FDA Denies Approval For NeuroOne Medical's Evo sEEG Electrode For Extended Use

  • The FDA has reviewed NeuroOne Medical Technologies Corporation's NMTC appeal for 510(k) clearance for its Evo sEEG Electrode for less than 30-day use. 
  • In a letter to the company, the FDA stated that they upheld their decision that the device is not substantially equivalent for extended use based on their analysis of the methodology used for exhaustive extraction testing.
  • The FDA also stated that NeuroOne Medical might submit a new 510(k) with new evidence related to the subacute toxicity endpoint to support a finding of substantial equivalence.  
  • The company is collecting the required 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 company expects to resubmit the application to the FDA in August 2022.
  • "In addition, the company will immediately explore the opportunity to market the device through Zimmer Biomet Holdings Inc ZBH for intraoperative use to gain product clinical experience while we progress with the re-submission to the FDA," said Dave Rosa, CEO.
  • In September 2021, the company received FDA clearance to market the Evo sEEG Electrode for temporary (less than 24 hours) use with equipment for the recording, monitoring, and stimulation of electrical signals at the subsurface level of the brain.
  • Price Action: NMTC shares are down 3.81% at $0.56 during the market session on the last check Tuesday.

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