on October 23rd, 2014
InVivo Therapeutics Holdings Corp. (NVIV) today announced that the Barnes-Jewish Hospital at Washington University Medical Center in St. Louis, MO, is the fourth clinical site in the company’s on-going IDE pilot study of its Neuro-Spinal Scaffold in patients with acute spinal cord injury (SCI). Barnes-Jewish Hospital is the largest regional trauma center in St. Louis and is one of the largest clinical spine care practices for the United States. Paul Santiago, MD, an Associate Professor of Neurological Surgery and Orthopedic Surgery at the Washington University School of Medicine in St. Louis, will be the study’s Principal Investigator at the Barnes-Jewish Hospital.
Dr. Santiago said, “We look forward to participating in the evaluation of this novel treatment for acute spinal cord injury and hope that it we will be able to advance the treatment of patients with spinal cord injuries.”
Mark Perrin, InVivo Chief Executive Officer, said, “We are pleased that patient enrollment has begun and look forward to bringing more centers of excellence into our current pilot study. With Dr. Santiago and the Barnes-Jewish Hospital, we now have four sites that will be ready to enroll patients once we re-open enrollment. We have received IRB approval from two additional sites, which we will announce in the coming weeks after we complete the final administrative steps of site start-up.”
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 approval to commence commercialization under a Humanitarian Device Exemption (HDE).
About InVivo Therapeutics
InVivo Therapeutics Holdings Corp. is a pioneering 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 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” and similar expressions, and include statements regarding the Company’s expectations with respect to the safety, feasibility, and clinical effectiveness of its scaffold device, the enrollment of additional patients in the scaffold pilot study following the reopening of enrollment; and its ability to conduct a second 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; 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 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, 2013, as amended, 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.
Brian Luque, 617-863-5535
Source: InVivo Therapeutics Holdings Corp.