{"id":15448,"date":"2025-11-20T17:45:00","date_gmt":"2025-11-20T16:45:00","guid":{"rendered":"https:\/\/www.maunakeatech.com\/?p=15448"},"modified":"2025-11-20T17:48:54","modified_gmt":"2025-11-20T16:48:54","slug":"mauna-kea-technologies-obtient-lapprobation-reglementaire-en-chine-pour-sa-plateforme-cellvizio-de-nouvelle-generation","status":"publish","type":"post","link":"https:\/\/www.maunakeatech.com\/fr\/actualites\/mauna-kea-technologies-obtient-lapprobation-reglementaire-en-chine-pour-sa-plateforme-cellvizio-de-nouvelle-generation\/","title":{"rendered":"Mauna Kea Technologies obtient l\u2019approbation r\u00e9glementaire en Chine pour sa plateforme Cellvizio\u00ae de nouvelle g\u00e9n\u00e9ration\u00a0"},"content":{"rendered":"\n

Homologation \u00ab NMPA \u00bb obtenue apr\u00e8s un processus de certification de 3 ans\u00a0<\/em><\/strong><\/p>\n\n\n\n

Mauna Kea \u00e9value d\u00e9sormais les options pour commercialiser le Cellvizio Gen 3 en Chine ind\u00e9pendamment de la JV avec Tasly <\/em><\/strong><\/p>\n\n\n\n

Paris et Boston, le 20 novembre 2025 – 17h45 CET – Mauna Kea Technologies (Euronext Growth : ALMKT) <\/strong>inventeur de Cellvizio\u00ae<\/sup>, la plateforme multidisciplinaire d’endomicroscopie confocale laser par minisonde et par aiguille (p\/nCLE), annonce aujourd’hui avoir obtenu l’approbation de la National Medical Products Administration (NMPA) en Chine pour l’importation et la commercialisation de sa plateforme Cellvizio de nouvelle g\u00e9n\u00e9ration (Gen 3).\u00a0<\/p>\n\n\n\n

L\u2019enregistrement a \u00e9t\u00e9 instruit et obtenu directement par Mauna Kea Technologies S.A. est et valide pour une dur\u00e9e de cinq ans, jusqu’en novembre 2030. Il autorise l’utilisation en Chine de la plateforme Gen 3 conjointement avec la gamme compl\u00e8te de sondes confocales de la Soci\u00e9t\u00e9 (GastroFlex\u2122 N, ColoFlex\u2122 N, CholangioFlex\u2122 N, AlveoFlex\u2122 N, AQ-Flex\u2122 19 N). <\/p>\n\n\n\n

Le syst\u00e8me Cellvizio\u00ae<\/sup> Gen 3 constitue la plateforme la plus avanc\u00e9e de la Soci\u00e9t\u00e9 et repr\u00e9sente un actif qui n\u2019est pas vis\u00e9 dans le p\u00e9rim\u00e8tre des accords pr\u00e9c\u00e9dents dans le cadre de la Joint Venture avec Tasly. En s\u00e9curisant cette approbation en direct, Mauna Kea renforce son portefeuille d’actifs en propre en Chine.\u00a0<\/p>\n\n\n\n

La Chine repr\u00e9sente un march\u00e9 tr\u00e8s important pour l’endoscopie interventionnelle, avec une forte demande pour les technologies de diagnostic de pr\u00e9cision. Fort de cette autorisation r\u00e9glementaire essentielle d\u00e9sormais en place, Mauna Kea \u00e9value actuellement ses options pour la commercialisation de la plateforme Cellvizio\u00ae de nouvelle g\u00e9n\u00e9ration aupr\u00e8s des h\u00f4pitaux chinois, dans le but de rendre cette technologie de pointe accessible aux praticiens et aux patients le plus efficacement possible. <\/p>\n\n\n\n

Sacha Loiseau, Pr\u00e9sident-Directeur g\u00e9n\u00e9ral, fondateur de Mauna Kea Technologies<\/strong>, d\u00e9clare : \u00ab L’approbation de notre Cellvizio Gen 3 en Chine est une excellente nouvelle car elle rouvre le march\u00e9 chinois, un march\u00e9 tr\u00e8s important pour l’endoscopie o\u00f9 nous avons historiquement eu une activit\u00e9 significative. Cette approbation nous positionne comme la technologie la plus avanc\u00e9e par rapport \u00e0 la concurrence existante sur ce march\u00e9 sp\u00e9cifiquement. Nous allons agir rapidement pour \u00e9valuer et identifier les meilleures options qui nous permettront de commercialiser notre nouvelle\u00a0plateforme d\u00e8s que possible, ce qui repr\u00e9senterait un surcro\u00eet de revenus par rapport \u00e0 notre plan actuel. \u00bb\u00a0<\/em><\/p>\n\n\n\n

VOIR LE COMMUNIQU\u00c9 DE PRESSE<\/a><\/p>\n","protected":false},"excerpt":{"rendered":"

Homologation \u00ab NMPA \u00bb obtenue apr\u00e8s un processus de certification de 3 ans\u00a0 Mauna Kea \u00e9value d\u00e9sormais les options pour commercialiser le Cellvizio Gen 3 en Chine ind\u00e9pendamment de la JV avec Tasly  Paris et Boston, le 20 novembre 2025 – 17h45 CET – Mauna Kea Technologies (Euronext Growth : ALMKT) inventeur de Cellvizio\u00ae, la […]<\/p>\n","protected":false},"author":5,"featured_media":3910,"comment_status":"closed","ping_status":"closed","sticky":false,"template":"","format":"standard","meta":{"_et_pb_use_builder":"off","_et_pb_old_content":"","_et_gb_content_width":"","footnotes":""},"categories":[29],"tags":[],"class_list":["post-15448","post","type-post","status-publish","format-standard","has-post-thumbnail","hentry","category-actualites"],"yoast_head":"\nMauna Kea Technologies obtient l\u2019approbation r\u00e9glementaire en Chine pour sa plateforme Cellvizio\u00ae de nouvelle g\u00e9n\u00e9ration\u00a0 - Mauna Kea Technologies<\/title>\n<meta name=\"description\" content=\"Mauna Kea Technologies annonce aujourd'hui avoir obtenu l'approbation de la National Medical Products Administration (NMPA) en Chine pour l'importation et la commercialisation de sa plateforme Cellvizio de nouvelle g\u00e9n\u00e9ration (Gen 3).\u00a0\" \/>\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.maunakeatech.com\/fr\/actualites\/mauna-kea-technologies-obtient-lapprobation-reglementaire-en-chine-pour-sa-plateforme-cellvizio-de-nouvelle-generation\/\" \/>\n<meta property=\"og:locale\" content=\"fr_FR\" \/>\n<meta property=\"og:type\" content=\"article\" \/>\n<meta property=\"og:title\" content=\"Mauna Kea Technologies obtient l\u2019approbation r\u00e9glementaire en Chine pour sa plateforme Cellvizio\u00ae de nouvelle g\u00e9n\u00e9ration\u00a0 - 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