Presentations on alfapump® and alfapump DSR at DGVS and TCT
Ghent, BELGIUM – 12 September 2019 – Sequana Medical NV (Euronext Brussels: SEQUA), innovators in the management of fluid overload in liver disease, malignant ascites and heart failure, today announces that it will be attending the following upcoming scientific conferences:
- HFSA 23rd Annual Scientific Meeting
- Heart Failure Society of America, 13-15 September 2019, Philadelphia, U.S.
- TCT 2019
- Transcatheter Cardiovascular Therapeutics, 25-30 September 2019, San Francisco, U.S.
- Presentation by Dr Jeffrey Testani on 28 September 2019: “Direct Sodium Removal with an ambulatory peritoneal dialysis system”
- DGVS 2019
- German Society of Gastroenterology, Digestive and Metabolic Diseases, 2-5 October 2019, Wiesbaden, Germany
- Lunch Symposium with Prof Trebicka, Prof Wong and Dr Herber on 4 October 2019: “Refractory Ascites: Reduce Fluid – Increase Quality of Life”
- AASLD – The Liver Meeting 2019
- American Association for the Study of Liver Diseases, 8-12 November 2019, Boston, U.S.
If you would like to meet with the Sequana Medical management team during one of these conferences, please contact IR@sequanamedical.com or one of the contacts listed below.
Presentations will be available on the Company’s website at www.sequanamedical.com/news-events/events-presentations/.
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 in 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 ascites due to cirrhosis is forecast to increase dramatically particularly in the U.S. due to the growing prevalence of NASH (Non-alcoholic Steatohepatitis), causing cirrhosis.
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 pivotal POSEIDON study in patients with cirrhosis and recurrent or refractory ascites is planned to start in the second half of 2019 and is expected to support approval of the alfapump in North America.
Sequana Medical has leveraged its alfapump experience and is developing alfapump DSR (Direct Sodium Removal) to deliver a 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.
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