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.
Copyright Business Wire 2013