NeuroOne Announces First in Human Ablations Completed With OneRF Ablation System
NeuroOne Announces First in Human Ablations Completed With OneRF Ablation System
Five ablations performed successfully in one patient
在一名患者中成功進行了五次消融術
Procedure performed at patient's bedside saving time and cost associated with the operating room
在患者牀邊進行手術,節省了與手術室相關的時間和成本
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.
明尼蘇達州伊甸草原,2024年6月25日(GLOBE NEWSWIRE)——專注於改善神經系統疾病患者手術護理選擇和療效的醫療技術公司NeuroOne醫療技術公司(納斯達克股票代碼:NMTC)(“NeuroOne” 或 “公司”)今天宣佈,位於佛羅里達州傑克遜維爾的一家著名醫院最近使用了OneRF消融系統,成功爲一名患者完成了五次消融術。
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.
該患者患有多竈性癲癇,這種發作是由大腦的多個區域觸發的。在這個過程中,十個 Evo SeeG 電極被放置在患者大腦的不同位置。四個電極識別出大腦中引發癲癇發作的問題區域。消融是使用溫度控制安全功能在目標區域進行的,其中兩次消融發生在一個電極上的不同接觸處。使用相同的電極,消融後的seeG記錄顯示組織消融時大腦活動不足,證實了成功的消融術。該手術是在患者牀邊進行的,節省了在手術室進行手術的時間和成本。
"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."
“公司目睹了使用OneRF消融系統進行的首次臨床消融術,這讓公司感到非常興奮。NeuroOne首席執行官戴夫·羅莎說,能夠在患者牀邊安全地進行這些手術將減少手術室的時間和成本,從而騰出手術室來進行其他手術。“我們期待使用該系統進行更多手術,目的是爲患者提供安全的治療方法,以監測和消滅有問題的腦組織。將來,該公司打算在未來向美國食品藥品管理局提交的申請中利用OneRF生成器來進行其他消融申請。”
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 消融系統是NeuroOne首款具有治療適應症的設備,也是其第三款獲得FDA 510(k)批准的設備。NeuroOne現在擁有全系列的薄膜電極技術,可滿足需要診斷性大腦映射手術以及使用相同SeeG電極進行射頻消融的患者的需求。除了 oneRF 消融系統,NeuroOne的其他經美國食品藥品管理局批准的設備包括Evo 皮質和 seeG 電極產品線,主要用於刺激、記錄和監測大腦電活動少於 30 天。
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估計,目前全球腦消融市場至少爲1億美元,並且增長迅速,基於臨床需求未得到滿足的大量可尋患者群體,有可能成倍增長。
About NeuroOne
關於 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是一家處於發展階段的公司,致力於爲患有癲癇、帕金森氏病、肌張力障礙、特發性震顫、背部手術失敗引起的慢性疼痛和其他相關神經系統疾病的患者提供微創和高清晰度的解決方案,這些解決方案可以改善患者預後並降低手術成本。該公司還可能尋求其他領域的申請,例如抑鬱症、情緒障礙、疼痛、尿失禁、高血壓和人工智能。欲了解更多信息,請訪問 。
Forward Looking Statements
前瞻性陳述
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.
本新聞稿可能包括經修訂的1933年《證券法》第27A條和經修訂的1934年《證券交易法》第21E條所指的前瞻性陳述。除歷史事實陳述外,本新聞稿中包含的任何信息都可能是前瞻性陳述,反映了NeuroOne當前對未來事件的看法,並且受已知和未知的風險、不確定性和其他因素的影響,這些因素可能導致我們的實際業績、活動水平、業績或成就與這些前瞻性陳述所表達或暗示的信息存在重大差異。在某些情況下,你可以通過以下詞語或短語來識別前瞻性陳述:“可能”、“可能”、“會”、“應該”、“期望”、“打算”、“計劃”、“目標”、“預測”、“估計”、“預測”、“項目”、“潛力”、“目標”、“尋求”、“考慮”、“考慮”、“考慮”、“繼續、“專注”、“承諾” 和 “持續”,或這些術語的否定詞,或旨在識別未來陳述的其他類似術語。前瞻性陳述可能包括有關將要進行的額外手術、FDA未來可能提交更多消融申請的陳述,以及OneRF消融系統減少住院時間、減少手術數量或減少不良事件的能力、業務戰略、市場規模、潛在增長機會和未來運營的陳述。儘管NeuroOne認爲我們的每項前瞻性陳述都有合理的依據,但我們提醒您,這些陳述是基於我們目前已知的事實和因素以及我們對未來的期望,我們無法確定這些事實和因素。由於我們無法控制的因素,我們的未來實際業績可能與預期存在重大差異,包括我們的合作伙伴關係可能無法促進我們技術的商業化或市場接受度的風險;是否是由於供應鏈中斷、勞動力短缺、根據臨床前和臨床試驗結果我們的技術無法按預期運行的風險;與公司實現業務目標的資本要求和籌集額外資金的能力相關的不確定性相關的風險:我們可能無法獲得或保留技術覆蓋範圍或充足補償的風險;我們技術開發過程中固有的不確定性;與監管要求或監管機構決策變化相關的風險;我們可能無法準確估計我們技術市場的規模和增長潛力;與我們保護知識產權的能力相關的風險;以及其他風險、不確定性和假設,包括我們在申報中 “風險因素” 標題下描述的風險、不確定性和假設與證券交易委員會合作。這些前瞻性聲明僅代表截至本新聞稿發佈之日,即使將來有新的信息,NeuroOne也沒有義務出於任何原因修改或更新任何前瞻性聲明。
"Caution: Federal law restricts this device to sale by or on the order of a physician"
“注意:聯邦法律限制此設備由醫生出售或按醫生的命令出售”
Contact:
聯繫人:
800-631-4030
ir@nmtc1.com
800-631-4030
ir@nmtc1.com
譯文內容由第三人軟體翻譯。