InVivo Therapeutics cleared to convert INSPIRE study to show probable benefit; shares up 8% premarket

• Thinly traded micro cap InVivo Therapeutics Holdings (NASDAQ:NVIV) is up 8% premarket on increased volume in response to its announcement that the FDA granted conditional approval to convert its ongoing pilot study of its Neuro-Spinal Scaffold in acute spinal cord injury into a pivotal probable benefit study. The clearance is conditional because of a minor change to the informed consent form that has already been submitted to the agency. Full approval should happen in the next 30 days.
• The pivotal study, which is formerly named The INSPIRE Study, will enroll up to 20 patients following the review of six-month safety data from the first five. The company expects to submit the data in Q2. The inclusion criteria have been broadened to include patients with T2 injuries (range: T2-T12/L1). The primary endpoint is the proportion of patients achieving an improvement of at least one ASIA Impairment Scale (AIS) grade at six months post-implantation.
• The FDA also approved an increase in U.S. trial sites to 40.
• The company will discuss the development this evening at 5:15 pm ET during its KOL Event and Company Update webcast.
• Previously: Third patient receiving InVivo's Neuro-Spinal Scaffold shows encouraging progress, shares up 10% premarket (July 6)
• Previously: First patient responds well to InVivo Spinal Scaffold (Jan. 21)