NeuroOne Medical Technologies Corp. (NMTC), Tuesday announced that it has accelerated the timeline for its 510(k) submission to the FDA for the OneRFTrigeminal Nerve Ablation System.
The submission, which was previously expected by the end of June 2025, is now anticipated in May 2025.
This system leverages NeuroOne's patented OneRF Technology Platform and aims to treat severe facial pain caused by trigeminal neuralgia through a minimally invasive procedure using radiofrequency or RF energy.
If approved by the FDA, the company expects to begin generating revenue from the device in late 2025, ahead of its previous forecast.
"By advancing our timeline, we're excited about the potential to bring this new technology to market sooner," said Dave Rosa, President and CEO of NeuroOne.
She further added, "This marks the second radiofrequency ablation technology in our portfolio using the OneRF platform, and we are exploring additional applications as we continue to grow our portfolio."
This submission highlights NeuroOne's commitment to developing advanced medical solutions for neurological disorders and further strengthens the company's position in the medical technology field.
Currently, NMTC is trading at $0.88, down by 2.07 percent on the Nasdaq.
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