CAMBRIDGE, Mass.–(BUSINESS WIRE)–InVivo Therapeutics Holdings Corp. (NVIV) today announced that the fifth patient has been enrolled in the company’s ongoing pilot study of its investigational Neuro-Spinal Scaffold™ implant in patients with acute thoracic spinal cord injury at the Keck Hospital of University of Southern California (USC) in Los Angeles.
“Enrolling the fifth patient in our first clinical study is a momentous milestone for the company, and we are pleased this accomplishment came ahead of previous guidance”
Patrick Hsieh, M.D., Principal Investigator at this site, performed the fifth-ever Neuro-Spinal Scaffold implantation approximately 69 hours after the injury occurred.
“Enrolling the fifth patient in our first clinical study is a momentous milestone for the company, and we are pleased this accomplishment came ahead of previous guidance,” said Mark Perrin, InVivo’s CEO and Chairman. “We are in productive discussions with the FDA regarding the transition to the pivotal probable benefit study, and our plan is to incorporate the pilot study into the pivotal probable benefit study. We expect to use this single study as the basis for a Humanitarian Device Exemption (HDE) application, which would allow us to dramatically reduce the time to approval and commercialization.”
Mr. Perrin continued, “While we are discussing plans with the FDA for the pivotal probable benefit study and the incorporation of the pilot study, we intend to request expanding the number of patients in the current pilot study beyond five to further compress clinical timelines. We anticipate that we will receive formal approval of this expansion within the next two months. During this interim period, additional eligible patients at participating clinical sites may receive the Neuro-Spinal Scaffold under the Emergency Use Expanded Access Mechanism on a case-by-case basis, and the safety and outcomes data from these patients will be included in the HDE application. We have fostered a collaborative relationship with the FDA, and we are optimistic that we will finalize the pivotal probable benefit study design in the coming months.”
For more information, please visit the company’s ClinicalTrials.gov registration site: http://clinicaltrials.gov/ct2/show/study/NCT02138110
About the Neuro-Spinal Scaffold™
Following an acute spinal cord injury, the 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 (HUD) designation and is currently being studied in an Investigational Device Exemption (IDE) pilot study for the treatment of patients with complete (AIS A) traumatic acute spinal cord injury.
About InVivo Therapeutics
InVivo Therapeutics Holdings Corp. is a research and clinical-stage biomaterials and biotechnology company with a focus on treatment of spinal cord injuries. The company was founded in 2005 with proprietary technology co-invented by Robert Langer, Sc.D., Professor at Massachusetts Institute of Technology, and Joseph P. Vacanti, M.D., who then was at Boston Children’s Hospital and who now is affiliated with Massachusetts General Hospital. In 2011 the company earned the David S. Apple Award from the American Spinal Injury Association for its outstanding contribution to spinal cord injury medicine. The publicly-traded company is headquartered in Cambridge, MA. For more details, visit www.invivotherapeutics.com.
