Sequana Medical announces terms of its IPO on Euronext Brussels

– BELGIUM, Ghent –   Sequana Medical NV, 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, today announced the terms of its 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 is an offering of up to 3,235,294 new shares of the Company.

The Company estimates to receive net proceeds of approximately €23.4 million in case of a placement of the maximum number of New Shares in the Offering and approximately €31.8 million in case of a placement of the maximum number of Offered Shares in the Offering. The principal purpose of the Offering is to obtain additional capital to support the execution of the Company’s strategy. In particular, the Issuer intends to use the net proceeds of the Offering to fund:

  • POSEIDON, the North American pivotal study on the alfapump for the treatment of liver recurrent and refractory ascites;
  • the European commercial roll-out;
  • the development of the alfapump DSR, the Company’s breakthrough therapy for the management of volume overload in heart failure, including the Single Dose DSR Proof of Concept and Repeated Dose DSR Proof of Concept ;
  • other clinical programmes, including a study on the alfapump for malignant ascites (which management estimates will cost around €1 million to complete), TOPMOST, a registry for cirrhosis patients that have been implanted with the alfapump and a study on the impact of albumin replacement therapy on clinical outcomes in alfapump patients ;
  • partial repayment of the principal outstanding under the loan with Bootstrap Europe S.C.Sp., equal to a maximum of €1.5 million, payment of €0.44 million in accrued and unpaid interest on the loan and payment of up to €0.33 million for the portion of the ‘Exit Fee’ under the Bootstrap Loan that is payable in cash;
  • general corporate purposes.

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 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.

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