InVivo Therapeutics Announces Rutgers New Jersey Medical School As New Clinical Site For Neuro-Spinal Scaffold
CAMBRIDGE, Mass.--(BUSINESS WIRE)--InVivo Therapeutics Holdings Corp. (NVIV) today announced that Rutgers New Jersey Medical School in Newark, NJ has been added as a clinical site in the company’s ongoing pilot study of its investigational Neuro-Spinal Scaffold in patients with acute spinal cord injury (SCI). Robert Heary, M.D., Professor of Neurological Surgery and Director of the Spine Center, has been named Principal Investigator at this site. The Spine Center is part of the Northern New Jersey Spinal Cord Injury System, one of 14 federally designated Spinal Cord Injury Model Systems in the United States and the only one in the state of New Jersey.
“We are pleased to welcome Dr. Heary and the New Jersey Medical School into InVivo’s ongoing pilot study. Having a Spinal Cord Injury Model System Center as part of our trial will be beneficial as we look to enroll the final two patients in our ongoing study.”
“We are delighted to join InVivo’s cutting-edge spinal cord injury trial,” Dr. Heary said. “Our integrated approach to spinal cord injury and our location in the nation’s largest metropolitan area make us an ideal candidate for this type of research.”
Mark Perrin, InVivo’s CEO and Chairman, said, “We are pleased to welcome Dr. Heary and the New Jersey Medical School into InVivo’s ongoing pilot study. Having a Spinal Cord Injury Model System Center as part of our trial will be beneficial as we look to enroll the final two patients in our ongoing study.”
There are currently 12 clinical sites that are open for enrollment:
- 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
- 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
- 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
This is the company’s first clinical study of its investigational degradable polymer Neuro-Spinal Scaffold. The Investigational Device Exemption (IDE) pilot study has been approved by the FDA and is intended to capture preliminary safety and effectiveness data of the Neuro-Spinal Scaffold in five subjects with acute thoracic spinal cord injury. Following the pilot trial, InVivo expects to conduct a pivotal study to obtain FDA approval to commence commercialization under a Humanitarian Device Exemption (HDE).
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) pilot 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 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.
InVivo Therapeutics Holdings Corp.
Brian Luque, 617-863-5535