La société de biotechnologie HEMARINA soutenue par Les Business Angels des Grandes Ecoles obtient le marquage CE pour sa technologie HEMO2life®.
Grâce au marquage CE obtenu pour son additif aux solutions de préservation d’organes HEMO2life®1, HEMARINA, entreprise Bretonne pionnière dans le domaine des biotechnologies marines, met à disposition des patients et des chirurgiens une innovation de rupture majeure. HEMO2life® révolutionne la préservation des greffons en attente de transplantation, sans modifier les protocoles cliniques, et avec un effet démontré sur la survie des patients post-greffe. Ce marquage CE consacre une aventure collective et va permettre à HEMARINA le déploiement du premier transporteur d’oxygène au monde pour la préservation des greffons rénaux.
L’Union Européenne reconnait le premier transporteur d’oxygène universel.
HEMARINA vient d’obtenir le marquage CE pour HEMO2life® 2, solution d’oxygénation pionnière3. Le marquage CE traduit la conformité du dispositif médical HEMO2life® aux exigences essentielles de sécurité et de bénéfice clinique fixées par la règlementation européenne et permet sa mise sur le marché européen. Pionnière, la technologie HEMO2life® permet d’optimiser le temps de conservation des greffons rénaux et leur qualité afin d’accélérer la reprise de fonction post-greffe (DGF: Delay Graft Function). L’amélioration de ces paramètres essentiels se traduit par une amélioration nette de la survie des patients. Cette technologie pourra désormais être une solution privilégiée pour chaque intervention dans les pays de l’Union Européenne et ceux où le marquage CE est reconnu. HEMO2life® permettra de faire basculer la transplantation d’une procédure d’urgence à une médecine programmée.
Parce-que préserver un organe, c’est sauver une vie !
De la recherche fondamentale au bloc opératoire, HEMO2life® est aujourd’hui le premier transporteur d’oxygène au monde à obtenir une autorisation de mise sur le marché. Fondateur d’HEMARINA, le docteur Franck Zal, conduit des recherches sur les propriétés exceptionnelles de l’hémoglobine extracellulaire du ver arénicole depuis plus de 15 ans. 250 fois plus petite que l’hémoglobine humaine, cette hémoglobine est capable de transporter 40 fois plus d’oxygène. HEMO2life®permet l’oxygénation physiologique des greffons rénaux optimisant ainsi leur temps de conservation et leur qualité.
Plusieurs études cliniques et de suivi à 4 ans des patients greffés ont été menées, notamment par les professeurs Le Meur (CHU de Brest) et Barrou (AP-HP), permettant aujourd’hui de démontrer pour un patient transplanté avec HEMO2life® :
- Un taux de survie de 98,3% après 4 ans contre 86% dans des conditions de préservation classiques.
- Une diminution des dommages d’ischémie-reperfusion permettant ainsi une reprise accélérée du greffon après transplantation : diminution du marqueur DGF de 7% (bras HEMO2life®) vs 26% (bras Contrôle).
- Une diminution de l’utilisation de Belatacept® sur une période de 4 ans, un immunosupresseur utilisé en cas d’un événement de rejet du greffon (0% bras HEMO2life® vs 11% bras Contrôle).
HEMARINA met à disposition sa première innovation.
Avec HEMO2life® HEMARINA propose d’apporter une solution à un enjeu de santé publique majeur lié à l’insuffisance rénale aigue. En France, plus de 20 000 patients étaient en attente d’une greffe de rein au 17 mars 2022, alors que moins de 6 000 transplantations ont lieu chaque année. Ces dernières années, cette innovation a notamment permis la réussite de deux transplantations de face réalisées par le Professeur Laurent Lantieri, de l’APHP HEGP et de l’Hôpital Militaire Percy, en 2018 et 2022. HEMO2life® a également était impliqué dans une double greffe des avant-bras. Première mondiale, cette opération a été réalisée en septembre 2021 à l’Institut Amrita des Sciences Médicales (AIMS) de Kochi en Inde par les Professeurs Mohit Sharma et Subramania Lyer.
Après plusieurs années de développement, cette première autorisation permet donc de démontrer la pertinence de la plateforme d’HEMARINA M-101 dans l’oxygénation des cellules humaines. Elle sera suivie par de nombreuses autres innovations en cours de développement, permettant d’alimenter sereinement son pipeline protégé par une soixantaine de brevets.
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