NeuroOne (Nasdaq:NMTC) CEO Dave Rosa today issued a letter to shareholders outlining the company’s exposure to tariff impact. Tariffs recently announced by the Trump Administration — then paused last week for at least 90 days — have created a stir in the industry. Medtech trade group AdvaMed praised the decision to suspend the tariffs earlier this week, […]
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NeuroOne prices $8M offering
NeuroOne (Nasdaq:NMTC) announced today that it priced an underwritten registered public offering of common stock worth $8 million. The Eden Prairie, Minnesota–based company priced 16 million shares of common stock at 50¢ apiece in the offering. It intends to sell all shares of common stock sold in the offering. The company also granted the underwriter […]
NeuroOne accelerates FDA submission timeline for nerve ablation tech
NeuroOne (Nasdaq:NMTC) announced today that it accelerated the anticipated timeline of the FDA submission for its nerve ablation tech. Eden Prairie, Minnesota–based NeuroOne now expects to submit the trigeminal nerve ablation for FDA 510(k) clearance in May. It previously projected a submission by the end of June. Trigeminal nerve ablation, a minimally invasive procedure, uses […]
NeuroOne expands distro deal with Zimmer Biomet to commercialize neuroablation tech
NeuroOne (Nasdaq:NMTC) announced today that it executed an amendment to its existing distribution agreement with Zimmer Biomet (NYSE:ZBH). The amendment provides Zimmer Biomet with exclusive rights to distribute NeuroOne’s OneRF ablation system for use in the brain. It provides NeuroOne with an upfront payment of $3 million and the potential to earn another milestone payment […]
NeuroOne touts breakthrough case with neuroablation system
NeuroOne Medical Technologies (Nasdaq:NMTC) today announced a breakthrough patient procedure using its OneRF ablation system. The OneRF system picked up FDA 510(k) clearance in December 2023 for the creation of radiofrequency (RF) lesions in nervous tissue for functional neurosurgical procedures. This technology uses already-implanted sEEG electrodes to record brain activity and enable the ablation of […]
NeuroOne signs distro deal for neuroablation system, brings in more than $5M
NeuroOne Medical Technologies (Nasdaq:NMTC) announced today that it signed a distribution deal for its OneRF ablation system. The Eden Prairie, Minnesota-based company signed a non-binding term sheet with an undisclosed global medical technology company. The partnership remains subject to the negotiation and execution of definitive documentation, due diligence and other closing conditions. NeuroOne’s latest partnership […]
NeuroOne completes first-in-human neuroablation procedures
NeuroOne Medical Technologies (Nasdaq:NMTC) announced the first human uses of its OneRF neuroablation system in Florida. Surgeons at a hospital in Jacksonville, Florida, successfully completed five ablations in one patient suffering from multifocal epilepsy. In the procedure, surgeons placed 10 Evo sEEG electrodes in various locations of the patient’s brain. Four electrodes identified problematic areas […]
NeuroOne implants first OneRF ablation electrode
NeuroOne Medical Technologies (Nasdaq:NMTC) today announced the first implant of its OneRF Ablation electrode. The OneRF Ablation system is FDA 510(k) cleared to create radiofrequency nervous tissue lesions for functional neurosurgical procedures. The electrodes are a thin-film, sEEG-guided RF system that records the electrical activity and ablates nervous tissue with the added benefit of temperature control. […]
NeuroOne begins neuroablation system launch in U.S.
NeuroOne Medical Technologies (Nasdaq:NMTC) announced today that it initiated a limited commercial launch for its OneRF ablation system. The Eden Prairie, Minnesota–based company said its initial rollout comes earlier than it previously expected. It picked up FDA 510(k) clearance for the OneRF system just over three months ago in December 2023. Indications cover the creation […]
NeuroOne stock is down on Q4 revenue misses
NeuroOne Medical Technologies (Nasdaq:NMTC) shares took a hit today on fourth-quarter results that fell shy of the consensus sales forecast. Shares of NMTC fell 8.2% at $1.58 apiece in mid-morning trading today. MassDevice’s MedTech 100 Index — which includes stocks of the world’s largest medical device companies — dipped 0.2%. The Eden Prairie, Minnesota-based company […]
FDA clears neuro ablation tech from NeuroOne
NeuroOne Medical Technologies (Nasdaq:NMTC) announced today that the FDA granted 510(k) clearance to its OneRF ablation system. Clearance makes OneRF the first FDA-cleared, thin-film, sEEG-guided radiofrequency (RF) system capable of recording electrical activity and ablating nervous tissue. The system, which also features temperature control, became the third FDA-cleared device at NeuroOne. It’s the first therapeutic […]
