InVivo Therapeutics Announces New Site for INSPIRE Study – Business Wire (press release)

CAMBRIDGE, Mass.--(BUSINESS WIRE)--InVivo Therapeutics Holdings Corp. (NVIV)today announced that the Brigham and Womens Hospital (BWH) in Boston, MA has been added as a 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. BWH is a teaching hospital of Harvard Medical School and hosts one of the largest neurosurgical intensive care units in the country.

Patients who suffer spinal cord injury face limited options for treatment. Im hopeful that spinal cord research, particularly in the area of axon regeneration, will expand the options available to these patients with devastating injuries, Yi Lu, M.D., Ph.D., said this week. Dr. Lu is a neurosurgeon at Brigham and Womens Hospital, assistant professor of neurosurgery at Harvard Medical School, and Principal Investigator at the study site.

Mark Perrin, InVivos CEO and Chairman, said, We are pleased to welcome Dr. Lu and the team at BWH to the INSPIRE Study. Dr. Lu is an active clinician scientist in the field of spinal cord injury, having won the 2011 Spinal Cord Injury Award given by the AANS/CNS Section on Neurotrauma and Critical Care.

There are now 31 clinical sites participating in the clinical study:

For more information, please visit the companys ClinicalTrials.gov registration site: http://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 regeneration across 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 pivotal probable benefit 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.

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 Childrens 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 companys investigational Neuro-Spinal Scaffold received the 2015 Beckers Healthcare Spine Device Award. The publicly-traded company is headquartered in Cambridge, MA. For more details, visit http://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 pace of enrollment. 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 companys ability to successfully open additional clinical sites for enrollment and to enroll additional patients; the timing of the Institutional Review Board process; the companys ability to commercialize its products; the companys ability to develop, market and sell products based on its technology; the expected benefits and efficacy of the companys 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 companys business, research, product development, regulatory approval, marketing and distribution plans and strategies identified and described in more detail in the companys Annual Report on Form 10-K for the year ended December 31, 2016, and its other filings with the SEC, including the companys 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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InVivo Therapeutics Announces New Site for INSPIRE Study - Business Wire (press release)