InVivo Therapeutics announced the FDA has given the company conditional approval to convert an ongoing study into the pivotal probable benefit study called, “ The INSPIRE Study: InVivo Study of Probable Benefit of the Neuro-Spinal Scaffold for Safety and Neurological Recovery in Subjects with Complete Thoracic AIS A Spinal Cord Injury.”
The approval was conditionally granted for a minor change in the informed consent form previously submitted to the FDA. InVivo expects full approval of the amendment within 30 days according to a company press release.
The FDA has given conditional approval for the INSPIRE Study to enroll 12 patients, but after the 6-month safety data review, InVivo expects the FDA will allow them the full 20 patients they wished to enroll. According to the press release, the FDA has allowed InVivo to broaden the study’s inclusion criteria.
The goal of the study is for the enrolled patients to improve in at least one American Spinal Injury Association Impairment Scale (AIS) grade after 6 months post-implantation.
According to the company, it aims to submit the data during the second quarter in 2016.
“This conditional approval marks one of the most significant corporate milestones the company has achieved to date,” Mark Perrin, chief executive officer and chairman of InVivo, said in the press release. “Being able to convert our pilot study into a small pivotal probable benefit study provides us with a very efficient path to commercialization. We anticipate completing enrollment in the pivotal probable benefit study and submitting an application for Humanitarian Device Exemption approval in 2017.”
InVivo will continually announce each patient’s enrollment, any changes in AIS grade and positive or negative events and plans to present results at scientific and medical meetings.