Invivo Therapeutics Holdings Corp (OTCMKTS:NVIV) announced that it added Froedtert & The MCW of Wisconsin as clinical sites in its IDE pilot study for Neuro-Spinal Scaffold. The study includes those patients that are suffering from acute spinal cord injury. Froedtert Hospital supports the only adult Level one trauma center in Wisconsin. The hospital gets several referred patients suffering from spinal cord injury from northern Illinois, northern Michigan, and Wisconsin. Shekar Kurpad, MD, Ph.D. and also a neurosurgery Professor at MCW will act as Principal Investigator at the site. Dr. Kurpad said that he is delighted to a member of the innovative and first-of-its-kind study.
Invivo enrolled its second patient in Neuro-Spinal Scaffold trial at its clinical site on January 22, 2015. The patient was enrolled at Carolinas Medical Center in Charlotte, NC. The first patient in the study was enrolled in last October at the Barrow Neurological Institute at Medical Center in Phoenix and St. Joseph’s Hospital.
The management view
Mark Perrin, the Chief Executive Officer of Invivo, commented that the company, management, and team is encouraged as MCW becomes a clinical site in the pilot study. It is a matter of product to have Dr. Kurpad as Principal Investigator at MCW clinical site. He has extensive experience and expertise in research related to spinal cord injury. Also, he was the recipient of the esteemed Van Wagenen Fellowship. It is given by the ‘American Association of Neurological Surgeons.’ After the addition of MCW, Invivo Therapeutics now has total seven clinical sites. All of them will enroll patients for Neuro-Spinal Scaffold study.
The IDE pilot study is the first clinical trial of Invivo of Neuro-Spinal Scaffold. The trial has been approved by the U.S. FDA and is intended to gather initial effectiveness and safety data of the Neuro-Spinal Scaffold. It will be first assessed in five subjects suffering from acute thoracic spinal cord injury.