Press release: Sequana Medical to Sponsor Liver Connect, 5th Annual Conference of Chronic Liver Disease Foundation

/EIN News/ -- Sequana Medical to Sponsor Liver Connect, 5^th Annual Conference of Chronic Liver Disease Foundation

Ghent, Belgium – 20 March 2025 – Sequana Medical NV (Euronext Brussels: SEQUA, the "Company" or "Sequana Medical"), a pioneer in the treatment of drug-resistant fluid overload in liver disease, heart failure and cancer, today announces that it is a silver sponsor of the Chronic Liver Diease Foundation’s (“CLDF”) 5th annual Liver Connect conference taking place in San Antonio, Texas (US) from 20-22 March 2025. Sequana Medical’s management will attend the conference and are available to meet.

CLDF is comprised of leading hepatology specialists committed to raising awareness of the effects of chronic liver disease and sharing latest insights and analyses with the global healthcare community and patients. The Liver Connect conference aims to bridge the gap between scientific discoveries and the practical applications of clinical evidence for healthcare professionals involved in liver disease care, including gastroenterologists, hepatologists, advanced practice providers (APPs), primary care physicians, endocrinologists, and other relevant practitioners. Over 500 participants attended the 2024 conference.

Dr. Saab, MD, MPH, Professor in the Departments of Medicine and Surgery at the David Geffen School of Medicine at UCLA (University of California Los Angeles) and Liver Connect course director commented: “I am delighted that Sequana Medical is a sponsor the 2025 Liver Connect conference. Following the US PMA approval of this breakthrough device, the conference is the ideal opportunity to present alfapump to the US hepatology community. For too long, US patients and doctors have had to put up with limited treatment options for recurrent or refractory ascites due to liver cirrhosis, and I believe that the alfapump has the potential to transform the care of these patients.”

Martijn Blom, Chief Commercial Officer of Sequana Medical NV, continued: "We are delighted to be sponsoring this prestige event of the US hepatology community. We have been very impressed with the CLDF’s commitment to bringing the latest clinical innovations to their members and this conference is an excellent opportunity to present the alfapump to this community.”

For more information, please contact:
Sequana Medical
Investor relations
E: IR@sequanamedical.com
T: +44 (0) 797 342 9917

About alfapump in recurrent or refractory ascites due to liver cirrhosis & the POSEIDON study
Recurrent or refractory ascites is a severe condition characterized by the accumulation of fluid in the abdomen. The current standard treatment involves therapeutic paracentesis, an invasive and burdensome procedure that drains ascites from the abdomen using a large needle over an extended period. The alfapump is approved by the US FDA for the treatment of recurrent or refractory ascites due to liver cirrhosis. It is the first active implantable medical device in the US that automatically and continuously removes ascites from the abdomen into the bladder, where it is naturally eliminated through urination.   To date, over 1,000 alfapump systems have been implanted.

The US market of recurrent and refractory ascites due to liver cirrhosis is forecast to grow by an average of 9% per year, from approximately 70,000 patients in 2025 to 130,000 patients by 2032, primarily driven by the increasing prevalence of NASH / MASH¹. The total market opportunity for alfapump is estimated at over $2 billion in 2025, including approximately $500 million from the Company’s initial priority target market of patients requiring at least 12 paracenteses per year.

The FDA’s approval of the PMA is based on the successful execution of Sequana Medical’s pivotal POSEIDON study, a landmark study across 18 centers in the US and Canada with a total of 69 patients implanted with the alfapump. The primary effectiveness endpoints at six months post-implantation in the Pivotal Cohort² exceeded the predefined thresholds with statistical significance, and primary safety endpoint data was in line with expectations³. Data at 12 months post-implantation continued to show a strong and durable clinical profile, virtually eliminating the need for therapeutic paracentesis and delivering an improvement in quality of life (as defined by subjective physical health (assessed by SF-36 PCS) and ascites symptoms (assessed by Ascites Q))⁴. At AASLD’s The Liver Meeting in November 2024, key POSEIDON investigators reported that the alfapump virtually eliminated the need for large volume paracentesis at 24 months, with overall survival of 62%⁵.

Data from the patient preference study and a matched cohort analysis of the NACSELD-III registry with the POSEIDON Pivotal Cohort indicated that US patients have a strong preference for the alfapump vs standard paracentesis procedures and that the safety profile of the alfapump is comparable to standard of care.⁶

About Sequana Medical

Sequana Medical NV is a pioneer in treating fluid overload, a serious and frequent clinical complication in patients with liver disease, heart failure and cancer. This causes major medical issues including increased mortality, repeated hospitalizations, severe pain, difficulty breathing and restricted mobility. Although diuretics are standard of care, they become ineffective, intolerable or exacerbate the problem in many patients. There are limited effective treatment options, resulting in poor clinical outcomes, high costs and a major impact on their quality of life. Sequana Medical is seeking to provide innovative treatment options for this large and growing "diuretic resistant" patient population. alfapump® and DSR® are Sequana Medical's proprietary platforms that work with the body to treat diuretic-resistant fluid overload, and are intended to deliver major clinical and quality of life benefits for patients, while reducing costs for healthcare systems.

The Company received US FDA approval for the alfapump System for the treatment of recurrent or refractory ascites due to liver cirrhosis in December 2024, following the grant of FDA Breakthrough Device Designation in 2019. Sequana Medical intends to start US commercialisation early in mid-Q3 2025 through a small specialty salesforce that it will establish to target the 90 US liver transplant centers that perform 95% of liver transplants.

Results of the Company's RED DESERT and SAHARA proof-of-concept studies in heart failure published in European Journal of Heart Failure in April 2024 support DSR's mechanism of action as breaking the vicious cycle of cardiorenal syndrome. All three patients from the non-randomized cohort of MOJAVE, a US randomized controlled multi-center Phase 1/2a clinical study, have been successfully treated with DSR, resulting in a dramatic improvement in diuretic response and virtual elimination of loop diuretic requirements⁷.

Sequana Medical is listed on the regulated market of Euronext Brussels (Ticker: SEQUA.BR) and headquartered in Ghent, Belgium. For further information, please visit www.sequanamedical.com.

Important Safety Information: For important safety information regarding the alfapump® system, see https://www.sequanamedical.com/wp-content/uploads/ISI.pdf.

The alfapump® System is currently not approved in Canada.

DSR® therapy is still in development and is currently not approved in any country. The safety and effectiveness of DSR® therapy has not been established.

Note: alfapump® and DSR® are registered trademarks.

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.

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¹ Based on US and Canada market assessment conducted by highly experienced international consulting group
² The Pivotal Cohort is used for the primary effectiveness endpoints and consists of 40 patients implanted with the alfapump
³ Data reported in press release of 25 October 2022
⁴ Data reported in press release of 19 October 2023
⁵ Based upon the pivotal cohort of the POSEIDON study, data reported in press release of 18 November 2024
⁶ Data reported in press release of 19 October 2023; Patient Preference study conducted by RTI Health Solutions, and matched cohort analysis presented by Dr. Bajaj at EASL Congress 2024.
⁷ Data reported in press release of March 25, 2024; mean increase of 326% in six-hour urinary sodium excretion at 3 months follow up vs baseline, and 95% reduction of loop diuretics over same period

Attachments

• 20250320 Press release_Sponsor Liver Connect_CLDF (NL)
• 20250320 Press release_Sponsor Liver Connect_CLDF (ENG)