Here are five takeaways:
1. The company established an Objective Performance Criterion in February, and a week later the study’s fifth patient experienced improvements from complete AIS A spinal cord injury to AIS B spinal cord injury.
2. Three of the five treated patients improved by at least one ASI grade six months post surgery.
3. InVivo only needs two more patients that experience improvement by at least one AIS grade to meet OPC requirements.
4. The FDA also accepted InVivo’s Humanitarian Devise Exemption modular shell and review process in March. The company hopes to submit the first module at the end of 2016.
5. Currently, 18 institutions serve as INSPIRE study clinical sites.
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