Descripción del proyecto
Pulgares arriba por una nueva prótesis implantable que restaura la destreza humana
Gracias a nuestros pulgares oponibles, podemos, entre muchas cosas, girar un pomo, levantar una copa para brindar por un amigo y abrochar una cremallera. Por desgracia, millones de personas en todo el mundo pierden la capacidad de llevar a cabo actividades de la vida cotidiana debido a artritis en la articulación de la base del pulgar. Hasta ahora, los tratamientos eficaces eran limitados y el desarrollo de prótesis resultaba complicado por los requisitos biomecánicos de este sistema en miniatura y sin embargo biológicamente potente, pero esta situación está a punto de cambiar. El proyecto InDx, financiado con fondos europeos, va a llevar al mercado la primera prótesis de base de pulgar del mundo. Está programado que esta prótesis, para la que se prevé llevar a cabo ensayos clínicos, obtener el marcado CE y la aprobación de la FDA, llegue al mercado en 2021.
Objetivo
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.
Ámbito científico
- 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
Programa(s)
Régimen de financiación
IA - Innovation actionCoordinador
H91 H2Y0 GALWAY
Irlanda
Organización definida por ella misma como pequeña y mediana empresa (pyme) en el momento de la firma del acuerdo de subvención.