InVivo Therapeutics Announces 75% Target Enrollment Achieved for the INSPIRE 2.0 Spinal Cord Injury Study
September 08 2021 - 08:00AM
Business Wire
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, today
announced that it has enrolled 15 patients with acute spinal cord
injury into the INSPIRE 2.0 Study, or 75% of the total 20-patient
enrollment target for the study. The INSPIRE 2.0 study is a
randomized, controlled trial (20-patient, 10 subjects in each study
arm), that is designed to enhance the existing clinical evidence
for the Neuro-Spinal Scaffold™ from the Company’s INSPIRE 1.0
study.
“The enrollment of these 15 patients into this study is an
important milestone achievement towards our completion of the
INSPIRE 2.0 Study, and we are grateful to the investigators and
staff at each of our clinical sites who continue to enroll in this
trial throughout the COVID-19 pandemic,” said Richard Toselli,
M.D., InVivo's President and Chief Executive Officer. “We remain
committed to serving the significant unmet medical need for the
spinal cord injury patient population, and we are proud of our
progress towards this goal.”
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 enrollment
of the Company’s INSPIRE 2.0 study, the target patient population
of the study, and the potential FDA approval of the Company’s
investigational 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
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 Quarterly Report on Form
10-Q for the quarter ended June 30, 2021, 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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