InVivo Therapeutics Announces Objective Performance Criterion For The INSPIRE Study

- Key Measure of Study Success -

CAMBRIDGE, Mass.--(BUSINESS WIRE)--InVivo Therapeutics Holdings Corp. (NVIV) today announced it has received approval of a significant protocol amendment from the U.S. Food and Drug Administration (FDA). The amended protocol establishes the Objective Performance Criterion (OPC) for 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. An OPC is a measure of study success used in clinical studies designed to demonstrate safety and probable benefit in support of a Humanitarian Device Exemption (HDE) approval.

“We have made tremendous progress with the FDA over the past year in the design of The INSPIRE Study, and it is very rewarding to complete the design of a study that has the potential to change the standard of care for acute spinal cord injury patients.”

The OPC for The INSPIRE Study is defined as 25% or more of the patients in the study demonstrating an improvement of at least one ASIA Impairment Scale (AIS) grade by six months post-implantation. Since The INSPIRE Study is designed to enroll 20 patients with complete (AIS A) spinal cord injuries (inclusive of the 5 patients enrolled in the company’s pilot trial) the OPC equates to having five patients convert to any other AIS grade by six months post-implantation. Natural history databases indicate that between 12-16% of patients with complete (AIS A) thoracic injury will spontaneously convert without treatment six months after injury.

“The approval of this amendment, which includes the OPC, is one of the most important regulatory milestones the company has reached to date. The OPC provides additional clarity regarding our path to commercialization,” said Mark Perrin, InVivo’s Chairman and Chief Executive Officer. “We have made tremendous progress with the FDA over the past year in the design of The INSPIRE Study, and it is very rewarding to complete the design of a study that has the potential to change the standard of care for acute spinal cord injury patients.”

HDE approval is not guaranteed if the OPC is met, and even if the OPC is not met, the FDA may approve a therapy if safety and probable benefit are supported by a comprehensive review of all clinical endpoints and preclinical results. The safety profile for the Neuro-Spinal Scaffold™ has been excellent to date.

A new CEO’s Perspective discussing the history of The INSPIRE Study can be found on the InVivo Therapeutics website: http://www.invivotherapeutics.com/about-invivo/ceo-perspective/

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 safety and effectiveness of the Neuro-Spinal Scaffold, FDA approval of a Humanitarian Device Exemption (HDE), and the potential 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 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.