Descrizione del progetto
Elogi a una nuova protesi impiantabile per ripristinare la destrezza umana
Grazie ai nostri pollici opponibili, possiamo ruotare la maniglia di una porta, alzare un bicchiere per brindare a un amico, chiudere una cerniera lampo e molto altro ancora. Sfortunatamente, milioni di persone in tutto il mondo perdono la capacità di svolgere alcune attività della vita quotidiana a causa di artrite nell’articolazione alla base del pollice. Fino a oggi, trattamenti efficaci sono stati limitati e lo sviluppo di protesi complicato dai requisiti biomeccanici di questo potente sistema biologico in miniatura. Tutto questo sta per cambiare. Il progetto InDx, finanziato dall’UE, sta lanciando sul mercato la prima protesi al mondo dell’articolazione alla base del pollice. Con piani per sperimentazioni cliniche, marcatura CE e approvazione FDA, il lancio sul mercato della protesi è previsto per il 2021.
Obiettivo
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.
Campo scientifico
- 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
Programma(i)
Argomento(i)
Meccanismo di finanziamento
IA - Innovation actionCoordinatore
H91 H2Y0 GALWAY
Irlanda
L’organizzazione si è definita una PMI (piccola e media impresa) al momento della firma dell’accordo di sovvenzione.