R-fix (rib-fixation) spinal growth system for early-onset spinal deformity
Active Project Grant Awarded Last action
- Award ID
- R44AR080507
- Recipient
-
Apex Orthopaedic Technologies LLC UEI CE1HQ5WGGJP9
- Awarding agency
-
National Insititue of Arthritis and Musculoskeletal and Skin Diseases
National Institutes of Health, Department of Health and Human Services
- Obligated
- $3,331,266
Award facts
- Assistance listing
- 93.846 Arthritis, Musculoskeletal and Skin Diseases Research
- Completion date 82% complete
- Originally
- Place of performance
- Mt Pleasant, SC 29464, USA
Award details come from USAspending.gov.
Description
- Abstract
- Early-onset spinal deformity is a subset of pediatric spinal deformity that begins before the age of 10 years. Unlike adolescent idiopathic scoliosis, IT is a life-threatening disease, which makes early intervention crucial. Surgical intervention must accommodate the growth of the developing spine, making this one of the most challenging orthopedic conditions to treat. Current intra-spinal based treatments, such as growing rods with pedicle screw fixation, have high complication rates and limited effectiveness. The r-fix (rib-fixation) spinal growth system is an alternative extra-spinal technique that uses rib-based fixation for correcting early-onset spinal deformity. This extra-spinal rib fixation is a paradigm shift from seeking correction of the spine to emphasizing correction of thorax malalignment. The r-fix system originated from a bioengineering lab (one of the applicants' labs) at clemson university and has been further developed by apex orthopaedic technologies. The r-fix spinal growth system has been granted breakthrough device designation by the FDA. The objective of this sbir phase II award is threefold: 1) complete the final design, manufacturing, and quality control processes for the new r-fix system components, 2) obtain the necessary biomechanical, biocompatibility, and sterility data resulting in successful 510(k) clearance of the r-fix system, and 3) demonstrate the safety and efficacy of new r-fix UNI-axial rib hook and rib band designs in an animal model. This research will be conducted over 24 months and the data obtained from this grant proposal will result in a 510(k) application for FDA clearance and follow-up niams pediatric medical device initiative clinical trial application. Major milestones to be achieved with this grant include 1) validation of new implantable r-fix components with surgeon feedback, 2) completion of benchtop performance testing and FDA 510(k) submission, and 3) assessment of the safety and efficacy of new r-fix components compared to pedicle screws in a pediatric hyperkyphosis porcine animal model.
Transactions
| Action | Obligated | Date |
|---|---|---|
| Amendment | $0 | |
| Amendment | $853,846 | |
| Amendment | $0 | |
| Amendment | $0 | |
| Amendment | $0 | |
| Amendment | $1,238,710 | |
| Original award | $1,238,710 |
Quick answers
Who received award R44AR080507?
R44AR080507 was awarded to Apex Orthopaedic Technologies LLC by National Insititue of Arthritis and Musculoskeletal and Skin Diseases (National Institutes of Health) on September 20, 2022.
How much is award R44AR080507 worth?
$3,331,266 has been obligated on R44AR080507.
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