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.
Of the 16 patients in the trial, 44% showed an ASIA impairment scale 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.
All patients who showed an ASIA conversion at six months retained the condition at 12 months, though a single patient was “lost to follow up after the 6-month visit and was not assessed at a 12-month visit,” the company said. A total of 19 patients were implanted with the neuro-spinal scaffold, with three dying within two weeks of implantation.
“We will continue to follow this cohort of patients as they progress through their 24-month follow up visit and remain encouraged by the continued stability of the AIS conversion rate past the six-month primary endpoint visit,” prez & CEO Dr. Richard Toselli said in a press release.
Earlier this month, InVivo saw shares fall after the medical device maker missed expectations on Wall Street with its second quarter results.