Live webinar with Dr. Vargas and Dr. Knuttinen on 15 July 2021 at 4 pm CET / 10 am ET
Ghent, BELGIUM – 17 June 2021 – Sequana Medical NV (Euronext Brussels: SEQUA, the “Company” or “Sequana Medical”), an innovator in the treatment of diuretic-resistant fluid overload in liver disease, malignant ascites and heart failure, today announces that it will host a Key Opinion Leader (KOL) call on July 15th, 2021 from 4 pm CET / 10 am ET to 5 pm CET / 11 am ET. The KOL call will discuss the impact of recurrent and refractory liver ascites on patients and healthcare systems and the potential of alfapump therapy in NASH-related ascites.
The webinar will feature a testimonial from a patient living with refractory ascites and treated with alfapump, followed by a presentation by KOLs Hugo E. Vargas, M.D. and Grace Knuttinen, M.D., Ph.D., both of Mayo Clinic, who will discuss the impact of ascites on the patients’ quality of life and the limitations of current treatment options. They will also share their experience with the alfapump implantation and discuss its potential in the treatment paradigm for these patients. A Q&A session with the KOLs and Sequana Medical management will follow the formal presentations.
Ascites is the most common reason for hospitalisation of patients with advanced liver disease and is forecast to grow dramatically driven by NASH-related cirrhosis. Sequana Medical’s alfapump has been granted FDA breakthrough device designation for the treatment of recurrent or refractory ascites due to liver cirrhosis.
The alfapump is a fully implantable pump system that moves ascites from the peritoneal cavity into the bladder, where it is passed naturally from the body through urination. The alfapump is approved in Europe and POSEIDON, the North American pivotal study to support regulatory approval in the US and Canada is underway. Positive interim data from the POSEIDON study were reported in November 2020 with further interim data expected in Q2 2021 and primary endpoint data in Q2 2022.
The webinar will be webcasted live at https://media.rampard.com/20210715b/. To get access to the webinar a registration in advance is required. The presentation and a replay of the webinar will be available on the website of Sequana Medical shortly after the event.
For more information, please contact:
Director Investor Relations
Tel: +32 498 05 35 79
Guillaume van Renterghem
Tel: +41 76 735 01 31
About Dr. Vargas
Hugo E. Vargas, M.D. is a Mayo Clinic Consultant in the Department of Gastroenterology and Hepatology and the Mayo Clinic Transplantation Center. His current clinical and research interests include management of cirrhosis complications, acute chronic liver disease and alcohol related liver disease. Dr. Vargas is the Medical Director for the Office of Clinical Research – Arizona and a Professor of Medicine in the Mayo Clinic Alix School of Medicine and is the Chair of the Clinical Research Subcommittee, and the Vice Chair of the Arizona Research Operations Management Team. Dr. Vargas received his M.D. from Hahnemann University Graduate School of Medicine, has authored or coauthored more than 125 peer-reviewed articles and is a Fellow of the AASLD, AGA, ACG, ASGE and ACP.
About Dr. Knuttinen
Grace Knuttinen, M.D., Ph.D. is a Mayo Clinic Consultant and Professor in the Department of Radiology. She is an interventional radiologist with Mayo Clinic in Phoenix, with clinical and research interests in hepatobiliary disease, the management of post liver transplant complications, and vascular disease. Dr. Knuttinen has more than 20 years’ experience in interventional radiology and is a member of the Leadership Academy of the Society of Interventional Radiology and an Invited ABR Board Examiner for International Radiology at the American Board of Radiology. She is the Director for the Mayo Alix School of Medicine Dual Degree program, and the Director for the Barretts ASU- Mayo Alix School of Medicine Premedical Scholars program. Dr. Knuttinen received her M.D. and Ph.D. from Northwestern University, has coauthored over 95 peer-reviewed articles and written 13 book chapters. She is a Fellow of the Society of Interventional Radiology (SIR) and is the chair of a national SIR committee and currently the principal investigator of an ongoing national prospective funded clinical trial.
About Sequana Medical
Sequana Medical is a commercial stage medical device company utilizing its proprietary alfapump® and DSR® (Direct Sodium Removal) technologies to develop innovative treatments for fluid overload in liver disease, malignant ascites and heart failure where diuretics are no longer effective. Fluid overload is a frequent complication of many large diseases including advanced liver disease driven by NASH (non-alcoholic steatohepatitis)-related cirrhosis and heart failure, with diuretic resistance being widespread. The U.S. market for the alfapump resulting from NASH-related cirrhosis is forecast to exceed €3 billion annually within the next 10-20 years. The heart failure market for DSR and the alfapump DSR® is estimated to be over €5 billion annually in the U.S. and EU5 by 2026.
The alfapump is a unique, fully implanted wireless device that automatically pumps fluid from the abdominal cavity into the bladder, where it is naturally eliminated through urination. DSR is Sequana Medical’s proprietary approach to managing sodium and fluid overload through use of a sodium-free infusate administered into the abdominal cavity.
In the U.S., the Company’s key growth market, the alfapump has been granted breakthrough device designation by the FDA for recurrent or refractory ascites due to liver cirrhosis. Interim data from the ongoing North American pivotal study (POSEIDON) showed positive outcomes against all primary endpoints of the study. This study is intended to support a future marketing application of the alfapump in the U.S. and Canada. In Europe, the alfapump is CE-marked for the management of refractory ascites due to liver cirrhosis and malignant ascites and is included in key clinical practice guidelines. Over 850 alfapump systems have been implanted to date.
Sequana Medical has combined its proven alfapump and proprietary DSR therapy, and is developing the alfapump DSR, a breakthrough approach to fluid overload due to heart failure. RED DESERT, the repeated dose alfapump DSR study in diuretic-resistant heart failure patients has demonstrated that repeated DSR therapy is able to both manage the fluid and sodium balance of these patients as well as restore their diuretic response and improve their cardio-renal status. The SAHARA DESERT study of alfapump DSR in decompensated heart failure patients is ongoing.
Sequana Medical is headquartered in Ghent, Belgium. For further information, please visit www.sequanamedical.com.
Important Regulatory Disclaimers
The alfapump® system is not currently approved in the United States or Canada. In the United States and Canada, the alfapump® system is currently under clinical investigation (POSEIDON Study) and is being studied in adult patients with refractory or recurrent ascites due to cirrhosis. For more information regarding the POSEIDON clinical study see www.poseidonstudy.com. The DSR® therapy is still in development and it should be noted that any statements regarding safety and efficacy arise from ongoing pre-clinical and clinical investigations which have yet to be completed. The DSR® therapy is not currently approved for clinical research in the United States or Canada. There is no link between the DSR® therapy and ongoing investigations with the alfapump® system in Europe, the United States or Canada.
Note: alfapump® is a registered trademark. DSR® and alfapump DSR® are registered trademarks in the Benelux.
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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