Project description
Thumbs up for a novel implantable prosthesis to restore human dexterity
Thanks to our opposable thumbs, we can turn a doorknob, raise a glass to toast a friend, zip a zipper, and so much more. Unfortunately, millions of people globally lose the ability to carry out activities of daily living due to arthritis in the joint at the base of the thumb. Until now, effective treatments were limited and development of prostheses complicated by the biomechanical requirements of this miniature yet powerful biological system. All that is about to change. The EU-funded InDx project is taking the world's first thumb-base-joint prosthesis to market. With plans for clinical trials, CE marking and FDA approval, the prosthesis is slated to hit the market in 2021.
Objective
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.
Fields of science
- 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)
Funding Scheme
IA - Innovation actionCoordinator
H91 H2Y0 GALWAY
Ireland
The organization defined itself as SME (small and medium-sized enterprise) at the time the Grant Agreement was signed.