CAMBRIDGE, Mass.--(BUSINESS WIRE)--InVivo Therapeutics Holdings Corp. (NVIV) today announced that the University of Virginia (UVA) Health System in Charlottesville, VA 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. The UVA Health System serves a large geographic area with a population base of approximately 800,000 in central Virginia and receives transfers from the rest of the state.
“Spinal cord injury is a devastating condition with severe personal and societal costs. We are excited to participate in this innovative study that has the potential to improve the outcomes in patients with the worst spinal cord injuries,” said Chris Shaffrey, M.D., Professor of Neurological Surgery, Director of the Neurosurgery Spine Division, and Principal Investigator at the study site.
Mark Perrin, InVivo’s CEO and Chairman, said, “We look forward to having Dr. Shaffrey and his team be a part of the INSPIRE study. The University of Virginia’s geographical reach and experience with spinal cord injury trials will be an asset as we seek to enroll additional INSPIRE subjects.”
There are now 19 clinical sites participating in the clinical study:
- 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
- Carolina Neurosurgery and Spine Associates/Carolinas Rehabilitation, Charlotte, NC
- Cooper Neurological Institute, Camden, NJ
- Goodman Campbell Brain and Spine /Indiana University Health Neuroscience Center, Indianapolis, IN
- Keck Hospital of University of Southern California, Los Angeles, CA
- Medical College of Wisconsin/Froedtert Hospital, Milwaukee, WI
- Mount Sinai Hospital, New York, NY
- Oregon Health & Science University, Portland, OR
- Rutgers New Jersey Medical School, Newark, NJ
- Thomas Jefferson University Hospital, Philadelphia, PA
- University of California, Davis Medical Center, Sacramento, CA
- University of California, San Diego Medical Center, San Diego, CA
- University of Louisville Hospital, Louisville, KY
- University of Kansas Medical Center, Kansas City, KS
- 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 complete (AIS A) traumatic acute 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 enrollment of additional patients in the INSPIRE pivotal probable benefit 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 obtain FDA approval to conduct future studies; 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, 2015, 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.
