InVivo Therapeutics Announces Mount Sinai Hospital In New York City As New Site For Neuro-Spinal Scaffold Clinical Trial

CAMBRIDGE, Mass.--(BUSINESS WIRE)--InVivo Therapeutics Holdings Corp. (NVIV) today announced that The Mount Sinai Hospital in New York has been added as a clinical site in the company’s ongoing clinical study of its investigational Neuro-Spinal Scaffold in patients with acute spinal cord injury (SCI). The Mount Sinai Hospital is acclaimed internationally for excellence in clinical care and is one of seven hospital campuses that make up the Mount Sinai Health System.

“I see the enormous unmet medical need presented by spinal cord injury first-hand in my practice. InVivo is taking steps to fill that need, and I’m looking forward to being a part of this study”

“I see the enormous unmet medical need presented by spinal cord injury first-hand in my practice. InVivo is taking steps to fill that need, and I’m looking forward to being a part of this study,” says Arthur Jenkins, M.D., Associate Professor of Neurosurgery and Orthopedic Surgery, who performs Spinal Cord Injury research at the Icahn School of Medicine, and who has been named local Principal Investigator of the trial at Mount Sinai.

Mark Perrin, InVivo’s CEO and Chairman, said, “Dr. Jenkins and his team bring a great deal of additional subject matter expertise to the table, and we are pleased to include them in our ongoing trial. Their experience and geographic reach will be valuable as we look to enroll additional patients into the study. As previously communicated, eligible patients at participating clinical sites can be treated using the Emergency Use Expanded Access Mechanism and the safety and outcomes data from these patients will be included in the Humanitarian Device Exemption (HDE) application for approval.”

There are now 14 clinical sites participating in the clinical study:

• 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 Arizona Medical Center, Tucson, AZ
• University of California/Davis Medical Center, Sacramento, CA
• University of Kansas Medical Center, Kansas City, KS
• University of Pittsburgh Medical Center Presbyterian, Pittsburgh, PA

For more information, please visit the company’s ClinicalTrials.gov registration site:
http://clinicaltrials.gov/ct2/show/study/NCT02138110

About the Neuro-Spinal Scaffold™

Following an acute spinal cord injury, the biodegradable Neuro-Spinal Scaffold is surgically implanted at the epicenter of the wound and is designed to act as a physical substrate for nerve sprouting. Appositional healing to spare spinal cord tissue, decreased post-traumatic cyst formation, and decreased spinal cord tissue pressure have been demonstrated in preclinical models of spinal cord contusion injury. The Neuro-Spinal Scaffold, an investigational device, has received a Humanitarian Use Device (HUD) designation and is currently being studied in an Investigational Device Exemption (IDE) clinical 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.

About the Mount Sinai Health System

The Mount Sinai Health System is an integrated health system committed to providing distinguished care, conducting transformative research, and advancing biomedical education. Structured around seven hospital campuses and a single medical school, the Health System has an extensive ambulatory network and a range of inpatient and outpatient services—from community-based facilities to tertiary and quaternary care.

The System includes approximately 6,100 primary and specialty care physicians; 12 minority-owned free-standing ambulatory surgery centers; more than 140 ambulatory practices throughout the five boroughs of New York City, Westchester, Long Island, and Florida; and 31 affiliated community health centers. Physicians are affiliated with the renowned Icahn School of Medicine at Mount Sinai, which is ranked among the highest in the nation in National Institutes of Health funding per investigator. Seven departments at The Mount Sinai Hospital and one at the New York Eye and Ear Infirmary (NYEE) ranked nationally in the top 25 in the 2015-2016 “Best Hospitals” issue of U.S. News & World Report. Mount Sinai’s Kravis Children’s Hospital also is ranked in seven out of ten pediatric specialties by U.S. News & World Report.

For more information, visit http://www.mountsinaihealth.org/ or find Mount Sinai on Facebook, Twitter and YouTube.

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, the enrollment of additional patients and the company’s ability to conduct a pivotal 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 volatility of the trading price of the company’s common stock; 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 modify its pilot trial protocol or to conduct a future study; 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.