The fifth patient underwent spinal cord injury surgery with the Neuro-Spinal Scaffold six months ago. All patients enrolled in the trial had complete AIS A injuries when they were enrolled in the study. Here are five key points on the results:
1. Three out of the first five patients treated have an AIS grade improvement six months after surgery. Fewer than 16 percent of patients with complete thoracic injuries have an AIS grade improvement by six months post-injury, according to natural history databases.
2. The fifth patient treated improved from the complete AIS A spinal cord injury to an incomplete AIS B spinal cord injury between the three-month and six-month post-injury assessment.
3. The Objective Performance Criterion success is defined as 25 percent or more of the patients improving by at least one AIS grade by six months after surgery. The fifth patient is the trial’s third conversion.
4. InVivo’s goal is to approach full enrollment of the INSPIRE study by the end of the year to submit for the Humanitarian Device Exemption in 2017.
5. InVivo added Louisville (Ky.) Hospital and Vidant Medical Center in Greenville, N.C., as clinical trial sites in the past month.
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