OrthoXel DAC is an emerging medical device start-up company founded in 2014 to develop and commercialise orthopaedic trauma products.
The first technology that OrthoXel will commercialise in the US & EMEA is a novel intramedullary nail for treatment of tibia and femoral fractures (The Apex Nailing system ). The basic R&D and proof of principle was completed in Cork Institute of Technology’s MEDIC centre over a 5 year timeframe.
That development program included iterative design-build-test activities such as bench testing, cadaver studies, and a GLP-controlled preclinical study. The output from the development program is patent-protected for tibial, femoral, and humeral use.
OrthoXel has now received FDA 510(k) clearance and the CE Mark for The Apex Tibial Nailing System, and will be working during 2018 to acquire the same approvals for The Apex Femoral Nailing system. OrthoXel is now working to identify key centres in the USA, Ireland and the UK to generate further clinical data to support the unique benefits of the Apex device along with post market approval follow up clinical studies. The company is also investigating distribution channels and sales channels for key markets of the USA and EMEA.