InVivo Therapeutics Announces Submission to the FDA of Its Nonclinical Studies Module for the Neuro-Spinal Scaffold™
March 21 2017 - 8:00AM
Business Wire
- First of Three Modules to be Submitted for
Product Approval -
InVivo Therapeutics Holdings Corp. (NVIV) today
announced that it has submitted its first module containing
nonclinical studies to the U.S. Food and Drug Administration (FDA)
as part of its Humanitarian Device Exemption (HDE) modular
submission and review process for the Neuro-Spinal Scaffold™.
InVivo’s modular HDE process is based on a submission of three
modules to the FDA that constitute a complete HDE submission once
all have been submitted: a nonclinical studies module, a
manufacturing module, and a clinical data module. This process
allows the FDA to review each module separately and provide timely
feedback, typically within 90 days of submission, thereby allowing
the applicant the opportunity to resolve any deficiencies earlier
in the review process compared to a traditional HDE
application.
“The submission of our nonclinical studies module marks the
accomplishment of another major milestone for the INSPIRE Study,”
Mark Perrin, InVivo’s Chief Executive Officer and Chairman, said.
“We expect to receive acceptance of the nonclinical module in the
third quarter of this year, and plan to submit the manufacturing
module in the second half of 2017 and the clinical module in 2018,
all as part of our strategy to pursue accelerated approval for the
Neuro-Spinal Scaffold™.”
About the Neuro-Spinal Scaffold™ Implant
This investigational device is being studied in the
INSPIRE 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. 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
complete (AIS A) traumatic acute 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,” “plan” and similar expressions, and include
statements regarding the safety and effectiveness of the
Neuro-Spinal Scaffold, and the timing of acceptance of FDA feedback
for the nonclinical module, and timing of the submission of
additional modules of the Humanitarian Device Exemption (HDE). 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, REC and HRA processes; 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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