InVivo Therapeutics Announces University of Louisville As New Site For INSPIRE Study

CAMBRIDGE, Mass.--(BUSINESS WIRE)--InVivo Therapeutics Holdings Corp. (NVIV) today announced that the University of Louisville (UofL) Hospital in Louisville, KY 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 University of Louisville is both a clinical site and the Data Management Center for the Christopher and Dana Reeve Foundation’s North American Clinical Trials Network for the Treatment of Spinal Cord Injury (NACTN), which is the nation’s largest research network for spinal cord injury. UofL Hospital (a part of KentuckyOne Health) is the Louisville metro area’s only Level I Trauma Center.

“We welcome UofL Hospital, our first NACTN site, to The INSPIRE Study. The hospital’s large catchment area and Dr. Boakye’s extensive expertise with leading spinal cord injury trials as part of NACTN will prove to be invaluable as we continue enrollment.”

“I can appreciate the enormous unmet medical need presented by spinal cord injury, from both my experience as a practicing neurosurgeon and as a pharmacoeconomics researcher. I look forward to participating in this exciting study,” said Maxwell Boakye, M.D., M.P.H, Chief of Spinal Neurosurgery and Clinical Director of the Kentucky Spinal Cord Injury Center, associate professor of neurological surgery and holder of the Ole A., Mabel Wise & Wilma Wise Nelson Endowed Research Chair at UofL, and the site Principal Investigator.

Mark Perrin, InVivo’s CEO and Chairman, said, “We welcome UofL Hospital, our first NACTN site, to The INSPIRE Study. The hospital’s large catchment area and Dr. Boakye’s extensive expertise with leading spinal cord injury trials as part of NACTN will prove to be invaluable as we continue enrollment.”

There are now 17 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
• University of California/Davis Medical Center, Sacramento, CA
• University of California/San Diego Medical Center, San Diego, CA
• University of Kansas Medical Center, Kansas City, KS
• University of Louisville Hospital, Louisville, KY
• University of Pittsburgh Medical Center Presbyterian, Pittsburgh, PA
• 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 expected further 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 Annual Report on Form 10-K for the year ended December 31, 2014, 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.