The Cambridge, Mass.-based company, which is developing a scaffold implant to treat traumatic spinal cord injuries, last month suspended its 16-patient Inspire study after its most recent patient passed away suddenly following hospital discharge. Although the death was found to be unrelated to the InVivo scaffold or its implantation procedure, the company temporarily halted enrollment to discuss potential changes to Inspire’s enrollment criteria with the FDA.
Yesterday InVivo said it plans to concentrate on reopening enrollment and completing Inspire ahead of a humanitarian device exemption submission. That spells layoffs for 13 workers, or 39% of the company’s roster and the suspension of its stem cell and gene therapy research programs while the company looks at spinout options for them. InVivo also said it’s stopping its Canadian cervical spine study, but plans to restart it after the FDA approves a U.S. enrollment protocol.
The company has said it hopes to resume enrollment in Inspire during the first half of next year and file its HDE bid during the second half.
“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,” chairman & CEO Mark Perrin said in prepared remarks.
InVivo said it expects the moves to save roughly $7.3 million next year and cut its monthly cash burn from about $2.0 million to about $1.5 million.
In July InVivo said it added Stanford Medicine as the 34th clinical site in the Inspire study of its neuro-spinal scaffold.
NVIV shares closed down -2.1% at $1.15 apiece yesterday.
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