InVivo Therapeutics Holdings Corp. (NVIV) today announced that University of Iowa Hospitals and Clinics in Iowa City, IA, 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. UI Hospitals and Clinics is a 732-bed hospital which, in fiscal year 2015, received more than 57,000 emergency room visits.
“Two active areas of spinal cord injury research involve timing and the use of biomaterials. The INSPIRE study represents the marriage of these two concepts and we look forward to participating,” said Patrick Hitchon, M.D., Professor in the departments of Neurosurgery and Biomedical Engineering and Principal Investigator at the study site. Saul Wilson, M.D., and Chandan Reddy, M.D. are co-investigators for the research trial.
Mark Perrin, InVivo’s CEO and Chairman, said, “We welcome Dr. Hitchon and his team to the INSPIRE study. This is the fourth new site we have announced in the last three weeks, and we look forward to bringing on more high-quality sites over the next several months.”
There are now 27 clinical sites participating in the clinical study:
For more information, please visit the company’s 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 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 addition of new sites, the safety and effectiveness of the Neuro-Spinal Scaffold, the expected timing of full enrollment in the INSPIRE study, the timing of the submission of the Humanitarian Device Exemption (HDE), the timing for opening of the pilot cervical SCI study, and the company’s anticipated cash balance. 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 ability to complete the INSPIRE study and submit an HDE; the company’s ability to receive regulatory approval for the Neuro-Spinal Scaffold; 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, 2015, 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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Last updated on: 09/11/2016
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