InVivo Therapeutics Holdings Inc. (NASDAQ: NVIV) stock gains by 30.73% in the current market trading session. InVivo Therapeutics is a biomaterials and biotechnology company focused on the cure of spinal cord injuries in the research and clinical stages.
The US Food and Drug Administration (FDA) has approved InVivo Therapeutics’ preclinical module, which is one of three needed modules for NVIV’s humanitarian device exemption (HDE) application. The FDA has finished its assessment of this HDE module and has no major questions, indicating that the module has been accepted. Prior to making a final approval decision, the remaining two HDE modules will need to be reviewed.
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NVIV’s planned HDE modular shell submission and evaluation process for the Neuro-Spinal Scaffold implant was previously authorized by the FDA. The preclinical research module, the production module, and the clinical data module make up the HDE modular shell. The modular shell submission, according to NVIV, might result in more efficient FDA review processes and deadlines. The FDA evaluates each module on a rolling basis as part of the process.
The preclinical module is NVIV’s initial submission to the FDA for approval. The HDE will not be finalized until the manufacturing and clinical modules have been submitted.
The INSPIRE 2.0 study, a key trial of the Neuro-Spinal Scaffold, is now recruiting patients with acute spinal cord damage. INSPIRE 2.0 is a 20-patient, randomized, controlled experiment that aims to build on the NVIV’s INSPIRE 1.0 study’s clinical data for the Neuro-Spinal Scaffold.
Richard Toselli, President and Chief Executive Officer of InVivo commented that It is exciting to see their ongoing progress in advancing the Neuro-Spinal Scaffold toward their full HDE submission and that they welcome the FDA’s continued engagement with them to help them reach this objective.