The US Food and Drug Administration (FDA) has granted conditional approval to InVivo Therapeutics, a medical device company, for proposed changes to the protocol and supporting documents for the safety trial of the company’s first degradable polymer scaffold for spinal cord injury.
Following the FDA conditional approval, the company will now move forward with its first clinical trial.
In November 2013, InVivo Therapeutics has submitted the proposed changes to the protocol and supporting documents. The company will follow the FDA’s approval conditions in their entirety in a submission to the FDA next week.
The company is likely to send its revised protocol and other supporting materials to six sites next week so that those sites can start their Institutional Review Board reviews and finalize contracts with InVivo.
Based on the specific experience of these sites, InVivo expects that these Institutional Review Board reviews and contract finalizations will take approximately 4-12 weeks, and that the first site will be ready to accrue subjects in the first half of March 2014.
InVivo interim CEO Michael Astrue said, "Today’s news is one more critical step forward toward testing our scaffold on our first patient."