The objective of the pilot study is to evaluate the safety and feasibility of the Neuro-Spinal Scaffold as well as to gather preliminary evidence of effectiveness.
Dr. Nicholas Theodore, Chief of Spinal Surgery, Barrow Neurosurgical Institute and Medical Director of the Neurological Trauma Program, is a Principal Investigator in this study and implanted the first-ever Neuro-Spinal Scaffold into an acute spinal cord injury patient.
"I am excited about my participation in this important clinical trial," Dr. Theodore said. "The surgery and Neuro-Spinal Scaffold implantation went smoothly and the patient is doing well at this time. I look forward to continuing to help evaluate this approach in patients with these devastating injuries."
Mark Perrin, InVivo’s CEO, said: "This is a major milestone not only for the company, but also for the field of traumatic SCI. InVivo is striving to provide benefit to the SCI patient population with such a huge unmet medical need, and this clinical trial is the first step. We look forward to communicating our progress and moving forward. InVivo will be making announcements after each site has joined the study, after each subject is enrolled, and once enrollment is re-opened for subsequent patients. We consider patient privacy of the utmost importance and will thus communicate any interim information according to industry standards. With the exception of dramatically positive or negative results, we will look to communicate progress at appropriate medical or scientific forums."
As previously stated and per FDA requirements, the company will follow the first enrolled subject for three months before re-opening enrollment.