Mount Sinai Hospital Added as InVivo Clinical Trial Site

Cambridge, Mass.-based InVivo Therapeutics Holdings Corp. has added The Mount Sinai Hospital in New York, N.Y., as a clinical site in the company’s ongoing clinical study of its investigational neuro-spinal scaffold in patients with acute spinal cord injury. The Mount Sinai Hospital is acclaimed internationally for excellence in clinical care and is one of seven hospital campuses that make up the Mount Sinai Health System.

“I see the enormous unmet medical need presented by spinal cord injury first-hand in my practice,” said Arthur Jenkins, M.D., associate professor of neurosurgery and orthopedic surgery, who performs spinal cord injury research at the Icahn School of Medicine, and who has been named local Principal Investigator of the trial at Mount Sinai. “InVivo is taking steps to fill that need, and I’m looking forward to being a part of this study.”

“Dr. Jenkins and his team bring a great deal of additional subject matter expertise to the table, and we are pleased to include them in our ongoing trial,” said Mark Perrin, InVivo’s CEO and chairman. “Their experience and geographic reach will be valuable as we look to enroll additional patients into the study. As previously communicated, eligible patients at participating clinical sites can be treated using the Emergency Use Expanded Access Mechanism and the safety and outcomes data from these patients will be included in the humanitarian device exemption application for approval.”

The addition of Mount Sinai brings the total number of clinical sites for InVivo’s trial to 14.

Following an acute spinal cord injury, InVivo’s biodegradable neuro-spinal scaffold is surgically implanted at the epicenter of the wound and is designed to act as a physical substrate for nerve sprouting. Appositional healing to spare spinal cord tissue, decreased post-traumatic cyst formation, and decreased spinal cord tissue pressure have been demonstrated in preclinical models of spinal cord contusion injury. The neuro-spinal scaffold, an investigational device, has received a Humanitarian Use Device designation and is currently being studied in an Investigational Device Exemption clinical study for the treatment of patients with complete traumatic acute spinal cord injury.

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