InVivo to Initiate Cervical Spinal Cord Injury Study
March 23 2017 - 8:00AM
Business Wire
- Company Receives Investigational Testing
Authorization from Health Canada to Conduct Cervical Spinal Cord
Injury Study -
InVivo Therapeutics Holdings Corp. (NVIV) today
announced that Health Canada has approved the company’s
Investigational Testing Authorization application to commence a
clinical study of the Neuro-Spinal Scaffold™ in patients with
acute, complete (AIS A) cervical (C5-T1) spinal cord injuries
(SCIs). InVivo currently is in late stage conversation with several
site Research Ethics Boards and expects to announce its first
Canadian site in the coming weeks.
“This approval is an important step towards our goal of
redefining the life of the spinal cord injury patient,” said Mark
Perrin, InVivo’s CEO and Chairman. “We are dedicated to helping as
many SCI patients as we can, and this approval helps us to evaluate
our investigational product in the most severe spinal cord injury
cases, with neurologically complete cervical injuries involving
impairment of the arms, hands, trunk, and legs. As I explain
further in my CEO’s Perspective, moving into the cervical spinal
cord is exciting, since each level of the cervical spinal cord has
a substantial functional impact. If the Neuro-Spinal Scaffold were
able to preserve, remyelinate and/or regenerate just a small area
of spinal cord, we believe this could have significant functional
consequences. We look forward to bringing sites onboard in Canada
to commence enrollment and ultimately to expanding our study of
cervical patients to the United Kingdom and the United States.”
A new CEO’s Perspective discussing the differences between
thoracic and cervical spinal cord injuries can be found on the
InVivo Therapeutics website:
http://www.invivotherapeutics.com/about-invivo/ceo-perspective/
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 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.
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, the ability of the company to open a site in Canada or
enroll patients in Canada, and the ability to expand the trial to
the United Kingdom and the United States. 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 impact of achieving the OPC on the FDA approval
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 Annual Report on Form
10-K for the year ended December 31, 2016, 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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