NeuroOne Medical Technologies Corporation (NMTC), a medical technology company, Monday said its has received clearance from the U.S. Food and Drug Administration (FDA) to market its OneRF Trigeminal Nerve Ablation System.
The system is indicated for use in procedures to create radiofrequency lesions for the treatment of pain, or for lesioning nerve tissue for functional neurosurgical procedures.
The company targets a limited commercial launch in the fourth quarter of this year.
This clearance utilizes the company's proprietary OneRF Ablation System RF generator platform for the treatment of trigeminal neuralgia, a chronic facial pain condition that affects approximately 150,000 people annually in the United States.
"With this clearance, we will continue our ongoing discussions with strategic partners and have the potential to begin generating revenues from trigeminal nerve ablation as soon as late calendar year 2025," the company said in a statement.
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