NeuroOne Medical Technologies Corporationa medical technology company focused on improving surgical care options and outcomes for patients suffering from neurological disorders, has filed its 510(k) submission to the FDA for trigeminal nerve ablation earlier than previous guidance.

NeuroOne医疗技术公司是一家专注于改善神经系统疾病患者手术治疗选择和结果的医疗技术公司，该公司已向FDA提交了关于三叉神经消融的510(k)申请，比之前的指导时间提前。

This submission leverages the Company’s proprietary OneRF® Ablation System RF generator platform for the treatment of trigeminal neuralgia, a chronic pain condition affecting approximately 100,000 people in the U.S.1. The trigeminal nerve is the main sensory nerve in the face associated with triggering excruciating pain for this condition.

该提交文件利用了公司专有的OneRF®消融系统射频发生器平台，用于治疗三叉神经痛，这是一种影响美国约10万人的慢性疼痛疾病。三叉神经是面部主要的感觉神经，与引发该疾病的剧烈疼痛有关。

Trigeminal neuralgia is typically treated with medication or invasive procedures, including microvascular decompression (MCD), radiosurgery, or other percutaneous techniques. The OneRF® Trigeminal Nerve Ablation technology features a minimally invasive surgical procedure that uses radiofrequency (RF) energy to destroy abnormal tissue to relieve severe, chronic pain in the face.

三叉神经痛通常通过药物或侵入性手术治疗，包括微血管减压术 (MCD)、放射外科手术或其他经皮技术。OneRF® 三叉神经消融技术采用微创手术，利用射频 (RF) 能量破坏异常组织，以缓解面部严重的慢性疼痛。

Differentiated features of this multi-contact probe are designed to use multi-point mapping of pain location, stimulation and ablation, all using the same electrode and with the safety of temperature-controlled ablation. These features are also present in the FDA 510(k) cleared OneRF sEEG (brain) Ablation System.

该多触点探头的差异化特点设计用于使用同一种电极进行疼痛位置、刺激和消融的多点映射，并且具备温度控制消融的安全性。这些特点也存在于FDA 510(k)认证的OneRF sEEG（大脑）消融系统中。

This system may allow for reduced procedural time, improved patient comfort and improved patient safety..

该系统可以缩短手术时间、提高患者舒适度和安全性。

Previously published data have shown that RF ablation offers high initial pain relief rates (~95%) and long-term efficacy, especially with repeat treatments, while maintaining a low complication rate2,3, These characteristics make it a preferred option for patients who are not candidates for major surgery or who are looking for less invasive approaches4..

先前发布的数据显示，射频消融术具有很高的初期疼痛缓解率（约95%）和长期疗效，尤其是通过重复治疗后，并且并发症发生率较低。这些特点使其成为不适合接受大型手术或寻求较少侵入性治疗的患者的首选方案。

Dave Rosa, President and CEO of NeuroOne, stated: “Our OneRF® ablation technology platform has already achieved successful commercialization and patient outcomes in lesioning nerve tissue for functional neurosurgical procedures, such as the treatment of epilepsy. Expanding into facial pain broadens the clinical impact of our technology and further validates the versatility and scalability of our platform.”.

NeuroOne的总裁兼首席执行官戴夫·罗莎表示：“我们的OneRF®消融技术平台已经在功能性神经外科手术（如癫痫治疗）中成功实现了商业化并取得了良好的患者疗效。将应用范围扩展到面部疼痛，不仅扩大了我们技术的临床影响力，也进一步验证了我们平台的多功能性和可扩展性。”

“If cleared by the FDA, we believe there is a potential to generate revenues from trigeminal nerve ablation in late calendar year 2025.”

“如果获得 FDA 批准，我们相信在 2025 年底有可能从三叉神经消融术中产生收入。”

NeuroOne’s OneRF® ablation technology has garnered significant media interest, including recent features on Fox News and Good Morning America. For more interviews and information on the company, please visit www.nmtc1.com.

NeuroOne的OneRF®消融技术引起了媒体的广泛关注，包括最近在福克斯新闻和早安美国的专题报道。如需更多关于该公司的采访和信息，请访问www.nmtc1.com。

About NeuroOne

关于NeuroOne

NeuroOne Medical Technologies Corporation (Nasdaq: NMTC) is developing and commercializing minimally invasive and hi-definition solutions for EEG recording, brain stimulation and ablation solutions for patients suffering from epilepsy, Parkinson’s disease, dystonia, essential tremors, chronic pain due to failed back surgeries and other related neurological disorders that may improve patient outcomes and reduce procedural costs.

NeuroOne医疗技术公司（纳斯达克股票代码：NMTC）正在开发和商业化用于癫痫、帕金森病、肌张力障碍、原发性震颤、因背部手术失败导致的慢性疼痛及其他相关神经疾病的微创和高清晰度脑电图记录、大脑刺激及消融解决方案，这些方案可能会改善患者的治疗效果并降低手术成本。

The Company may also pursue applications for other areas such as depression, mood disorders, pain, incontinence, high blood pressure, and artificial intelligence. For more information, visit nmtc1.com..

公司还可以寻求其他领域的应用，如抑郁症、情绪障碍、疼痛、尿失禁、高血压和人工智能。欲了解更多信息，请访问 nmtc1.com。

Forward Looking Statements

前瞻性声明

This press release may include forward-looking statements within the meaning of Section 27A of the Securities Act of 1933, as amended, and Section 21E of the Securities Exchange Act of 1934, as amended. Except for statements of historical fact, any information contained in this press release may be a forward–looking statement that reflects NeuroOne’s current views about future events and are subject to known and unknown risks, uncertainties and other factors that may cause our actual results, levels of activity, performance or achievements to be materially different from the information expressed or implied by these forward-looking statements.

本新闻稿可能包含1933年《证券法》第27A条（经修订）和1934年《证券交易法》第21E条（经修订）所指的前瞻性陈述。除历史事实陈述外，本新闻稿中包含的任何信息可能为前瞻性陈述，反映了NeuroOne对未来的当前看法，事件受已知和未知的风险、不确定性以及其他因素的影响，可能导致我们的实际结果、活动水平、表现或成就与这些前瞻性陈述明示或暗示的信息有重大差异。

In some cases, you can identify forward–looking statements by the words or phrases “may,” “might,” “will,” “could,” “would,” “should,” “expect,” “intend,” “plan,” “forecasts,” “objective,” “anticipate,” “believe,” “estimate,” “predict,” “project,” “potential,” “target,” “seek,” “contemplate,” “continue, “focused on,” “committed to” and “ongoing,” or the negative of these terms, or other comparable terminology intended to identify statements about the future.

在某些情况下，你可以通过“可能”、“也许”、“将”、“能够”、“会”、“应该”、“预期”、“打算”、“计划”、“预测”、“目标”、“预期”、“相信”、“估计”、“预计”、“项目”、“潜力”、“目标”、“寻求”、“考虑”、“继续”、“专注于”、“致力于”和“持续进行”等词语或短语，或者这些术语的否定形式，或者其他用于识别未来陈述的类似措辞来辨别前瞻性陈述。

Forward–looking statements may include statements regarding the potential to receive 510(k) clearance for our trigeminal nerve ablation system, the potential to receive revenue from the commercialization of our trigeminal nerve ablation program in 2025 or at all, our business strategy, market size, potential growth opportunities, future operations, future efficiencies, and other financial and operating information.

前瞻性声明可能包括关于我们三叉神经消融系统获得510(k)许可的潜力、2025年或任何时候通过三叉神经消融项目商业化获得收入的潜力、我们的业务战略、市场规模、潜在增长机会、未来运营、未来效率以及其他财务和运营信息的声明。

Although NeuroOne believes that we have a reasonable basis for each forward-looking statement, we caution you that these statements are based on a combination of facts and factors currently known by us and our expectations for the future, about which we cannot be ce.

虽然NeuroOne认为我们对每项前瞻性声明都有合理的依据，但我们提醒您，这些声明是基于我们目前所知的事实和因素以及我们对未来的期望，而这些期望我们无法确定。

Caution: Federal law restricts this device to sale by or on the order of a physician.

注意：联邦法律限制此设备仅可通过医生或医生处方销售。

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电子邮件地址

Source: globenewswire.com

来源：globenewswire.com