InVivo Therapeutics Holdings Corp. (NVIV) today announced that
the U.S. Food and Drug Administration (FDA) has approved the expansion
of the number of patients from five to ten in the company’s pilot study
of its investigational Neuro-Spinal Scaffold™ implant in patients
with acute thoracic spinal cord injury. As previously communicated,
InVivo intends to transition the pilot study into a pivotal probable
benefit study and to use this single study as the basis for a
Humanitarian Device Exemption (HDE) application.
“I am very pleased to have come to such a positive agreement with the
FDA ahead of schedule, which will avoid any disruption in patient
enrollment. While we continue to enroll subjects in our ongoing pilot
study, we are working diligently with the FDA to finalize the transition
to the pivotal probable benefit study. We anticipate announcing the
study design and updating associated timelines before the end of the
year,” said Mark Perrin, InVivo’s CEO and Chairman.
About the Neuro-Spinal Scaffold™
Following an acute spinal cord injury, the biodegradable Neuro-Spinal
Scaffold is surgically implanted at the epicenter of the wound and
is designed to act as a physical substrate for nerve sprouting.
Appositional healing to spare spinal cord tissue, decreased
post-traumatic cyst formation, and decreased spinal cord tissue pressure
have been demonstrated in preclinical models of spinal cord contusion
injury. The Neuro-Spinal Scaffold, an investigational device, has
received a Humanitarian Use Device (HUD) designation and is currently
being studied in an Investigational Device Exemption (IDE) pilot 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,” and similar expressions, and include
statements regarding the expected timing and receipt of FDA approval of
a pivotal probable benefit study and subsequent Humanitarian Device
Exemption (HDE) application. 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
process; the company’s ability to obtain FDA approval to modify its
pilot trial protocol or to conduct a future study; 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, 2014, 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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