CAMBRIDGE, Mass.--(BUSINESS WIRE)--InVivo Therapeutics Holdings Corp. (NVIV) today announced that it has sent to the United States Food and Drug Administration the revised protocol and related study documents for a clinical study to test the safety of its investigational scaffold device for spinal cord repair. The revised protocol includes all changes that were conditions of approval by the FDA. On Monday, it will send the revised protocol and related study documents to six sites in the United States so that they can now begin their Institutional Review Board submissions and finalize clinical study contracts with InVivo.
With the in-house manufacturing process still on track to provide scaffolds in mid-February, InVivo expects that its first clinical study site will be ready to enroll subjects in the first two weeks of March, although it is difficult to project when the first subject will both present at the hospital and consent to participate in the study. The company expects that the wait for each enrolled subject will decrease as the number of sites expands to six.
The company also announced that it has completed a strategic review of its Hydrogel program and will focus its efforts on accelerating one program rather than diluting its limited resources with multiple projects. The company expects that it will decide in the second quarter whether that program will be funded by a partnership currently under discussion with a larger company which owns a proprietary protein or whether it will be a self-generated program. In the meantime, InVivo scientists are producing more safety data on their Hydrogel platform so that products being developed will be more ready for licensing and clinical trials.
Interim Chief Executive Officer Michael Astrue said, “Today’s announcements mark the end of a difficult but successful transition period for InVivo. Our incoming Chief Executive Officer, Mark Perrin, will inherit dedicated employees and a realistic strategic plan that can generate enormous value for shareholders. I am confident in Mark’s ability to take this company to the next level.”
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, the timing of Institutional Review Board submissions and contract finalization, and expectations with respect to the hydrogel program, including, but not limited to, a possible partnership and the ability of such partnership to fund such program. 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 availability; 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.