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. […]
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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 […]
NeuroOne is pursuing drug delivery with neural probes
NeuroOne Medical Technologies (Nasdaq:NMTC) announced today that it received a patent for drug delivery with neural probe devices. The United States Patent and Trademark Office (USPTO) issued the patent titled “Agent-Delivering Neural Probe Devices and Related Systems and Methods.” It covers novel electrodes that can operate as a standard neural electrode that delivers a treatment […]
NeuroOne picks former Cardiovascular Systems VP as new COO
NeuroOne Medical Technologies (Nasdaq:NMTC) announced that it appointed Christopher R. Volker as its chief operating officer (COO). Volker joins the Eden Prairie, Minnesota-based neurotech company from Abbott. He previously served as VP and GM of international at Cardiovascular Systems (CSI), which Abbott acquired earlier this year. “Chris’ appointment further strengthens our executive leadership team and […]
NeuroOne expects FDA nod for neuro ablation tech next year
NeuroOne (Nasdaq:NMTC) announced today that it responded to FDA questions regarding the 510(k) submission of its OneRF ablation system. Eden Prairie, Minnesota–based NeuroOne submitted OneRF for FDA clearance in June. It’s the company’s first therapeutic device. The technology uses already-implanted sEEG electrodes to record brain activity and enable the ablation of nervous tissue. It connects […]
NeuroOne prices $5.25M public offering
NeuroOne Medical Technologies (Nasdaq:NMTC) announced today that it priced an underwritten registered public offering. Eden Prairie, Minnesota-based NeuroOne’s offering includes 5.25 million shares of common stock priced at $1 per share. All shares included in the offering will be sold by the company. NeuroOne also granted the underwriter a 30-day option to purchase up to […]
NeuroOne submits RF ablation system for FDA 510(k) clearance
NeuroOne Medical Technologies (Nasdaq:NMTC) announced today that it submitted an FDA 510(k) application for its OneRF ablation system. This technology uses already-implanted sEEG electrodes to record brain activity and enable the ablation of nervous tissue. It connects to a proprietary radiofrequency (RF) generator. NeuroOne’s electrodes provide a similar function at the subsurface level of the […]
First clinical case performed with NeuroOne Evo sEEG, Zimmer Biomet Rosa One Brain
NeuroOne Medical Technologies (Nasdaq:NMTC) today announced the first clinical case performed with its Evo sEEG in robotic neurosurgery. Dr. William Bingaman performed the procedure with the electrode — exclusively marketed by Zimmer Biomet — at Cleveland Clinic. It marks the first procedure to utilize NeuroOne’s Evo sEEG with Zimmer Biomet’s Rosa One Brain. The Rosa […]
NeuroOne launches Evo sEEG electrodes in the U.S.
NeuroOne Medical Technologies (Nasdaq:NMTC) announced today that it commercially launched its Evo sEEG electrode line in the U.S. Zimmer Biomet holds exclusive worldwide distribution rights to the Evo Cortical and sEEG product lines. NeuroOne expects the line to utilize Zimmer Biomet’s Rosa One Brain robotic surgery platform for neurosurgical procedures. Zimmer paid $3.5 million to […]