InVivo Therapeutics Announces New Patient Enrollment into The INSPIRE Study at Thomas Jefferson University Hospital
June 27 2017 - 8:00AM
Business Wire
InVivo Therapeutics Holdings Corp. (NVIV) today
announced that a new patient has been enrolled into The
INSPIRE Study (InVivo Study of Probable Benefit of
the Neuro-Spinal Scaffold™ for Safety and Neurologic
Recovery in Subjects with Complete Thoracic AIS A Spinal
Cord Injury) at Thomas Jefferson University Hospital in
Philadelphia, PA. James Harrop, M.D., Professor of Neurological and
Orthopedic Surgery, Co-Director at the Delaware Valley Spinal Cord
Injury Center, and Principal Investigator at the site, and Josh
Heller, M.D., successfully performed the surgery and implantation
approximately 22 hours after the injury occurred.
Dr. Harrop said, “The surgery and implantation went smoothly and
the patient is recovering well. We are excited to be part of The
INSPIRE Study and we look forward to following and communicating
the patient’s progress.”
Mark Perrin, InVivo’s Chief Executive Officer and Chairman,
said, “We are pleased to hear that the patient is doing well. We
now have 17 patients enrolled and in follow up, and with this
patient marking the second enrollment in the last week, we remain
enthusiastic about completing INSPIRE enrollment during the third
quarter of this year.”
For more information on The INSPIRE Study, please visit the
company’s ClinicalTrials.gov registration site:
http://clinicaltrials.gov/ct2/show/study/NCT02138110
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
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.
For more information on the cervical study, refer to
https://clinicaltrials.gov/ct2/show/study/NCT03105882.
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 progress of the clinical program. 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 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 of the
three months ended March 31, 2017, 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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version on businesswire.com: http://www.businesswire.com/news/home/20170627005319/en/
InVivo TherapeuticsInvestor RelationsHeather Hamel,
617-863-5530Investor-relations@invivotherapeutics.com
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