# A Smart, Fully Subcutaneous Distraction System to Improve Outcomes in Patients with Congenital or Acquired Craniofacial Differences

> **NIH NIH R44** · OSTIIO LLC · 2024 · $849,999

## Abstract

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 system addresses many of the issues associated with DO treatment as the first fully
subcutaneous, programmable DO system for the CMF skeleton. At a high level, the Ostiio distraction 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 Phase II proposal aims to a) achieve design freeze of the integrated Ostiio distraction system, incorporating
design improvements to ensure device biocompatibility and functionality throughout active distraction, and b)
demonstrate the system can be used safe...

## Key facts

- **NIH application ID:** 10929326
- **Project number:** 5R44DE031195-03
- **Recipient organization:** OSTIIO LLC
- **Principal Investigator:** Jessica DesNoyer
- **Activity code:** R44 (R01, R21, SBIR, etc.)
- **Funding institute:** NIH
- **Fiscal year:** 2024
- **Award amount:** $849,999
- **Award type:** 5
- **Project period:** 2023-09-14 → 2026-09-13

## Primary source

NIH RePORTER: https://reporter.nih.gov/project-details/10929326

## Citation

> US National Institutes of Health, RePORTER application 10929326, A Smart, Fully Subcutaneous Distraction System to Improve Outcomes in Patients with Congenital or Acquired Craniofacial Differences (5R44DE031195-03). Retrieved via AI Analytics 2026-05-23 from https://api.ai-analytics.org/grant/nih/10929326. Licensed CC0.

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