InVivo Therapeutics Announces Publication in Peer-Reviewed Journal of Neurosurgery: Spine
February 16 2021 - 8:00AM
Business Wire
Manuscript Details Complete Six-Month INSPIRE
1.0 Primary Endpoint Study Results
InVivo Therapeutics Holdings Corp. (Nasdaq: NVIV) today
announced the recent publication of a peer-reviewed manuscript in
the Journal of Neurosurgery: Spine describing the previously
presented complete six-month primary endpoint results from the
company's single-arm INSPIRE 1.0 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), titled “A study of probable benefit of a bioresorbable
polymer scaffold for safety and neurological recovery in patients
with complete thoracic spinal cord injury: 6-month results from the
INSPIRE study.”
Richard Toselli, M.D., InVivo’s President and Chief Executive
Officer, said, “It was rewarding to see our manuscript on the
six-month INSPIRE 1.0 results published in the peer-reviewed
Journal of Neurosurgery: Spine, and we want to thank the
investigators and staff at each of the clinical trial sites, as
well as the patients, who help us remain optimistic that this data
supports the continued clinical investigation of the Neuro-Spinal
Scaffold in our INSPIRE 2.0 study.”
InVivo has officially closed the INSPIRE 1.0 study and is
actively enrolling patients into a second pivotal clinical study of
the Neuro-Spinal Scaffold™ in patients with acute SCI (INSPIRE
2.0). The INSPIRE 2.0 study is a 20-patient (10 subjects in each
study arm), randomized, controlled trial that is designed to
enhance the existing clinical evidence for the Neuro-Spinal
Scaffold™ from the INSPIRE 1.0 study. For more information about
the INSPIRE 2.0 clinical trial, visit:
https://clinicaltrials.gov/ct2/show/NCT03762655.
The publication is now available electronically at:
https://thejns.org/spine/view/journals/j-neurosurg-spine/aop/article-10.3171-2020.8.SPINE191507/article-10.3171-2020.8.SPINE191507.xml.
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. 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 about the continued clinical
investigation of the investigational Neuro-Spinal scaffold device.
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 impact of the
COVID-19 pandemic on the Company’s operations, including its
clinical trials; 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 general economic
and market conditions and other factors discussed in the “Risk
Factors” section of the Company’s Annual Report on Form 10-K for
the year ended December 31, 2019, 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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Investor Contact: Bret Shapiro, Managing Partner CORE IR
brets@coreir.com (516) 222-2560
Media Contact Gina Nugent Ten Bridge Communications
gina@tenbridgecommunications.com 617-460-3579
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