OrthoXel announced the first implantation of its Apex tibial nailing system, which was performed in a patient at Cork University Hospital Trauma Center.
The patient, who presented with a spiral midshaft tibial fracture, was treated by James A. Harty, MB, MSc, MRCSI, FRCSI(Tr&Orth), a consultant orthopedic surgeon and head of the department of orthopedics at Cork University Hospital. According to a company press release, OrthoXel has been working with the Health Research Board Clinical Research Facility, Cork, a collaboration with University College of Cork, to commence clinical trials at Cork University Hospital.
According to the release, the company’s focus is to open the commercial market for the Apex tibial nail in the United States and to open a company base there. The tibial nail was presented at the American Academy of Orthopaedic Surgeons Annual Meeting in New Orleans.
“Following 3 years of research and development and considerable investment, it is a significant milestone to have the first successful surgical implantation of our device,” Charles Daly, co-founder and chief technical officer of OrthoXel, said in the release. “OrthoXel is now working on a second device, the Apex femoral nailing system for the specific treatment of femoral fractures. We will secure U.S. FDA and CE mark approval by year end alongside clinical case studies and will be market ready for early 2019. Our incredible engineering and design team in Cork, has really set our devices apart from any other intramedullary nails on the market today.”