Irish medtech Orthoxel nailing a successful expansion in the USA

The global intramedullary nail market is valued at €2bn, with the tibia and femoral market segments worth €800m

OrthoXel, a medtech firm whose secondary bone healing system, Apex Tibial Nail, is the next evolution in fracture fixation.

Medical device company OrthoXel was founded to create innovative orthopaedic trauma instruments that are inspired by surgeons and focused on delivering superior patient outcomes. 

Company culture is guided by a philosophy of evidence-based design through a team drawn from large multinational medical device firms, regulatory agencies, academia and clinical research companies.

 Founded in 2014, and partially funded under the Enterprise Ireland High Potential Start-Upfund, OrthoXel is a specialist orthopaedic trauma device company using innovative engineering design to evolve next generation fracture fixation devices. 

Led by a leadership with experience in clinical biomechanics and the medical device industry, it includes orthopaedic trauma engineers with a wide range of experience across regulatory affairs and medtech quality assurance. OrthoXel’s flagship tibial and femoral products grew out of five years of research and development work in the Medical Engineering Design and Innovation Centre at Cork Institute of Technology. 

The company continues to be supported by Enterprise Ireland, Local Enterprise Office Cork, Cork Institute of Technology, University College Cork and others who saw the vision for OrthoXel’s long term potential. 

Pat O'Connor, founder and CEO of OrthoXel.

“OrthoXel is focused on improving implant design to achieve the best possible health outcomes for patients,” says co-founder and CEO, Pat O’Connor. “We care passionately about our purpose to challenge the accepted and improve health, and we are committed to offering patients, surgeons and hospitals innovative and cost-effective fracture care solutions. 

"OrthoXel introduced the world’s first intra-medullary nail with controlled micromotion fixation. The Apex Tibial Nail is the next evolution in fracture fixation — the first and only nailing system to promote secondary bone healing with controlled axial micromotion and outstanding torsional stability.”

 As the former CEO of ABK Biomedical, O’Connor has over twenty years experience in the medical device industry having worked with Boston Scientific, Sherwood Medical and Stryker Orthopaedics. He also collaborated with Cork Institute of Technology to establish the Medic Centre to work with surgeons on developing medical device technologies.

OrthoXel’s presence at the Orthopedic Trauma Association’s Annual Meeting in Seattle last October was another opportunity to connect with over 400 orthopaedic trauma surgeon presenters, moderators and authors — an activity the company remains committed to at medical conferences across the US.

 “We are proud to unveil the latest addition to our Apex range of intramedullary nails, the Femoral Retrograde Nail, which features our patented micromotion technology, which has been shown to assist with faster healing.” 

Published papers have noted that micromotion may have a favourable impact on clinical challenges associated with femoral nonunion and delayed healing. The Apex Femoral Retrograde Nailing System has received FDA 510(k) clearance in the United States, and CE Mark approval in Europe, and is now accessible for professional use. Following FDA clearance and European CE mark approval, the first patient in Cork University Hospital Trauma Centre had the Apex Tibial Nail implanted.

The patient, a 42 year-old female, 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. 

“It was a major milestone to use the Apex Tibial Nailing System from OrthoXel in a live trauma case,” said Prof Harty. “As was expected, the surgical procedure was smooth and uncomplicated. We are proud to introduce a comprehensive solution that combines cutting-edge technology with an unwavering commitment to patient care. With the Apex system, surgeons will have the tools they need to achieve optimal results, while patients will benefit from a faster recovery and improved quality of life.”

Patient care and safety are at the forefront of OrthoXel’s mission, and the Apex Femoral Retrograde Nailing System reflects this commitment, says CEO Pat O’Connor. The OrthoXel business focus is on developing the commercial market in the United States for both the Apex Tibial and Femoral Nailing Systems as well as identifying select markets outside the US, and is now working to identify potential commercial partners. 

“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,” O’Connor explains. 

“Our products really should be the devices of choice for orthopaedic trauma care. Having completed the product development cycle and with regulatory approvals and compelling clinical data, we have several surgeons who are interested in using our technology, and means we have feet on the ground in the USA to further expand clinical use by surgeons in US hospitals. We are looking forward to continuing to build on our relationship with both the surgeons, hospitals and distributors into the future.” 

The global intramedullary nail market is valued at €2 billion, with the tibia and femoral market segments estimated at €800 million.

 “The US is a large and very lucrative market and getting further traction there continues to be a big objective for us over the next twelve months.”