CAMBRIDGE, Mass.--(BUSINESS WIRE)--
InVivo Therapeutics Holdings Corp. (NVIV) announced today that it has received conditional approval from the Food and Drug Administration for proposed changes to the protocol and supporting documents for the safety trial of its first investigational product, a degradable polymer scaffold for spinal cord injury. InVivo submitted these proposed changes to the FDA on November 21, 2013 and will follow the FDA’s approval conditions in their entirety in a submission to the FDA next week.
InVivo also plans to send its revised protocol and other supporting materials to six sites next week so that those sites can start their Institutional Review Board reviews and finalize contracts with InVivo. Based on the specific experience of these sites, InVivo expects that these Institutional Review Board reviews and contract finalizations will take approximately 4-12 weeks, and that the first site will be ready to accrue subjects in the first half of March.
InVivo Interim CEO Michael Astrue said, “Today’s news is one more critical step forward toward testing our scaffold on our first patient.”
About InVivo Therapeutics
InVivo Therapeutics Holdings Corp. is a pioneering biomaterials company with unique technologies for drug development and 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, M.D., who 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. 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 for the scaffold product and the timing of Institutional Review Board reviews and contract finalization. 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 participation of appropriate clinical sites; the Institutional Review Board review and approval process; the Company’s ability to enter into contracts with the sites necessary to begin accruing patients; the timing of patient consents; the Company’s ability to enter into partnerships; 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-Qs and our current reports on Form 8-K. We do not undertake to update these forward-looking statements made by us.
- Health Care Industry
- Pharmaceuticals & Drug Trials
- Food and Drug Administration
- spinal cord injury
- Institutional Review Board
Brian Luque, 617-863-5535
Director, Investor Relations