CAMBRIDGE, Mass. -- (BUSINESS WIRE) -- InVivo Therapeutics Holdings Corp. (NVIV), a developer of groundbreaking technologies for the treatment of spinal cord injuries (SCI) and other neurotrauma conditions, today announced an update on the clinical timeline for its biopolymer scaffolding to treat acute SCI. The Company now expects that, based on the judgment of new management, it will enroll the first patient during the first quarter of 2014.
Under the conditions of the FDA’s approval of the Investigational Device Exemption, the five-person pilot trial will be staggered such that each patient will be followed for three months prior to requesting approval to enroll the next patient. Because the Company must obtain FDA approval to enroll each subsequent patient, the Company anticipates that from the date of the first enrolled patient, it will take at least 21 months to complete enrollment. Consistent with FDA guidance, the Company then expects to conduct a pivotal study with a control group to obtain FDA approval to commence commercialization under a Humanitarian Device Exemption.
Michael Astrue, Interim Chief Executive Officer of InVivo, said, “We remain fully committed to beginning this study as soon as possible. While the study will take additional time, we look forward to bringing this important therapy into the clinic.”
Further, management has undertaken a comprehensive project and timeline review of its hydrogel technologies platform, as well as its application to pain treatment, dural sealants, dural replacements, nerve conduits and fibrosis treatment, and will provide an update as to the status of those programs as data is available.
About InVivo Therapeutics
InVivo Therapeutics Holdings Corp. is focused on utilizing polymers as a platform technology to develop treatments to improve function in individuals paralyzed as a result of traumatic spinal cord injury. The Company was founded in 2005 on the basis of proprietary technology co-invented by Robert Langer, ScD., Professor at Massachusetts Institute of Technology, and Joseph P. Vacanti, M.D., who is affiliated with Massachusetts General Hospital. In 2011, the Company earned the prestigious 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. Any forward-looking statements contained herein are based on current expectations, but are subject to a number of risks and uncertainties, and include statements regarding the Company’s expectations with respect to the commencement of human clinical trials, the length of time to complete human clinical trials and conducting additional studies. The 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 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 our filings with the SEC, including our Form 10-K and 10-Q’s and our current reports on Form 8-K. We do not undertake to update these forward-looking statements made by us.