A Cork company with an invention that accelerates fracture healing has set its sights on the US market after getting approval by the US Food and Drug Administration (FDA).
OrthoXel said that following the first patient in Cork University Hospital (CUH) trauma centre to have its Apex Tibial Nail implanted during surgery to repair a fractured shinbone, it had been given the green light by the FDA and also secured the CE certification for selling products in the EU.
The product is said to offer surgeons the greatest range of locking options of any nail on the market, and is designed to heal fractures in a quicker timeframe.
OrthoXel said after clinical trials at CUH, a similar clinical trial is about to be initiated on the US east coast, as well as negotiations with a number of high profile orthopaedic trauma centres.
After the showcasing of the nail at the American Association of Orthopaedic Surgeons AGM in New Orleans, the firm said the focus was now on the commercial market in the US.
Founded in 2014, the Rubicon Centre, Bishopstown-based firm has doubled in size in the past nine months with an investment of almost €3m into developing the product.
Co-founder and chief technical officer, Charles Daly said: “OrthoXel is now working on a second device, the Apex Femoral Nailing System for the specific treatment of femoral fractures. We will secure FDA and CE mark approval by year end alongside clinical case studies and will be market ready for early 2019.