InVivo Therapeutics Holdings Corp. (NASDAQ: NVIV) shares absolutely skyrocketed on Wednesday after the firm provided an update on a recent study. Specifically, these results are from the company’s single-arm INSPIRE study.
These results came from a presentation by Stuart Lee, M.D., Division of Neurosurgery, Vidant Health, at the 2018 American Association of Neurological Surgeons annual meeting. This is the first presentation at a medical meeting of the complete six-month data from the INSPIRE study.
In the study, seven of 16 (44%) patients who reached the six-month primary endpoint visit in the INSPIRE study had an ASIA Impairment Scale (AIS) conversion at six months, which is the primary endpoint of the trial.
Altogether, 19 patients have been implanted with the Neuro-Spinal Scaffold. Three patients died within two weeks of implantation. The Objective Performance Criterion for the study was a 25% AIS conversion rate based on the published conversion rates for thoracic spinal cord injury (SCI) reported in the literature.
InVivo has officially closed the INSPIRE study and has received supplemental Investigational Device Exemption approval from the US Food and Drug Administration (FDA) for a second pivotal clinical study of the company’s Neuro-Spinal Scaffold in patients with acute SCI. The 20-patient, randomized, controlled trial was designed to enhance the existing clinical evidence for the Neuro-Spinal Scaffold from the company’s single-arm INSPIRE study.
Shares of InVivo were last seen up 65% at $13.05, with a consensus analyst price target of $118.75 and a 52-week range of $6.25 to $96.25.