InVivo Therapeutics Announces Enrollment of Third Patient in Pilot Spinal Cord Injury Trial

InVivo Therapeutics Holdings Corp. (NVIV) today announced that a third patient has been enrolled in the company's ongoing pilot trial of its investigational Neuro-Spinal Scaffold in patients with acute spinal cord injury at the Carolinas Medical Center, part of the Carolinas HealthCare System in Charlotte, NC. Dr. Dom Coric, of the Carolina Neurosurgery and Spine Associates and Chief of Neurosurgery at Carolinas Medical Center, together with Dr. William Bockenek, Chief Medical Officer at Carolinas Rehabilitation, are Co-Principal Investigators at this site. Dr. Coric along with Dr. Mark Smith of the Carolina Neurosurgery and Spine Associates, performed the third-ever Neuro-Spinal Scaffold implantation into an acute spinal cord injury patient. The implantation took place about three and a half days after the injury. Dr. Coric said, "The implantation procedure went smoothly and the patient is doing very well. It has been rewarding to be involved in this clinical study, and I look forward to following the patient's progress." Mark Perrin, InVivo's CEO and Chairman, said, "This third patient affords us the opportunity to further extend our experience with the Neuro-Spinal Scaffold and will provide us with additional data for the design of a future pivotal study." This is the company's first clinical study of its investigational degradable polymer Neuro-Spinal Scaffold. The Investigational Device Exemption (IDE) pilot study has been approved by the FDA and is intended to capture preliminary safety and effectiveness data of the Neuro-Spinal Scaffold in five subjects with acute thoracic spinal cord injury. Following the pilot trial, InVivo expects to conduct a pivotal study to obtain FDA approval to commence commercialization under a Humanitarian Device Exemption (HDE). For more information, please visit the company's ClinicalTrials.gov registration site: http://clinicaltrials.gov/ct2/show/study/NCT02138110