SUMMARY / ABSTRACT
Each year, ~200,000 newborns worldwide, 80-85% of whom require surgical intervention, are afflicted with
congenital conditions that cause impaired growth of the skull or mandible, leading to abnormalities that affect
breathing, hearing, speech, visual function, neurologic development, and mastication. Unfortunately, current
surgical treatments, including endoscopic surgery, open reconstruction, and distraction osteogenesis (DO),
suffer inherent drawbacks, impacting outcomes. A better solution is needed for this vulnerable patient population.
DO is a widely recognized treatment modality that harnesses the body’s natural ability to regenerate bone in
order to correct skeletal deficiencies and defects. While still emerging for craniomaxillofacial (CMF) applications,
surgeons have shown the utility of DO for restoring functional discrepancies in patients with craniofacial
differences. The technique of DO involves surgical placement of one or more distractors, which are devices
used to slowly separate two opposing bony fragments at an osteotomy site, to gradually lengthen and reshape
the affected bone and stimulate new bone growth. However, DO is not without shortcomings. First, all current
distractors have an external component for manual expansion. The external component significantly increases
patient risk for complications such as infection (35%), device dislodgement (3.0%), increased analgesic use, and
scarring (15.6%). Second, since the burdensome responsibility for manual expansion lies with the caregiver,
treatment noncompliance (4.7%) is a serious issue, introducing vulnerabilities ranging from inconsistent device
expansion to complete treatment failure. Therefore, DO necessitates extensive physician clinic time and patient
radiation exposure to monitor therapeutic progress and thus has not been widely adopted in the CMF skeleton
despite recognition of potential advantages over endoscopic surgery (narrower indication for use) and open
reconstruction (more invasive, longer anesthesia time, higher blood transfusion rate, longer hospital stay).
The Ostiio distraction (OD) system addresses many of the issues associated with DO treatment as the first fully
subcutaneous, contactless DO system for the CMF skeleton. At a high level, the OD system leverages magnetic
coupling to transfer torque from the hand-held driver (HHD) to the implant, thereby expanding the implant in a
contactless fashion. This novel approach will markedly reduce infection, scarring, and manipulation
noncompliance. In addition, because the design uniquely permits wireless communication between the implant
and HHD, it will enable physicians to better control and monitor treatment progress.
This proposal aims to validate a key performance spec of the OD system by demonstrating it can rigorously meet
distraction force performance parameters similar to those achieved by the current standard of care. Successful
demonstration of this outcome will support Phase II in which we will further development of the OD system by
validating function and performance in an in vivo model and formative human factors study. This work will speed
to market a novel approach to CMF surgery that can significantly improve DO patient outcomes and experience.
