Company Notes: Following acute spinal cord injury, surgical implantation of the biodegradable Neuro-Spinal Scaffold within the decompressed and debrided injury epicenter is intended to support appositional healing, thereby reducing post-traumatic cavity formation, sparing white matter, and allowing neural regeneration across the healed wound epicenter. The Neuro-Spinal Scaffold, an investigational device, has received a Humanitarian Use Device (HUD) designation and currently is being evaluated in The INSPIRE Study for the treatment of patients with acute, complete (AIS A), thoracic traumatic spinal cord injury and a pilot study for acute, complete (AIS A), cervical (C5-T1) traumatic spinal cord injury. For more information on the cervical study, go here.
InVivo Therapeutics Holdings Corp. (NVIV) today announced that a new patient has been enrolled into The INSPIRE Study (InVivo Study of Probable Benefit of the Neuro-Spinal Scaffold™ for Safety and Neurologic Recovery in Subjects with Complete Thoracic AIS A Spinal Cord Injury) at Oregon Health & Science University (OHSU) in Portland, Oregon. Jason J. Chang, M.D., Assistant Professor of Neurological Surgery and co-study investigator, performed the surgery and implantation approximately 77 hours after the injury occurred.
Mark Perrin, InVivo’s Chief Executive Officer and Chairman, said, “We were pleased to hear that the procedure was a success and that the patient is doing well. We now have 15 patients enrolled and in follow up, and we look forward to completing enrollment in the INSPIRE study.”
For more information on the INSPIRE study, please visit the company’s ClinicalTrials.gov registration site: http://clinicaltrials.gov/ct2/show/study/NCT02138110