InVivo Therapeutics Opens First Site in the United Kingdom for INSPIRE Study
July 11 2017 - 08:00AM
Business Wire
- Prominent Spinal Cord Researcher Manjunath
Prasad and James Cook University Hospital Join INSPIRE -
InVivo Therapeutics Holdings Corp. (NVIV) today
announced that James Cook University Hospital in Middlesbrough,
United Kingdom has been added as the UK’s first clinical site for
The INSPIRE Study: InVivo Study of Probable Benefit
of the Neuro-Spinal Scaffold™ for Safety and Neurologic
Recovery in Subjects with Complete Thoracic AIS A Spinal
Cord Injury. The Golden Jubilee Regional Spinal Cord Injuries
Centre located at the James Cook University Hospital, a major
trauma center, focuses exclusively on patients with spinal cord
injuries and is one of eight specialist centers within England.
“I am enthusiastic about the opportunity to be joining the
INSPIRE study and I look forward to helping InVivo evaluate this
exciting experimental technology while bringing awareness of the
study to the United Kingdom,” Dr. Prasad said.
Mark Perrin, InVivo’s CEO and Chairman, said, “We are thrilled
to open our first INSPIRE site in the United Kingdom and are
looking forward to working with Dr. Prasad and the staff at James
Cook University Hospital. The INSPIRE Study is now open for
enrollment across three countries: the United States, Canada, and
the United Kingdom.”
There are now 33 clinical sites participating in the clinical
study:
- Allegheny General Hospital, Pittsburgh,
PA
- Banner University Medical Center,
Tucson, AZ
- Barnes-Jewish Hospital at Washington
University Medical Center, St. Louis, MO
- Barrow Neurological Institute – St.
Joseph’s Hospital and Medical Center, Phoenix, AZ
- Ben Taub Hospital/Baylor College of
Medicine, Houston, TX
- Beth Israel Deaconess Medical Center,
Boston, MA
- Brigham and Women’s Hospital, Boston,
MA
- Carolina Neurosurgery and Spine
Associates/Carolinas Rehabilitation, Charlotte, NC
- Cooper Neurological Institute, Camden,
NJ
- Foothills Medical Centre, Calgary,
Alberta, Canada
- Goodman Campbell Brain and
Spine/Indiana University Health Neuroscience Center, Indianapolis,
IN
- Hospital of the University of
Pennsylvania, Philadelphia, PA
- James Cook University Hospital,
Middlesbrough, UK
- Keck Hospital of University of Southern
California, Los Angeles, CA
- Medical College of Wisconsin/Froedtert
Hospital, Milwaukee, WI
- Mount Sinai Hospital, New York, NY
- Northwestern Medicine, Chicago, IL
- Oregon Health & Science University,
Portland, OR
- Rhode Island Hospital, Providence,
RI
- Rutgers New Jersey Medical School,
Newark, NJ
- St. Michael’s Hospital, Toronto,
Ontario, Canada
- Thomas Jefferson University Hospital,
Philadelphia, PA
- Toronto Western Hospital, Toronto, ON,
Canada
- UC Health Memorial Hospital, Colorado
Springs, CO
- University of California, Davis Medical
Center, Sacramento, CA
- University of California, San Diego
Medical Center, San Diego, CA
- University of Iowa Hospitals and
Clinics, Iowa City, IA
- University of Kansas Medical Center,
Kansas City, KS
- University of Louisville Hospital,
Louisville, KY
- University of New Mexico Hospital,
Albuquerque, NM
- University of Pittsburgh Medical Center
Presbyterian, Pittsburgh, PA
- University of Virginia Health System,
Charlottesville, VA
- Vidant Medical Center, Greenville,
NC
About The INSPIRE Study
The INSPIRE Study: InVivo Study of Probable
Benefit of the Neuro-Spinal Scaffold™ for Safety and
Neurologic Recovery in Subjects with Complete Thoracic AIS A
Spinal Cord Injury, is designed to demonstrate the safety and
probable benefit of the Neuro-Spinal Scaffold™ for the
treatment of complete T2-T12/L1 spinal cord injury in support of a
Humanitarian Device Exemption (HDE) application for approval. For
more information, refer to
https://clinicaltrials.gov/ct2/show/study/NCT02138110.
About the Neuro-Spinal Scaffold™ Implant
Following acute spinal cord injury, surgical implantation of the
biodegradable Neuro-Spinal Scaffold within the decompressed and
debrided injury epicenter is intended to support appositional
healing, thereby reducing post-traumatic cavity formation, sparing
white matter, and allowing neural repair within and around the
healed wound epicenter. The Neuro-Spinal Scaffold, an
investigational device, has received a Humanitarian Use Device
(HUD) designation and currently is being evaluated in The INSPIRE
Study for the treatment of patients with acute, complete (AIS A),
thoracic traumatic spinal cord injury and a pilot study for acute,
complete (AIS A), cervical (C5-T1) traumatic spinal cord injury.
For more information on the cervical study, refer to
https://clinicaltrials.gov/ct2/show/study/NCT03105882.
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 progress of the clinical program. 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 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 Quarterly Report of the
three months ended March 31, 2017, 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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InVivo TherapeuticsHeather Hamel, 617-863-5530Investor
RelationsInvestor-relations@invivotherapeutics.com
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