InVivo Therapeutics (NSDQ:NVIV) said today that it added another site to the clinical trial of its neurospinal scaffold, taking the total number of participating sites to 22.
That includes the 1st Canadian site, added last week after Health Canada OK’d the trial.
The latest site to join the Inspire study is the Ben Taub Hospital at the Texas Medical Center in Houston, InVivo said. Its device is a bioresorbable scaffold designed to encourage nerve regeneration after traumatic spinal cord injuries.
“I’m thrilled to bring the Inspire study to the Ben Taub Hospital,” principal site investigator Dr. Alexander Ropper said in prepared remarks. “Implanting the first neuro-spinal scaffold at the Barrow Neurological Institute with Dr. Theodore was a rewarding experience and I look forward to leveraging that experience here.”
“We are pleased to welcome Dr. Ropper and the Ben Taub Hospital into the Inspire study. His experience with the first implantation will be invaluable as we look to enroll additional patients into the study,” added InVivo chairman & CEO Mark Perrin.
In the U.S., the FDA has approved the expansion of the Inspire trial to up to 20 patients. Ten patients have been implanted with the InVivo device, a surgical implant designed to act as a physical substrate for nerve sprouting after acute spinal cord injuries. The 10th patient in the trial died of a stroke that was unrelated to the InVivo device implantation, the company said this week.
Last month, InVivo touted a case study of the 1st implantation of its spinal scaffold published in Neurosurgery, the journal of the Congress of Neurological Surgeons. The case involved a 25-year-old man with an American Spinal Injury Assn. Grade A spinal cord injury sustained in a motocross accident. Dr. Nicholas Theodore implanted an InVivo spinal scaffold directly into the traumatic cavity.
After 3 months, the patient had improved to a Grade C incomplete injury, according to the study, and at 6 months there were no procedural complications or safety issues related to the device. InVivo has said that the patient demonstrated an 8-point gain on the 50-point AIS lower extremity motor score and additional bilateral motor function improvements between the 6-month and 12-month follow-ups.
In December 2015, InVivo won conditional approval from the FDA to convert its the ongoing pilot study to a pivotal probable benefit study, allowing the company a faster path to FDA approval. Earlier this year the company raised a $32 million funding round.