InVivo Therapeutics Holdings Corp (NVIVQ)

[DDobserver]

From Form K10 3-7-2017

Pilot Study in Acute, Cervical SCI

In addition to the thoracic pivotal study described above, we are in active discussions with Health Canada to initiate an early feasibility human pilot study, as the initial phase of a larger pivotal study, of our Neuro-Spinal Scaffold under an Investigational Testing Authorization application (“ITA”) for the treatment of complete, traumatic cervical acute SCI. We expect that the pilot study will be approved and initiated in the first half of 2017.

Although we desire to support a similar cervical study in the United States, the FDA has notified us that our proposed study was disapproved in the United States, pending submission of additional data from The INSPIRE Study. We remain in discussions with the FDA regarding such disapproval and are hopeful that data generated in The INSPIRE Study will support moving into cervical SCI in the United States.