CAMBRIDGE, Mass.--(BUSINESS WIRE)--InVivo Therapeutics Holdings Corp. (NVIV) today announced that the fifth patient has been enrolled in the company’s ongoing pilot study of its investigational Neuro-Spinal Scaffold™ implant in patients with acute thoracic spinal cord injury at the Keck Hospital of University of Southern California (USC) in Los Angeles.
Patrick Hsieh, M.D., Principal Investigator at this site, performed the fifth-ever Neuro-Spinal Scaffold implantation approximately 69 hours after the injury occurred.
“Enrolling the fifth patient in our first clinical study is a momentous milestone for the company, and we are pleased this accomplishment came ahead of previous guidance,” said Mark Perrin, InVivo’s CEO and Chairman. “We are in productive discussions with the FDA regarding the transition to the pivotal probable benefit study, and our plan is to incorporate the pilot study into the pivotal probable benefit study. We expect to use this single study as the basis for a Humanitarian Device Exemption (HDE) application, which would allow us to dramatically reduce the time to approval and commercialization.”
Mr. Perrin continued, “While we are discussing plans with the FDA for the pivotal probable benefit study and the incorporation of the pilot study, we intend to request expanding the number of patients in the current pilot study beyond five to further compress clinical timelines. We anticipate that we will receive formal approval of this expansion within the next two months. During this interim period, additional eligible patients at participating clinical sites may receive the Neuro-Spinal Scaffold under the Emergency Use Expanded Access Mechanism on a case-by-case basis, and the safety and outcomes data from these patients will be included in the HDE application. We have fostered a collaborative relationship with the FDA, and we are optimistic that we will finalize the pivotal probable benefit study design in the coming months.”
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 FDA’s approval of a new pivotal study and/or an expansion of the company’s pilot study and the timing of such approvals and the nature of the company’s negotiations with the FDA and the timeline for commercialization of the Neuro-Spinal Scaffold. 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.