Policy & Regulation
InVivo Therapeutics Presents Twelve-Month Results from the INSPIRE Study of the Investigational Neuro-Spinal Scaffold in Acute Thoracic Complete Spinal Cord Injury
22 April 2019 - - US-based biomaterials and biotechnology company InVivo Therapeutics Holdings Corp. (NASDAQ: NVIV) has presented the twelve-month results from the company's single-arm 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), the company said.

The findings were presented at the 2019 AANS Meeting in San Diego, CA through an e-poster titled, "Twelve Month Results from the INSPIRE Study of the Investigational Neuro-Spinal Scaffold in Acute Thoracic Complete Spinal Cord Injury."

As previously announced by InVivo, 7 of 16 patients who reached the six-month primary endpoint visit in the INSPIRE study had an ASIA Impairment Scale conversion at six months, which is the primary endpoint of the trial (defined as improvement in AIS grade from baseline for all evaluable patients at the six-month visit).

Of the seven patients who reached the six-month primary endpoint visit, six patients were later evaluated at the 12-month exam and one patient was lost to follow-up before the 12-month exam.

All six patients who were examined at the 12-month exam and had previously converted at the six-month exam remained converted at the 12-month exam.

Further, two of those six patients were assessed to have AIS B spinal cord injury at the six-month primary endpoint but were later assessed to have improved to AIS C SCI at the 12-month visit.

The Objective Performance Criterion (study success definition) for the study was a 25% AIS conversion rate based on the published conversion rates for thoracic SCI reported in the literature.

InVivo Therapeutics Holdings Corp. is a research and clinical-stage biomaterials and biotechnology company with a focus on treatment of spinal cord injuries.

The company was founded in 2005 with proprietary technology co-invented by Robert Langer, Sc.D., Professor at Massachusetts Institute of Technology, and Joseph P. Vacanti, M.D., who then was at Boston Children's Hospital and who now is affiliated with Massachusetts General Hospital.

In January 2018, the company announced updated clinical evidence, including improvements in patients with acute spinal cord injury, from its INSPIRE study of the Neuro-Spinal Scaffold. The publicly traded company is headquartered in Cambridge, MA.