CAMBRIDGE, Mass.--(BUSINESS WIRE)--InVivo Therapeutics Holdings Corp. (NVIV) today announced that the first subject has been enrolled in the pilot study of its Neuro-Spinal Scaffold for the treatment of complete traumatic spinal cord injury (SCI) at the Barrow Neurological Institute at St. Joseph’s Hospital and Medical Center in Phoenix, AZ. The objective of the pilot study is to evaluate the safety and feasibility of the Neuro-Spinal Scaffold as well as to gather preliminary evidence of effectiveness.
Dr. Nicholas Theodore, Chief of Spinal Surgery, Barrow Neurosurgical Institute and Medical Director of the Neurological Trauma Program, is a Principal Investigator in this study and implanted the first-ever Neuro-Spinal Scaffold into an acute spinal cord injury patient. “I am excited about my participation in this important clinical trial,” Dr. Theodore said. “The surgery and Neuro-Spinal Scaffold implantation went smoothly and the patient is doing well at this time. I look forward to continuing to help evaluate this approach in patients with these devastating injuries.”
Mark Perrin, InVivo’s CEO, said: “This is a major milestone not only for the company, but also for the field of traumatic SCI. InVivo is striving to provide benefit to the SCI patient population with such a huge unmet medical need, and this clinical trial is the first step. We look forward to communicating our progress and moving forward. InVivo will be making announcements after each site has joined the study, after each subject is enrolled, and once enrollment is re-opened for subsequent patients. We consider patient privacy of the utmost importance and will thus communicate any interim information according to industry standards. With the exception of dramatically positive or negative results, we will look to communicate progress at appropriate medical or scientific forums.”
As previously stated and per FDA requirements, the company will follow the first enrolled subject for three months before re-opening enrollment.
For more information, please visit our ClinicalTrials.gov registration
site:
http://clinicaltrials.gov/ct2/show/study/NCT02138110
About InVivo Therapeutics
InVivo Therapeutics Holdings Corp. is a pioneering 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, ScD. Professor at Massachusetts Institute of Technology, and Joseph P. Vacanti, MD, who then was at Boston Children’s Hospital and 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. 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" and similar expressions, and include statements regarding the Company’s expectations with respect to the safety, feasibility, and clinical effectiveness of its scaffold device, the enrollment of subsequent patients in the scaffold pilot study following the reopening of enrollment, and the potential market for the treatment of spinal cord injuries. 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; the timing of the Institutional Review Board process; the Company’s ability to obtain FDA approval 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 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, 2013, as amended, 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.
