CAMBRIDGE, Mass. (August 28, 2017) – InVivo Therapeutics Holdings Corp. (NVIV) today announced that it is executing a strategic restructuring in order to focus on 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 The strategic restructuring will allow the company to concentrate its efforts on reopening patient enrollment for INSPIRE, completing INSPIRE, and filing a Humanitarian Device Exemption (HDE) submission for the Neuro-Spinal Scaffold. The INSPIRE Study is designed to demonstrate the safety and probable benefit of the Neuro-Spinal Scaffold in patients with complete thoracic spinal cord injury, and currently has 16 patients in follow-up.
As part of the decision to focus exclusively on INSPIRE, the company also has announced the suspension of its chronic SCI stem cell and gene therapy research programs and a halt in enrollment into its Canadian cervical study of the Neuro-Spinal Scaffold. The company is evaluating strategic options for allowing the cell and gene therapy programs to move forward outside of the company and plans to restart the cervical study once the FDA approves a protocol that allows for enrollment in the United States.
In conjunction with the corporate restructuring, the company is undergoing a reduction in force (RIF), in which it is eliminating 13 positions, or approximately 39% of its workforce. The RIF, the recent update to the INSPIRE timeline, the suspension of the chronic SCI programs, and the halt to the cervical study together are projected to result in 2018 operating expense savings of approximately $7.3 million and to reduce 2018 cash burn from approximately $2.0 million per month to approximately $1.5 million per month.
“I feel confident that going forward, we have aligned our operational efforts and financial resources to fully support our core goal of bringing the Neuro-Spinal Scaffold to market. We continue to work with the FDA as expeditiously as possible with the goal of reopening enrollment in INSPIRE, and we look forward to completing the study and submitting our HDE application,” InVivo’s CEO and Chairman Mark Perrin said.