InVivo Therapeutics (NSDQ:NVIV) said today it added a clinical site at the Vidant Medical Center in Greenville, N.C.to its Inspire study examining the probable benefit of its Neuro-Spinal Scaffold, designed to treat patients with complete thoracic AIS A spinal cord injuries.
The Cambridge, Mass.-based company’s neuro-spinal scaffold is surgically implanted following acute spinal cord injuries to act as a physical substrate for nerve sprouting.
“We are quite excited to take part in a study that has the potential to change the standard of care for acute, traumatic spinal cord injury,” site principal investigator Dr. Stuart Lee said in prepared remarks.
“I am pleased to welcome Dr. Lee and his team to the study and am looking forward to continuing to enroll patients into The Inspire Study,” CEO Mark Perrin said in a prepared statement.
Yesterday, InVivo said that the FDA accepted its proposed Humanitarian Device Exemption modular shell submission and review process for its Neuro-Spinal Scaffold.
InVivo said its HDE modular shell for the Neuro-Spinal Scaffold is composed of 3 modules, including a preclinical study module, manufacturing module and clinical data module. The submission of the final module triggers a 75-day HDE review clock, the company said.
On Monday, InVivo said the FDA approved a protocol amendment for its Inspire study examining the benefit of its Neuro-Spinal Scaffold for treating patients with complete thoracic AIS A spinal cord injuries, establishing objective performance criterion for the trial.