InVivo Therapeutics Announces Topline Data from Pivotal INSPIRE 2.0 Study in Acute Spinal Cord Injury
March 09 2023 - 8:55AM
Business Wire
Study did not achieve primary endpoint of
defined improvement on standard impairment scale
InVivo to evaluate full data set and strategic
options for the company
InVivo Therapeutics Holdings Corp. (Nasdaq: NVIV), a research
and clinical-stage biomaterials and biotechnology company with a
focus on the treatment of spinal cord injuries (SCI), today
announced topline results from the company’s INSPIRE 2.0 study,
which was designed to evaluate the safety and probable benefit of
InVivo’s investigational Neuro-Spinal Scaffold™, a bioresorbable
scaffold-based device in development for patients with acute SCI.
The study did not meet its primary endpoint, which was assessed by
the proportion of treated patients achieving an improvement of at
least one American Spinal Injury Association (ASIA) Impairment
Scale (“AIS”) grade at six months post-scaffold implantation,
versus a control group that received standard of care surgery.
“We are disappointed by the outcome of this study as treatments
for spinal cord injury are so urgently needed and we know many in
the SCI patient and advocate community wait in hope for therapeutic
options. We have rigorously pursued the science and believe that,
upon full assessment, the INSPIRE 2.0 data set will provide a
significant addition to the clinical literature around the
treatment of SCI,” said Richard Toselli, M.D., InVivo’s President
and Chief Executive Officer. “I extend our deepest thanks to our
patients and clinical sites who have supported InVivo’s work to
bring our science to patients, and the InVivo team who have
tirelessly pursued our mission.”
InVivo management will conduct a full assessment of the study
data set and plans to share its findings in full in a peer-reviewed
medical venue at a later date. The company will also evaluate its
strategic options and provide an update on corporate direction when
appropriate.
About InVivo Therapeutics
InVivo Therapeutics is a clinical-stage biomaterials and
biotechnology company with a focus on the treatment of spinal cord
injuries. The company was founded in 2005 with proprietary
technology co-invented by Robert Langer, Sc.D., and Joseph P.
Vacanti, M.D. InVivo 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 regarding the company's
assessment of the full INSPIRE 2.0 data set and evaluation of
strategic options. 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 its ability
to identify strategic options and other risks identified and
described in more detail in the company's Annual Report on Form
10-K for the year ended December 31, 2022, and in other filings
that the company may make with the Securities and Exchange
Commission in the future. The company does not undertake to update
these forward-looking statements.
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