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ICD-10-PCS code for first to market, FDA-cleared thin-film, sEEG-guided RF ablation system effective October 1, 2024
ICD-10-PCS代码首次上市,FDA批准的薄膜sEEG引导射频消融系统于2024年10月1日生效
Specific procedure code positions OneRF™ Ablation System for broader adoption and awareness throughout the healthcare system
特定的程序代码定位OneRF™消融系统,以便在整个医疗保健系统中得到更广泛的采用和认可
EDEN PRAIRIE, Minn., June 20, 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 Centers for Medicare and Medicaid Services (CMS) has approved and granted a new ICD-10-PCS (International Classification of Diseases, 10th Revision, Procedure Coding System) code for the OneRF™ Ablation procedure.
明尼苏达州伊甸园大草原,2024年6月20日(环球通讯社)--NeuroOne医疗技术公司(纳斯达克:NMTC)(“NeuroOne”或“公司”),一家专注于改善患有神经系统疾病的患者的手术护理选择和结果的医疗技术公司,今天宣布,医疗保险和医疗补助服务中心(CMS)已批准并授予OneRF™消融程序的新ICD-10-PCS(国际疾病分类,第10版,程序编码系统)代码。
The new code is 00503Z4 Destruction of Brain Using Stereoelectroencephalographic Radiofrequency Ablation, Percutaneous Approach. This code allows hospital reporting of inpatient procedures that are performed using the OneRF™ Ablation system, which has FDA 510(k) clearance for creation of radiofrequency (“RF”) lesions in nervous tissue for functional neurosurgical procedures.
新代码是00503Z4使用立体脑电图射频消融,经皮途径破坏大脑。该代码允许医院报告使用OneRF™消融系统进行的住院手术,该系统具有FDA 510(k)许可,可在神经组织中产生射频(“RF”)病变,用于功能性神经外科手术。
ICD-10-PCS codes play a critical role in the healthcare system, ensuring efficient and accurate documentation, billing, and analysis. The code goes into effect beginning October 1, 2024..
ICD-10-PCS代码在医疗保健系统中起着至关重要的作用,可确保高效准确的文档记录、计费和分析。该准则自2024年10月1日起生效。。
“We are pleased that CMS has provided an ICD-10-PCS code that describes our OneRF procedure, which we believe will drive better recognition of our technology and greater utilization within the healthcare system,” said Dave Rosa, CEO of NeuroOne. “In our view, CMS approval of our new code is a critical step in facilitating broader market acceptance of our technology’s potential to reduce hospital stays, numbers of surgeries, and adverse events, while offering enhanced patient safety.”.
NeuroOne首席执行官戴夫·罗莎(DaveRosa)表示:“我们很高兴CMS提供了一个描述我们OneRF程序的ICD-10-PCS代码,我们相信这将推动我们的技术得到更好的认可,并在医疗保健系统中得到更大的利用。”。“在我们看来,CMS批准我们的新代码是促进更广泛的市场接受我们的技术的潜力,以减少住院时间,手术次数和不良事件,同时提高患者安全性的关键一步。”。
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.
OneRF™消融系统是NeuroOne的第一个具有治疗适应症的设备,也是其第三个FDA 510(k)许可的设备。NeuroOne现在拥有全套薄膜电极技术,可以解决需要诊断性大脑定位程序以及使用相同sEEG电极进行射频消融的患者。
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..
除了OneRF™消融系统外,NeuroOne的其他FDA批准的设备还包括Evo®皮质和sEEG电极产品线,这些产品线主要用于刺激,记录和监测大脑中不到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,目前全球大脑消融市场的规模至少为1亿美元,并且增长迅速,基于大量可寻址的患者群体,临床需求尚未得到满足,因此有可能增长多倍。
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.
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,原发性震颤,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EEG记录,脑刺激和消融解决方案的微创和高清解决方案,这些可能会改善患者的预后并降低手术成本。
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 www.nmtc1.com..
该公司还可能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。有关更多信息,请访问www.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.
本新闻稿可能包括经修订的《1933年证券法》第27A节和经修订的《1934年证券交易法》第21E节所指的前瞻性声明。除历史事实声明外,本新闻稿中包含的任何信息都可能是前瞻性声明,反映了NeuroOne对未来事件的当前观点,并受到已知和未知风险、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结果、活动水平、绩效或成就与这些前瞻性声明所表达或暗示的信息存在重大差异。
In some cases, you can identify forward–looking statements by the words or phrases 'may,' 'might,' 'will,' 'could,' 'would,' 'should,' 'expect,' 'intend,' 'plan,' '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,你可以通过单词或短语“可能”、“可能”、“会”、“会”、“应该”、“期望”、“打算”、“计划”、“目标”、“预期”、“相信”、“估计”、“预测”、“项目”、“潜力”、“目标”、“寻求”、“沉思”、“继续”、“专注”、“承诺”和“持续”或这些术语的负面影响来识别前瞻性陈述,或者其他旨在识别未来陈述的类似术语。
Forward–looking statements may include statements regarding the ability of the ICD-10-PCS code to drive better recognition of our technology and greater utilization within the healthcare system, and facilitate broader market acceptance, 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.
前瞻性声明可能包括关于ICD-10-PCS代码能够更好地认可我们的技术和提高医疗保健系统的利用率,促进更广泛的市场接受度,以及OneRF消融系统能够减少住院时间,减少手术次数或减少不良事件,业务战略,市场规模,潜在的增长机会和未来运营的声明。
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 of the future, about w.
虽然NeuroOne认为我们对每个前瞻性陈述都有一个合理的基础,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,即w。
“Caution: Federal law restricts this device to sale by or on the order of a physician”
“注意:联邦法律限制该设备由医生或根据医生的指示销售”
Contact:
联系人:
800-631-4030
800-631-4030
ir@nmtc1.com
ir@nmtc1.com