InVivo Therapeutics Announces FDA Acceptance of Preclinical Module in Support of Company’s Complete HDE Submission
July 13 2021 - 7:00AM
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 the
acceptance by the U.S. Food and Drug Administration (FDA) of its
preclinical module, which is one of three individual modules
required for the Company’s humanitarian device exemption (HDE)
application. Acceptance of the module indicates that FDA has
completed its review of this module of the HDE and has no
outstanding questions. Review of the remaining two HDE modules,
when complete, will be required prior to a final approval
decision.
The FDA previously approved the Company’s proposed HDE modular
shell submission and review process for the Neuro-Spinal Scaffold™
implant. The HDE modular shell is comprised of three modules: the
preclinical studies module, a manufacturing module and a clinical
data module. The Company believes that the modular shell submission
could allow for potentially more efficient review processes and
timelines with the FDA. As part of the process, the FDA reviews
each module on a rolling basis.
The preclinical module is the first module that the Company has
submitted for review to the FDA. The HDE submission will not be
complete until the manufacturing and clinical modules are also
submitted.
InVivo is actively enrolling patients with acute spinal cord
injury into its INSPIRE 2.0 study, a pivotal trial of the
Neuro-Spinal Scaffold™. INSPIRE 2.0 is a 20-patient, randomized,
controlled trial that is designed to expand upon the existing
clinical evidence for the Neuro-Spinal Scaffold™ from the Company’s
INSPIRE 1.0 study.
Richard Toselli, M.D., InVivo's President and Chief Executive
Officer, said, “It is rewarding to see our continued progress in
advancing the Neuro-Spinal Scaffold™ towards our complete HDE
submission, and we value the FDA’s continued collaboration with us
to help achieve 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 future modular
submissions for the Company’s Neuro-Spinal Scaffold implant and the
timing and processes involved for review of such submissions. 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 March 31, 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
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