InVivo Therapeutics Holdings Corp is executing a strategic restructuring to enable the company to focus its resources on the INSPIRE Study of the Neuro-Spinal Scaffold for use in patients with spinal cord injury.
The restructuring will allow the company to concentrate its efforts on reopening patient enrollment for the INSPIRE study, completing the study, and filing a Humanitarian Device Exemption (HDE) submission for the Neuro-Spinal Scaffold.
As part of the company’s restructuring, the chronic SCI stem cell and gene therapy research programs have been suspended, and enrollment into its Canadian cervical study of the Neuro-Spinal Scaffold has been halted.
Strategic options for allowing the cell and gene therapy programs outside of the company are being evaluated. In addition, there are plans to restart the cervical study once the FDA approves a protocol that allows for enrollment in the United States.
Along with the restructuring is the elimination of 13 positions, or approximately 39% of InVivo’s workforce.
All these changes point to a projected 2018 operating expense savings of approximately $7.3 million and a reduction of 2018 cash burn from approximately $2.0 million per month to approximately $1.5 million per month, according to a media release from InVivo Therapeutics.
“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,” states InVivo CEO and Chairman Mark Perrin, in the release.
[Source(s): InVivo Therapeutics, Business Wire]