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InVivo Therapeutics Holdings Corp. announced that Health Canada has approved the company’s Investigational Testing Authorization application to commence clinical studies in Canada. The authorization will allow the company to enroll Canadian patients into the ongoing INSPIRE study once a Canadian 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 coming 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,” Mark Perrin, InVivo’s CEO and Chairman, said. “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.”
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 (HDE) application for approval.
