InVivo Therapeutics (OTC:NVIV) said it added a 3rd clinical site to an 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 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, InVivo said.
"We look forward to contributing our years of expertise in spinal cord injury research, which includes using stem cells for spinal cord injury, and our institution’s unique resources – cutting-edge academic, research and clinical centers, our urban location, and our multidisciplinary team of highly skilled and experienced sub-investigators and staff – to this clinical trial. We are hopeful that this study will yield good results," Hsieh said in prepared remarks.
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.
"We welcome Dr. Hsieh and the Keck Hospital of USC into InVivo’s ongoing pilot study. Dr. Hsieh’s extensive experience and the hospital’s urban location will be key assets as we move forward with our study. As previously disclosed, we look forward to reopening concurrent enrollment of the final three subjects in our pilot study in the coming days," InVivo chairman & CEO Mark Perrin said in prepared remarks.
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.