An investment in the offered shares involves substantial risks and uncertainties. Prospective investors should read the entire Prospectus that will be prepared by the Company, and, in particular, should see the section "Risk Factors" of the Prospectus for a discussion of certain factors that should be considered in connection with an investment in the offered shares. The risk factors that will be described in the Prospectus will include the risks that Sequana Medical has incurred operating losses, negative operating cash flows and an accumulated deficit since inception and may not be able to achieve or subsequently maintain profitability, that Sequana Medical's future financial performance will depend on the commercial acceptance of the alfa pump ® (Sequana Medical's only commercial-stage product to date), the alfa pump ® DSR and/or any future products in target markets, that Sequana Medical will likely require additional funds in the future in order to meet its capital and expenditure needs and further financing may not be available when required or could significantly limit Sequana Medical's access to additional capital, and that, not taking into account any proceeds of the Offering, Sequana Medical does not have sufficient working capital to meet its working capital needs for a period of at least 12 months from the date of the Prospectus. All of these factors should be considered before investing in the offered shares. Prospective investors must be able to bear the economic risk of an investment in the offered shares and should be able to sustain a partial or total loss of their investment.
Press Release
Sequana Medical receives Breakthrough Device designation from the FDA for its alfa pump ®
Administrative process for the move of its business from Switzerland to Belgium completed
Ghent, BELGIUM – 29 January 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 U.S. Food and Drug Administration (FDA) has granted Breakthrough Device designation for the alfa pump® for the treatment of liver recurrent or refractory ascites.
The FDA’s Breakthrough Devices Program is designed to facilitate the development and expedite the review of devices that provide more effective treatment or diagnosis of life-threatening or irreversibly debilitating diseases or conditions, and to provide patients and healthcare providers with timely access to these medical devices. Devices that receive this designation are eligible for more frequent interactions with the FDA’s experts to identify areas of agreement in a timely way and are eligible for prioritized review of the submission package to obtain regulatory approval in the U.S.
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 recurrent or 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 carry the risk of significant or life-threatening side effects, provide only short-term symptomatic relief or have very limited availability.
The alfa pump® 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. The potential of the alfa pump® to address this unmet medical need in patients with liver recurrent or refractory ascites has been demonstrated in multiple clinical studies showing 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.
A feasibility study in North America 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. Preparations are underway to start a North American pivotal study in the second half of this year for approval of the alfa pump® in North America.
Dr Patrick S. Kamath, Professor of Medicine at the Mayo Clinic, College of Medicine and Science Rochester MN commented: “This is encouraging news for patients and their families. Patients suffering from recurrent or refractory ascites currently have limited treatment options. Ascites significantly reduces quality of life and requires frequent visits to a medical facility for treatment. The alfa pump® treats ascites at home without the risk of hepatic encephalopathy and is associated with improved quality of life. The designation of FDA Breakthrough Device status for the alfa pump® could make a much needed effective treatment of refractory or recurrent ascites available sooner for doctors and their patients.”
Ian Crosbie, Chief Executive Officer at Sequana Medical, added: “The designation of Breakthrough Device status by the FDA is a recognition both of the high unmet medical need in patients with recurrent or refractory ascites and the potential for the alfa pump® to improve the lives of these patients. The forecast growth in liver cirrhosis resulting from NASH makes the need for improved treatments all the more important. We look forward to continuing to work with the FDA to expedite the development process and bring the alfa pump® to U.S. patients as quickly as possible.”
Update regarding the status of the Initial Public Offering on Euronext Brussels: The administrative process for the move of Sequana Medical’s business from Switzerland to Belgium has been completed. Meanwhile, the IPO preparations continue being progressed according to plan, and the Company will provide a further update on the IPO process in due course.
Contacts: 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 ENDS
Note to Editors
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 alfa pump ® 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 alfa pump ® systems have been implanted and since April 2018, the alfa pump ® has been included in the EASL (European Association for the Study of the Liver) clinical practice guidelines for decompensated cirrhosis. The alfa pump ® 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 alfa pump ® has not yet received regulatory approval in the United States (the "U.S.").
The alfa pump ® 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 alfa pump ® prevents fluid build-up and its possible complications, improving patient quality of life and nutrition, and potentially reducing hospital visits and healthcare costs. The alfa pump ® DirectLink technology allows clinicians to receive pump performance information and more effectively manage patients treated by the alfa pump ® .
Sequana Medical is developing the alfa pump ® DSR, built upon the proven alfa pump ® 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 .
Important Regulatory Disclaimer
Any statement in this press release about safety and efficacy of the alfa pump ® does not apply to the U.S. and Canada because the device is currently undergoing clinical investigation in these territories.
Important Information
This announcement does not constitute, or form part of, an offer or invitation to sell or issue, or any solicitation of an offer to purchase or subscribe for shares of Sequana Medical NV (the "Company"). Any purchase of, subscription for or application for, shares in the Company to be issued in connection with the intended offering should only be made on the basis of information contained in the prospectus in connection with the intended offering and any supplements thereto, as the case may be (the "Prospectus"). When the Prospectus is published (as the case may be), it will (inter alia) be made available to prospective investors at no cost at the Company's registered office. Subject to country restrictions, the Prospectus will also be available to prospective investors on the following website: www.sequanamedical.com .
This announcement is not a prospectus. The information contained in this announcement is for informational purposes only and does not purport to be full or complete. Investors should not subscribe for any securities referred to in this document except on the basis of information contained in the Prospectus that the Company expects to publish after its approval by the Belgian Financial Services Markets Authority. The Prospectus will contain detailed information about the Company and its business, management, risks associated with investing in the Company, as well as financial statements and other financial data. This announcement cannot be used as basis for any investment agreement or decision.
This announcement is not for distribution, directly or indirectly, in or into the United States or to any U.S. person within the meaning of the United States Securities Act of 1933, as amended (the "U.S. Securities Act"). It does not constitute or form a part of any offer or solicitation to purchase or subscribe for securities in the United States. The securities mentioned herein have not been, and will not be, registered under the U.S. Securities Act and may not be offered or sold in the United States, except pursuant to an exemption from, or in a transaction not subject to, the registration requirements of the U.S. Securities Act. The Company has not registered, and does not intend to register, any portion of the intended offering of the offered shares in the United States, and does not intend to conduct a public offering of securities in the United States.
This announcement is only addressed to and directed at persons in member states of the European Economic Area ("EEA") other than Belgium who are "qualified investors" within the meaning of Article 2(1)(e) of the Prospectus Directive (Directive 2003/71/EC and amendments thereto, including Directive 2010/73/EU, to the extent implemented in the relevant Member State of the EEA, and together with any implementing measure in each relevant Member State of the EEA, the "Prospectus Directive"). In addition, in the United Kingdom, this announcement is only addressed to and directed at (i) persons having professional experience in matters relating to investments falling within the definition of "investment professionals" in Article 19(5) of the Financial Services and Markets Act 2000 (Financial Promotion) Order 2005, as amended (the "Order"), (ii) high net worth entities, etc. falling within Article 49(2)(a) to (d) of the Order, and (iii) any other person to whom it may otherwise lawfully be communicated (all such persons together being referred to as "relevant persons"). The intended offering, as the case may be, will only be available to, and any invitation, offer or agreement to subscribe for, purchase, or otherwise acquire securities will be engaged in only with relevant persons. Any person who is not a relevant person should not act or rely on this announcement or any of its contents.
This announcement and the information contained herein does not constitute an offer to sell nor a solicitation to buy securities of the Company and it does not constitute a prospectus or a similar communication within the meaning of article 752, 652a and/or 1156 of the Swiss Code of Obligations or a listing prospectus within the meaning of the listing rules of the SIX Swiss Exchange.
This announcement and the information contained herein are not for publication, distribution or release in, or into, the United States of America, Australia, Canada, Japan, South Africa or any other jurisdiction where to do so would be prohibited by applicable law.
The date of completion of listing on the regulated market of Euronext Brussels may be influenced by things such as market conditions. There is no guarantee that such listing will occur and investors should not base their financial decisions on the Company's intentions in relation to such listing at this stage.
Acquiring investments to which this announcement relates may expose an investor to a significant risk of losing the entire amount invested. Persons considering such investments should consult an authorised person specialising in advising on such investments. This announcement does not constitute a recommendation concerning the intended offering. The value of the shares can decrease as well as increase. Potential investors should consult a professional advisor as to the suitability of the intended offering for the person concerned.
No action has been taken by the Company that would permit an offer of Company's shares or the possession or distribution of these materials or any other offering or publicity material relating to such shares in any jurisdiction outside of Belgium where action for that purpose is required. The release, publication or distribution of these materials in certain jurisdictions may be restricted by law and therefore persons in such jurisdictions into which they are released, published or distributed, should inform themselves about, and observe, such restrictions. The issue, the subscription for or purchase of shares of the Company can be subject to special legal or statutory restrictions in certain jurisdictions. The Company is not liable if the aforementioned restrictions are not complied with by any person.
The contents of this announcement include statements that are, or may be deemed to be, "forward-looking statements". In some cases, forward-looking statements can be identified by the use of forward-looking terminology, including the words "believes", "estimates," "anticipates", "expects", "intends", "may", "will", "plans", "continue", "ongoing", "potential", "predict", "project", "target", "seek" or "should" or, in each case, their negative or other variations or comparable terminology or by discussions of strategies, plans, objectives, targets, goals, future events or intentions. Forward-looking statements include statements regarding the Company's intentions, beliefs or current expectations concerning, among other things, its results of operations, prospects, growth, strategies and dividend policy and the industry in which the Company operates. By their nature, forward-looking statements involve known and unknown risks and uncertainties. New risks can emerge from time to time, and it is not possible for the Company to predict all such risks, nor can the Company assess the impact of all such risks on its business or the extent to which any risks, or combination of risks and other factors, may cause actual results to differ materially from those contained in any forward-looking statements. Forward-looking statements are not guarantees of future performance. Given these risks and uncertainties, the reader should not rely on forward-looking statements as a prediction of actual results. Without prejudice to the Company's obligations under applicable law in relation to disclosure and ongoing information, the Company does not intend, and does not assume any obligation, to update forward-looking statements.
KBC Securities NV/SA, Kempen & Co N.V. and Mirabaud Securities Limited (the "Underwriters") are acting for the Company and no one else in relation to the intended offering, and will not be responsible to anyone other than the Company for providing the protections offered to their respective clients nor for providing advice in relation to the intended offering.
The Company assumes responsibility for the information contained in this announcement. None of the Underwriters or any of their respective affiliates or any of their respective directors, officers, employees, advisers or agents accepts any responsibility or liability whatsoever for or makes any representation or warranty, express or implied, as to the truth, accuracy or completeness of the information in this announcement (or whether any information has been omitted from the announcement) or any other information relating to the Company, whether written, oral or in a visual or electronic form, and howsoever transmitted or made available or for any loss howsoever arising from any use of this announcement or its contents or otherwise arising in connection therewith. Each of the Underwriters and each of their respective affiliates accordingly disclaim, to the fullest extent permitted by applicable law, all and any liability whether arising in tort, contract or otherwise which they might otherwise be found to have in respect of this announcement or any such statement or information. No representation or warranty express or implied, is made by any of the Underwriters or any of their respective affiliates as to the accuracy, completeness, verification or sufficiency of the information set out in this announcement, and nothing in this announcement will be relied upon as a promise or representation in this respect, whether or not to the past or future.
