InVivo submits 1st HDE module for neuro-spinal scaffold

InVivo Therapeutics (NSDQ:NVIV) said today it submitted its 1st nonclinical study model to the FDA as part of its humanitarian device exemption submission for its neuro-spinal scaffold.

The neuro-spinal scaffold is designed to be surgically implanted following acute spinal cord injuries to act as a physical substrate for nerve sprouting, the Cambridge, Mass.-based company said.

The submission is the 1st of 3 modules it must present to the FDA as it seeks HDE approval for the device.

“The submission of our nonclinical studies module marks the accomplishment of another major milestone for the Inspire Study. We expect to receive acceptance of the nonclinical module in the third quarter of this year, and plan to submit the manufacturing module in the second half of 2017 and the clinical module in 2018, all as part of our strategy to pursue accelerated approval for the neuro-spinal scaffold,” CEO Mark Perrin said in a press release.

Yesterday, InVivo said it enrolled a new patient in the Inspire study of its neuro-spinal scaffold, bringing the total number treated up to 13. The procedure was performed at Camden, N.J.’s Cooper Neurological Institute in New Jersey by site principal investigator Dr. Steven Yocom.

Earlier this month, InVivo Therapeutics saw shares rise slightly after the medical device developer posted 4th quarter and full year 2016 earnings that mostly fell in line with consensus on Wall Street.

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