OrthoXel is an orthopaedic trauma company focussed on the development and commercialisation of innovative tibia and femoral nails which have several differentiating features including micromotion technology to promote accelerated healing.
The Apex Tibial Nailing System includes a range of nails, screws, endcaps and instrumentation to provide the surgeon with new insertion and locking options to promote accelerated fracture healing along with retaining current standard options available from existing products. The Apex Femoral Nail includes enhanced nail insertion and locking options to promote healing while retaining all principles and locking options of current femoral products on the market.
1st Product: Apex Tibial Nailing System: Product differentiation includes nail insertion and securement options to: • Promote accelerated healing (up to 20% reduction in tibia fracture healing time; • Treat unstable proximal fractures; • Provide a stable revision treatment option for delayed/non-union fractures. In addition, retains all locking options that are available on existing tibia nails. 2nd Product: Apex Femoral Nail Built on the same platform as the Tibia Nail, the Apex Femoral Nail provides the surgeon with new treatment options to promote healing as well as retaining the existing treatment options in an “all-in-one” device General Comments: • High Volume sub supply manufacturers established; • OrthoXel device manufacturing costs are in line with existing products on the market; • Strong Margins (particularly in the US); • Experienced team with significant track record of medical device development and commercialisation.
• ISO 13485 Quality Management Systems Certification • CE Mark Certification and FDA 510k Clearance for Apex Tibia Nail • CE Mark imminent for Apex Femoral Nail and US FDA 510k review in progress
• Medical Devices - Orthopaedic Trauma
• Orthopaedic Trauma Surgeons • Hospitals in Europe and USA
• Health Innovation Hub Ireland • Clinical Research Facility, Cork (CRF-C) • Cork University Hospital – Orthopaedic and Radiography Departments • Manufacturing, Packaging and sterilisation sub suppliers
Rubicon Centre CIT Campus Bishopstown Cork
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