InVivo Therapeutics Receives Investigational Testing Authorization from Health Canada

InVivo Therapeutics Holdings Corp. executives said Health Canada has approved the company’s Investigational Testing Authorization application to begin clinical studies there. The authorization enables the company to enroll Canadian patients into its ongoing INSPIRE study once a site is open for enrollment. InVivo currently is in late stage conversation with various Canadian Research Ethics Boards and expects to announce its first Canadian site in the next few weeks.
 
“The Canadian scientific and medical community recognizes spinal cord injury as a significant unmet medical need and has been at the forefront of researching potential therapies for years,” said Mark Perrin, InVivo’s CEO and chairman. “Partnering with countries and institutions that share our commitment to advancing the field is a significant step in furthering the company’s global mission: to redefine the life of the spinal cord injury patient.”
 
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, is designed to demonstrate the safety and probable benefit of the Neuro-Spinal Scaffold for the treatment of complete T2-T12/L1 spinal cord injury in support of a humanitarian device exemption application for approval.

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 designation and currently is being evaluated in the INSPIRE pivotal probable benefit study for the treatment of patients with complete (AIS A) traumatic acute spinal cord injury.
 
InVivo Therapeutics Holdings Corp. is a research and clinical-stage biomaterials and biotechnology company with a focus on treating spinal cord injuries. The company was founded in 2005 with proprietary technology co-invented by Robert Langer, Sc.D., professor at the 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, InVivo earned the David S. Apple Award from the American Spinal Injury Association for its contribution to spinal cord injury medicine. In 2015, the Cambridge, Mass.-based company’s investigational Neuro-Spinal Scaffold received the 2015 Becker’s Healthcare Spine Device Award.