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InVivo Therapeutics Announces Keck Hospital of University of Southern California as New Site for Neuro-Spinal Scaffold Clinical Trial
[March 25, 2015]

InVivo Therapeutics Announces Keck Hospital of University of Southern California as New Site for Neuro-Spinal Scaffold Clinical Trial


InVivo Therapeutics Holdings Corp. (NVIV) today announced that the Keck Hospital of University of Southern California (USC) in Los Angeles, CA (News - Alert) has been added as a clinical site in the company's ongoing Investigational Device Exemption (IDE) pilot study of its Neuro-Spinal Scaffold in patients with acute spinal cord injury (SCI). The Keck Hospital of USC is a 401-bed acute care hospital for the Keck Medical Center of USC, a system that comprises more than 500 faculty physicians. Patrick Hsieh, MD, Director of Neurosurgery Spine Program and Associate Professor of Neurological Surgery, has been named Principal Investigator at the site.

"We look forward to contributing our years of expertise in spinal cord injury research, which includes using stem cells for spinal cord injury, and our institution's unique resources - cutting edge academic, research and clinical centers, our urban location, and our multidisciplinary team of highly skilled and experienced sub-investigators and staff - to this clinical trial. We are hopeful that this study will yield good results." Dr. Hsieh said.

Mark Perrin, InVivo's CEO and Chairman, said, "We welcome Dr. Hsieh and the Keck Hospital of USC into InVivo's ongoing pilot study. Dr. Hsieh's extensive experience and the hospital's urban location will be key assets as we move forward with our study. As previously disclosed, we look forward to reopening concurrent enrollment of the final three subjects in our pilot study in the coming days."

InVivo's first patient was enrolled in October 2014 at the Barrow Neurological Institute at St. Joseph's Hospital and Medical Center in Phoenix, AZ. In January 2015, InVivo announced enrollment of its second patient in the study at Carolinas Medical Center in Charlotte, NC.

This is the company's first clinical study of its investigational degradable polymer Neuro-Spinal Scaffold. The 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 approva 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 acts 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 designation and is currently being studied in a pilot study for the treatment of 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, ScD, Professor at Massachusetts Institute of Technology, and Joseph P. Vacanti, MD, 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 (News - Alert) 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" and similar expressions, and include statements regarding reopening of enrollment of the scaffold pilot study barring any significant safety issues 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 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 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 (News - Alert), 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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