Health Canada has approved InVivo Therapeutics Holdings Corp’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, Probable Benefit of the Neuro-Spinal Scaffold for Treatment of AIS A Thoracic Acute Spinal Cord Injury, 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.
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 (HUD) 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.
“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.”