InVivo Therapeutics Announces Foothills Medical Centre in Calgary, Alberta as New Canadian Site for INSPIRE Study
October 19 2016 - 8:00AM
Business Wire
Institution is One of the Busiest Level I
Trauma Centers in Canada
InVivo Therapeutics Holdings Corp. (NVIV) today
announced that the Foothills Medical Centre in Calgary, Alberta has
been added as a Canadian 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 Foothills Medical Centre is the largest hospital
in Alberta and is one of the most recognized medical facilities in
Canada, providing advanced healthcare services to over two million
people from Calgary and southern Alberta, the northwestern United
States, southeastern British Columbia, and southern
Saskatchewan.
“InVivo’s Neuro-Spinal Scaffold is one of the more innovative
approaches to treating acute spinal cord injury in recent history
and we look forward to being a part of the INSPIRE study,” said
Steven Casha, M.D., Ph.D., Assistant Professor of Neurosurgery in
the Department of Clinical Neurosciences and Principal Investigator
at the study site.
Mark Perrin, InVivo’s CEO and Chairman, said, “We are pleased to
welcome Dr. Casha and his team at the Foothills Medical Centre to
the INSPIRE study. We will continue to expand our footprint in both
the US and Canada.”
A new CEO’s Perspective discussing the current status of the
INSPIRE study can be found on the InVivo Therapeutics website:
http://www.invivotherapeutics.com/about-invivo/ceo-perspective/
There are now 24 clinical sites participating in the clinical
study:
- Banner University Medical Center,
Tucson, AZ
- Barnes-Jewish Hospital at Washington
University Medical Center, St. Louis, MO
- Ben Taub Hospital/Baylor College of
Medicine, Houston, TX
- Barrow Neurological Institute – St.
Joseph’s Hospital and Medical Center, Phoenix, AZ
- 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
- 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
- Rutgers New Jersey Medical School,
Newark, NJ
- Thomas Jefferson University Hospital,
Philadelphia, PA
- Toronto Western Hospital, Toronto, ON,
Canada
- University of California, Davis Medical
Center, Sacramento, CA
- University of California, San Diego
Medical Center, San Diego, CA
- University of Kansas Medical Center,
Kansas City, KS
- University of Louisville Hospital,
Louisville, KY
- University of Pittsburgh Medical Center
Presbyterian, Pittsburgh, PA
- University of Virginia Health System,
Charlottesville, VA
- Vidant Medical Center, Greenville,
NC
For more information, please visit the company’s
ClinicalTrials.gov registration site:
http://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 regeneration across 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 pivotal probable
benefit 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 or the CEO
Perspective referred to herein 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, the
expected timing of full enrollment in the INSPIRE study, the timing
of the submission of the Humanitarian Device Exemption (HDE), the
timing for opening of the pilot cervical SCI study, and the
company’s anticipated cash balance. 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 ability to complete the INSPIRE study and
submit an HDE; the company’s ability to receive regulatory approval
for the Neuro-Spinal Scaffold; 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, 2015, 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 TherapeuticsBrian Luque, 617-863-5535Investor
Relationsbluque@invivotherapeutics.com
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