The Cambridge, Mass.-based company’s neuro-spinal scaffold is a novel, biodegradable device designed to be surgically implanted following acute spinal cord injuries to act as a physical substrate for nerve sprouting.
Results from the trial were presented at the 2019 AANS Meeting in San Diego, InVivo Therapeutics said.
Of the 16 patients in the trial, 44%, or 7, showed an ASIA Impairment Scale (AIS) conversion at six months, which served as the trial’s primary endpoint, passing the objective performance criterion of the study which was defined at a 25% AIS conversion rate.
Of those patients, six were later evaluated at the 12-month exam as a single patient was lost prior to the follow-up exam, InVivo said. Two of the six remaining patients were assessed to have an AIS B spinal cord injury at six months taht improved to an AIS C SCI at 12 months.
“In addition to focusing on enrollment in the INSPIRE 2.0 Study, we look forward to continuing to follow this cohort of INSPIRE patients through their 24-month follow up visit, and we remain encouraged by the continued stability of the AIS conversion rates,” prez & CEO Dr. Richard Toselli said in a press release.