InVivo Therapeutics Initiates First Clinical Trial of Neuro-Spinal Scaffold

Published: April 28, 2014  |  Source: online.wsj.com
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InVivo TherapeuticsScaffold Designed to Facilitate Neural Growth in Spinal Cord Injury

CAMBRIDGE, Mass.–(BUSINESS WIRE)–April 28, 2014– InVivo Therapeutics Holdings Corp. (NVIV) announced today that it has begun shipment of its innovative investigational device, a degradable polymer Neuro-Spinal Scaffold for spinal cord injury (SCI) patients, for initiation of the company’s first clinical trial. InVivo has pioneered a new treatment platform utilizing a biocompatible polymer-based device that is intended to promote structural support for spinal cord regeneration while improving functional recovery and prognosis after a traumatic SCI. In preclinical studies, the Neuro-Spinal Scaffold promoted cell adhesion, neurite sprouting, the growth of remodeled spinal cord tissue containing myelinated axons, and improved motor function.

There currently is no effective treatment for paralysis caused by SCI. The company estimates the worldwide market for treating acute complete SCI to be over $500 million annually, and the chronic SCI market to be over $10 billion. This is the first in-human trial of InVivo’s novel investigational device, a critical step in addressing a major unmet need for patients with SCI.

This first clinical study, which is approved by the FDA, is a pilot trial to capture preliminary safety and effectiveness data of the Neuro-Spinal Scaffold in five subjects with acute thoracic spinal cord injury. The Company then expects to conduct a pivotal study to obtain FDA approval to commence commercialization under a Humanitarian Device Exemption (HDE).

The initial clinical site, The University of Arizona Medical Center in Tucson, AZ, has received Institutional Review Board (IRB) approval and has executed all necessary contracts with InVivo. Surgical training will occur upon receipt of the Neuro-Spinal Scaffold, allowing the site to then begin subject enrollment. Ali A. Baaj, MD, Assistant Professor of Surgery and Director of the Spinal Neurosurgery Program at The University of Arizona Medical Center, is the Principal Investigator. In commenting about the significance of this trial, Dr. Baaj said: “Spinal cord injury research is a priority for us at the University of Arizona Spinal Neurosurgery program. We are excited to collaborate with InVivo Therapeutics on this groundbreaking clinical trial as we strive to help patients who are affected by this devastating condition.”

InVivo has received IRB approval from two additional sites and expects these two sites to be open for enrollment in the second quarter. “The InVivo team has put forth a tremendous effort to bring this innovative product to the clinic,” InVivo CEO Mark Perrin said. “I anticipate continued momentum as additional sites are initiated in this important study. We are dedicated to patients whose lives have been forever changed by their traumatic injury. InVivo’s Neuro-Spinal Scaffold technology may again change their lives … this time for the better.”

About InVivo Therapeutics

InVivo Therapeutics Holdings Corp. is a pioneering biomaterials company with unique technologies for drug delivery 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, M.D., who 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 relate to future events or to the Company’s future operating or financial performance, including statements regarding the Company’s expectations with respect to the commencement of its pilot study for its scaffold, the opening of additional clinical sites for enrollment, and its ability to complete its clinical studies and commercialize its scaffold . Any forward-looking statements contained herein are based on current expectations, and are subject to a number of risks and uncertainties. Given these uncertainties, you should not place undue reliance on these forward-looking statements. 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 its pilot study; the timing of the Institutional Review Board process; the Company’s ability to finalize contracts with additional clinical sites; 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; the Company’s ability to maintain its licensing arrangements and protect its intellectual property; the Company’s ability to attract and retain key personnel; 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 our Annual Report on Form 10-K for the year ended December 31, 2013 and our other filings with the SEC, including our Form 10-Qs and our current reports on Form 8-K. We do not undertake to update these forward-looking statements made by us.