InVivo Therapeutics spent the third quarter focused on reopening enrollment for the Neuro-Spinal Scaffold clinical study after shutting down the study earlier this year due to non-implant related patient deaths.
"Enrollment into the INSPIRE study is currently on hold as we engage with the United States Food & Drug Administration to determine the most appropriate clinical path forward," said CEO Mark Perrin. "We continue to engage in discussions with the FDA regarding our clinical program and will provide appropriate updates as we obtain further clarity on the issue."
Here are five things to know:
1. There are currently 19 patients who have received implants in the INSPIRE study, and 16 are in follow-up. Fourteen of the patients reached the six-month primary endpoint visit and 42.9 percent of the patients reported improvement from complete AIS A SCI to incomplete SCI.
2. For the third quarter, InVivo reported a $9.4 million net loss, up significantly from the $6.2 million net loss reported at the end of the third quarter last year. The company reported sales were impacted by an increase in general and administrative expenses as well as a warrant change in August. The nine-month net loss was $22.1 million.
3. InVivo reported $17.2 million in cash, cash equivalents and marketable securities at the end of the quarter.
4. Mr. Perrin reported the company reduced its workforce by 39 percent in the third quarter and expects the change to result in $7.3 million in operating expense savings next year.
5. The company is still working toward the FDA's Humanitarian Device Exemption for the Neuro-Spinal Scaffold.