CAMBRIDGE, Mass.--(BUSINESS WIRE)--InVivo Therapeutics Holdings Corp. (NVIV) today announced that Health Canada has approved the company’s Investigational Testing Authorization application to commence a clinical study of the Neuro-Spinal Scaffold™ in patients with acute, complete (AIS A) cervical (C5-T1) spinal cord injuries (SCIs). InVivo currently is in late stage conversation with several site Research Ethics Boards and expects to announce its first Canadian site in the coming weeks.
“This approval is an important step towards our goal of redefining the life of the spinal cord injury patient,” said Mark Perrin, InVivo’s CEO and Chairman. “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.”
A new CEO’s Perspective discussing the differences between thoracic and cervical spinal cord injuries can be found on the InVivo Therapeutics website: http://www.invivotherapeutics.com/about-invivo/ceo-perspective/
About the Neuro-Spinal Scaffold™ Implant
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 acute, complete (AIS A), thoracic traumatic spinal cord injury and a pilot study for acute, complete (AIS A), cervical (C5-T1) traumatic 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.
Safe Harbor Statement
Any statements contained in this press release that do not describe historical facts may constitute forward-looking statements within the meaning of the federal securities laws. These statements can be identified by words such as "believe," "anticipate," "intend," "estimate," "will," "may," "should," "expect," “designed to,” “potentially,” and similar expressions, and include statements regarding the safety and effectiveness of the Neuro-Spinal Scaffold, the ability of the company to open a site in Canada or enroll patients in Canada, and the ability to expand the trial to the United Kingdom and the United States. Any forward-looking statements contained herein are based on current expectations, and are subject to a number of risks and uncertainties. Factors that could cause actual future results to differ materially from current expectations include, but are not limited to, risks and uncertainties relating to the company’s ability to successfully open additional clinical sites for enrollment and to enroll additional patients; the timing of the Institutional Review Board process; the impact of achieving the OPC on the FDA approval process; the company’s ability to commercialize its products; the company’s ability to develop, market and sell products based on its technology; the expected benefits and efficacy of the company’s products and technology in connection with the treatment of spinal cord injuries; the availability of substantial additional funding for the company to continue its operations and to conduct research and development, clinical studies and future product commercialization; and other risks associated with the company’s business, research, product development, regulatory approval, marketing and distribution plans and strategies identified and described in more detail in the company’s Annual Report on Form 10-K for the year ended December 31, 2016, and its other filings with the SEC, including the company’s Form 10-Qs and current reports on Form 8-K. The company does not undertake to update these forward-looking statements.