InVivo Therapeutics Opens First Site in the United Kingdom for INSPIRE Study


– Prominent Spinal Cord Researcher Manjunath Prasad and James Cook University Hospital Join INSPIRE –

CAMBRIDGE, Mass. (July 11, 2017) – InVivo Therapeutics Holdings Corp. (NVIV) today announced that James Cook University Hospital in Middlesbrough, United Kingdom has been added as the UK’s first 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 Golden Jubilee Regional Spinal Cord Injuries Centre located at the James Cook University Hospital, a major trauma center, focuses exclusively on patients with spinal cord injuries and is one of eight specialist centers within England.

“I am enthusiastic about the opportunity to be joining the INSPIRE study and I look forward to helping InVivo evaluate this exciting experimental technology while bringing awareness of the study to the United Kingdom,” Dr. Prasad said.

Mark Perrin, InVivo’s CEO and Chairman, said, “We are thrilled to open our first INSPIRE site in the United Kingdom and are looking forward to working with Dr. Prasad and the staff at James Cook University Hospital. The INSPIRE Study is now open for enrollment across three countries: the United States, Canada, and the United Kingdom.”

There are now 33 clinical sites participating in the clinical study:

  • Allegheny General Hospital, Pittsburgh, PA
  • 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
  • Ben Taub Hospital/Baylor College of Medicine, Houston, TX
  • Beth Israel Deaconess Medical Center, Boston, MA
  • Brigham and Women’s Hospital, Boston, MA
  • Carolina Neurosurgery and Spine Associates/Carolinas Rehabilitation, Charlotte, NC
  • Cooper Neurological Institute, Camden, NJ
  • Foothills Medical Centre, Calgary, Alberta, Canada
  • Goodman Campbell Brain and Spine/Indiana University Health Neuroscience Center, Indianapolis, IN
  • Hospital of the University of Pennsylvania, Philadelphia, PA
  • James Cook University Hospital, Middlesbrough, UK
  • Keck Hospital of University of Southern California, Los Angeles, CA
  • Medical College of Wisconsin/Froedtert Hospital, Milwaukee, WI
  • Mount Sinai Hospital, New York, NY
  • Northwestern Medicine, Chicago, IL
  • Oregon Health & Science University, Portland, OR
  • Rhode Island Hospital, Providence, RI
  • Rutgers New Jersey Medical School, Newark, NJ
  • St. Michael’s Hospital, Toronto, Ontario, Canada
  • Thomas Jefferson University Hospital, Philadelphia, PA
  • Toronto Western Hospital, Toronto, ON, Canada
  • UC Health Memorial Hospital, Colorado Springs, CO
  • University of California, Davis Medical Center, Sacramento, CA
  • University of California, San Diego Medical Center, San Diego, CA
  • University of Iowa Hospitals and Clinics, Iowa City, IA
  • University of Kansas Medical Center, Kansas City, KS
  • University of Louisville Hospital, Louisville, KY
  • University of New Mexico Hospital, Albuquerque, NM
  • University of Pittsburgh Medical Center Presbyterian, Pittsburgh, PA
  • University of Virginia Health System, Charlottesville, VA
  • Vidant Medical Center, Greenville, NC

About The INSPIRE Study

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, is designed to demonstrate the safety and probable benefit of the Neuro-Spinal Scaffold™ for the treatment of complete T2-T12/L1 spinal cord injury in support of a Humanitarian Device Exemption (HDE) application for approval. For more information, refer to https://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 repair within and around 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 Study for the treatment of patients with acute, complete (AIS A), thoracic traumatic spinal cord injury and a pilot study for acute, complete (AIS A), cervical (C5-T1) traumatic spinal cord injury. For more information on the cervical study, refer to https://clinicaltrials.gov/ct2/show/study/NCT03105882.

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 progress of the clinical program. 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 Quarterly Report of the three months ended March 31, 2017, 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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