InVivo Therapeutics Holdings Corp. (NVIV) today announced that
Rutgers New Jersey Medical School in Newark, NJ has been added as a
clinical site in the company’s ongoing pilot study of its
investigational Neuro-Spinal Scaffold in patients with acute spinal cord
injury (SCI). Robert Heary, M.D., Professor of Neurological Surgery and
Director of the Spine Center, has been named Principal Investigator at
this site. The Spine Center is part of the Northern New Jersey Spinal
Cord Injury System, one of 14 federally designated Spinal Cord Injury
Model Systems in the United States and the only one in the state of New
Jersey.
“We are delighted to join InVivo’s cutting-edge spinal cord injury
trial,” Dr. Heary said. “Our integrated approach to spinal cord injury
and our location in the nation’s largest metropolitan area make us an
ideal candidate for this type of research.”
Mark Perrin, InVivo’s CEO and Chairman, said, “We are pleased to welcome
Dr. Heary and the New Jersey Medical School into InVivo’s ongoing pilot
study. Having a Spinal Cord Injury Model System Center as part of our
trial will be beneficial as we look to enroll the final two patients in
our ongoing study.”
There are currently 12 clinical sites that are open for enrollment:
-
Barnes-Jewish Hospital at Washington University Medical Center, St.
Louis, MO
-
Barrow Neurological Institute – St. Joseph’s Hospital and Medical
Center, Phoenix, AZ
-
Carolina Neurosurgery and Spine Associates/ Carolinas Rehabilitation,
Charlotte, NC
-
Goodman Campbell Brain and Spine / Indiana University Health
Neuroscience Center, Indianapolis, IN
-
Keck Hospital of University of Southern California, Los Angeles, CA
-
Medical College of Wisconsin/Froedtert Hospital, Milwaukee, WI
-
Oregon Health & Science University, Portland, OR
-
Rutgers New Jersey Medical School, Newark, NJ
-
University of Arizona Medical Center, Tucson, AZ
-
University of California/Davis Medical Center, Sacramento, CA
-
University of Kansas Medical Center, Kansas City, KS
-
University of Pittsburgh Medical Center Presbyterian, Pittsburgh, PA
This is the company’s first clinical study of its investigational
degradable polymer Neuro-Spinal Scaffold. The Investigational Device
Exemption (IDE) pilot study has been approved by the 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.
Following the pilot trial, InVivo expects to conduct a pivotal study to
obtain FDA approval to commence commercialization under a Humanitarian
Device Exemption (HDE).
For more information, please visit the company’s ClinicalTrials.gov
registration site: http://clinicaltrials.gov/ct2/show/study/NCT02138110
About the Neuro-Spinal Scaffold
Following an acute spinal cord injury, the biodegradable Neuro-Spinal
Scaffold is surgically implanted at the epicenter of the wound and is
designed to act as a physical substrate for nerve sprouting.
Appositional healing to spare spinal cord tissue, decreased
post-traumatic cyst formation, and decreased spinal cord tissue pressure
have been demonstrated in preclinical models of spinal cord contusion
injury. The Neuro-Spinal Scaffold, an investigational device, has
received a Humanitarian Use Device (HUD) designation and is currently
being studied in an Investigational Device Exemption (IDE) pilot study
for the treatment of patients with complete (AIS A) traumatic acute
spinal cord injury.
About InVivo Therapeutics
InVivo Therapeutics Holdings Corp. is a research and clinical-stage
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, Sc.D., Professor at
Massachusetts Institute of Technology, and Joseph P. Vacanti, M.D., 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. In 2015, the
company’s investigational Neuro-Spinal Scaffold received the 2015
Becker’s Healthcare Spine Device Award. 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,"
“designed to,” “potentially,” and similar expressions, and include
statements regarding the safety and effectiveness of the Neuro-Spinal
Scaffold and the company’s ability to conduct a 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 volatility of the trading price of the
company’s common stock; 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 modify its pilot trial
protocol or to conduct a future study; the company’s ability 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 the
treatment of 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, 2014, 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.
View source version on businesswire.com: http://www.businesswire.com/news/home/20150630005045/en/
Copyright Business Wire 2015