The modular HDE review process is based on individual sections that constitute a complete HDE submission when all have been submitted, and allows for separate review and more timely feedback to aid in resolving potential deficiencies earlier on in the review process.
“InVivo’s regulatory approach centers on efficiency and swiftness to market. We expect to submit and receive acceptance of the preclinical module by the end of this year and plan to submit the manufacturing and clinical modules in 2017,” CEO Mark Perrin said in a press release.
InVivo said its HDE modular shell for the Neuro-Spinal Scaffold is composed of 3 modules, including a preclinical study module, manufacturing module and clinical data module. The submission of the final module triggers a 75-day HDE review clock, the company said.
Yesterday, InVivo said the FDA approved a protocol amendment for its Inspire study examining the benefit of its Neuro-Spinal Scaffold for treating patients with complete thoracic AIS A spinal cord injuries, establishing objective performance criterion for the trial.
The newly set OPC for the trial is defined as 25% more of the patients in the study demonstrating an improvement of at least one ASIA Impairment Scale grade at 6 months after implantation, the Cambridge, Mass.-based company said. An OPC is a measure used in clinical studies designed to demonstrate safety and benefit to support a Humanitarian Device Exemption.
The Inspire study is slated to enroll 20 patients with complete AIS A spinal cord injuries, and will require 5 patients enrolled in the trial to convert to another AIS grade by 6-months to reach the OPC.