InVivo Therapeutics Announces Positive Motor Recovery Assessments in Two Patients in the INSPIRE Study of the Neuro-Spinal Sc...
28 June 2017 - 10:00PM
Business Wire
– Continued Improvement from AIS B to AIS C for
Two Patients with Early Conversions –
InVivo Therapeutics Holdings Corp. (NVIV) today
announced that two patients in the INSPIRE study of the
Neuro-Spinal Scaffold have improved from sensory incomplete AIS B
spinal cord injury (SCI) to motor incomplete AIS C SCI in their
most recent INSPIRE assessments. These are the second and third
patients in the INSPIRE study to have reached AIS C motor
incomplete classification.
One of these patients was enrolled in May 2016 and converted
from complete AIS A SCI to incomplete AIS B SCI at the three-month
exam in August 2016. At the 12-month visit, the patient regained
motor function associated with the most sacral segments of the
spinal cord and was assessed to be AIS C. Stuart Lee, M.D., is the
Principal Investigator at Vidant Medical Center in Greenville,
North Carolina, where this patient was implanted with the
Neuro-Spinal Scaffold.
Dr. Lee said, “The patient’s continued improvement at the one
year exam is encouraging. Return of sacral motor function may be
related to improvements in bowel and bladder function that can have
an appreciable impact on a patient’s quality of life. We look
forward to monitoring this patient’s recovery and hope for
continued progress.”
The second patient was enrolled in June 2015 and converted from
complete AIS A SCI to incomplete AIS B SCI at the one-month exam in
July 2015. At the 24-month per protocol ISNCSCI exam (see About the
ISNCSCI Exam below), the patient was assessed to be AIS C with the
ability to contract two muscles of one leg. The motor function was
not noted in a separate medical evaluation earlier in the day that
did not include a full ISNCSCI exam. Domagoj Coric, M.D., of
Carolina Neurosurgery and Spine Associates, and William Bockenek,
M.D., of Carolinas Rehabilitation, are Co-principal Investigators
at the site where this patient was implanted.
Dr. Bockenek said, “This patient moved from AIS A to AIS B
shortly after the initial injury and implantation with the
Neuro-Spinal Scaffold two years ago, and now is noted on the
ISNCSCI exam to have moved to an AIS C based on trace movements in
one leg. Though the clinical significance of this change is unknown
at this time, we remain cautiously optimistic that there may be a
possibility for additional changes.”
InVivo CEO and Chairman Mark Perrin said, “We are excited that
these two patients have continued to progress beyond the period of
early improvement. Three of the five patients with an AIS
conversion in INSPIRE have demonstrated motor recovery and are now
classified as AIS C conversions. Having assessments of motor
improvements occurring one or two years post-implantation is
uncommon and may be indicative of prolonged neural repair.”
About the ISNCSCI Exam
The International Standards for Neurological Classification of
Spinal Cord Injury (ISNCSCI) exam is a full neurological exam
designed to characterize a patient’s SCI, including full motor and
sensory testing. Based upon the findings of the ISNCSCI exam, an
American Spinal Injury Association Impairment Scale (“AIS”) grade
classification is determined. For more information, refer to the
ISNCSCI exam worksheet at:
http://asia-spinalinjury.org/wp-content/uploads/2016/02/International_Stds_Diagram_Worksheet.pdf
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 repair within and around 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 Quarterly Report on Form 10-Q for the quarter ended March
31, 2017, and its other filings with the SEC, including the
company’s Annual Report on Form 10-K, its 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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