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NeuroOne Announces First in Human Ablations Completed With OneRF Ablation System

NeuroOne Announces First in Human Ablations Completed With OneRF Ablation System

NeuroOne宣布已完成使用OneRF消融系统的人体消融手术。
GlobeNewswire ·  06/25 09:00

Five ablations performed successfully in one patient

一个病人成功进行了五次消融治疗

Procedure performed at patient's bedside saving time and cost associated with the operating room

手术在病人床边进行,节省了在手术室进行手术所需的时间和成本

EDEN PRAIRIE, Minn., June 25, 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 at a prestigious hospital located in Jacksonville, Florida to successfully complete five ablations in one patient.

2024年6月25日,明尼苏达伊登普雷里(EDEN PRAIRIE)——神经一医疗技术公司,专注于改善神经系统疾病患者的手术治疗选择和治疗效果,今天宣布,著名医院位于佛罗里达州杰克逊维尔市的一台OneRF消融系统,近期成功地在一名病人身上完成了五次消融治疗。该病人患有多灶性癫痫,这种情况是指癫痫发作是由大脑多个区域引起的。在这个过程中,十个Evo sEEG电极分别放置在病人大脑的不同位置上。其中四个电极确定了引发癫痫的大脑存在问题的区域。使用温度控制安全功能在目标区域进行消融治疗,其中两次消融治疗在同一电极上的不同接触点进行。使用相同的电极,通过消融治疗后的sEEG记录,证实了消融治疗在组织消融点没有脑活动。手术在病人床边进行,节省了在手术室进行手术所需的时间和成本。

The patient was suffering from multifocal epilepsy, a condition whereby seizures are triggered from multiple areas of the brain. In this procedure, ten Evo sEEG electrodes, were placed in various locations of the patient's brain. Four electrodes identified problematic areas of the brain that were triggering seizures. Ablations were performed at the targeted areas using the temperature control safety feature, and two of these ablations occurred at different contacts on one electrode. Using the same electrodes, the successful ablations were confirmed by post ablation sEEG recordings demonstrating lack of brain activity at the point of tissue ablation. The procedure was performed at the patient's bedside saving both the time and cost of having to conduct the procedure in an operating room.

该病人患有多灶性癫痫,这种情况是指癫痫发作是由大脑多个区域引起的。十个Evo sEEG电极分别放置在病人大脑的不同位置上。其中四个电极确定了引发癫痫的大脑存在问题的区域。使用温度控制安全功能在目标区域进行消融治疗,其中两次消融治疗在同一电极上的不同接触点进行。使用相同的电极,通过消融治疗后的sEEG记录,证实了消融治疗在组织消融点没有脑活动。手术在病人床边进行,节省了在手术室进行手术所需的时间和成本。

"It was exciting for the Company to witness the first clinical ablations performed using the OneRF Ablation System. The ability to safely perform these procedures at the patient's bedside will reduce operating room time and cost, freeing up the operating room to conduct additional procedures," said Dave Rosa, CEO of NeuroOne. "We look forward to additional procedures utilizing the system with the goal of providing a safe therapy for patients to both monitor and ablate problematic brain tissue. In the future, the Company intends to leverage the OneRF generator with future FDA submissions for additional ablation applications."

“公司非常高兴目睹第一个使用OneRF消融系统进行临床消融治疗。在病人床边安全地进行这些手术的能力将减少手术室的时间和成本,为进行额外的手术提供了必要的空间,”NeuroOne的首席执行官Dave Rosa说道。“我们期待使用该系统进行更多的手术治疗,以提供安全的治疗方法,帮助患者监测和消融存在问题的大脑组织。在未来,公司打算利用OneRF发电机进行未来FDA提交的其他消融应用。”

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的第一款带有治疗指示的设备,也是其第三款获得FDA 510(k)的设备。NeuroOne现在拥有一整套用于诊断性脑电图映射程序的薄膜电极技术,以及使用相同sEEG电极进行RF消融。除了OneRF消融系统外,NeuroOne的其他FDA认证设备还包括Evo皮层和sEEG电极产品系列,主要用于在不到30天的时间内刺激,记录和监测大脑的电活动。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.NeuroOne将当前的脑消融市场估计为至少1亿美元,并正在迅速增长,具有多倍增长的潜力,可满足具有未满足临床需求的大量可寻址患者人群。

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 Medical Technologies Corporation是一家发展阶段公司,致力于为癫痫、帕金森病、肌张力障碍、根治椎间盘手术后慢性疼痛和其他相关神经系统疾病患者提供脑电记录、大脑刺激和消融解决方案,以改善患者预后并降低手术成本。该公司还可以将其应用于其他领域,如抑郁症、情绪障碍、疼痛、失禁、高血压和人工智能。有关更多信息,请访问。

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是一家开发阶段的公司,致力于为癫痫、帕金森病、肌张力障碍、特发性震颤、由于腰椎手术失败而导致的慢性疼痛和其他相关神经系统疾病患者提供最小侵入和高清晰度的EEG记录、脑刺激和消融解决方案,旨在改善患者疗效和降低手术成本。公司还可能在其他领域开展应用,如抑郁症、情感障碍、疼痛、失禁、高血压和人工智能。有关更多信息,请访问.

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. 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.

本新闻稿可能包含根据1933年修订版证券法第27A条和1934年修订版证券交易法第21E条拟议中的前瞻性声明。除了历史事实声明外,本新闻稿中包含的任何信息都可能是反映NeuroOne当前对未来事件的看法的前瞻性声明,这些声明可能会受到已知和未知的风险、不确定性和其他因素的影响,可能会导致我们的实际结果、活动水平、表现或成果与这些前瞻性声明所表达或暗示的信息有实质性差异。在某些情况下,您可以根据“可能”、“也许”、“将、”“可能”、“应该”、“预期”、“打算”、“计划”、“目标”、“预期、”“相信”、“估计”、“预测”、“项目”、“潜力”、“目标”、“寻找”、“考虑”、“继续”、“关注”、“致力于”和“持续等词或短语,以及旨在识别有关未来的陈述的其他可比术语。前瞻性声明可能包括关于进行其他程序的声明、未来FDA提交其他消融应用的潜力以及OneRF消融系统降低医院住院时间、减少手术次数或降低不良事件的能力、业务策略、市场规模以及未来经营等方面的声明。尽管NeuroOne认为我们为每个前瞻性声明都有合理的基础,但我们提醒您,这些声明是基于我们目前所知道的事实和因素的组合以及我们对未来的预期。与我们几乎无法控制的因素有关,我们实际的未来结果可能会与我们预期的结果有实质性的不同,包括由于风险使我们的技术无法按预期表现,基于我们的临床前和临床试验结果:与该公司实现业务目标所需的资本要求相关的风险以及筹集额外资金的能力;我们可能无法获得或保留我们的技术的充足的保险覆盖或适当的补偿;我们的技术开发过程中固有的不确定性的风险;与监管要求的变化或监管部门决定有关的风险;我们可能没有正确估计我们技术市场的规模和增长潜力的风险;基于我们拥有的一项或多项专利的顾虑;以及其他风险、不确定性和假设,包括我们在证券交易委员会备案的文件“风险因素”的标题下所描述的内容。这些前瞻性声明仅于本新闻稿之日发布,NeuroOne不承诺为了任何原因修订或更新任何前瞻性声明,即使未来出现新信息:

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

“注意:联邦法令规定本设备仅可应由医生订购。”

Contact:

联系方式:

800-631-4030
ir@nmtc1.com

800-631-4030
ir@nmtc1.com


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