InVivo Therapeutics Announces New Patient Enrollment into The INSPIRE Study at Allegheny General Hospital
June 20 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 Allegheny General Hospital in Pittsburgh, PA, part
of the Allegheny Health Network (AHN). Drs. Dan Altman, Nestor
Tomycz, and Terrence Julien successfully performed the surgery and
implantation approximately 21 hours after the injury occurred.
Dr. Julien, System Co-Director of Minimally Invasive Spine
Surgery and Principal Investigator, said, “We are all hoping for
the best possible outcome for this and all patients enrolled in the
study. This will certainly be a landmark study and once again
demonstrates the AHN Neurosurgery Department’s commitment to world
class research endeavors brought to the Pittsburgh region.”
Mark Perrin, InVivo’s Chief Executive Officer and Chairman,
said, “The patient is stable and the implantation procedure was a
success. We now have 16 patients in follow up, and with the
reported increase in spinal cord injury incidence during the summer
months, we remain on track to complete enrollment into INSPIRE
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 StatementAny 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, the progress of the
clinical program and the timing of the completion of enrollment in
the INSPIRE 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
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/20170620005497/en/
InVivo TherapeuticsInvestor RelationsHeather Hamel,
617-863-5530Investor-relations@invivotherapeutics.com
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