InVivo Therapeutics Announces Indiana’s Goodman Campbell Brain and Spine as New Site for Neuro-Spinal Scaffold Clinical Trial
InVivo Therapeutics Holdings Corp. (NVIV) today announced that Goodman Campbell Brain and Spine in Indianapolis, IN 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). Goodman Campbell Brain and Spine is the merger of two highly-respected institutions: Indianapolis Neurosurgical Group and Indiana University Department of Neurological Surgery, providing a complement of exceptional medical-practice expertise and world-renowned academic research. Procedures will be performed at Indiana University Health Methodist Hospital. Eric Horn, M.D., Ph.D., Assistant Professor of Neurological Surgery and Director of Spinal Neurosurgery at Indiana University Department of Neurological Surgery, has been named Principal Investigator at this site.
“We are pleased to be an investigative site for the cutting-edge spinal cord injury research study by InVivo Therapeutics,” Dr. Horn said. “Goodman Campbell Brain and Spine and Indiana University Department of Neurological Surgery are ideally suited to be a primary investigator site for this exciting research project.”
Mark Perrin, InVivo’s CEO and Chairman, said, “We are pleased to welcome Dr. Horn and Goodman Campbell Brain and Spine into InVivo’s ongoing pilot study, which has reopened for concurrent enrollment. Having Indiana’s largest Level I trauma center and one of the nation’s leading neurocritical care units for acute brain and spinal injuries will be invaluable as we look to enroll the final three patients into our trial.”
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 U.S. Food and Drug Administration (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. InVivo then 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. 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 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.
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