InVivo Therapeutics (NSDQ:NVIV) said today 4th patient in the Inspire study of its Neuro-Spinal Scaffold has improved from a complete AIS A spinal cord injury to an incomplete AIS B spinal cord injury.
The Cambridge, Mass.-based company’s neuro-spinal scaffold is surgically implanted following acute spinal cord injuries to act as a physical substrate for nerve sprouting.
“The proportion of patients in the Inspire study that have recovered some neurological function is impressive. This most recent conversion brings us closer to achieving the study’s objective performance criterion of five patient conversions. We will be enrolling 13 additional evaluable patients in order to reach 20 patients at 6 months, and we only need to observe 1 additional conversion in order to meet the OPC. Our goal is to approach full enrollment by the end of this year and file for humanitarian device exemption approval next year,” CEO Mark Perrin said in a press release.
The company said its objective performance criterion for the study is an improvement of at least 1 AIS grade by 6-months post implantation – and the most recent patient improvement brings the total to 4 of 6 in the trial that have improved from a complete AIS A to an incomplete AIS B grade spinal cord injury.
“We’re encouraged by the progress the patient has made in the first two months after injury. It’s still early in the patient’s recovery period, and we look forward to monitoring this patient for signs of further neurological recovery,” Dr. Wilson Ray who performed the implantation at St. Louis’ Barnes-Jewish Hospital said in a prepared statement.
Earlier this month, InVivo said the 8th patient enrolled in a clinical trial of its spinal scaffold succumbed to his injuries nearly 5 days after a severe car accident. The death appears to be unrelated to InVivo’s bioresorbable neuro-spinal scaffold, which is designed to help heal traumatic spinal cord injuries.
The patient was implanted April 12 with the InVivo device about 71 hours after the car crash, by principal investigator Dr. Travis Dumont of Tucson’s Banner University Medical Center, the company said. The patient died from his injuries 2 days later, InVivo said.