FDA approves expanded trial for InVivo Therapeutics spinal cord treatment

InVivo Therapeutics (OTC:NVIV) said today that it won a nod from the FDA to double the enrollment in a clinical trial of its neuro-spinal scaffold.

Cambridge, Mass.-based InVivo enrolled the 5th patient in the pilot study last month. Its bioabsorbable device is designed to treat acute spinal cord injuries.

“I am very pleased to have come to such a positive agreement with the FDA ahead of schedule, which will avoid any disruption in patient enrollment. While we continue to enroll subjects in our ongoing pilot study, we are working diligently with the FDA to finalize the transition to the pivotal probable benefit study. We anticipate announcing the study design and updating associated timelines before the end of the year,” chairman & CEO Mark Perrin said in prepared remarks.

Listen to a MassDevice.com podcast with InVivo Therapeutics chairman & CEO Mark Perrin

The FDA approved the expansion of enrollment in the pilot study from 5 to 10 patients. InVivo said it plans to transition the pilot study into a pivotal probable benefit trial and use it as the basis for a bid for humanitarian device exemption from the U.S. safety watchdog.

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