InVivo Therapeutics Holdings Corp. (NASDAQ: NVIV) saw its shares surge by over 25% on a pivotal announcement from its Inspire study. The company announced a six-month post-implant update for the fifth patient in the “Inspire Study: InVivo Study of Probable Benefit of the Neuro-Spinal Scaffold for Safety and Neurologic Recovery in Subjects with Complete Thoracic AIS A Spinal Cord Injury.”
All patients enrolled in this study had complete ASIA Impairment Scale (AIS) A injuries at the time of enrollment. In the time between the three-month and the six-month post-injury assessment, the fifth patient treated improved from a complete AIS A spinal cord injury to an incomplete AIS B spinal cord injury. The AIS is a five-grade scale (A to E) that measures the severity of a spinal cord injury.
The primary endpoint is the proportion of patients with an improvement in AIS grade by the six-month visit. At this point, three out of the first five patients treated (60%) have had an AIS grade improvement by six months. Also it’s worth noting that the Objective Performance Criterion measure of study success for the Inspire study is defined as 25% or more of the patients improving by at least one AIS grade by six months post-implantation.
Mark Perrin, CEO and chairman of InVivo, commented:
We are encouraged to see this patient’s significant neurological progress. This third conversion brings us one step closer to achieving the Objective Performance Criterion (OPC) for The INSPIRE Study. Our goal is to approach full enrollment of the pivotal INSPIRE study by the end of the year, which will allow for an HDE (Humanitarian Device Exemption) submission in 2017.
So far in 2016, InVivo has outperformed the broad markets, with the stock up nearly 5% year to date, excluding Monday’s move. Over the past 52 weeks, the stock is down 36%.
Shares of InVivo Therapeutics were up more than 24% at $9.38 in the noon hour Monday, with a consensus analyst price target of $25.00 and a 52-week trading range of $3.50 to $19.68.