InVivo Therapeutics Holdings Corp. (NVIV) today announced that
the Oregon Health & Science University (OHSU) in Portland, OR is the
fifth clinical site in the company’s ongoing IDE pilot study of its
Neuro-Spinal Scaffold in patients with acute spinal cord injury (SCI).
OHSU is a nationally prominent research university and Oregon’s only
public academic health center, seeing nearly one million patients every
year. Ahmed Raslan, MD, an Assistant Professor of Neurological Surgery
at OHSU, will be the study’s Principal Investigator at that site.
“It is very exciting to be a part of this first-in-human trial for the
Neuro-Spinal Scaffold,” Dr. Raslan said. “This important contribution to
science demonstrated promising results in pre-clinical studies and
provides, for the first time, a categorically distinct form of potential
repair after SCI. I would like to thank InVivo for its pioneering
efforts in tackling this formidable problem.”
On October 15, InVivo announced enrollment of its first patient at
Barrow Neurological Institute in Phoenix, Arizona. Mark Perrin, InVivo’s
CEO, said, “We continue to bring great centers into our study and are
delighted to have Dr. Raslan and OHSU join us. OHSU and the other
centers will be able to enroll the next subject following the
three-month observation period for first patient.”
This is the company’s first clinical study of its investigational
degradable polymer Neuro-Spinal Scaffold. The IDE pilot study has been
approved by the U.S. Food and Drug Administration (FDA) and is intended
to capture preliminary safety and effectiveness data of the Neuro-Spinal
Scaffold in five subjects with acute thoracic spinal cord injury. InVivo
then expects to conduct a pivotal study to obtain FDA approval to
commence commercialization under a Humanitarian Device Exemption (HDE).
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.
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 safety,
feasibility, and clinical effectiveness of its scaffold device, the
enrollment of additional patients in the scaffold pilot study following
the reopening of enrollment; and its ability to conduct a second pivotal
study.. 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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