InVivo Therapeutics Holdings Corp. (NVIV) today announced that a
fourth patient has been enrolled in the company’s ongoing pilot trial of
its investigational Neuro-Spinal Scaffold in patients with acute
thoracic spinal cord injury at the UC Davis Medical Center in
Sacramento, CA.
Kee Kim, M.D., Principal Investigator at this site, performed the
fourth-ever Neuro-Spinal Scaffold implantation approximately 53 hours
after the injury occurred.
Mark Perrin, InVivo’s CEO and Chairman, said, “We continue to make
meaningful progress in our ongoing clinical trial. With the fourth
patient successfully enrolled, we look forward to enrolling the fifth
and final patient in our pilot study and preparing for our pivotal
probable benefit study.”
This is the company’s first clinical study of its investigational
degradable polymer Neuro-Spinal Scaffold. The Investigational Device
Exemption (IDE) pilot study has been approved by the FDA and is intended
to capture preliminary safety and effectiveness data of the Neuro-Spinal
Scaffold in five subjects with acute thoracic spinal cord injury.
Following the pilot trial, InVivo expects to conduct a pivotal study to
obtain FDA approval to commence commercialization under a Humanitarian
Device Exemption (HDE).
For more information, please visit the company’s ClinicalTrials.gov
registration site:
http://clinicaltrials.gov/ct2/show/study/NCT02138110
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. 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 safety and effectiveness of the Neuro-Spinal
Scaffold and the company’s ability to enroll the fifth patient in its
pilot trial and to conduct a pivotal study. 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
volatility of the trading price of the company’s common stock; 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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