InVivo Therapeutics Holdings Corp has received supplemental Investigational Device Exemption (IDE) approval from the US Food and Drug Administration (FDA) for a second clinical study of the company’s Neuro-Spinal Scaffold in patients with acute spinal cord injury (SCI).
The 20-patient (10 subjects in each study arm), randomized, controlled trial is designed to enhance the existing clinical evidence for the Neuro-Spinal Scaffold from the company’s single-arm INSPIRE study (InVivo Study of Probable Benefit of the Neuro-Spinal Scaffold for Safety and Neurologic Recovery in Subjects with Complete Thoracic AIS A Spinal Cord Injury).
For the study to be considered successful, the difference in the proportion of subjects who demonstrate an improvement of at least one grade on AIS assessment at the 6-month primary endpoint follow-up visit between the Scaffold Arm and the Comparator Arm must be equal to or greater than 20%, InVivo notes in a media release.
“We are pleased to announce the FDA’s approval of this randomized, controlled trial and appreciate the agency’s collaboration with us on the development of a protocol to address the substantial unmet needs in this patient population,” says Richard Toselli, MD, president and chief executive officer of InVivo, in the release.
“We believe this now sets us in a direction towards a clear and efficient path to approval under the HDE regulatory program, and we are focused on engaging with the investment community and exploring financing mechanisms to support this approved randomized study. We look forward to providing further updates as we obtain clarity on financing and the timing for our second pivotal trial,” he adds.
[Source(s): InVivo Therapeutics Holdings Corp, Business Wire]