Rib-based spinal growth device for young children with early-onset spinal deformity
Official title: R-FIX (Rib-FIXation) Spinal Growth System for Early-onset Spinal Deformity
Funded at Apex Orthopaedic Technologies LLC · NIH-11196772 · Data updated 2026-11-12
This project develops a rib-based implant to help correct life‑threatening spine and chest deformities in children under 10 while allowing their spine to grow.
Quick facts
| Grant type | Sbir 2 grant |
|---|---|
| Study type | NIH-funded research |
| Funding institution | Apex Orthopaedic Technologies LLC NIH-funded |
| Lab location | 1 site (Mount Pleasant, United States) |
| Project start | September 20, 2022 |
| Project end | August 31, 2026 |
| Funding year | 2025 |
| Award (this year) | $853,846 |
| NIH project number | 5R44AR080507-03 |
| Project ID | NIH-11196772 on NIH RePORTER |
Who could benefit from this research
✓Could help
Children under about 10 years old with early‑onset spinal deformity or scoliosis with thoracic malalignment who may require growth‑accommodating surgical correction.
✕Less likely to help
Older adolescents and adults, children with mild or nonprogressive curves managed without surgery, or patients whose issues are not related to rib/thoracic malalignment are unlikely to benefit.
What this research studies
If your child has early‑onset spinal deformity, this work is creating a new rib‑based implant that aims to correct both spine and chest alignment while the child grows. The team is finishing device design and completing manufacturing and quality control steps. They will run lab tests for strength, biocompatibility, and sterility and collect the data needed for FDA 510(k) clearance. The plan includes demonstrating safety and performance of new rib hooks and bands as a potential surgical option.
Why it matters
Potential benefit: Could provide a growth‑friendly surgical option with fewer complications that improves chest shape and breathing while reducing the need for repeat operations.
How similar studies have gone: Some rib‑based devices (for example VEPTR) and growing‑rod techniques have helped children but have limitations, and the R‑FIX approach is newer and viewed as a novel refinement that has received FDA breakthrough designation.
Where this research is happening
-
Apex Orthopaedic Technologies LLC
Mount Pleasant, United States Active
Researchers
- Principal investigator: Gross, Richard H. — Apex Orthopaedic Technologies LLC
- Study coordinator: Gross, Richard H.
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About this research
- This is an active NIH-funded research project — typically early-stage science, not a clinical trial accepting patient enrollment.
- Some NIH-funded labs run parallel clinical studies or seek volunteers for related work. To check, contact the principal investigator or institution listed above.
- For full project details, budget, and progress reports, visit the official NIH RePORTER page.