Our Story

OrthoXel – About Us2024-04-26T16:10:54+01:00

ABOUT ORTHOXEL

WHO WE ARE

OrthoXel is an orthopaedic trauma device company dedicated to advancing the future of fracture fixation with our orthopaedic trauma portfolio. We aim to improve patient outcomes and transform trauma healthcare driven by insights from surgeons and committed to enhancing patient recovery. OrthoXel’s culture is guided by a philosophy of evidence-based design and our process integrates the best available clinical evidence with a focus on surgeon needs to develop devices that achieve technological advances without compromising ease of implantation.

OUR FOCUS

OrthoXel is focused on improving implant design to achieve the best possible health outcomes for patients.

COMPANY MILESTONES

  • 2010 - 2013 Concept Development

    • Clinical need identified and micromotion nail concept developed.
    • Bench testing to establish the required technical parameters.
    • Preclinical testing completed at the Musculoskeletal Research Unit at University of Zurich.
  • 2014 Company Founded

    • Acquired background development work from Munster Technological University (preclinical testing, patents etc.).
    • Commenced working to translate the science of micromotion into a commercially viable intramedullary nail product.
    • Developed the quality management system structure along with key personnel.
  • 2014 – 2017 First Products Developed

    • Developed the current micromotion insert design concept to allow controlled axial movement while limiting torsional and shear movements.
    • Patented the sliding insert concept.
    • Identified an outsourced manufacturing model to supply the Apex Tibial Nail System.
    • Obtained FDA 510(k) clearance and CE Mark for the Apex Tibial Nails System.
    • Commenced the development of the Apex Femoral Nail project – application of micromotion to femoral shaft fractures.
  • 2018 – 2021 Clinical Studies & Further Products

    • Apex Tibia Nail first-in-man implantation followed by clinical study to establish the benefits of a micromotion-enabled intramedullary nail.
    • Clinical study demonstrated the benefits of micromotion with all patients healing faster than the current comparator device.
    • Publication of clinical study results in Bone and Joint Open.
    • Regulatory approval (FDA 510(k) & CE Mark) of the Apex Femoral nail product, including antegrade (hip) and retrograde (knee) insertion approaches.
  • 2021 Instrumentation System updates and U.S. implantations

    • Upgrade of all Apex Tibial and Femoral instrumentation along with the addition of suprapatellar clinical approach for tibial nail implantation.
    • Establishment of a United States centralized distribution hub along with onboarding of initial distributors.
    • First U.S. implantation of an Apex Tibial Nail.
  • 2022 Company Expansion

    • Relocation to larger office and warehousing space at Cube House in Cork, Ireland.
    • Expansion of all company departments.
    • Development of pipeline products for the treatment of hip fractures.
  • 2023 Femoral Product Launch & New Products

    • Expansion of the commercial team with a focus on the U.S. market.
    • Manufacture, design verification, cadaver test and regulatory submission of the Vertex nail for the treatment of hip fractures.
    • Launch of Apex Femoral Antegrade and Retrograde systems and initiation of Apex Femoral clinical study at Cork University Hospital.
  • 2024 Present

    • Focused on gathering further clinical evidence on the benefits of micromotion for enhanced fracture healing.
    • FDA 510(k) clearance for the Vertex Nailing System.
Present
2010 - 201320142014 – 20172018 – 20212021202220232024
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