IDE Approval Given to InVivo Therapeutics Spine Scaffold

FDA has given IDE approval to InVivo Therapeutics Holdings for a second pivotal clinical study involving the company’s Neuro-Spinal Scaffold in patients with acute spinal cord injury. The 20-patient, randomized, controlled trial is designed to complement existing clinical evidence from the company’s single-arm INSPIRE study. In the new trial, study success is defined as 20% or more scaffold-arm subjects who demonstrate an improvement of at least one grade on the American Spinal Injury Association Impairment Scale (AIS) at the six-month primary endpoint follow-up visit versus comparator-arm subjects. The company recently reported that seven of 16 (43.8%) evaluable patients in the INSPIRE study experienced an improvement in AIS grade from baseline at six months. Data from the studies is expected to support a potential Humanitarian Device Exemption submission to FDA, the company says.