InVivo Therapeutics Announces FDA Acceptance Of A Modular Submission And Review Process For The Neuro-Spinal Scaffold

CAMBRIDGE, Mass.--(BUSINESS WIRE)--InVivo Therapeutics Holdings Corp. (NVIV) today announced that the U.S. Food and Drug Administration (FDA) has accepted its proposed Humanitarian Device Exemption (HDE) modular shell submission and review process for the Neuro-Spinal Scaffold™. This investigational device is being studied in 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.

“InVivo’s regulatory approach centers on efficiency and swiftness to market”

The modular HDE review process is based on a submission of individual sections or “modules” that constitute a complete HDE submission once all have been submitted. The modular approach allows the FDA to review each module separately, allowing the applicant to receive timely feedback and potentially resolve any deficiencies earlier in the review process compared to a traditional HDE application. InVivo’s HDE modular shell is comprised of three modules: a preclinical studies module, a manufacturing module, and a clinical data module. Following the submission of each module, the FDA reviews and provides feedback, typically within 90 days. Upon receipt of the final module, the FDA will make a filing decision that, if positive, triggers the HDE 75-day review clock for an approval decision.

“InVivo’s regulatory approach centers on efficiency and swiftness to market,” Mark Perrin, InVivo’s Chief Executive Officer and Chairman, said. “We expect to submit and receive acceptance of the preclinical module by the end of this year and plan to submit the manufacturing and clinical modules in 2017.”

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 benefits of the modular shell submission and review process and the timing of FDA review and acceptance of HDE preclinical module and future modular submissions. 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 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, 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.