InVivo Therapeutics (NSDQ:NVIV) said today it won Health Canada approval to initiate a clinical study of its neuro-spinal scaffold in patients with acute, complete AIS A cervical spinal cord injuries.
The Cambridge, Mass.-based company said it is in late stage conversations with several site research ethics boards, and expects to announce the 1st Canadian site for the study “in the coming weeks.”
The neuro-spinal scaffold is designed to be surgically implanted following acute spinal cord injuries to act as a physical substrate for nerve sprouting, InVivo said.
“This approval is an important step towards our goal of redefining the life of the spinal cord injury patient. We are dedicated to helping as many SCI patients as we can, and this approval helps us to evaluate our investigational product in the most severe spinal cord injury cases, with neurologically complete cervical injuries involving impairment of the arms, hands, trunk, and legs. As I explain further in my CEO’s perspective, moving into the cervical spinal cord is exciting, since each level of the cervical spinal cord has a substantial functional impact. If the neuro-spinal scaffold were able to preserve, remyelinate and/or regenerate just a small area of spinal cord, we believe this could have significant functional consequences. We look forward to bringing sites onboard in Canada to commence enrollment and ultimately to expanding our study of cervical patients to the United Kingdom and the United States,” InVivo CEO Mark Perrin said in a press release.
Earlier this week, InVivo said it submitted its 1st nonclinical study module to the FDA as part of its humanitarian device exemption submission for its neuro-spinal scaffold.
The submission is the 1st of 3 modules it must present to the FDA as it seeks HDE approval for the device.