Sequana Medical NV announced today that SFPIM and other existing shareholders have invested an additional EUR 6.3 million in the company's 2025 Convertible Loan, originally announced in March 2025. Combined with the previously announced investment from EQT and Partners in Equity, this brings the total new capital invested in the 2025 Convertible Loan to EUR 10.3 million.
The Belgian medical device company, which specializes in treating drug-resistant fluid overload in liver disease, heart failure and cancer, confirmed that this new investment extends its cash runway into Q1 2026 based on expected drawdowns of the initial EUR 20 million commitment under the GEM committed share subscription facility.
US Commercial Launch on Track
Sequana Medical remains on track for first US sales of the alfapump in Q3 2025 through its own specialty salesforce that will target liver transplant centers. The company reports receiving very positive feedback from US clinicians and expects strong demand based on initial launch center responses.
"We are very grateful for the strong support from SFPIM and other existing shareholders, complementing the previous investment from EQT and Partners in Equity," said Ian Crosbie, Chief Executive Officer of Sequana Medical. "With this additional significant investment, together with our existing financial arrangements, we can move forward with confidence for US commercial launch in Q3."
Production of the alfapump systems for the launch remains on track, with necessary clinical, logistical and quality assurance arrangements for supporting the launch currently underway.
FDA-Approved Innovation for Liver Disease
The alfapump system received US FDA approval in December 2024 for the treatment of recurrent or refractory ascites due to liver cirrhosis, building upon the FDA breakthrough designation received in 2019. It represents 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 worldwide. The device addresses a significant unmet medical need, as recurrent or refractory ascites is a severe condition characterized by fluid accumulation in the abdomen. Current standard treatment involves therapeutic paracentesis, an invasive and burdensome procedure that drains ascites using a large needle over an extended period.
Strong Clinical Evidence from POSEIDON Study
The FDA's approval was based on Sequana Medical's pivotal POSEIDON study, a landmark investigation across 18 centers in the US and Canada with 69 patients implanted with the alfapump. The primary effectiveness endpoints at six months post-implantation in the Pivotal Cohort of 40 patients exceeded predefined thresholds with statistical significance, while primary safety endpoint data was in line with expectations.
Data at 12 months post-implantation continued to demonstrate a strong and durable clinical profile, virtually eliminating the need for therapeutic paracentesis and delivering improvements in quality of life as measured by subjective physical health (SF-36 PCS) and ascites symptoms (Ascites Q).
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%. The POSEIDON manuscript published in the American Journal of Gastroenterology in January 2025 concluded that "the results from the literature indicate that the overall survival of patients with the alfapump was not worse as compared to TIPS and was higher than reported for standard of care (LVP)."
Substantial Market Opportunity
The US market for 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/MASH. The total market opportunity for alfapump is estimated at over $2 billion in 2025, and is forecast to reach over $5 billion by 2035.
Sequana Medical plans to commercialize through a small specialty salesforce targeting the 90 US liver transplant centers that perform 95% of liver transplants. Data from patient preference studies and matched cohort analysis indicated that US patients have a strong preference for the alfapump versus standard paracentesis procedures, with a safety profile comparable to standard of care.
Investor Confidence
Céline Vaessen, Chief Investment Officer at SFPIM, expressed strong confidence in the company's progress: "Since we invested in Sequana Medical at the time of the IPO, we have remained a loyal and supportive investor with the aim to bring the alfapump to the patient. We are very pleased with the strong progress the Company has made and are excited to continue supporting the team at this important time."
The investment demonstrates continued institutional support for Sequana Medical's mission to provide innovative treatment options for the large and growing "diuretic resistant" patient population, where limited effective treatment options result in poor clinical outcomes, high costs and major impact on quality of life.
