In December 2024, Sequana Medical received U.S. FDA Premarket Approval (PMA) for the alfapump® system, becoming the first FDA-approved active implantAble medical device (Class III) for recurrent or refractory ascites due to liver cirrhosis. In 2025, the company commenced U.S. commercialization, secured CMS NTAP reimbursement of up to USD 21,450, and completed the first U.S. commercial implant at Mount Sinai Hospital, New York. By February 2026, five U.S. centers had completed alfapump® implants. The company targets a Full U.S. Launch in Q2 2026 with a goal of at least 70 commercial implants during the Soft Launch phase. Over 1,000 alfapump® devices have been implanted globally, with cumulative fluid removal exceeding 52,000 liters.
Company Profile (Updated April 2026)
Sequana Medical NV is a publicly listed medical device company headquartered in Sint-Denijs-Westrem/Ghent, Belgium. Founded in 2006 by Dr. Noel L. Johnson, the company is listed on the Euronext Brussels stock exchange under the ticker SEQUA (ISIN: BE0974340722). Sequana Medical is dedicated to developing and commercializing innovative treatments for patients with drug-resistant fluid overload in liver disease, heart failure, and cancer. The company operates in Belgium, Germany, France, the United States, and other international markets.
Development History:
- 2006: Founded by Dr. Noel L. Johnson in Ghent, Belgium, with the vision of creating a fully implantable pump for refractory ascites
- 2012-2013: PIONEER study in Europe demonstrated safety and performance of alfapump® in 40 patients with liver refractory ascites
- 2017: ARIA randomized controlled study in Europe (58 patients) confirmed alfapump® superiority over large volume paracentesis (LVP)
- 2019: U.S. FDA granted Breakthrough Device designation to alfapump® for recurrent or refractory liver ascites
- 2016: Ian Crosbie appointed CEO following the passing of founder Dr. Johnson
- 2021-2022: POSEIDON pivotal study roll-in cohort completed; positive top-line results from pivotal cohort reported
- December 2023: Premarket Approval (PMA) application submitted to U.S. FDA based on POSEIDON data
- December 2024: U.S. FDA granted PMA approval for alfapump® system
- 2025: U.S. commercial launch commenced; CMS NTAP reimbursement approved; first U.S. commercial implant at Mount Sinai Hospital, New York
- 2025: DSR® therapy received additional U.S. patent; MOJAVE heart failure study advanced
- February 2026: Five U.S. centers completed alfapump® system implants
Core Mission: To transform the treatment of drug-resistant fluid overload by providing patients with innovative, implantable therapeutic solutions that improve quality of life, reduce hospital dependency, and address unmet medical needs in liver disease, heart failure, and oncology.
2024-2025 Breakthrough: U.S. FDA Approval and Commercial Launch
FDA PMA Approval (December 2024)
Regulatory Milestone:
- In December 2024, the U.S. FDA approved the alfapump® system via the Premarket Approval (PMA) pathway
- Indication: Treatment of recurrent or refractory ascites due to liver cirrhosis
- Classification: The first U.S. approved active implantable medical device (Class III) for this indication
- Clinical Basis: The pivotal POSEIDON study, conducted across 18 centers in the U.S. and Canada, enrolling 69 patients (40 pivotal cohort + 29 roll-in cohort)
- Primary Endpoints: At 6 months, the pivotal cohort ACHieved a 100% median reduction in the number of therapeutic paracentesis procedures per month, exceeding predefined thresholds with statistical significance
- Quality of Life: Patients gained an average of 10 additional good health days per month, with significant improvements in SF-36 Physical Component Summary (PCS) and Ascites-Q scores
- Durability: 12-month and 24-month follow-up data continued to demonstrate strong, durable clinical benefits and virtual elimination of therapeutic paracentesis needs
- Publication: Six-month POSEIDON data published in the American Journal of Gastroenterology (January 2025)
U.S. Commercial Rollout (2025-2026)
- Soft Launch: Target of at least 70 U.S. commercial implants during the initial soft launch phase
- Full Launch: On track for Q2 2026
- Reimbursement: CMS approved NTAP (New Technology Add-on Payment) "top-up" reimbursement of up to USD 21,450 per procedure
- First Implant: Mount Sinai Hospital, New York (November 2025)
- Adoption: Five U.S. centers completed implants by February 2026; multiple additional highly regarded sites in advanced discussions
- Team: Dedicated U.S. commercial team of 10 professionals
Core Products and Technology
alfapump® System
World's First FDA-Approved Active Implant for Refractory Ascites:
- Design: A fully implantable, battery-powered pump system that automatically and continuously moves fluid from the peritoneal (abdominal) cavity into the bladder, where it is naturally eliminated through urination
- Implantation: Minimally invasive procedure taking approximately 80 minutes, performed under local anaesthesia with sedation by interventional radiologists
- Wireless Charging: Patients recharge the battery daily through the skin using a Smart Charger for approximately 30 minutes; pump performance data is simultaneously transferred to the charger
- Remote Monitoring: Pump performance data (volume pumped, charging status) is transmitted to secure servers, enabling clinicians to monitor patients remotely and receive notifications of performance changes
- Patient Mobility: Because the system is fully implanted with no external tubes, patients retain normal mobility and activity
- Programmability: Physicians wirelessly program the device to define daily fluid removal volumes tailored to individual patient needs and daily routines
- Global Use: Over 1,000 devices implanted; cumulative pumping time exceeding 414 years; over 52,900 liters of ascites removed
- Regulatory Status: FDA approved (U.S., December 2024); CE Mark (Europe); not approved in Canada
DSR® (Direct Sodium Removal) Therapy
- Mechanism: A novel therapy that removes sodium directly from the body via the peritoneal cavity using a specialized infUSAte solution, addressing persistent congestion in diuretic-resistant heart failure patients
- Delivery: Administered through a peritoneal dialysis catheter; designed to restore euvolemia and diuretic response while suspending loop diuretic treatment
- Clinical Program: Multiple studies completed including CHIHUAHUA (Phase 1), RED DESERT (repeated dose), SAHARA (randomized repeated dose in decompensated HF), and MOJAVE (U.S. Phase 1/2a with DSR® 2.0)
- MOJAVE Study: U.S. Phase 1/2a study of DSR® 2.0 in diuretic-resistant chronic heart failure; DSMB approved progression to randomized cohort in 2024
- Intellectual Property: Additional U.S. patent granted in December 2025
- Regulatory Status: Still in development; not yet approved in the U.S., Canada, or Europe
Financial Performance (2023-2025)
2025 Half-Year Results
Sequana Medical NV Overall:
- Liquidity Position: EUR 7.3 million as of 30 June 2025
- Debt Reduction: EUR 2 million reduction through partial conversion of Kreos loan and 2025 convertible loan
- Financing Secured (H1 2025): EUR 13.6 million in equity and convertible financing
- Additional Financing (May 2025): EUR 6.3 million convertible financing from SFPIM and other existing shareholders
Historical Performance:
- 2023 Operating Loss: EUR 32.6 million
- H1 2024 Operating Loss: EUR 11.1 million
- Cumulative Loss Brought Forward (Dec 2023): EUR 206.0 million
- Cumulative Loss Brought Forward (Jun 2024): EUR 217.1 million
- Market Capitalization: Approximately EUR 49-51 million (late 2025)
- Share Price: Approximately EUR 0.63 (November 2025); 52-week range EUR 0.58 - 4.39
Capital Structure and Financing
- Share Capital Evolution (Jan 2025): 7,980,409 new shares issued via loan conversions, bringing total outstanding shares to 52,416,601
- GEM Share Subscription Facility: Multiple subscription notices issued in 2025-2026 to extend financing runway
- 2026 Capital Increase: Tenth subscription request notice under GEM facility settled in April 2026
- Runway: Financing extended to at least Q1 2026; company continues evaluating all equity and debt financing options
Company Leadership and Governance
Executive Team
Ian Crosbie - Chief Executive Officer (since 2016):
- Executive director since 2019; over 25 years of healthcare sector experience in medical devices, pharmaceuticals, and investment banking
- Former CFO of GC Aesthetics Ltd; Senior VP Corporate Development at Circassia Pharmaceuticals (led GBP 210 million IPO)
- Former Managing Director, Healthcare Investment Banking at Jefferies International and Director at Deutsche Bank
- Degree in Engineering, Economics and Management from Oxford University
Kirsten Van Bockstaele - Chief Financial Officer:
- Over 20 years of international healthcare finance experience
- Former VP Finance at Fagron North America; CFO of Arseus Dental ＆ Medical Solutions
- Former Financial Controller at Omega Pharma and Audit Manager at PwC
- Degrees in Business Economics (EHSAL) and Financial and Fiscal Sciences (University of Antwerp)
Pierre Chauvineau - Chairman of the Board:
- Over 31 years in international medtech leadership
- Former 20-year career at Medtronic; led commercialization at Cameron Health (acquired by Boston Scientific in 2012)
- Also chairman of Aurigen Medical and Aryballe; board member of Rhythm AI and Comphya
Global Market Position and Competition
Market Landscape
Liver Ascites Burden:
- Ascites is the most common complication of decompensated liver cirrhosis
- Approximately 50% of patients with cirrhosis develop ascites within 10 years of diagnosis
- Refractory ascites affects a significant subset of patients who no longer respond to diuretics
- Current standard of care involves repeated large volume paracentesis (LVP) - needle drainage procedures that are burdensome, carry infection risk, and severely impact quality of life
Heart Failure Fluid Overload:
- Persistent congestion in heart failure leads to frequent hospitalizations and poor outcomes
- Many patients become resistant to loop diuretics, creating a major unmet need
Primary Competitors
- Standard of Care (LVP): Repeated therapeutic paracentesis remains the most common treatment for refractory ascites
- Transjugular Intrahepatic Portosystemic Shunt (TIPS): Interventional radiology procedure to reduce portal pressure; invasive and carries significant complications
- Diuretics: First-line medical therapy, but ineffective in refractory cases
- Heart Failure Competitors: Loop diuretics, SGLT2 inhibitors, and emerging ultrafiltration/implantable fluid removal devices
Competitive Advantages
- First and Only FDA-Approved Active Implant: alfapump® is the only active implantable device approved in the U.S. for this indication
- Physiological Elimination: Fluid is moved to the bladder and urinated away naturally, unlike passive drainage systems
- Proven Clinical Evidence: POSEIDON study published in a leADINg peer-reviewed journal with 24-month durability data
- Quality of Life: Virtually eliminates need for repeated hospital visits for paracentesis, restoring patient autonomy
- Remote Monitoring: Unique digital health ecosystem enabling proactive clinical management
- Dual Pipeline: alfapump® for liver ascites and DSR® for heart failure provide two distinct growth avenues
- European Commercial Base: Established CE Mark and clinical adoption in Europe provides revenue Foundation during U.S. ramp-up
Clinical Implementation Cases
POSEIDON Pivotal Study (U.S. and Canada, 2021-2024)
- Design: Single-arm, open-label, within-subject crossover study
- Enrollment: 69 patients implanted across 18 centers (40 pivotal cohort + 29 roll-in cohort)
- Milestone: Landmark study demonstrating 100% median reduction in therapeutic paracentesis and significant quality of life improvement
- Principal Investigators: Led by key opinion leaders in hepatology and interventional radiology across North America
ARIA Randomized Study (Europe, 2017)
- Design: Prospective, multi-center, randomized, controlled study of alfapump® versus LVP standard of care
- Enrollment: 58 patients with liver refractory ascites
- Significance: First randomized evidence demonstrating clinical and quality of life superiority of implantable pump therapy over repeated paracentesis
2026 Outlook and Strategic Priorities
alfapump® Commercial Expansion
- U.S. Full Launch: Execute Q2 2026 full commercial launch with expanded center network and sales force
- Center Expansion: Continue onboarding highly regarded U.S. transplant and hepatology centers
- Reimbursement: Maintain and expand payer coverage beyond NTAP, including private payers and Medicare Advantage
- European Growth: Continue expanding adoption in existing CE Mark markets (Belgium, Germany, France)
DSR® Development Roadmap
- MOJAVE Study: Complete U.S. Phase 1/2a randomized cohort and report data
- Regulatory Strategy: Advance toward U.S. regulatory filing for DSR® in diuretic-resistant heart failure
- IP Protection: Leverage expanded U.S. patent portfolio for DSR® technology
Financial Sustainability
- Secure additional financing to support U.S. commercial scale-up and DSR® clinical development
- Evaluate strategic partnerships, direct investments into alfapump® and DSR® activities, and non-dilutive funding opportunities
Contact Information
Headquarters
Address: Kortrijksesteenweg 1112 (box 102), 9051 Sint-Denijs-Westrem, Ghent, Belgium
Website: www.sequanamedical.com
Investor Relations
Listing: Euronext Brussels (SEQUA)
ISIN: BE0974340722
Investor Website: www.sequanamedical.com/investors
Email: info@sequanamedical.com
Keywords: Sequana Medical, alfapump, DSR, Direct Sodium Removal, ascites, liver cirrhosis, refractory ascites, heart failure, fluid overload, implantable pump, FDA PMA, CE Mark, NTAP, CMS, Euronext Brussels, SEQUA, Ghent, Belgium, Ian Crosbie, POSEIDON study, therapeutic paracentesis, large volume paracentesis, LVP, Breakthrough Device, Class III, medical device, liver disease, diuretic resistant, MOJAVE, SAHARA, RED DESERT, ARIA, PIONEER
