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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宣佈已完成使用OneRF消融系統的人體消融手術。
GlobeNewswire ·  06/25 09:00

Five ablations performed successfully in one patient

一位患者成功進行了五次消融手術。

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

在病人牀邊進行手術可節省與手術室相關的時間和費用

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.

明尼蘇達州伊登城,2024年6月25日 /美通社/ -- 神經一醫療技術公司(納斯達克股票代碼: NMTC)(“神經一”或“公司”),一家專注於改善神經系統疾病患者手術護理選擇和結果的醫療技術公司,今天宣佈 OneRF Ablation System 最近在佛羅里達州傑克遜維爾的一家知名醫院成功地爲一名患者完成了五次消融手術。

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.

患者患有多竈性癲癇,這是一種通過多個大腦區域觸發癲癇的病症。在這個手術中,患者腦中的各個部位埋入了十個Evo治療系統的用於電極腦電圖的電極。四個電極確定了引起癲癇的大腦的有問題的區域。在使用了溫度控制安全功能的情況下,對具有針對性的區域進行了消融手術,其中有兩個消融手術是在一個電極的不同電極上進行的。使用相同的電極,通過消融組織的點進行了後置EEG記錄,證實了消融手術成功。這種手術方式可以在患者牀邊進行,節省了手術室進行手術的時間和費用。神經一的CEO Dave Rosa表示,“神經一公司能夠見證OneRF Ablation System首次進行臨床消融手術是令人振奮的。安全地在患者牀邊進行這些手術,將減少手術室的時間和費用,從而有助於開展其他手術。我們期待利用該系統進行更多的手術,以達到爲患者提供安全的治療和監測有問題的腦組織消融的目的。未來,公司有意通過OneRF 發電機實現更多消融應用的FDA申請。”

"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."

神經一醫療技術公司致力於爲癲癇、帕金森病、肌張力障礙、原發性震顫、由於腰背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EEG記錄、腦部刺激和消融解決方案的遠程解決方案,並可能在其他領域尋求應用,如抑鬱症、心境障礙、疼痛、失禁、高血壓和人工智能。有關更多信息,請訪問。"

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的第一款帶有治療指示的設備,也是其第三款獲得FDA 510(k)的設備。NeuroOne現在擁有一整套用於診斷性腦電圖映射程序的薄膜電極技術,以及使用相同sEEG電極進行RF消融。除了OneRF消融系統外,NeuroOne的其他FDA認證設備還包括Evo皮層和sEEG電極產品系列,主要用於在不到30天的時間內刺激,記錄和監測大腦的電活動。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將當前的腦消融市場估計爲至少1億美元,並正在迅速增長,具有多倍增長的潛力,可滿足具有未滿足臨床需求的大量可尋址患者人群。

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是一家發展階段公司,致力於爲癲癇、帕金森病、肌張力障礙、根治椎間盤手術後慢性疼痛和其他相關神經系統疾病患者提供腦電記錄、大腦刺激和消融解決方案,以改善患者預後並降低手術成本。該公司還可以將其應用於其他領域,如抑鬱症、情緒障礙、疼痛、失禁、高血壓和人工智能。有關更多信息,請訪問。

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 .

本公司是一家尋求提供癲癇、帕金森病、肌張力障礙、原發性震顫、由於腰背手術失敗引起的慢性疼痛、以及其他相關神經系統疾病的EEG記錄、腦電刺激和消融解決方案的發展階段公司,其解決方案爲遠程解決方案,可能提高患者的預後及手術成本。公司還可能追求其他領域的應用,例如抑鬱症、情緒障礙、疼痛、尿失禁、高血壓和人工智能等。欲了解更多信息,請訪問網站。".

Forward Looking Statements

前瞻性聲明

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.

本新聞稿可能包含根據1933年證券法修正案第27(A)節和1934年證券交易法修正案第21(E)節的前瞻性聲明。除了歷史事實陳述之外,本新聞稿中包含的任何信息均可能是反映NeuroOne對未來事件的觀點,並且可能受到已知和未知風險,不確定性和其他因素的影響,這些因素可能會導致我們的實際結果,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實質差異。在某些情況下,您可以通過“可能”、“可能”、“將”、“可能”、“將”、“應該”、“期望”、“意圖”、“計劃”、“目標”、“預計”、“相信”、“估計”、“預測”、“項目”、“潛力”、“目標”、“尋求”、“思考”、“繼續”、“專注於”、“致力於”和“持續”或這些術語的否定,或其他意圖識別未來聲明的類似術語。前瞻性陳述可能包括有關執行其他程序,將來還可能提交用於其他消融應用的FDA申請機會,以及OneRF消融系統能夠縮短住院時間,減少手術次數或減少不良事件,業務策略,市場規模,潛在增長機會和未來運營的聲明。儘管NeuroOne認爲我們對每個前瞻性聲明都有合理的依據,但我們提醒您,這些聲明基於我們目前已知的事實和因素的組合以及我們對未來的期望,我們無法確定。由於這些因素很大程度上超出了我們的控制範圍,例如我們的合作伙伴可能無法促進我們的技術的商業化或市場接受度;由於供應鏈中斷、勞動力短缺、我們的技術可能不會根據我們的臨床前和臨床試驗結果表現如預期的風險;與公司實現業務目標的資本需求和籌集額外資金的能力相關的風險:我們可能無法獲得或保持對我們技術的足夠的覆蓋範圍或報銷;我們技術開發過程中的固有不確定性的風險;與監管要求的變化或監管機構的決策相關的風險;我們可能沒有準確估計技術市場的規模和增長潛力的風險;與保護我們的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,包括在我們提交給證券交易委員會的備案文件中“風險因素”標題下所述的那些風險。這些前瞻性陳述僅代表本新聞稿發佈之日的觀點,NeuroOne不承諾因任何原因修訂或更新任何前瞻性陳述,即使在未來提供了新信息。

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

“注意:聯邦法令規定本設備僅可應由醫生訂購。”

Contact:

聯繫方式:

800-631-4030
ir@nmtc1.com

800-631-4030
ir@nmtc1.com


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