FDA Gives InVivo Therapeutics the Green Light for Pivotal Probable Benefit Study

January 4, 2016

The FDA has given its blessing to InVivo Therapeutics to convert its ongoing pilot study of the Neuro-Spinal scaffold into a pivotal probable benefit study.

The INSPIRE study is designed to enroll 20 patients with complete thoracic spinal cord injury (AIS A) implanted with the scaffold.

A biodegradable device, the scaffold is implanted at the epicenter of a wound. It is designed to act as a physical substrate for nerve sprouting. — Michael Cipriano