InVivo Therapeutics will include Christopher & Dana Reeve Foundation NACTN Registry data in its Contemporary Thoracic SCI Registry Study.
Here are five things to know:
1. The Contemporary Thoracic SCI Registry Study is a complement to InVivo's INSPIRE study.
2. The CONTEMPO Registry Study is designed to offer natural history benchmarks for INSPIRE study results, including spinal cord injury patients with similar baseline characteristics treated since 2006.
3. The NACTN registry encompasses data from academic hospital neurosurgical departments, inclusive of acute patient data, post-injury complications and treatments, MRI data and follow-up neurological exams.
4. InVivo submitted a protocol for the CONTEMPO Registry Study to the FDA.
5. The company hopes the INSPIRE study combined with the CONTEMPO Registry Study will offer evidence for the Humanitarian Device Exemption approval process.