InVivo Therapeutics Holdings Corp. (NVIV) today announced a
12-month post-implant update for the first study patient in the
company’s ongoing pilot trial of its investigational Neuro-Spinal
Scaffold™ in patients with complete acute spinal cord injury.
In the time between the 6-month and 12-month post-injury assessments,
the patient continued to demonstrate improvement in the American Spinal
Injury Association (ASIA) lower extremity motor score with an additional
8 points gained on this 50 point score. The patient demonstrated
additional bilateral improvements in the motor function of hip flexors
and knee extensors and for the first time bilateral contractions of the
ankle dorsiflexors and ankle plantar flexors.
A large natural history database shows that patients with similar level
injuries (T10-T12) have an average increase of lower extremity motor
scores between 6 and 12 months of fewer than 2 points.
“I am delighted that our first patient continued to experience
significant motor improvement after the 6-month visit. It is
particularly exciting that the patient is regaining motor function in
the ankle region as this indicates recovery is occurring not only in
muscles that demonstrated some early recovery, but also in new muscles
further down the legs. We are all hoping for continued improvement for
the patient in the future. It was a brave decision to volunteer to be
the first person ever to receive our investigational product, and it has
been rewarding to observe the patient’s steady improvement over the last
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 expected benefits, efficacy and future clinical
outcomes of the company’s Neuro-Spinal Scaffold. 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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