– First of Three Modules to be Submitted for Product Approval –
CAMBRIDGE, Mass. (Mar 21, 2017) – InVivo Therapeutics Holdings Corp. (NVIV) today announced that it has submitted its first module containing nonclinical studies to the U.S. Food and Drug Administration (FDA) as part of its Humanitarian Device Exemption (HDE) modular submission and review process for the Neuro-Spinal Scaffold™. InVivo’s modular HDE process is based on a submission of three modules to the FDA that constitute a complete HDE submission once all have been submitted: a nonclinical studies module, a manufacturing module, and a clinical data module. This process allows the FDA to review each module separately and provide timely feedback, typically within 90 days of submission, thereby allowing the applicant the opportunity to resolve any deficiencies earlier in the review process compared to a traditional HDE application.
“The submission of our nonclinical studies module marks the accomplishment of another major milestone for the INSPIRE Study,” Mark Perrin, InVivo’s Chief Executive Officer and Chairman, said. “We expect to receive acceptance of the nonclinical module in the third quarter of this year, and plan to submit the manufacturing module in the second half of 2017 and the clinical module in 2018, all as part of our strategy to pursue accelerated approval for the Neuro-Spinal Scaffold™.”
About the Neuro-Spinal Scaffold™ Implant
This investigational device is being studied in the 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. 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,” “plan” and similar expressions, and include statements regarding the safety and effectiveness of the Neuro-Spinal Scaffold, and the timing of acceptance of FDA feedback for the nonclinical module, and timing of the submission of additional modules of the Humanitarian Device Exemption (HDE). 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 timing of the Institutional Review Board, REC and HRA processes; the impact of achieving the OPC on the FDA approval process; 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, 2016, 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.