Description du projet
Pouces en l’air pour une nouvelle prothèse implantable destinée à restaurer la dextérité humaine
Grâce à nos pouces opposables, nous pouvons tourner une poignée de porte, lever un verre pour porter un toast à un ami, fermer une fermeture à glissière, et bien plus encore. Malheureusement, des millions de personnes dans le monde perdent la capacité de mener des activités quotidiennes à cause de l’arthrite dans l’articulation à la base du pouce. Jusqu’à présent, les traitements efficaces étaient limités et le développement de prothèses compliqué par les exigences biomécaniques de ce système biologique miniature, mais puissant. Tout cela est sur le point de changer. Le projet InDx, financé par l’UE, met sur le marché la première prothèse d’articulation du pouce au monde. Avec l’intention de mettre en place des essais cliniques, le marquage CE et l’approbation de la FDA, la prothèse devrait arriver sur le marché en 2021.
Objectif
The thumb base joint is fundamental for human dexterity and functional activity but is prone to debilitating arthritis. Approximately 5% of the world population suffers from this condition with over 25 million Europeans affected. Simple tasks become impossible such as getting dressed, opening a jar, using a key to open a door. This is certainly a relevant socioeconomic and humanitarian concern, which causes a substantial cost burden on healthcare systems, yet the effective treatment for end-stage thumb base arthritis lags far behind other joints, given challenges of the small, complex anatomy.
The InDx project aims to enable the commercialization of the InDx implant, the world’s first implant designed to accommodate the complex biomechanics of the thumb base joint and restore the natural movement of the thumb. The consortium is led by Loci Orthopaedics, a technology-driven SME spin-out company from the National University of Ireland, Galway. The partners include EndoLab in Germany, that has developed a novel dynamic test station for implants, NAMSA in the UK, a leading medical research organization with extensive experience in running international clinical investigations, and Medvie, an Irish based SME with extensive project management, dissemination and commercialization expertise. Together, the consortium have brought the implant to TRL 6 level. As part of the InDx project, the consortium will undertake the final stages of product development and will validate clinical results in a clinical study that will prepare the CE marking and market access. Market launch is planned within 24 months from the project start date, following FDA 510K approval in the USA and CE marking in Europe. The consortium estimates cumulative revenues of €51M within 5 years from the start of commercialisation and an employment growth of 25 FTEs for the consortium partners. The InDx has the potential to be a disruptive innovation in the surgical management of thumb base joint arthritis.
Champ scientifique
- medical and health sciencesbasic medicineanatomy and morphology
- medical and health sciencesclinical medicinerheumatology
- medical and health sciencesclinical medicinesurgerysurgical procedures
- medical and health sciencesclinical medicineorthopaedics
- medical and health sciencesmedical biotechnologyimplants
Programme(s)
Régime de financement
IA - Innovation actionCoordinateur
H91 H2Y0 GALWAY
Irlande
L’entreprise s’est définie comme une PME (petite et moyenne entreprise) au moment de la signature de la convention de subvention.