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

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