InVivo issues new protocols for spinal scaffold study
Massachusetts-based InVivo Therapeutics awaits final consent after sending new study protocols to FDA regulators and the 6 sites participating in the company's revamped spinal scaffold clinical trial.
With investigational approval in hand, InVivo Therapeutics (OTC:NVIV) is preparing to launch a U.S. clinical study of its degradable polymer scaffold for treating spinal cord injury, issuing a revised trial protocol to FDA regulators and to the clinical sites participating in the study.
All revisions were approved under the FDA's newly granted investigational device exemption, InVivo said. The hospitals involved in the study can now review the documents and decide whether agree to the clinical trial contract with InVivo.