{"id":10035,"date":"2026-04-20T16:09:24","date_gmt":"2026-04-20T14:09:24","guid":{"rendered":"https:\/\/hemerion.com\/lagence-europeenne-du-medicament-ema-accorde-le-statut-de-dispositif-medical-orphelin-a-la-plateforme-heliance-developpee-par-hemerion\/"},"modified":"2026-05-21T16:44:50","modified_gmt":"2026-05-21T14:44:50","slug":"lagence-europeenne-du-medicament-ema-accorde-le-statut-de-dispositif-medical-orphelin-a-la-plateforme-heliance-developpee-par-hemerion","status":"publish","type":"post","link":"https:\/\/hemerion.com\/fr\/lagence-europeenne-du-medicament-ema-accorde-le-statut-de-dispositif-medical-orphelin-a-la-plateforme-heliance-developpee-par-hemerion\/","title":{"rendered":"L\u2019Agence Europ\u00e9enne du M\u00e9dicament (EMA) accorde le statut de dispositif m\u00e9dical orphelin \u00e0 la plateforme Heliance d\u00e9velopp\u00e9e par Hemerion"},"content":{"rendered":"\n

Hemerion a re\u00e7u le 20 avril 2026 l’aval du groupe d’experts de l’EMA (European Medicines Agency) concernant le statut de dispositif m\u00e9dical orphelin (Orphan Medical Device) pour sa plateforme d\u2019illumination Heliance, utilis\u00e9e en th\u00e9rapie photodynamique (PDT)<\/a> dans le traitement du glioblastome de novo op\u00e9rable.<\/p>\n\n\n\n

Hemerion devient l’une des premi\u00e8res healthtech europ\u00e9ennes \u00e0 b\u00e9n\u00e9ficier de ce nouveau statut, qui confirme le potentiel th\u00e9rapeutique majeur d\u2019Heliance et permet d\u2019acc\u00e9l\u00e9rer et de s\u00e9curiser le parcours r\u00e9glementaire en vue de l\u2019autorisation de mise sur le march\u00e9.<\/p>\n\n\n\n

Hemerion figure d\u00e9sormais parmi les entreprises pionni\u00e8res s\u00e9lectionn\u00e9es pour la phase pilote de ce programme europ\u00e9en, d\u00e9di\u00e9 aux technologies de rupture ciblant des maladies rares et mettant en jeu le pronostic vital des patients.<\/p>\n\n\n\n

Ce statut permet \u00e0 notre \u00e9quipe de b\u00e9n\u00e9ficier d’un acc\u00e8s pr\u00e9coce aux conseils du groupe d’experts de l’EMA afin d’affiner sa strat\u00e9gie de d\u00e9veloppement clinique et de pr\u00e9parer le d\u00e9p\u00f4t de la documentation technique pour le marquage CE.<\/p>\n\n\n\n

Le panel d’experts de l’EMA a fond\u00e9 sa d\u00e9cision sur une analyse approfondie des donn\u00e9es soumises par Hemerion, concluant que le dispositif remplit les crit\u00e8res stricts du r\u00e8glement MDCG 2024-10.<\/p>\n\n\n\n

Une th\u00e9rapie prometteuse pour faire progresser le standard de soins <\/h2>\n\n\n\n

Le standard de soin pour le glioblastome repose depuis plus de 20 ans sur la r\u00e9section chirurgicale maximale suivie du protocole Stupp (radio-chimioth\u00e9rapie). Pourtant, la survie m\u00e9diane reste faible (14,6 \u00e0 20,9 mois) et les cellules tumorales r\u00e9siduelles en marge de r\u00e9section sont la cause quasi constante de r\u00e9cidive. <\/p>\n\n\n\n

L\u2019analyse du panel d\u2019experts a soulign\u00e9 l\u2019espoir majeur que repr\u00e9sente la th\u00e9rapie d\u00e9velopp\u00e9e par Hemerion, qui cible ces cellules tumorales infiltr\u00e9es, qui \u00e9chappent aux soins conventionnels et provoquent 85 % des r\u00e9cidives.<\/p>\n\n\n\n

L’avis met en avant les r\u00e9sultats spectaculaires des essais cliniques d\u00e9j\u00e0 men\u00e9s, qui montrent une survie globale (OS) m\u00e9diane de 23,1 mois pour les patients trait\u00e9s, contre environ 14,6 mois pour les traitements actuels, le tout avec un profil de s\u00e9curit\u00e9 favorable et sans \u00e9v\u00e9nement ind\u00e9sirable grave li\u00e9 au dispositif.<\/p>\n\n\n\n

Une \u00e9tape d\u00e9cisive dans le parcours r\u00e9glementaire<\/h2>\n\n\n\n

L’obtention de ce statut de dispositif orphelin marque une \u00e9tape d\u00e9cisive dans le parcours r\u00e9glementaire d’Hemerion.<\/p>\n\n\n\n

Ce statut permet de b\u00e9n\u00e9ficier d\u2019une collaboration \u00e9troite et active du groupe d’experts de l’EMA pour mettre au point la strat\u00e9gie clinique et clarifier les \u00e9tapes n\u00e9cessaires avant le d\u00e9p\u00f4t d\u2019une demande de marquage CE.<\/p>\n\n\n\n

Ces \u00e9changes directs avec les experts de l\u2019EMA offrent aussi une visibilit\u00e9 pr\u00e9cieuse pour finaliser l\u2019\u00e9valuation clinique de la th\u00e9rapie et acc\u00e9l\u00e9rer son d\u00e9ploiement sur le march\u00e9 europ\u00e9en.<\/p>\n\n\n\n

Il valide aussi le positionnement d’Heliance dans le standard de soins comme une solution d’avenir face \u00e0 la tumeur c\u00e9r\u00e9brale primaire la plus agressive et la plus r\u00e9pandue aujourd\u2019hui<\/a>.<\/p>\n\n\n\n

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\"Dispositif<\/figure>\n\n\n\n
\"Dispositif<\/figure>\n\n\n\n
\"Dispositif<\/figure>\n<\/figure>\n","protected":false},"excerpt":{"rendered":"

Hemerion a re\u00e7u le 20 avril 2026 l’aval du groupe d’experts de l’EMA (European Medicines Agency) concernant le statut de dispositif m\u00e9dical orphelin (Orphan Medical Device) pour sa plateforme d\u2019illumination Heliance, utilis\u00e9e en th\u00e9rapie photodynamique (PDT) dans le traitement du glioblastome de novo op\u00e9rable. Hemerion devient l’une des premi\u00e8res healthtech europ\u00e9ennes \u00e0 b\u00e9n\u00e9ficier de ce … <\/p>\n

Lire plus<\/a><\/p>\n","protected":false},"author":207845438,"featured_media":10026,"comment_status":"closed","ping_status":"open","sticky":false,"template":"","format":"standard","meta":{"_coblocks_attr":"","_coblocks_dimensions":"","_coblocks_responsive_height":"","_coblocks_accordion_ie_support":"","_jet_sm_ready_style":"","_jet_sm_style":"","_jet_sm_controls_values":"","_jet_sm_fonts_collection":"","_jet_sm_fonts_links":"","_jetpack_newsletter_access":"","_jetpack_dont_email_post_to_subs":false,"_jetpack_newsletter_tier_id":0,"_jetpack_memberships_contains_paywalled_content":false,"_wpcom_ai_launchpad_first_post":false,"_jetpack_hide_featured_image":false,"_jetpack_featured_image_duplicate_dismissed":0,"_jetpack_feature_clip_id":0,"_jetpack_memberships_contains_paid_content":false,"footnotes":"","jetpack_post_was_ever_published":false},"categories":[6342],"tags":[],"class_list":["post-10035","post","type-post","status-publish","format-standard","has-post-thumbnail","hentry","category-actualites"],"yoast_head":"\nL\u2019Agence Europ\u00e9enne du M\u00e9dicament (EMA) accorde le statut de dispositif m\u00e9dical orphelin \u00e0 la plateforme Heliance d\u00e9velopp\u00e9e par Hemerion - Hemerion<\/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:\/\/hemerion.com\/fr\/lagence-europeenne-du-medicament-ema-accorde-le-statut-de-dispositif-medical-orphelin-a-la-plateforme-heliance-developpee-par-hemerion\/\" \/>\n<meta property=\"og:locale\" content=\"fr_FR\" \/>\n<meta property=\"og:type\" content=\"article\" \/>\n<meta property=\"og:title\" content=\"L\u2019Agence Europ\u00e9enne du M\u00e9dicament (EMA) accorde le statut de dispositif m\u00e9dical orphelin \u00e0 la plateforme Heliance d\u00e9velopp\u00e9e par Hemerion - Hemerion\" \/>\n<meta property=\"og:description\" content=\"Hemerion a re\u00e7u le 20 avril 2026 l’aval du groupe d’experts de l’EMA (European Medicines Agency) concernant le statut de dispositif m\u00e9dical orphelin (Orphan Medical Device) pour sa plateforme d\u2019illumination Heliance, utilis\u00e9e en th\u00e9rapie photodynamique (PDT) dans le traitement du glioblastome de novo op\u00e9rable. 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