Sequana Medical NV

📢 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!

📢 Good news for the PMA file of our alfapump – the US FDA has accepted our file for completeness in advance of anticipated timing and will now start the in-depth substantive review. Pending FDA approval, which Sequana Medical anticipates in the second half of 2024, alfapump could become the first active implantable medical device in the US for treating liver ascites. Read the full press release here: https://lnkd.in/ejEBCGa3 #sequanamedical #alfapump #PMA #ascites #transforminglives

📢 Delighted to announce that an independent Data Safety Monitoring Board rated our DSR therapy as safe and approved the start of the randomized MOJAVE cohort, following review of the safety data reported from the non-randomized cohort. First patient expected to be enrolled in the randomized controlled cohort of our US Phase 1/2a study (MOJAVE) in Q1 2024. Initial data from US patients treated with DSR in the non-randomized cohort confirm the dramatic improvement in diuretic response and at least 95% reduction in loop diuretic requirements, up to almost four months after their last DSR therapy. Read the full press release here: https://lnkd.in/edW7Q-ey #sequanamedical #DSR #heartfailure #cardiorenalsyndrome #transforminglives

🌟 Support Love Your Liver Month: Focus on Ascites Awareness 🌟 This Love Your Liver Month, we at #sequanamedical are putting a spotlight on ascites, a serious condition often linked to liver health. 🔹 Ascites Awareness: Understand the causes, symptoms, and prevention. 🔹 Liver-Healthy Eating: Our cafeteria now features special options to promote liver wellness. For more information and resources, visit our website at www.alfapump.com Together, let's enhance liver health and tackle ascites! #LoveYourLiver #Ascites #alfapump

📢 News alert - Following the submission of our PMA application to the FDA last week for approval of our alfapump in the US, we are delighted to announce the issuance of 6 US CPT III reimbursement codes for our alfapump system, which will facilitate reimbursement and broader adoption by US healthcare professionals. Read the full press release here: https://lnkd.in/evm6DUjJ #sequanamedical #alfapump #liverascites #reimbursement #transforminglives

The submission of our Premarket Approval application to the FDA for approval of our alfapump in the US is a fact - a key milestone for Sequana Medical! #sequanamedical #alfapump #transforminglives