Cambridge, Mass.-based InVivo said it expects the FDA to OK its Inspire study, designed to enroll 20 patients with spinal cord injuries, after it submits 6-month data during the 2nd quarter from 5 patients already enrolled in the pilot study.
InVivo’s neuro-spinal scaffold is a bioabsorbable device designed to treat acute spinal cord injuries. The company said it’s discussing the Inspire study’s objective performance criterion for probable benefit, using historical benchmarks, with the federal safety watchdog.
“Receiving full approval to convert our pilot study into a pivotal probable benefit study is a significant step forward for InVivo,” chairman & CEO Mark Perrin said in prepared remarks. “It is extraordinary to think that just over a year after enrolling the 1st patient in our study, we are now running a pivotal trial with planned international expansion and the intent to file an application for HDE approval in just 2 years.”