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OrthoXel, a Cork based innovative orthopaedic trauma company, pioneering the use of enhanced fracture fixation to stimulate callus formation with the goal to reduce healing time, is delighted to announce that following United States FDA 510k clearance and European CE mark approval, the first patient in Cork University Hospital Trauma Centre has had the Apex Tibial Nail implanted. 

The patient presented with a spiral mid-shaft tibial fracture and was treated by Professor James Harty, Consultant Orthopaedic Surgeon and Head of the Department of Orthopaedics at Cork University Hospital.  Prof. Harty along with the surgical team, successfully completed the world’s first clinical use of the Apex Tibial Nailing System in Cork University Hospital earlier this month.

OrthoXel has been working closely with the Health Research Board Clinical Research Facility, Cork (CRF-C) a collaboration with University College Cork, to initiate the clinical trials at Cork University Hospital, a further renowned Irish hospital is to be added to the trial later this Spring.   A similar clinical trial is about to be initiated on the East Coast of United States with OrthoXel in advanced discussions with a number of high profile Orthopaedic Trauma Centres.

In the past 9 months alone OrthoXel has doubled in size and the exciting milestone of the world’s first surgical implantation has been reached following investment of almost €3m to get to this point.  Currently the focus is on opening-up the commercial market in the United States and OrthoXel is now working both to identify commercial partners and to establish a company base in the USA.  Recently, the whole senior management team attended The American Association of Orthopaedic Surgeons Annual Meeting in New Orleans, USA to showcase the Apex Tibial Nailing System and to start to secure commercial and clinical partners for the United States – all of this in the week prior to An Taoiseach Leo Varadkar’s visit to promote US & Ireland Trade Relations focusing on investment and job creation.

Professor James Harty, Consultant Orthopaedic Surgeon, Cork University Hospital – “It was a major milestone to use the Apex Tibial Nailing System from OrthoXel with unique axial micromotion in a live trauma case.  As was expected, the surgical procedure was smooth and uncomplicated and barring any extenuating circumstances, I expect the patient recovery to be full and swift.”

Charles Daly Co-Founder & Chief Technical Officer, OrthoXel – “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.  OrthoXel is now working on a second device, the Apex Femoral Nailing System for the specific treatment of femoral fractures.   We will secure US 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.” 

About OrthoXel

Founded in 2014, and partially funded by the Local Enterprise Office, Cork City and under the Enterprise Ireland, High Potential Start-Up (HPSU) fund OrthoXel is the only orthopaedic trauma company focused exclusively on improving patient outcomes through enhanced fixation to stimulate callus formation, with the aim of reducing healing time when the OrthoXel Apex Intramedullary Nailing Systems are implanted. 

For more information about the Apex Tibial Nailing System and OrthoXel visit: www.orthoxel.net/product

 

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