InVivo Therapeutics Holdings Corp. announced the acceptance by the U.S. Food and Drug Administration (FDA) of its preclinical module, which is one of three individual modules required for the Company’s humanitarian device exemption (HDE) application. Acceptance of the module indicates that FDA has completed its review of this module of the HDE and has no outstanding questions. Review of the remaining two HDE modules, when complete, will be required prior to a final approval decision. The FDA previously approved the Company’s proposed HDE modular shell submission and review process for the Neuro-Spinal Scaffold™ implant. The HDE modular shell is comprised of three modules: the preclinical studies module, a manufacturing module and a clinical data module. The Company believes that the modular shell submission could allow for potentially more efficient review processes and timelines with the FDA. As part of the process, the FDA reviews each module on a rolling basis. The preclinical module is the first module that the Company has submitted for review to the FDA. The HDE submission will not be complete until the manufacturing and clinical modules are also submitted. InVivo is actively enrolling patients with acute spinal cord injury into its INSPIRE 2.0 study, a pivotal trial of the Neuro-Spinal Scaffold™. INSPIRE 2.0 is a 20-patient, randomized, controlled trial that is designed to expand upon the existing clinical evidence for the Neuro-Spinal Scaffold™ from the Company’s INSPIRE 1.0 study.