InVivo Therapeutics Announces University of Iowa Hospitals and Clinics as New Site for INSPIRE Study
November 09 2016 - 8:00AM
Business Wire
InVivo Therapeutics Holdings Corp. (NVIV) today
announced that University of Iowa Hospitals and Clinics in Iowa
City, IA, has been added as a 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. UI Hospitals and Clinics is a 732-bed hospital which,
in fiscal year 2015, received more than 57,000 emergency room
visits.
“Two active areas of spinal cord injury research involve timing
and the use of biomaterials. The INSPIRE study represents the
marriage of these two concepts and we look forward to
participating,” said Patrick Hitchon, M.D., Professor in the
departments of Neurosurgery and Biomedical Engineering and
Principal Investigator at the study site. Saul Wilson, M.D., and
Chandan Reddy, M.D. are co-investigators for the research
trial.
Mark Perrin, InVivo’s CEO and Chairman, said, “We welcome Dr.
Hitchon and his team to the INSPIRE study. This is the fourth new
site we have announced in the last three weeks, and we look forward
to bringing on more high-quality sites over the next several
months.”
There are now 27 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
- 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 Iowa Hospitals and
Clinics, Iowa City, IA
- 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 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 addition of new sites, 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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version on businesswire.com: http://www.businesswire.com/news/home/20161109005163/en/
InVivo Therapeutics Holdings Corp.Brian Luque,
617-863-5535Investor Relationsbluque@invivotherapeutics.com
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