CAMBRIDGE, Mass.--(BUSINESS WIRE)--
InVivo Therapeutics Holdings Corp. (NVIV) today announced that it has received approval from the Toronto Western Hospital’s Research Ethics Board to enroll patients as part of its cervical spinal cord injury study. Toronto Western Hospital is the first study site for the company’s cervical spinal cord injury study and Michael Fehlings, M.D., Ph.D., has been named Principal Investigator at the site. Dr. Fehlings is currently Director of the Spinal Program, part of Toronto Western Hospital’s Krembil Neuroscience Centre at the University Health Network, Professor in the Department of Surgery, full member of the Institute of Medical Sciences School of Graduate Studies, a Scholar in the McLaughlin Centre of Molecular Medicine, a Scientist in the McEwen Centre for Regenerative Medicine, a Senior Scientist at the Krembil Research Institute, Director of the University of Toronto Neuroscience Program, Co-Director of the University of Toronto Spine Program, and Krembil Chair in Neural Repair and Regeneration. Dr. Fehlings has published over 725 peer-reviewed articles principally in the area of spinal cord injury and complex spinal surgery. He is also currently the Principal Investigator at the site for InVivo’s INSPIRE study, which is studying the Neuro-Spinal Scaffold™ in acute, complete (AIS A) thoracic patients.
Dr. Fehlings said, “Our centre remains enthusiastic about addressing the unmet need in cervical spinal cord injuries and being part of InVivo’s pioneering efforts in this exciting and promising field.”
“We are thrilled to launch our cervical study in Canada with one of the most prominent leaders in spinal cord injury research,” Mark Perrin, InVivo’s CEO and Chairman, said. “We admire Dr. Fehlings’ and Toronto Western Hospital’s dedication to helping us evaluate our technology through both the cervical study and the INSPIRE study. We look forward to continuing to work with Dr. Fehlings and Toronto Western Hospital.”
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.
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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. 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 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.
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