Invivo Therapeutics Holdings Corp (OTCMKTS:NVIV) updated that it added UC Davis Medical Center located in Sacramento as one of the clinical sites for its underway IDE pilot trial of Neuro-Spinal Scaffold in patients suffering with acute spinal cord injury. The center serves a massive 65,000 square-mile territory that covers 33 nations and 6 million residents across central and northern California.
The new center
Mark Perrin, the CEO and Chairman commented that Invivo management is delighted with the newest addition to ongoing clinical trial of lead product Neuro-Spinal Scaffold. There are now total ten clinical trial sites open to register the remaining three subjects in the pilot trial. The company registered its first patient in last October at the Barrow Neurological Institute. In January, it enrolled its second patient in the pilot study at Carolinas Medical Center.
The trial
Invivo Therapeutics Holdings Corp (OTCMKTS:NVIV) said that it is the first clinical study of its lead product that is Neuro-Spinal Scaffold. The key study has been officially accepted by the U.S. Food and Drug Administration and is intended to evaluate preliminary safety and effectiveness findings of the Neuro-Spinal Scaffold in total five enrollments with acute thoracic spinal cord injury. The company then expects to start a pivotal study to get FDA approval to start with commercialization process under a Humanitarian Device Exemption.
The product
Following an acute SCI, the Neuro-Spinal Scaffold is surgically fixed at the epicenter of the injury and serves as a physical substrate for nerve development. Appositional cure to spare spinal cord tissue, and lower spinal cord tissue pressure and reduced post-traumatic cyst formation have been noticed in preclinical system of spinal cord contusion injury. Invivo’s Neuro-Spinal Scaffold is an investigational and biodegradable device that has secured a Humanitarian Use Device status and is currently being assessed in a pilot study for the cure of acute spinal cord injury.
