With investigational approval in hand, InVivo Therapeutics (OTC:NVIV) is preparing to launch a U.S. clinical study of its degradable polymer scaffold for treating spinal cord injury, issuing a revised trial protocol to FDA regulators and to the clinical sites participating in the study.
All revisions were approved under the FDA’s newly granted investigational device exemption, InVivo said. The hospitals involved in the study can now review the documents and decide whether agree to the clinical trial contract with InVivo.
That’s huge news for InVivo, which has devoted significant resources to the spinal scaffold product, pulling resources from its hydrogel product development to focus on the new clinical trial. The progress sets up incoming CEO Mark Perrin to lead the path to the market, the company said.
InVivo is prepared to provide scaffolds starting mid-February, with initial clinical trial patients expected in March.
The announcements "mark the end of a difficult but successful transition period for InVivo," interim CEO Michael Astrue said in prepared remarks. "Our incoming chief executive officer, Mark Perrin, will inherit dedicated employees and a realistic strategic plan that can generate enormous value for shareholders. I am confident in Mark’s ability to take this company to the next level."
The company earlier this month named Perrin its new CEO, effective yesterday. Perrin took over for Astrue, who held the role in an interim capacity since the August resignation of company co-founder Frank Reynolds, who stepped down for health reasons.