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Home  /   Forum   /   Sequana Medical   /   Sequana Médical -NASH / MASH !!! Alfapump - lancering in augustus

Forum SEQUANA MEDICAL BE0974340722

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Sequana Médical -NASH / MASH !!! Alfapump - lancering in augustus

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  1. Dariusz 23 juni 2025 18:40
    US market opportunity estimated at over $2 billion in 2025, growing at 9%[1] due to MASH/NASH[2] and alcoholic liver disease
    US commercial launch planned for H2 2025 through speciality salesforce targeting liver transplant centers
    POSEIDON pivotal study shows virtual elimination of therapeutic paracentesis and improvement in quality of life[3][4]
    Over 1,000 alfapump Systems implanted
    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 has received Premarket Approval (PMA) from the US Food and Drug Administration (FDA) to market alfapump® for the treatment of recurrent or refractory ascites due to liver cirrhosis in the United States. With this major regulatory milestone, achieved earlier than market expectations, alfapump is the first active implantable medical device in the US that automatically and continuously removes ascites from the abdomen into the bladder. The Company estimates there will be approximately 70,000 patients in the US with recurrent or refractory ascites, representing a market opportunity in excess of $2 billion for the alfapump in 2025. This population is forecast to reach 130,000 patients by 2032, primarily driven by NASH/MASH and alcoholic liver disease[1].

    Dr. H.E. Vargas, M.D., Professor of Medicine for the Mayo Clinic College of Medicine (Phoenix, Arizona, US), POSEIDON Study Principal Investigator, commented: “The approval of alfapump by the FDA opens the door to a breakthrough therapeutic option for patients with ascites. The introduction of the system will be welcome by patients, families and their care providers as this technology not only provides effective treatment, but also has been shown to improve quality of life[4].”

    Ian Crosbie, Chief Executive Officer of Sequana Medical, continued: “With a standard of care that has seen minimal change in thousands of years, today marks a huge milestone for the large and growing liver ascites community in the US. Our vision is to transform the lives of these patients. Recurrent or refractory liver ascites is a devastating condition with a terrible impact on the lives of our patients and their caregivers, not only for the painful and burdensome paracentesis procedure itself but also in the weeks leading up to each drainage. The POSEIDON clinical study results demonstrate that the alfapump can virtually eliminate the need for therapeutic paracentesis, and improve patient quality of life, with a safety profile comparable to standard of care, delivering a twenty-first century solution that can allow these patients to take back their lives[3][4]. We wish to thank all the patients and investigators who made this possible by participating in the POSEIDON study. With over 1,000 alfapump systems implanted to date, we look forward to starting commercialisation in H2 2025, bringing this innovative solution to many more patients in need.”

    The Company is preparing for the US commercial launch of the alfapump System in H2 2025, through a focused specialty sales force concentrating on the 90 liver transplant centers that represent the large majority of target customers. The Company has received FDA Breakthrough Device Designation for the alfapump System and has applied, and expects to receive, NTAP (new technology add-on payments) which should facilitate patient access to the device. In addition to the existing ICD-10 procedure codes for the alfapump procedure, the American Medical Association has granted six new CPT®[5] III reimbursement codes, available for use by healthcare professionals and payors since July 1st, 2024, for procedures related to the alfapump System.
  4. Dariusz 23 juni 2025 20:33
    alfapump® is het eerste actieve implanteerbare medische hulpmiddel dat in de Verenigde Staten is goedgekeurd (klasse III) voor de behandeling van recidiverende of refractaire ascites als gevolg van levercirrose.
    PMA-goedkeuring en FDA Breakthrough Device Designation.
    De Amerikaanse marktkansen worden geschat op meer dan $ 2 miljard in 2025, met een groei van 9%1 als gevolg van MASH/NASH2 en alcoholische leverziekte.
  6. forum rang 4 Riding the Tiger 26 juni 2025 08:57
    Dariusz, heb jij een zicht op de Convertible notes van GEM ? Die hebben 20 Mio euro in de pot gegooid, die tot 60 Mio kan uitbreiden.

    Ik vermoed dat deze partij belang heeft om de koers nu laag te houden, zodat ze de aandelen zo laag mogelijk kunnen inslaan (gemiddelde koers over 30 dagen).

    Klopt dat ? En van hoeveel naar hoeveel aandelen gaan we dan. En wat wordt dan de verwatering .

    Ik geloof in de technologie, maar die convertible notes kunnen een killer zijn voor de koers...
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