NeuroOne Medical Technologies has announced the submission of a special 510(k) to the US Food and Drug Administration (FDA) for its stereoelectroencephalography (sEEG) electrode to extend the duration of use from less than 24 hours to less than 30 days.
A special 510(k), according to FDA guidance, is usually reviewed within 30 days of receipt, rather than the 90 days for a traditional 510(k), a NeuroOne press release details.
Dave Rosa, CEO of NeuroOne, said: “Our employees and contractors worked exceptionally hard to expedite the testing and resubmission of our sEEG electrode 510(k) application ahead of our timeline. We are excited with the results provided by an accredited independent test facility and look forward to continuing the dialogue with FDA regarding this submission to reach a successful conclusion.”
On 16 May, NeuroOne issued a press release stating the FDA’s decision to uphold the not substantially equivalent decision after the company had appealed the ruling. The FDA also informed NeuroOne it could submit a new 510(k) with new evidence specifically as it relates to the subacute toxicity biocompatibility endpoint, the release notes.
Earlier this month, NeuroOne also announced that it had entered into an amendment to its exclusive development and distribution agreement with Zimmer Biomet, which it claims will provide the company with a US$3.5 million accelerated payment within 10 business days that relates to certain milestone payments.
In addition, Zimmer will receive a warrant to purchase 350,000 shares of NeuroOne’s common stock, with an exercise price of US$3.00 per share. Under the exclusive development and distribution agreement signed by both parties in July 2020, Zimmer has exclusive global distribution rights to distribute the company’s Cortical and sEEG diagnostic electrode technology too.