A Cork medical device firm will look to the American market for growth after its second revolutionary orthopaedic surgery nailing system was greenlit by US regulatory bodies.
Following approval earlier this year for its Apex Tibial Nail System, OrthoXel has now been cleared by the US Food and Drug Administration (FDA) for its Apex Femoral Nailing System.
The tibial 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.
The femoral product is geared towards the specific treatment of femoral fractures.
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 earlier this year, it was given the greenlight by the FDA and also secured the CE certification for selling products in the EU.
The second product will allow it to take on bigger medical device firms in the huge US market, according to the firm.
Co-founder and chief executive Pat O’Connor said: “While we recognise the challenge of entering markets dominated by large multinationals, OrthoXel is confident that the unique locking options and advantageous biomechanics of both our Apex Femoral and our Apex Tibial Nailing Systems confers real market advantage. Our products really should be the devices of choice for orthopaedic trauma care.”
Fellow co-founder and chief technical officer, Charles Daly said the firm will now be focusing on generating clinical case studies and will be market ready in 2019.
Meanwhile, Cork-based specialist supplier of innovative healthcare, Healthcare21 received approval from the Competition and Consumer Protection Commission (CCPC) to buy a majority in Aquilant from H2 Equity Partners.The newly combined business employs more than 450 staff in Ireland, UK, Germany and Austria and has turnover in excess of €150m, Healthcare21 said, which has now more than doubled in size over the past two years.Aquilant provides specialist healthcare and scientific products and services.