InVivo Therapeutics Announces Seventh Patient Conversion in The INSPIRE Study of the Neuro-Spinal Scaffold™
March 28 2017 - 8:00AM
Business Wire
- Patient Converts from Complete to Incomplete
Spinal Cord Injury with Sensory and Motor Improvements -
InVivo Therapeutics Holdings Corp. (NVIV) today
announced that the patient enrolled in January in the INSPIRE study
of the Neuro-Spinal Scaffold has improved from a complete AIS A
spinal cord injury (SCI) to an incomplete AIS B SCI in the time
between the one-month and the two-month evaluations. This is the
seventh out of the 11 patients (63.6% conversion rate) with at
least one month of follow-up to have had an AIS grade improvement.
Two additional patients are early in follow-up and have not yet had
their one-month visit. The AIS conversion rate observed in the
INSPIRE study to date is considerably higher than published rates
observed in a range of SCI natural history databases that are all
below 25%.
In addition to the AIS conversion, the patient has also
experienced substantial improvements in sensory and motor function.
Prior to surgery, the subject had a T12 neurological level of
injury with some spared bilateral sensation on the front of the
legs and unilateral palpable hip muscle contraction but no ability
to move either leg. The patient had no sensory function on the
front of the legs from just below the knee and no sensory function
on the back of the body from just below the waist. At the two-month
visit, the patient was able to move his hips and knees bilaterally
and had regained at least some sensory function in almost all
regions across the lower legs, feet, and the back of the body from
just below the waist.
Travis Dumont, M.D., Director of the Neurovascular Program and
Principal Investigator at Banner -University Medical Center Tucson,
performed the implantation in January. Dr. Dumont said, “It has
been rewarding to be a part of the INSPIRE study and to follow this
patient’s recovery. This patient had a very low thoracic
neurological level of injury, and such patients have the best
prognosis. Nonetheless, I have been impressed with this patient’s
recovery to date and am hopeful that the positive trajectory will
continue.”
“We are excited to announce the seventh AIS conversion in the
INSPIRE study,” CEO and Chairman Mark Perrin said. “We are equally
pleased that this patient has experienced considerable motor and
sensory improvement over the first two months following injury. We
look forward to following the patient’s progress and hope for
continued recovery.”
About the Neuro-Spinal Scaffold™ Implant
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 acute, complete
(AIS A), thoracic traumatic spinal cord injury and a pilot study
for acute, complete (AIS A), cervical (C5-T1) traumatic 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 safety and effectiveness of the
Neuro-Spinal Scaffold and the sufficiency of the INSPIRE study
design to support application for an 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
process; the company’s ability to obtain regulatory approval for
the Neuro-Spinal Scaffold; 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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