Preclinical studies on axial micromotion at the fracture site revealed that it stimulates the formation of callus and enhances stiffness compared to rigid fixation.

Clinical studies demonstrated the benefits of axial interfragmentary motion for faster fracture healing, with clinical trials showing 20% faster healing with micromotion compared to rigid locking. Preclinical studies established that micromotion must start early, within the first 6 weeks, and be axial in direction.

Clinical outcomes with third-generation nails converge on a 12% nonunion rate for tibial fractures. Delayed union remains a challenge, with 25% of tibial shaft fractures not healed within 5 months and 25% of femoral shaft fractures not healed within 7 months.

The micromotion nailing concept was developed to address the unmet clinical need of nonunion and delayed healing. Bench testing was commenced to establish the required technical parameters. Preclinical testing completed at the Musculoskeletal Research Unit at University of Zurich.

Locking plate constructs with micromotion – far cortical locking and dynamic locking screws – were developed to enhance fracture healing through interfragmentary motion.

Micromotion-enabled tibial nailing allows controlled, low-force axial micromotion with high torsional stability, the evidence-based ideal biomechanics for fracture healing.

OrthoXel acquired background intellectual property from Munster Technological University and commenced working to translate the science of micromotion into a commercially viable intramedullary nail product. The quality management system structure and key personnel were put in place.

Patents applications submitted covering the sliding micromotion insert design that allows controlled axial movement while limiting torsional and shear movements. FDA 510(k) clearance and CE Mark certification obtained for the Apex Tibial Nailing System. Development of the Apex Femoral Nailing system commenced to apply micromotion to femoral shaft fractures.

First clinical results for micromotion nailing of tibial fractures showed faster healing and significant reduction of delayed healing and nonunion compared to standard-of-care locked (third generation) nailing.