Publication date: 07/02/2019
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 base offering of 3,235,294 new shares of its Offering (as defined below) is fully covered at the bottom of the price range.
The Company's initial public offering of new shares, with the admission of all of its shares to trading on the regulated market of Euronext Brussels (the "Offering") was announced on 31 January 2019. The Offering relates to an offering of up to 3,235,294 new shares of the Company (the "New Shares", and each existing share or New Share representing the Company's share capital a "Share"). The aggregate number of New Shares offered in the Offering may be increased by up to 15% of the aggregate number of New Shares initially offered (the "Increase Option"). Any decision to exercise the Increase Option will be communicated, at the latest, on the date of the announcement of the final offer price (the "Offer Price"). KBC Securities NV/SA, as stabilisation manager (the "Stabilisation Manager"), acting on behalf of KBC Securities NV/SA, Kempen & Co N.V. and Mirabaud Securities Limited, is expected to be granted a warrant to purchase additional new Shares in a number equal to up to 15% of the number of New Shares subscribed for in the Offering (including the new Shares subscribed for pursuant to the effective exercise of the Increase Option, if any) at the Offer Price to cover over-allotments or short positions, if any, in connection with the Offering (the "Over-allotment Option", and (i) the New Shares, (ii) the additional new Shares issued pursuant to the Increase Option and (iii) the additional new Shares issued pursuant to the Over-allotment Option collectively being referred to as the "Offered Shares"). The price range of the Offering is between EUR 8.50 and EUR 9.00 per Offered Share. The offering period began on 31 January 2019 and is expected to end no later than 4:00 p.m. (CET) on 7 February 2019, subject to early closing or extension.
A prospectus has been approved by the Belgian Financial Services and Markets Authority on 30 January 2019 (the "Prospectus"). This Prospectus is available to prospective investors in Belgium in English and Dutch. The Prospectus will be made available to prospective investors at no cost at the Company's registered office and can be obtained by prospective investors in Belgium on request from KBC Securities NV/SA at www.kbc.be/sequana, www.bolero.be/nl/sequana and www.kbcsecurities.com. Subject to country restrictions, the Prospectus is also available to prospective investors on the following website: www.sequanamedical.com.
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 and investors include NeoMed Management, LSP (Life Science Partners), VI Partners, BioMedPartners, Capricorn Venture Partners, Entrepreneur's Fund, Salus Partners, Newton Biocapital, PMV and SFPI-FPIM. For further information, please visit www.sequanamedical.com.