InVivo Therapeutics announces presentation of twelve-month INSPIRE study results
InVivo Therapeutics Holdings announced the presentation of the twelve-month results from the company's single-arm INSPIRE study. The findings were presented at the 2019 AANS Meeting in San Diego, CA through an e-poster titled, "Twelve Month Results from the INSPIRE Study of the Investigational Neuro-Spinal Scaffold(TM) in Acute Thoracic Complete Spinal Cord Injury". As previously announced by InVivo, 7 of 16 patients who reached the six-month primary endpoint visit in the INSPIRE study had an ASIA Impairment Scale conversion at 6 months, which is the primary endpoint of the trial. Of the seven patients who reached the six-month primary endpoint visit, six patients were later evaluated at the 12-month exam and one patient was lost to follow-up before the 12-month exam. All six patients who were examined at the 12-month exam and had previously converted at the six-month exam remained converted at the 12-month exam. Further, two of those six patients were assessed to have AIS B spinal cord injury at the six-month primary endpoint but were later assessed to have improved to AIS C SCI at the 12-month visit. The Objective Performance Criterion for the study was a 25% AIS conversion rate based on the published conversion rates for thoracic SCI reported in the literature.