Sequana Medical
DefunctGhent, BE Β· Founded 2006 Β· 50 employees on LinkedIn Β· 9 known investors
Sequana Medical develops the alfapump system and DSR therapy for treating fluid overload in patients with conditions such as liver disease and heart failure. It is a publicly listed medical device company addressing unmet needs in the management of ascites and related conditions.
Also known as SEQUA Β· Sequana Medical NV
Investors Β· 9
Company profile
researched Aug 2026Sequana Medical NV is a Belgian medical device company, listed on Euronext Brussels under the ticker SEQUA, that developed treatments for fluid overload in patients whose condition no longer responds to diuretics. Its two proprietary platforms are the alfapump, a fully implanted, wireless pump system, and DSR (Direct Sodium Removal) therapy. Target indications span liver disease (including MASH) and ascites, heart failure with fluid overload, and cancer-related fluid accumulation.
The alfapump automatically and continually moves fluid from the abdominal cavity into the bladder, where it is eliminated through normal urination, reducing or eliminating the need for therapeutic paracentesis in patients with decompensated cirrhosis and recurrent or refractory ascites. The device carries a CE mark in Europe, received FDA Breakthrough Device status in December 2019, and in December 2024 obtained U.S. FDA approval (PMA P230044) as, per the company, the first U.S.-approved active implantable medical device (Class III) for recurrent or refractory ascites due to liver cirrhosis. The alfapump is not approved for commercial use in Canada, and DSR therapy remained in development and unapproved in the United States and Canada.
In June 2026 the board decided to file for bankruptcy, and by judgment dated 30 June 2026 the Ghent Enterprise Court declared Sequana Medical NV and its subsidiary DSRCo BV bankrupt.
Business model
Development and commercialization of proprietary implantable medical device and therapy platforms (alfapump and DSR) for fluid overload indications, with market access dependent on regulatory approvals such as CE marking in Europe and FDA premarket approval in the United States.
Traction
The company reported more than 1,000 alfapump devices implanted to date, and published cumulative measures of pumping time and liters of ascites removed. Clinical evidence includes the POSEIDON pivotal study, which reported a 100% median reduction in the number of therapeutic paracenteses per month in the pivotal cohort, improvements in quality of life measured by SF-36 PCS and Ascites Q, and approximately 10 additional good health days per month; results were published in the American Journal of Gastroenterology in January 2025.
Latest developments
A post-hoc analysis of the POSEIDON study on recompensation of decompensated cirrhosis following alfapump placement, reporting long-term resolution of ascites and early signs of liver function recovery, was slated for presentation at the EASL Congress 2026 (announced 29 May 2026). On 26 June 2026 the board announced a decision to file for bankruptcy, and on 24 July 2026 the company announced that the Ghent Enterprise Court had declared Sequana Medical NV and subsidiary DSRCo BV bankrupt by judgment dated 30 June 2026.
βΈFull profile β market position, technology, go-to-market, geography, history, risks & controversies
Market position
Positioned as a developer of implant-based and pharmacologic-style approaches to fluid overload across liver disease, heart failure and cancer, with the alfapump described by the company as the first U.S.-approved active implantable medical device for recurrent or refractory ascites due to liver cirrhosis.
Technology
The alfapump is a fully implanted, wireless active implantable medical device (Class III) that automatically and continually pumps ascitic fluid from the abdominal cavity into the bladder for natural elimination via urination. The company's second platform, DSR (Direct Sodium Removal) therapy, targets sodium and fluid overload and remained in development, unapproved in the U.S. and Canada.
Go-to-market
Patients with fluid overload where diuretics are no longer effective, including patients with decompensated liver cirrhosis and recurrent or refractory ascites, heart failure patients with fluid overload, and cancer patients with fluid accumulation; treatment is delivered by clinicians and hospital specialists.
Geography
Headquartered at Kortrijksesteenweg 1112, 9051 Sint-Denijs-Westrem, Ghent, Belgium. Commercial and clinical activity spanned Europe (CE mark) and the United States (FDA approval in December 2024); the alfapump was not approved for commercial use in Canada.
History
The company raised capital through public equity markets, including an IPO in 2019 and subsequent equity placements in January 2020, February 2021, March 2022 and April 2023, plus a 2024-2025 financing. The alfapump received FDA Breakthrough Device status in December 2019 and U.S. FDA approval in December 2024. In June 2026 the board resolved to file for bankruptcy and the Ghent Enterprise Court declared the company and its subsidiary DSRCo BV bankrupt.
Risks & controversies
The company and its subsidiary DSRCo BV were declared bankrupt by the Ghent Enterprise Court in 2026. DSR therapy remained unapproved in the United States and Canada, and the alfapump was not approved for commercial use in Canada; the company stated that safety and efficacy statements for DSR arise from ongoing, incomplete pre-clinical and clinical investigations.
Compiled by commissioned research from 1 cited public sources β announcements, filings, and press listed under research sources below.
Key figures
latest reportedCompany-reported or press-reported figures, each dated to when it was claimed β not independently audited.
Timeline Β· 5
launches, deals, and filingsBy judgment of the Ghent Enterprise Court dated 30 June 2026, Sequana Medical NV and its subsidiary DSRCo BV were declared bankrupt; announced 24 July 2026.
Sequana Medical NV (Euronext Brussels: SEQUA) announced that its board had decided to file for bankruptcy.
Announced presentation of a post-hoc analysis from the POSEIDON study on recompensation of decompensated cirrhosis following alfapump placement, reporting long-term resolution of ascites and early signs of liver function recovery.
The alfapump received U.S. FDA approval, described by the company as the first U.S.-approved active implantable medical device (Class III) for the treatment of recurrent or refractory ascites due to liver cirrhosis.
The alfapump system received Breakthrough Device status from the U.S. FDA.
Dated company events from announcements, filings, and press; legal rows summarize public dockets and regulator releases.
βΈResearch sources Β· 1
primary sources listed
- Sequana Medicalsequanamedical.com Β· web
1 public sources were cited for this profile; the first-party ones are listed here.
Frequently asked questions
- What does Sequana Medical do?
- Belgian medical device company behind the alfapump implant and DSR therapy for fluid overload; declared bankrupt in 2026.
- Who are Sequana Medical's investors?
- Sequana Medical's investors include Newton Biocapital, BlackRock, EQT Life Sciences, Kreos Capital, Rosetta Capital Ltd., VI Partners, Bootstrap Europe, PMV and 1 more.
- Where is Sequana Medical headquartered?
- Sequana Medical is headquartered in Ghent, BE.