InVivo Therapeutics (OTC:NVIV) said today that it’s added a 4th site to the ongoing feasibility study of its biodegradable implant to treat acute spinal cord injuries.
The Cambridge, Mass.-based company hopes to gather preliminary safety and effectiveness data in the study of its neuro-spinal scaffold from 5 patients who have acute thoracic spinal cord injury. Once the pilot study is complete, InVivo plans to launch a pivotal trial ahead of a bid for FDA approval under a humanitarian device exemption.
The trial’s 4th site is the University of Kansas Medical Center in Kansas City, where Dr. Paul Arnold will serve as principal investigator, InVivo said.
"We look forward to participating in this exciting pilot study of an innovative device that is targeted at addressing the huge unmet medical need in the treatment of acute spinal cord injury patients," Arnold said in prepared remarks.
Chairman & CEO Mark Perrin added that the UK Medical Center is the 9th site for the trial.
"We welcome Dr. Arnold and the University of Kansas Medical Center into InVivo’s ongoing pilot study, which was recently reopened for concurrent enrollment of the final three patients. We are pleased to be working with a researcher of Dr. Arnold’s caliber, and are pleased as well that we now have 9 sites open to enroll subjects," Perrin said.
The neuro-spinal scaffold is a biodegradable device designed to be surgically implanted at the epicenter of a spinal cord wound. It is designed as a regenerative treatment for spinal cord injuries, according to the company.
Last week InVivo said the trial’s 3rd site in the investigational device exemption trial is Keck Hospital of the University of Southern California in Los Angeles. Dr. Patrick Hsieh, director of the hospital’s neurosurgery spine program and associate professor of neurological surgery, will serve as the lead investigator there, the company said.
Back in October 2014, InVivo enrolled the 1st patient in the pilot study at the Barrow Neurological Institute at St. Joseph’s Hospital and Medical Center in Phoenix, Ariz. A 2nd patient enrolled in January at Charlotte’s Carolinas Medical Center. Last month InVivo said it planned to raise $12 million in a direct offering. The company is also planning a 1-for-4 reverse stock split in preparation for a planned listing on the NASDAQ exchange, both of which are slated for April 8.