Sequana Medical NV

Thank you to Robert Barrie for featuring Sequana Medical NV FDA approval of our alfapump® device, which removes excess fluid that’s built up in the abdominal cavity, typically due to hashtag #liver disease. https://lnkd.in/e7k9V9Rq

📽️ Hear from our CEO, Ian Crosbie, on #OptimumTV where he discusses the US FDA approval of alfapump® for the treatment of recurrent or refractory #ascites due to #livercirrhosis!   👇 Watch the full video below as Ian highlights this major milestone news for #SequanaMedical and learn more about #alfapump, the first US approved active implantable medical device that automatically and continuously removes #ascites from the abdomen into the bladder.   Read the full press release via the link in the comments below.

📢 #SequanaMedical receives US FDA approval of alfapump® for the treatment of recurrent or refractory #ascites due to #livercirrhosis! 📢 We are proud to announce today that we have achieved a major milestone for the company – PMA Approval for the alfapump, alongside the existing FDA Breakthrough Device Designation. alfapump is the first US approved active implantable medical device that automatically and continuously removes ascites from the abdomen into the bladder. Our CEO, Ian Crosbie, commented on this exciting news: "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 [1]. “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.” Discover more about the alfapump in the press release linked in the comments below as we prepare for US commercial launch in H2 2025. Join our KOL webcast on Wednesday 8 January, 2025 at 15:00 CET/09:00 ET. Click the link here for webcast registration: https://bit.ly/4gN61Lp   #alfapump #transforminglives #cirrhosis [1] POSEIDON study results in SSED (PMA P230044, FDA approval letter on file) – 100% median reduction in number of therapeutic paracentesis per month in Pivotal Cohort; Quality of life as defined by subjective physical health (assessed by SF-36 PCS) and ascites symptoms (assessed by Ascites Q)

📢 Press news: Sequana Medical announces the publication in Kidney Medicine highlighting the benefits of its proprietary DSR 2.0 in its Direct Sodium Removal program as a potential therapy for cardiorenal syndrome and diuretic resistance in heartfailure #SequanaMedical #DSR #directsodiumremoval #heartfailure #cardiorenalsyndrome Ian Crosbie

📢 PRESS NEWS: Sequana Medical Announces Strong 24-Month Results from POSEIDON Study at AASLD The Liver Meeting® in San Diego. More info on: https://lnkd.in/eJPMjJSf #SequanaMedical #alfapump #POSEIDON #study #US #TheLiverMeeting  Ian Crosbie Hugo E. Vargas

📢 Thank you to Dr Bajaj on the oral poster presentation at #EASL2024 of the matched cohort analysis of #alfapump POSEIDON pivotal cohort vs the contemporaneous NACSELD3 registry. This analysis supports our strong clinical positioning vs standard of care as it shows i) a statistically significant improvement in quality of life for alfapump, which was not seen in the NACSELD3 registry, and ii) no statistically significant difference in mortality, hospitalisations or liver transplants between the two groups. Recurrent and refractory #ascites are in clear need of improved treatment options, especially given the strong growth due to #NASH / #MASH. The #SequanaMedical team is working hard to finalise the limited number of remaining topics in our #PMA Read the full press release here: https://lnkd.in/dwg-eGqM #sequanamedical #transforminglives

📢 Strong progress with our alfapump PMA submission with the US FDA. Following our Day 100 meeting, the FDA confirms completion of their substantial review and no further new questions. We are working hard to address the outstanding questions and intend to submit our responses to those by end of Q3. Based on our recent interactions, we no longer expect an FDA Advisory Panel and planned US commercial launch remains H2 2025. Read the full press release here: https://lnkd.in/e2eU9wwF #sequanamedical #alfapump #PMA #ascites #transforminglives

📢 Strong data from our DSR® therapy in patients with diuretic-resistant heart failure published in the prestigious peer-reviewed journal European Journal of Heart Failure. Check it out here: https://lnkd.in/ed7b5q4J #sequanamedical #DSR #heartfailure #congestion #transforminglives

📢 Good news from our DSR® program: Three-month follow-up data from the non-randomized cohort of the MOJAVE study in patients with diuretic-resistant heart failure confirms dramatic improvement in diuretic response and virtual elimination of loop diuretics following DSR therapy. Read the full press release here: https://lnkd.in/eP8it8vW #sequanamedical #DSR #heartfailure #congestion #transforminglives

Good morning all - welcome at our booth at the VFB Happening in Antwerp- the place to be today!