{"id":19862,"date":"2024-12-02T08:00:00","date_gmt":"2024-12-02T07:00:00","guid":{"rendered":"https:\/\/www.sequanamedical.com\/?p=19862"},"modified":"2025-02-12T12:22:41","modified_gmt":"2025-02-12T11:22:41","slug":"sequana-medical-kondigt-update-over-de-tweede-tranche-van-de-converteerbare-bruglening-aan-2","status":"publish","type":"post","link":"https:\/\/www.sequanamedical.com\/nl\/persberichten\/sequana-medical-kondigt-update-over-de-tweede-tranche-van-de-converteerbare-bruglening-aan-2\/","title":{"rendered":"Sequana Medical kondigt update over de tweede tranche van de converteerbare bruglening aan"},"content":{"rendered":"\n<p><strong>PERSBERICHT&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp; <\/strong><strong><\/strong><\/p>\n\n\n\n<p><strong>GEREGLEMENTEERDE INFORMATIE \u2013 VOORWETENSCHAP&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;<\/strong><\/p>\n\n\n\n<p><span style=\"text-decoration: underline;\">2 december 2024, 08:00 a.m. CET<\/span><\/p>\n\n\n\n<p><strong>Gent, Belgi\u00eb \u2013 <\/strong><strong>2 <\/strong><strong>december 2024 \u2013 Sequana Medical NV (Euronext Brussels: SEQUA) (de &#8220;Vennootschap&#8221; of &#8220;Sequana Medical&#8221;)<\/strong>, een pionier in de behandeling van vochtoverbelasting in leveraandoeningen, hartfalen en kanker, geeft een update over de Converteerbare Overbruggingslening waarover eerder werd gerapporteerd op 30 september 2024.&nbsp; In verband met de Converteerbare Overbruggingslening is de Vennootschap ook een (niet-bindende) intentieverklaring aangegaan met betrekking tot de wijziging van bepaalde terugbetalings- en andere voorwaarden van de lening van EUR 10.000.000 met Kreos Capital VII (UK) Limited, op grond waarvan de Vennootschap ten minste een extra bedrag van EUR 3.000.000 in contanten moest ontvangen van de kredietverstrekkers onder de Converteerbare Overbruggingslening (d.w.z., de tweede tranche van de Converteerbare Overbruggingslening), of van een derde partij onder in wezen gelijkaardige voorwaarden en geen slechtere economische voorwaarden als de Converteerbare Overbruggingsleningovereenkomst, uiterlijk om 16.00 uur op 30 november 2024.&nbsp; Vanwege de persoonlijke omstandigheden van een persoon die betrokken is bij dit proces, zijn de partijen overeengekomen om deze datum te verschuiven naar 16.00 uur op 6 december 2024.<strong><\/strong><\/p>\n\n\n\n<p><strong>Voor meer informatie, gelieve contact op te nemen met:<\/strong><\/p>\n\n\n\n<p><strong>Sequana Medical<\/strong><\/p>\n\n\n\n<p>Ian Crosbie<\/p>\n\n\n\n<p>CEO<\/p>\n\n\n\n<p>E: <a href=\"mailto:IR@sequanamedical.com\">IR@sequanamedical.com<\/a><\/p>\n\n\n\n<p>T: +44 7973 42 99 17<\/p>\n\n\n\n<p><a><strong>Over Sequana Medical<\/strong><\/a><\/p>\n\n\n\n<p>Sequana Medical NV is een pionier in de behandeling van vochtoverbelasting, een ernstige en frequente klinische complicatie bij pati\u00ebnten met leverziekte, hartfalen en kanker. Dit veroorzaakt ernstig medische problemen, waaronder verhoogde mortaliteit, herhaalde ziekenhuisopnames, hevige pijn, moeilijke ademhaling en beperkte mobiliteit. Hoewel diuretica tot de standaardzorg behoren, zijn ze bij veel pati\u00ebnten niet meer effectief, onverdraagbaar of verergeren ze het probleem. Er zijn beperkte effectieve behandelingsopties voor deze pati\u00ebnten, wat resulteert in zwakke klinische resultaten, hoge kosten en een grote impact op hun kwaliteit van leven. Sequana Medical tracht innovatieve behandelingsopties aan te bieden voor deze grote en groeiende \u201cdiuretica-resistente\u201d pati\u00ebntenpopulatie. <strong>alfa<\/strong>pump\u00ae en DSR\u00ae zijn de gepatenteerde toepassingen van Sequana Medical die samenwerken met het lichaam om diuretica-resistente vochtoverbelasting te behandelen, wat belangrijke klinische voordelen en voordelen voor de kwaliteit van leven voor pati\u00ebnten oplevert en de kosten voor gezondheidszorgsystemen verlaagt.<\/p>\n\n\n\n<p>De Premarket Approval (PMA) aanvraag voor de <strong>alfa<\/strong>pump van de Vennootschap werd ingediend bij de Amerikaanse FDA in december 2023 en aanvaard voor inhoudelijke review in januari 2024, na positieve primaire en secundaire eindpuntresultaten te hebben gerapporteerd van de Noord-Amerikaanse baanbrekende POSEIDON studie bij terugkerende of refractaire ascites als gevolg van levercirrose. De Amerikaanse marktgoedkeuring van de <strong>alfa<\/strong>pump wordt verwacht voor het einde van het eerste kwartaal van 2025, met een geplande commerci\u00eble lancering in de VS in de tweede helft van 2025.<\/p>\n\n\n\n<p>Resultaten van de Vennootschap\u2019s RED DESERT en SAHARA proof-of-concept studies bij hartfalen ondersteunen het werkingsmechanisme van DSR als het doorbreken van de vicieuze cirkel van het cardiorenaal syndroom. Alle drie pati\u00ebnten uit het niet-gerandomiseerde cohort van MOJAVE, een Amerikaanse gerandomiseerde gecontroleerde multi-center fase 1\/2a klinische studie, zijn met succes behandeld met DSR, wat resulteerde in een drastische verbetering van de diuretische respons en het vrijwel verdwijnen van de behoefte aan lisdiuretica. De onafhankelijke Data Safety Monitoring Board keurde de start goed van het gerandomiseerde MOJAVE cohort van maximaal nog eens 30 pati\u00ebnten, dat gepland is na de PMA-goedkeuring van <strong>alfa<\/strong>pump in de VS.<\/p>\n\n\n\n<p>Sequana Medical is genoteerd op de gereglementeerde markt van Euronext Brussels (Ticker: SEQUA.BR) en heeft haar hoofdkantoor in Gent, Belgi\u00eb. Ga voor meer informatie naar <a href=\"https:\/\/www.sequanamedical.com\">www.sequanamedical.com<\/a>.<\/p>\n\n\n\n<p><strong><em>Belangrijke Regulatoire Disclaimers<\/em><\/strong><\/p>\n\n\n\n<p><em>Het<\/em><strong><em> alfa<\/em><\/strong><em>pump systeem is momenteel niet goedgekeurd in de Verenigde Staten of Canada. In de Verenigde<\/em><\/p>\n\n\n\n<p><em>Staten en Canada wordt het alfapump systeem momenteel klinisch onderzocht (POSEIDON-studie) en wordt het bestudeerd bij volwassen pati\u00ebnten met refractaire of terugkerende ascites als gevolg van levercirrose. DSR\u00ae therapie is nog in ontwikkeling en er dient te worden opgemerkt dat eventuele verklaringen met betrekking tot veiligheid en effici\u00ebntie voortkomen uit lopende preklinische en klinische onderzoeken die nog moeten worden afgerond. Er is geen verband tussen DSR therapie en de lopende onderzoeken met het alfapump systeem in Europa, de Verenigde Staten of Canada.<\/em><\/p>\n\n\n\n<p><strong><em>Opmerking: alfa<\/em><\/strong><em>pump\u00ae en DSR\u00ae zijn geregistreerde handelsmerken<\/em><\/p>\n\n\n\n<p><a><\/a><strong><em>Toekomstgerichte verklaringen<\/em><\/strong><strong><em><\/em><\/strong><\/p>\n\n\n\n<p><a><\/a><em>Dit persbericht kan voorspellingen, schattingen of andere informatie bevatten die als toekomstgerichte mededelingen kunnen worden beschouwd. Dergelijke toekomstgerichte mededelingen zijn geen garantie voor toekomstige resultaten.<\/em><\/p>\n\n\n\n<p><em>Deze toekomstgerichte mededelingen vertegenwoordigen het huidige oordeel van Sequana Medical over wat de toekomst brengt, en zijn onderhevig aan risico&#8217;s en onzekerheden die ertoe kunnen leiden dat de werkelijke resultaten substantieel verschillen. Sequana Medical wijst uitdrukkelijk elke verplichting of verbintenis af om updates of herzieningen van toekomstgerichte mededelingen in dit persbericht vrij te geven, behalve als dit specifiek vereist wordt door de wet of regelgeving. Men mag geen onvoorwaardelijk vertrouwen stellen in toekomstgerichte mededelingen, die de meningen van Sequana Medical alleen op de datum van dit persbericht weergeven.<\/em><\/p>\n\n\n\n<p><\/p>\n","protected":false},"excerpt":{"rendered":"<p>PERSBERICHT&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp; GEREGLEMENTEERDE INFORMATIE \u2013 VOORWETENSCHAP&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp; 2 december 2024, 08:00 a.m. CET Gent, Belgi\u00eb \u2013 2 december 2024 \u2013 Sequana Medical NV (Euronext Brussels: SEQUA) (de &#8220;Vennootschap&#8221; of &#8220;Sequana Medical&#8221;), een pionier in de behandeling van vochtoverbelasting in leveraandoeningen, hartfalen en kanker, geeft een update over de Converteerbare Overbruggingslening waarover eerder werd gerapporteerd op 30 september [&hellip;]<\/p>\n","protected":false},"author":4,"featured_media":0,"comment_status":"closed","ping_status":"closed","sticky":false,"template":"","format":"standard","meta":{"_acf_changed":false,"footnotes":""},"categories":[74],"tags":[97,91],"class_list":["post-19862","post","type-post","status-publish","format-standard","hentry","category-persberichten","tag-gereglementeerd","tag-voorwetenschap"],"acf":[],"yoast_head":"<!-- This site is optimized with the Yoast SEO plugin v27.6 - https:\/\/yoast.com\/product\/yoast-seo-wordpress\/ -->\n<title>Sequana Medical kondigt update over de tweede tranche van de converteerbare bruglening aan - Sequana Medical<\/title>\n<meta name=\"robots\" content=\"index, follow, max-snippet:-1, max-image-preview:large, max-video-preview:-1\" \/>\n<link rel=\"canonical\" href=\"https:\/\/www.sequanamedical.com\/nl\/persberichten\/sequana-medical-kondigt-update-over-de-tweede-tranche-van-de-converteerbare-bruglening-aan-2\/\" \/>\n<meta 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GEREGLEMENTEERDE INFORMATIE \u2013 VOORWETENSCHAP&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp; 2 december 2024, 08:00 a.m. CET Gent, Belgi\u00eb \u2013 2 december 2024 \u2013 Sequana Medical NV (Euronext Brussels: SEQUA) (de &#8220;Vennootschap&#8221; of &#8220;Sequana Medical&#8221;), een pionier in de behandeling van vochtoverbelasting in leveraandoeningen, hartfalen en kanker, geeft een update over de Converteerbare Overbruggingslening waarover eerder werd gerapporteerd op 30 september [&hellip;]\" \/>\n<meta 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GEREGLEMENTEERDE INFORMATIE \u2013 VOORWETENSCHAP&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp; 2 december 2024, 08:00 a.m. CET Gent, Belgi\u00eb \u2013 2 december 2024 \u2013 Sequana Medical NV (Euronext Brussels: SEQUA) (de &#8220;Vennootschap&#8221; of &#8220;Sequana Medical&#8221;), een pionier in de behandeling van vochtoverbelasting in leveraandoeningen, hartfalen en kanker, geeft een update over de Converteerbare Overbruggingslening waarover eerder werd gerapporteerd op 30 september 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