14th August 2019
Sequana Medical announces date change for Half Year 2019
Business Update and Financial Results
Results and conference call with live webcast will take place on 25 September 2019
Ghent, BELGIUM – 14 August 2019 – Sequana Medical NV (Euronext Brussels: SEQUA), innovators in the management of fluid overload in liver disease, malignant ascites and heart failure, announces today that it has changed the date of its Half Year 2019 Results to Wednesday, 25 September 2019.
The management team will host a conference call with a live webcast presentation at 14.00 CEST / 08.00 ET on the day of the results.
The webcast can be accessed by registering here. To participate in the Q&A, please dial one of the numbers below, using confirmation code 475648. The webcast and conference call will be conducted in English and a replay will be available on the Company’s website shortly thereafter.
Belgium: +32 2 792 0434
Switzerland: +41 43 456 9986
The Netherlands: +31 20 794 8426
U.K.: +44 20 3003 2666
U.S.: +1 212 999 6659
For more information, please contact:
Lies Vanneste, Director IR
Tel: +32 498 05 35 79
Consilium Strategic Communications
Amber Fennell, Sukaina Virji, Melissa Gardiner
Tel: +44 203 709 5000
Tel: +41 79 367 6254
About Sequana Medical
Sequana Medical is a commercial stage medical device company focused on the development of innovative treatment options for the management of fluid overload due to liver disease, malignant ascites and heart failure.
Sequana Medical's technology is based on its proprietary alfapump platform, which is applicable across multiple life-threatening disorders. The alfapump is being commercialised in Europe for the management of refractory ascites (chronic fluid build-up in the abdomen) due to liver cirrhosis and malignant ascites. The number of patients with refractory liver ascites is forecast to increase dramatically due to the growing prevalence of NASH (Non-alcoholic Steatohepatitis).
Over 700 alfapump systems have been implanted to date. The alfapump has been endorsed by key independent third parties in Europe and has been included in the EASL (European Association for the Study of the Liver) clinical practice guidelines for decompensated cirrhosis, the German treatment guidelines (DGVS) for complications of liver cirrhosis and the U.K. NICE interventional procedure guidance for treatment of refractory ascites caused by cirrhosis. In January 2019, the U.S. FDA granted Breakthrough Device designation to the alfapump for the treatment of recurrent or refractory liver ascites. The Company expects to start POSEIDON, the North American pivotal study, in the second half of 2019 to support approval of the alfapump in recurrent or refractory liver ascites.
Sequana Medical has leveraged its alfapump experience and is developing alfapump DSR (Direct Sodium Removal) to deliver a convenient and fully implanted system for DSR therapy, its novel and proprietary approach for the management of volume overload in patients suffering from heart failure. Volume overload is a major clinical problem in heart failure, a condition that results in $13 billion of U.S. hospital admission costs annually.
Data from the first-in-human single dose DSR proof-of-concept study presented at Heart Failure 2019 demonstrated that DSR can result in the removal of large quantities of sodium and fluid in a safe and tolerable manner. The first clinical study of alfapump DSR in patients with volume overload due to heart failure is expected to start in the second half of 2019.
Sequana Medical is headquartered in Ghent, Belgium. For further information, please visit www.sequanamedical.com.
Important Regulatory Disclaimers
The alfapump has not yet received regulatory approval in the U.S. and Canada. 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.
DSR therapy is still in development and it should be noted that any statements in this press release regarding safety and efficacy arise from pre-clinical studies and ongoing 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 U.S. and Canada.
This press release may contain predictions, estimates or other information that might be considered forward-looking statements. 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.