InVivo to evaluate strategic options as trial for spinal injury device fails
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Update 10:15 AM EST: Adds latest share price move
After announcing a trial setback for its Neuro-Spinal Scaffold device in spinal cord injury (SCI), the development stage MedTech company InVivo Therapeutics (NASDAQ:NVIV) said Thursday that it would evaluate strategic options.
InVivo (NVIV) plunged ~51% after its shares resumed for trading following a pre-market halt in reaction to the news.
Citing topline data, the company said that INSPIRE 2.0 study, which was designed to evaluate the Neuro-Spinal Scaffold in acute SCI, did not reach the primary endpoint.
The investigators have assessed the percentage of patients indicating an improvement of at least one grade in a Spinal Injury scale as the primary endpoint, comparing the effect of Neuro-Spinal Scaffold versus the standard-of-care surgery after six months of therapy.
"We are disappointed by the outcome of this study as treatments for spinal cord injury are so urgently needed and we know many in the SCI patient and advocate community wait in hope for therapeutic options," Chief Executive Richard Toselli noted.
On the strategic review, InVivo (NVIV) said it would issue an update on the company's future direction when appropriate.
The setback follows InVivo’s (NVIV) shareholder agreements in October to raise ~$9M in gross proceeds through stock offerings.