NeuroOne’s Bid for Long-term Use of Evo sEEG Shot Down by FDA

NeuroOne Medical Technologies faced a huge blow from FDA regarding its Evo sEEG Electrode this past week.

The agency said it was upholding its decision that the device is not substantially equivalent for extended use based on its analysis of the methodology used for exhaustive extraction testing.

The Eden Prairie, MN-based company’s Evo sEEG Electrode is cleared for less than 24-hour use. NeuroOne was vying for a maximum of 30-day use in the now-rejected clearance. Evo sEEG Electrode is cleared for use with equipment for the recording, monitoring, and stimulation of electrical signals at the subsurface level of the brain.

FDA said the company could submit a new 510(k) with new evidence, specifically as it relates to the subacute toxicity endpoint, to support a finding of substantial equivalence. 

NeuroOne said it is in the process of collecting the data and intends to submit a Special 510(k) which according to FDA guidance is processed within 30 days of receipt, rather than the 90 days for a traditional 510(k). The firm said it expects to resubmit the application to FDA in August.

"While the appeal decision is disappointing, we remain optimistic that the current product design and materials will successfully demonstrate substantial equivalence at the conclusion on the ongoing subacute toxicity test," said Dave Rosa, CEO of NeuroOne.  "Once completed, we intend to submit the new test data results to the FDA while referencing the previous 510(k) submission. In addition, the company will immediately explore the opportunity to market the device through Zimmer Biomet for intraoperative use to gain product clinical experience while we progress with the re-submission to FDA."