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NeuroOne Announces Breakthrough Case Completed With OneRF Ablation System at the University Hospitals in Cleveland

NeuroOne Announces Breakthrough Case Completed With OneRF Ablation System at the University Hospitals in Cleveland

NeuroOne在克利夫兰大学医院成功完成了使用OneRF消融系统的突破性案例。
GlobeNewswire ·  09/10 09:00

Forty-four ablations performed successfully in one patient

在一名患者中成功进行了四十四次消融术

Patient currently reportedly seizure free with improvements in mood and memory

据报道,患者目前没有癫痫发作,情绪和记忆力有所改善

EDEN PRAIRIE, Minn., Sept. 10, 2024 (GLOBE NEWSWIRE) -- NeuroOne Medical Technologies Corporation (Nasdaq: NMTC) ("NeuroOne" or the "Company"), a medical technology company focused on improving surgical care options and outcomes for patients suffering from neurological disorders, today announced that the OneRF Ablation System was recently used in a breakthrough patient procedure at the University Hospitals in Cleveland to successfully complete forty four ablations in one patient.

明尼苏达州伊甸草原,2024年9月10日(GLOBE NEWSWIRE)——专注于改善神经系统疾病患者外科护理选择和预后的医疗技术公司NeuroOne医疗技术公司(纳斯达克股票代码:NMTC)(“NeuroOne” 或 “公司”)今天宣布,OneRF消融系统最近被用于克利夫兰大学医院的一项突破性患者手术,成功完成了四十四例ABL 一名患者的体内。

In mid-July, led by Dr. Michael Staudt, Neurosurgeon, a patient benefitted from forty-four ablations through six different implanted OneRF electrodes over a two-day period. These ablations were performed based on guidance provided by the sEEG recordings that confirmed the focal epileptic zone in the patient. The ablation sessions were performed at the patient's bedside and were well-tolerated by the patient. Immediate and short-term clinical evaluation suggests a positive outcome of the ablation procedure. At two months follow-up, the patient is seizure-free with self-reported improvements in mood and memory. Long term outcomes will be evaluated over time.

7月中旬,在神经外科医生迈克尔·施陶特博士的带领下,一名患者在两天内通过六种不同的植入式OneRF电极接受了44次消融手术。这些消融术是根据证实患者局灶性癫痫区的 seeG 记录提供的指导进行的。消融术是在患者床边进行的,患者耐受性良好。即时和短期临床评估表明,消融手术取得了积极的结果。在两个月的随访中,患者没有发作,自我报告的情绪和记忆力有所改善。长期结果将随着时间的推移进行评估。

Dr. Staudt commented "We are very pleased with how NeuroOne's OneRF system performed in this case, and we look forward to adopting this capability in our clinical practice. We think many patients could benefit from this technology in the near future."

Staudt博士评论说:“我们对NeuroOne的OneRF系统在这种情况下的表现感到非常满意,我们期待在临床实践中采用这种能力。我们认为,在不久的将来,许多患者可以从这项技术中受益。”

"We are extremely pleased that the OneRF system had a positive impact for the patient. This case was unique in that it far exceeded the range of ablations found in clinical literature. It was exciting to see the system safely perform forty-four ablations and yield a positive outcome to date. We appreciate Dr. Staudt and his staff's support during the case and look forward to future cases," said Dave Rosa, CEO of NeuroOne.

“我们对OneRF系统对患者产生积极影响感到非常高兴。该病例的独特之处在于它远远超过了临床文献中发现的消融范围。看到该系统安全地进行了四十四次消融手术,迄今为止取得了积极的结果,真是令人兴奋。我们感谢施陶特博士及其员工在案件审理期间的支持,并期待未来的病例。” NeuroOne首席执行官戴夫·罗莎说。

The OneRF Ablation System is NeuroOne's first device with a therapeutic indication and its third FDA 510(k)-cleared device. NeuroOne now boasts a full line of thin film electrode technology to address patients requiring diagnostic brain mapping procedures as well as RF ablation using the same sEEG electrode. In addition to the OneRF Ablation System, NeuroOne's other FDA-cleared devices include the Evo cortical and sEEG electrode product lines which are used primarily for stimulation, recording and monitoring of electrical activity in the brain for less than 30 days.

OneRF消融系统是NeuroOne首款具有治疗适应症的设备,也是其第三款获得美国食品药品管理局510(k)批准的设备。NeuroOne现在拥有全系列的薄膜电极技术,可满足需要诊断性大脑映射手术以及使用相同SeeG电极进行射频消融的患者的需求。除了OneRF消融系统外,NeuroOne的其他经美国食品药品管理局批准的设备还包括Evo皮质和seeG电极产品系列,这些产品主要用于刺激、记录和监测大脑中小于30天的电活动。

NeuroOne estimates the current brain ablation market to be at least $100M worldwide and growing rapidly, with the potential to grow multifold based on large addressable patient populations with unmet clinical needs.

NeuroOne估计,目前全球脑消融市场至少为1亿美元,并且增长迅速,基于临床需求未得到满足的大量可寻患者群体,有可能成倍增长。

About NeuroOne

关于 NeuroONE

NeuroOne Medical Technologies Corporation is a developmental stage company committed to providing 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. 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 .

NeuroOne Medical Technologies Corporation是一家处于发展阶段的公司,致力于为患有癫痫、帕金森氏病、肌张力障碍、特发性震颤、背部手术失败引起的慢性疼痛和其他相关神经系统疾病的患者提供微创和高清晰度的解决方案,这些解决方案可以改善患者预后并降低手术成本。该公司还可能寻求其他领域的申请,例如抑郁症、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。

Forward Looking Statements

前瞻性陈述

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. In some cases, you can identify forward–looking statements by the words or phrases "may," "might," "will," "could," "would," "should," "expect," "intend," "plan," "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. Forward–looking statements may include statements regarding additional procedures to be performed, the potential for future FDA submissions for additional ablation applications, and the ability of the OneRF Ablation System to reduce hospital stays, reduce the number of surgeries, or reduce adverse events, business strategy, market size, potential growth opportunities, and future operations. 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 of the future, about which we cannot be certain. Our actual future results may be materially different from what we expect due to factors largely outside our control, including risks that our partnerships may not facilitate the commercialization or market acceptance of our technology; whether due to supply chain disruptions, labor shortages, risks that our technology will not perform as expected based on results of our pre-clinical and clinical trials; risks related to uncertainties associated with the Company's capital requirements to achieve its business objectives and ability to raise additional funds: the risk that we may not be able to secure or retain coverage or adequate reimbursement for our technology; uncertainties inherent in the development process of our technology; risks related to changes in regulatory requirements or decisions of regulatory authorities; that we may not have accurately estimated the size and growth potential of the markets for our technology; risks related to our ability to protect our intellectual property rights; and other risks, uncertainties and assumptions, including those described under the heading "Risk Factors" in our filings with the Securities and Exchange Commission. These forward–looking statements speak only as of the date of this press release and NeuroOne undertakes no obligation to revise or update any forward–looking statements for any reason, even if new information becomes available in the future.

本新闻稿可能包括经修订的1933年《证券法》第27A条和经修订的1934年《证券交易法》第21E条所指的前瞻性陈述。除历史事实陈述外,本新闻稿中包含的任何信息都可能是前瞻性陈述,反映了NeuroOne当前对未来事件的看法,并且受已知和未知的风险、不确定性和其他因素的影响,这些因素可能导致我们的实际业绩、活动水平、业绩或成就与这些前瞻性陈述所表达或暗示的信息存在重大差异。在某些情况下,你可以通过以下词语或短语来识别前瞻性陈述:“可能”、“可能”、“会”、“应该”、“期望”、“打算”、“计划”、“目标”、“预测”、“估计”、“预测”、“项目”、“潜力”、“目标”、“寻求”、“考虑”、“考虑”、“考虑”、“继续、“专注”、“承诺” 和 “持续”,或这些术语的否定词,或旨在识别未来陈述的其他类似术语。前瞻性陈述可能包括有关将要进行的额外手术、FDA未来可能提交更多消融申请的陈述,以及OneRF消融系统减少住院时间、减少手术数量或减少不良事件的能力、业务战略、市场规模、潜在增长机会和未来运营的陈述。尽管NeuroOne认为我们的每项前瞻性陈述都有合理的依据,但我们提醒您,这些陈述是基于我们目前已知的事实和因素以及我们对未来的期望,我们无法确定这些事实和因素。由于我们无法控制的因素,我们的未来实际业绩可能与预期存在重大差异,包括我们的合作伙伴关系可能无法促进我们技术的商业化或市场接受度的风险;是否是由于供应链中断、劳动力短缺、根据临床前和临床试验结果我们的技术无法按预期运行的风险;与公司实现业务目标的资本要求和筹集额外资金的能力相关的不确定性相关的风险:我们可能无法获得或保留技术覆盖范围或充足补偿的风险;我们技术开发过程中固有的不确定性;与监管要求或监管机构决策变化相关的风险;我们可能无法准确估计我们技术市场的规模和增长潜力;与我们保护知识产权的能力相关的风险;以及其他风险、不确定性和假设,包括我们在申报中 “风险因素” 标题下描述的风险、不确定性和假设与证券交易委员会合作。这些前瞻性声明仅代表截至本新闻稿发布之日,即使将来有新的信息,NeuroOne也没有义务出于任何原因修改或更新任何前瞻性声明。

"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由医生出售或按医生的命令出售”

Contact:
800-631-4030
ir@nmtc1.com

联系人:
800-631-4030
ir@nmtc1.com


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