InVivo Therapeutics Holdings Corp. (NVIV) today announced the
University of Pittsburgh Medical Center (UPMC) Presbyterian in
Pittsburgh, PA as a clinical site in the company’s ongoing IDE pilot
study of its Neuro-Spinal Scaffold in patients with acute spinal cord
injury (SCI). UPMC is the largest non-governmental employer in
Pennsylvania (with more than 62,000 employees) and operates more than 20
academic, community, and specialty hospitals and 400 outpatient sites.
David Okonkwo, MD, PhD, is the Director of Neurotrauma and Director of
Scoliosis and Spinal Deformity at UPMC Presbyterian and Associate
Professor of Neurological Surgery and Clinical Director of the Brain
Trauma Research Center at the University of Pittsburgh. Dr. Okonkwo will
be the study’s Principal Investigator at that site.
“We have been searching for decades for an option for patients with
these challenging injuries,” Dr. Okonkwo said. “The InVivo study is a
unique, never-before tried intervention for spinal cord injury. I’m
excited to see if it will prove to be a new way of treating thoracic
spinal cord injuries.”
On October 15, 2014, InVivo announced enrollment of its first patient in
the study at its clinical site, Barrow Neurological Institute in
Phoenix, Arizona. Mark Perrin, InVivo’s CEO, said, “We’re very pleased
to have Dr. Okonkwo and UPMC Presbyterian join our pilot trial. Dr.
Okonkwo is a thought leader in this area and UPMC is a center of
excellence in treating spinal cord injury patients and it is an honor to
have them on board. We now have six sites that will be ready to enroll
patients once we re-open enrollment.”
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 the Company’s ClinicalTrials.gov
registration site: http://clinicaltrials.gov/ct2/show/study/NCT02138110
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.
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.
Copyright Business Wire 2014