequanamedical.com.
Important Regulatory Disclaimer
Any statement in this press release about safety and efficacy of the alfapump does not apply to the U.S. and Canada because the device is currently undergoing clinical investigation in these territories.
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