CAMBRIDGE, Mass.--(BUSINESS WIRE)--InVivo Therapeutics Holdings Corp. (NVIV) today announced that the Brigham and Women’s Hospital (BWH) in Boston, MA has been added as a clinical site for 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. BWH is a teaching hospital of Harvard Medical School and hosts one of the largest neurosurgical intensive care units in the country.
“Patients who suffer spinal cord injury face limited options for treatment. I’m hopeful that spinal cord research, particularly in the area of axon regeneration, will expand the options available to these patients with devastating injuries,” Yi Lu, M.D., Ph.D., said this week. Dr. Lu is a neurosurgeon at Brigham and Women’s Hospital, assistant professor of neurosurgery at Harvard Medical School, and Principal Investigator at the study site.
Mark Perrin, InVivo’s CEO and Chairman, said, “We are pleased to welcome Dr. Lu and the team at BWH to the INSPIRE Study. Dr. Lu is an active clinician scientist in the field of spinal cord injury, having won the 2011 Spinal Cord Injury Award given by the AANS/CNS Section on Neurotrauma and Critical Care.”
There are now 31 clinical sites participating in the clinical study:
- Allegheny General Hospital, Pittsburgh, PA
- Banner University Medical Center, Tucson, AZ
- Barnes-Jewish Hospital at Washington University Medical Center, St. Louis, MO
- Barrow Neurological Institute – St. Joseph’s Hospital and Medical Center, Phoenix, AZ
- Ben Taub Hospital/Baylor College of Medicine, Houston, TX
- Beth Israel Deaconess Medical Center, Boston, MA
- Brigham and Women’s Hospital, Boston, MA
- Carolina Neurosurgery and Spine Associates/Carolinas Rehabilitation, Charlotte, NC
- Cooper Neurological Institute, Camden, NJ
- Foothills Medical Centre, Calgary, Alberta, Canada
- Goodman Campbell Brain and Spine/Indiana University Health Neuroscience Center, Indianapolis, IN
- Hospital of the University of Pennsylvania, Philadelphia, PA
- Keck Hospital of University of Southern California, Los Angeles, CA
- Medical College of Wisconsin/Froedtert Hospital, Milwaukee, WI
- Mount Sinai Hospital, New York, NY
- Northwestern Medicine, Chicago, IL
- Oregon Health & Science University, Portland, OR
- Rhode Island Hospital, Providence, RI
- Rutgers New Jersey Medical School, Newark, NJ
- St. Michael’s Hospital, Toronto, Ontario, Canada
- Thomas Jefferson University Hospital, Philadelphia, PA
- Toronto Western Hospital, Toronto, ON, Canada
- University of California, Davis Medical Center, Sacramento, CA
- University of California, San Diego Medical Center, San Diego, CA
- University of Iowa Hospitals and Clinics, Iowa City, IA
- University of Kansas Medical Center, Kansas City, KS
- University of Louisville Hospital, Louisville, KY
- University of New Mexico Hospital, Albuquerque, NM
- University of Pittsburgh Medical Center Presbyterian, Pittsburgh, PA
- University of Virginia Health System, Charlottesville, VA
- Vidant Medical Center, Greenville, NC
For more information, 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 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 pace of enrollment. 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 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.
