InVivo Therapeutics eliminated 13 positions in a quest to focus attention on the Inspire Study and earn an FDA humanitarian device exemption for the Neuro-Spinal Scaffold.
Here are five things to know:
1. InVivo launched a corporate restructuring plan to focus on the Inspire study, which examines the Neuro-Spinal Scaffold for patients with spinal cord injury. The company suspended the trial last month after three patients died but found the deaths were not a result of the device. InVivo hopes to reopen enrollment after the restructuring.
2. The company suspended its chronic spinal cord injury stem cell and gene therapy research programs as well as enrollment in the Canadian cervical study of the Neuro-Spinal Scaffold. InVivo may move the cell and gene therapy programs outside of the company in the future and plans to restart the cervical study after the FDA approves a protocol for enrollment in the U.S.
3. In conjunction with the restructuring, InVivo eliminated 39 percent of its workforce, which will save around $7.3 million in operating expenses for 2018.
4. The company expects to lower 2018 cash burden from $2 million to $1.5 million per month after the restructuring.
5. Going forward, InVivo will focus efforts on filing a humanitarian device exemption for the Neuro-Spinal Scaffold. There are currently 16 patients enrolled in the Inspire study who are undergoing regular follow-up. The company's core goal is to bring the Neuro-Spinal Scaffold to market.