US stock futures flounder amid tech weakness, Fed caution
NeuroOne Medical (TASE:BLWV) Technologies Corp. (NASDAQ:NMTC) announced Monday that it has received U.S. Food and Drug Administration 510(k) clearance to market its OneRF Trigeminal Nerve Ablation System. The system is intended for use in procedures that create radiofrequency lesions to treat pain or for lesioning nerve tissue during functional neurosurgical procedures. The announcement sparked investor interest, with the stock posting an 11% gain over the past week.
The company, based in Eden Prairie, Minnesota, stated that the clearance allows it to market the OneRF system for clinical use in the United States. The announcement was made in a press release filed with the Securities and Exchange Commission.
NeuroOne Medical Technologies is incorporated in Delaware and its common stock is listed on the Nasdaq Stock Market under the symbol NMTC.
The 510(k) clearance process is a regulatory pathway used by the FDA to review medical devices for safety and effectiveness before they are marketed in the U.S. According to the filing, the OneRF system is designed for use in procedures involving the trigeminal nerve, which is associated with facial sensation and pain.
The information in this article is based on a press release statement included in an SEC filing.
In other recent news, NeuroOne Medical Technologies reported its Q3 2025 earnings, surpassing revenue expectations with a total of $1.7 million, compared to the anticipated $1.55 million. The company’s earnings per share improved to -$0.03, beating the forecasted -$0.05. Additionally, NeuroOne received FDA clearance to market its OneRF Trigeminal Nerve Ablation System, which is designed to treat trigeminal neuralgia. This new system is set for a limited commercial launch in the fourth quarter of 2025.
In financial developments, NeuroOne has filed an updated prospectus for an at-the-market offering, allowing for the sale of up to $6.75 million of its common stock. This offering is facilitated through JonesTrading Institutional Services LLC under a Capital on Demand Sales Agreement. These recent developments highlight NeuroOne’s strategic efforts in both product innovation and capital raising.
This article was generated with the support of AI and reviewed by an editor. For more information see our T&C.