InVivo Therapeutics Updates Clinical Plan
CAMBRIDGE, Mass. (August 27, 2013) – InVivo Therapeutics Holdings Corp. (NVIV), a developer of groundbreaking technologies for the treatment of spinal cord injuries (SCI) and other neurotrauma conditions, today announced an update on the clinical timeline for its biopolymer scaffolding to treat acute SCI. The Company now expects that, based on the judgment of new management, it will enroll the first patient during the first quarter of 2014.
Under the conditions of the FDA’s approval of the Investigational Device Exemption, the five-person pilot trial will be staggered such that each patient will be followed for three months prior to requesting approval to enroll the next patient. Because the Company must obtain FDA approval to enroll each subsequent patient, the Company anticipates that from the date of the first enrolled patient, it will take at least 21 months to complete enrollment. Consistent with FDA guidance, the Company then expects to conduct a pivotal study with a control group to obtain FDA approval to commence commercialization under a Humanitarian Device Exemption.
Michael Astrue, Interim Chief Executive Officer of InVivo, said, “We remain fully committed to beginning this study as soon as possible. While the study will take additional time, we look forward to bringing this important therapy into the clinic.”
Further, management has undertaken a comprehensive project and timeline review of its hydrogel technologies platform, as well as its application to pain treatment, dural sealants, dural replacements, nerve conduits and fibrosis treatment, and will provide an update as to the status of those programs as data is available.