InVivo Therapeutics Holdings Corp. (NVIV) today announced that the U.S. Food and Drug Administration (FDA) has approved the expansion of the number of patients from five to ten in the company’s pilot study of its investigational Neuro-Spinal Scaffold™ implant in patients with acute thoracic spinal cord injury. As previously communicated, InVivo intends to transition the pilot study into a pivotal probable benefit study and to use this single study as the basis for a Humanitarian Device Exemption (HDE) application.
“I am very pleased to have come to such a positive agreement with the FDA ahead of schedule, which will avoid any disruption in patient enrollment. While we continue to enroll subjects in our ongoing pilot study, we are working diligently with the FDA to finalize the transition to the pivotal probable benefit study. We anticipate announcing the study design and updating associated timelines before the end of the year,” said Mark Perrin, InVivo’s CEO and Chairman.
About the Neuro-Spinal Scaffold™
Following an acute spinal cord injury, the biodegradable Neuro-Spinal Scaffold is surgically implanted at the epicenter of the wound and is designed to act as a physical substrate for nerve sprouting. Appositional healing to spare spinal cord tissue, decreased post-traumatic cyst formation, and decreased spinal cord tissue pressure have been demonstrated in preclinical models of spinal cord contusion injury. The Neuro-Spinal Scaffold, an investigational device, has received a Humanitarian Use Device (HUD) designation and is currently being studied in an Investigational Device Exemption (IDE) pilot study for the treatment of patients with complete (AIS A) traumatic acute spinal cord injury.
About InVivo Therapeutics
InVivo Therapeutics Holdings Corp. is a research and clinical-stage biomaterials and biotechnology company with a focus on treatment of spinal cord injuries. The company was founded in 2005 with proprietary technology co-invented by Robert Langer, Sc.D., Professor at Massachusetts Institute of Technology, and Joseph P. Vacanti, M.D., who then was at Boston Children’s Hospital and who now is affiliated with Massachusetts General Hospital. In 2011, the company earned the David S. Apple Award from the American Spinal Injury Association for its outstanding contribution to spinal cord injury medicine. In 2015, the company’s investigational Neuro-Spinal Scaffold received the 2015 Becker’s Healthcare Spine Device Award. The publicly-traded company is headquartered in Cambridge, MA. For more details, visit www.invivotherapeutics.com.