Invivo Therapeutics Holdings Corp (OTCMKTS:NVIV) announced the addition of Keck Hospital of University of Southern California to the list of clinical centers for the trial of Neuro-Spinal Scaffold. The company has already enrolled two patients and is hoping to enroll three more in the near future. Invivo’s CEO, Mark Perrin, praised the collaboration with Keck Hospital of USC, citing the extensive experience of the lead investigator at the site known as Patrick Hsieh.
Some five subjects are expected to be enrolled in Invivo Therapeutics Holdings Corp (OTCMKTS:NVIV)’s ongoing Neuro-Spinal Scaffold trial. The study is targeting patients with acute spinal cord injury (SCI). The first patient in the study was enrolled at the Barrow Neurological Institute at St. Joseph’s Hospital and Medical Center, Phoenix, AZ last October. The second patient was enlisted at the Carolinas Medical Center in Charlotte, NC.
Invivo Therapeutics Holdings Corp (OTCMKTS:NVIV) disclosed that Hsieh will be the principal investigator at the new clinical site at Keck Hospital of USC. Hsieh is an Associate Professor of Neurological Surgery and Director of Neurosurgery Spine Program. Invivo’s CEO termed both Keck Hospital of USC and Hsieh’s experience as key assets in pushing forward their study of Neuro-Spinal Scaffold.
According to Perrin, Invivo Therapeutics Holdings Corp (OTCMKTS:NVIV) looks forward to enrolling more patients in the coming days in the pilot study of Neuro-Spinal Scaffold.
Pilot and pivotal studies
The ongoing study of Neuro-Spinal Scaffold seeks to obtain preliminary efficacy and safety data in some five patients. Invivo will be able to conduct what it has termed as pivotal study of Neuro-Spinal Scaffold after it concludes the current pilot project. The pivotal study is expected to help the company file for FDA approval for commercialization of Neuro-Spinal Scaffold under what is known as Humanitarian Device Exemption (HDE).
A look at Invivo’s most recent financial report shows that the company has $13.45 million of cash, $14.95 million of current assets with total assets coming up at $16.69 million. The company’s total liabilities were $10.77 million for the year ended December 31, 2014. Invivo had a net loss of $18.34 million for the year and there was no revenue.