A patient implanted with Cambridge, Mass.-based InVivo Therapeutics' Neuro-Spinal Scaffold in the INSPIRE study has improved from a complete AIS A spinal cord injury to an incomplete AIS B spinal cord injury.
Here are six takeaways:
1. This conversion took place between the two-and three-month evaluations.
2. This patient represents the fifth out of eight patients to experience an AIS grade improvement, representing a 62.5 percent conversion rate.
3. The Objective Performance Criterion for the INSPIRE study indicates five or more of the 20 evaluable patients improve by at least one AIS grade at the six months post-implantation follow-up.
4. If the current five converted patients don't revert to AIS A before the six-month follow-up, then InVivo will have met the OPC.
5. The INSPIRE study tests the Neuro-Spinal Scaffold's efficacy and safety for complete thoracic AIS A spinal cord injury.
6. Twenty-three clinical sites around the country are participating in the INSPIRE study.
"Having five patients improve AIS grades so early in the INSPIRE study is a fantastic achievement and a major milestone for InVivo," said Mark Perrin, CEO and chairman, InVivo. "If we continue to observe AIS conversions at a similar rate, we will dramatically exceed the Objective Performance Criterion measure of study success."