InVivo Therapeutics ($NVIV) planned to kick off a study of its investigational spinal implant in the coming months, but an FDA roadblock has made that impossible, news that sent the devicemaker's stock on a nearly 40% plunge Tuesday.
The company is working to get its biopolymer scaffolding for spinal injuries onto the U.S. market through the FDA's Humanitarian Device Exemption, and while the agency approved InVivo's plan for a first-in-human trial, the conditions require it to enroll just one patient every three months, running each one by the FDA.
That means InVivo can't start until the first quarter of next year, and the total enrollment will take at least 21 months, the company said, putting off a potential pivotal study and hoped-for commercialization indefinitely.
"We remain fully committed to beginning this study as soon as possible," interim CEO Michael Astrue said in a statement. "While the study will take additional time, we look forward to bringing this important therapy into the clinic."
Astrue's commitment wasn't convincing enough to shareholders, apparently, and InVivo's stock price fell to $2.07 before Tuesday's close--a roughly 40% drop--trading at 5 times average volume, according to the Associated Press.
The scaffolding delay comes just a week after co-founder and longtime CEO Frank Reynolds abrubtly resigned, citing a health issue. The company is in the midst of a search for a full-time replacement and hopes to wrap that up by year's end.
- read the announcement
- check out the AP story