News

Ghent, BELGIUM – 19 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 the appointments of Dr. Javed Butler, Dr. Maria Rosa Costanzo, Dr. Wilson Tang and Dr. Jeffrey Testani as the Company’s Heart Failure Scientific Advisors.

The Sequana Medical management team will work closely with the Scientific Advisors on the development of alfapump DSR (Direct Sodium Removal). Built on its proven alfapump platform, alfapump DSR is Sequana Medical’s breakthrough approach for the management of fluid overload in patients suffering from heart failure. Positive data from the first-in-human single dose DSR proof-of-concept study were presented at the Heart Failure 2019 congress in May 2019 and a first-in-human alfapump DSR study is planned to commence later this year, with results expected in the first half of 2020.

“The global heart failure market represents a tremendous opportunity for Sequana Medical and we are honoured to work closely with such prominent experts in the field,” commented Ian Crosbie, Chief Executive Officer of Sequana Medical. “They each bring vast medical and scientific expertise and have all been involved in the development of multiple new treatment options for patients suffering from heart failure. We look forward to rapidly progressing the alfapump DSR clinical development by leveraging our extensive experience of the alfapump in liver disease and malignant ascites.”

“Through my experience with Cameron Health and Boston Scientific, I have seen the value that leading scientific advisors bring to the development of innovative treatment options,” added Pierre Chauvineau, Chairman of Sequana Medical. “Each of these advisors bring invaluable experience to Sequana Medical, which will be key to the success of our alfapump DSR heart failure programme.”

About Dr. Butler

Dr. Butler is the Patrick H. Lehan Chair in Cardiovascular Research, and Professor and Chairman of the Department of Medicine at the University of Mississippi Medical Center. Dr. Butler's research focuses on clinical trials in patients with heart failure. He serves on several national committees including: the American College of Cardiology, American Heart Association, National Institutes of Health, and the Heart Failure Society of America. He is a recipient of the Simon Dack Award by the American College of Cardiology as well as the Time, Feeling, and Focus Award by the American Heart Association. Dr. Butler has authored more than 550 peer-reviewed publications. He serves on the editorial board of several peer-reviewed cardiovascular journals and has been cited in America’s Best Doctors list.

About Dr. Costanzo

Dr. Costanzo is the Medical Director of the Edward Center for Advanced Heart Failure and Medical Director, Heart Failure Research for the Advocate Heart Institute. She is a Fellow of the American College of Cardiology, American Heart Association and European Society of Cardiology. Dr. Costanzo is also a member of the Ordine Dei Medici (The Italian National Medical Professional Association) and a member of the Board of Directors of the Heart Failure Society of America. Dr. Costanzo has led several multi-centre randomised clinical trials, has written more than 200 papers, abstracts and articles and has presented nationally and internationally on numerous topics related to heart failure and cardiac transplantation.

About Dr. Tang

Dr. Tang is Professor of Medicine at Cleveland Clinic Lerner College of Medicine at Case Western Reserve University. Dr. Tang is a practicing heart failure/transplant cardiologist specialising in specific cardiomyopathies, cardio-renal diseases, and cancer-related heart diseases. Dr. Tang is credited for unravelling the contemporary physiologic and molecular understanding of a subset of patients with cardio-renal syndrome, including the recognition of venous congestion, intra-abdominal pressure, and metabolic dysregulation as key determinants. Dr. Tang’s NIH-funded translational research focuses on understanding the mechanisms through which nitrative stress and epigenetics contribute to disease progression in heart failure and cardiomyopathy in humans, with the goal of identifying preventive treatment strategies for heart failure. Dr. Tang has authored over 630 peer-reviewed scientific manuscripts, editorials, and book chapters, which include the latest national heart failure guidelines.

About Dr. Testani

Dr. Testani is Associate Professor of Medicine and Director of Heart Failure Research at Yale University School of Medicine. Dr. Testani’s primary research interest is the mechanistic understanding of cardiac-renal interactions, fluid and sodium homeostasis, and diuretic resistance in heart failure. He has over 100 peer reviewed publications with the key focus of this work understanding cardio-renal interactions in heart failure. His laboratory utilises techniques of translational research using prospective human clinical trials and large animal models to better understand mechanism and develop new therapies and diagnostics. His lab is funded by the National Institutes of Health and industry sources totaling over $15 million, and is considered by many to be amongst the top laboratories in the world in this field of study.

About Sequana Medical

Sequana Medical is a commercial stage medical device company developing the alfapump platform for the management of fluid overload in liver disease, malignant ascites and heart failure. Fluid overload is a fast-growing complication of advanced liver disease driven by NASH (non-alcoholic steatohepatitis) related cirrhosis and a common complication in heart failure. The U.S. market resulting from NASH-related cirrhosis is forecast to exceed €3 billion within the next 10-20 years and the global heart failure market is estimated to be over €5 billion by 2026. Both indications leverage Sequana Medical’s alfapump, a unique, fully implanted wireless device that automatically pumps fluid from the abdomen into the bladder, where it is naturally eliminated through urination.

In the U.S., the company’s key growth market, the alfapump has been granted breakthrough device designation by the FDA. The North American pivotal study in recurrent and refractory ascites due to liver cirrhosis is expected to start in H2 2019 and a commercial launch in the U.S. is planned for H1 2022. 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 700 alfapump devices have been implanted to date.

Building on its proven alfapump platform, Sequana Medical is developing alfapump DSR (Direct Sodium Removal) a breakthrough, proprietary approach for fluid overload due to heart failure. Clinical proof-of-concept was achieved in a first-in-human single dose DSR study and a repeated dose alfapump DSR study in heart failure patients is planned to start in H2 2019, with results expected in H1 2020.

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.

Forward-looking statements

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.