Magnet-Actuated Craniofacial (MAC) Distraction System for Improved Treatment of Craniofacial Deformities

Background & Unmet Need

• Craniosynostosis is a condition characterized by premature fusion of cranial sutures that affects ~ 1 in every 2,500 live births globally
• If left untreated, craniosynostosis can lead to disrupted skull growth, elevated intracranial pressure and serious neurodevelopmental abnormalities
• Craniofacial distraction osteogenesis (DO) enables gradual distraction and controlled bone regeneration for patients with abnormal craniofacial morphology
• However, conventional craniofacial DO systems require external activation ports that increase the risk of wound infection, mechanical failure, and premature removal of the distraction system.
• Additionally, manual external actuation introduces user-dependent variability and mechanical inconsistency
• Unmet Need: Craniofacial DO systems with reduced risk of infection and more precise control of the distraction mechanism

Technology Overview

• The Technology: A magnet-actuated craniofacial (MAC) distraction system for contactless, noninvasive delivery of the mechanical forces required for craniofacial DO
• The MAC system exploits magnetic coupling between external and internal magnets to generate noninvasive, controlled mechanical forces without direct physical contact with the external environment
• Three-dimensional magnetostatic finite element modeling (FEM) demonstrated the feasibility of achieving clinically relevant transmissible torque using magnetic actuation
• PoC Data: In a cadaveric feasibility study, the MAC system exhibited reliable mechanical performance, positional stability, and resistance to back-drivability under anatomically relevant conditions

Technology Applications

• Treatment of complex craniosynostosis, including syndromic, multi-suture craniosynostosis
• Treatment of other craniofacial abnormalities such as mandibular micrognathia and midface hypoplasia

Technology Advantages

• Potential to reduce the risk of infection and mechanical failure
• Magnetic coupling enables predictable, adaptable, and patient-specific control of distraction kinetics