NeuroOne Medical Technologies Corporation (“NeuroOne” or the “Company”), a medical technology company focused on improving surgical care options and outcomes for patients suffering from neurological disorders, today announces that the U.S. Food and Drug Administration (the “FDA”) has completed its review of the Company’s appeal for 510(k) clearance for its Evo® sEEG Electrode for less than 30-day use. In a letter to the Company dated May 13, 2022, the FDA stated that they were upholding 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 the Company may submit a new 510(k) with new evidence, specifically as it relates to the subacute toxicity endpoint, to support a finding of substantial equivalence. The Company is in the process of collecting such 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.
“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, Chief Executive Officer 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 the FDA.”
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.
NeuroOne Medical Technologies Corporation is a developmental stage company committed to providing minimally invasive and hi-definition solutions for EEG recording, brain stimulation and ablation solutions for patients suffering from epilepsy, Parkinson’s disease, dystonia, essential tremors, chronic pain due to failed back surgeries and other related neurological disorders that may improve patient outcomes and reduce procedural costs