InVivo Therapeutics Holdings Corp. (NVIV) today announced that
the US Food and Drug Administration (FDA) has approved various changes
to the protocol for the company’s ongoing IDE pilot trial for acute
spinal cord injury (SCI), including expanding the number of allowable
clinical sites to 20 (previously six) and broadening the eligibility
criteria. With this approval, the upper end of the age range has been
increased from 55 to 65, the spinal cord injury level has been expanded
from T3-T11 to T3-T12/L1, the enrollment window has been extended from
10 to 21 days post injury, and the Body Mass Index upper limit has been
increased from 35 to 39.
Mark Perrin, InVivo’s CEO, said, “We have been working closely with the
FDA to optimize enrollment for our acute SCI trial and are very pleased
with this approval. We continue to take a proactive approach in
broadening such critical variables to expedite subject 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 who 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.
About the Neuro-Spinal Scaffold
The biodegradable Neuro-Spinal Scaffold is surgically implanted at the
epicenter of the wound after an acute spinal cord injury and acts by
appositional healing to spare spinal cord tissue, decrease
post-traumatic cyst formation, and decrease spinal cord tissue pressure
in preclinical models of spinal cord contusion injury. The Neuro-Spinal
Scaffold, an investigational device, has received a Humanitarian Use
Device designation and is currently being studied in a pilot study for
the treatment of complete (AIS A) traumatic acute spinal cord injury.
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 pace of
enrollment of additional patients in the scaffold pilot study following
the reopening of enrollment. 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 and to enroll
additional patients; 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.
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