Autonomix Completes First Three Patient Procedures In Human Clinical Trial, First Trial To Ever Evaluate Radiofrequency Ablation In A Transvascular Approach To Reduce The Pain Associated With Pancreatic Cancer
Autonomix Completes First Three Patient Procedures In Human Clinical Trial, First Trial To Ever Evaluate Radiofrequency Ablation In A Transvascular Approach To Reduce The Pain Associated With Pancreatic Cancer
First trial to ever evaluate radiofrequency (RF) ablation in a transvascular approach to reduce the pain associated with pancreatic cancer
有史以來第一項評估跨血管射頻（RF）消融以減輕胰腺癌相關疼痛的試驗
THE WOODLANDS, TX, March 14, 2024 (GLOBE NEWSWIRE) -- Autonomix Medical, Inc. (NASDAQ:AMIX) ("Autonomix" or the "Company"), a medical device company focused on advancing innovative technologies to revolutionize how diseases involving the nervous system are diagnosed and treated, today announced the safe completion of the first three patient procedures for its proof-of-concept (PoC) human clinical trial evaluating the use of transvascular RF ablation for the treatment of pancreatic cancer pain.
德克薩斯州伍德蘭茲，2024年3月14日（GLOBE NEWSWIRE）——Autonomix Medical, Inc.（納斯達克股票代碼：AMIX）（“Autonomix” 或 “公司”）是一家專注於推進創新技術以徹底改變涉及神經系統的疾病的診斷和治療方式的醫療器械公司，今天宣佈，其評估經血管使用的概念驗證（PoC）人體臨床試驗的前三例患者手術已安全完成射頻消融治療胰腺癌疼痛。
"We are pleased to have safely completed the first patient procedures utilizing RF ablation in a transvascular approach to reduce the pain associated with pancreatic cancer. The Principal Investigator was able to navigate the catheter to the target treatment area and perform the specified ablations with no significant adverse events. These completed procedures represent a significant milestone as well as important momentum in the advancement of both our technology and the treatment landscape for pancreatic cancer pain where there remains an unmet need," commented Lori Bisson, Chief Executive Officer of Autonomix.
“我們很高興安全地完成了第一批使用射頻消融術的患者手術，採用跨血管方法來減輕與胰腺癌相關的疼痛。首席研究員能夠將導管導航到目標治療區域並進行指定的消融手術，沒有出現明顯的不良事件。Autonomix首席執行官洛裏·比森評論說，這些已完成的手術代表了我們的技術和胰腺癌疼痛治療領域進步的重要里程碑和重要勢頭，而胰腺癌疼痛的需求仍未得到滿足。
The primary objective of the PoC human clinical trial is to successfully ablate relevant somatic nerves and mitigate pain in patients with pancreatic cancer pain utilizing RF ablation in a transvascular approach to the nerves in the region. Twenty (20) subjects will be enrolled at one clinical trial site for the trial. Confirmation of suitability will be affirmed by the primary oncology service caring for the patients. Up to 5 additional patients will be included and treated according to protocol to ensure the physician's familiarity with the procedure. However, they will not be included in the analysis of the trial objectives. Enrollment is expected to be completed before the end of 2024.
PoC人體臨床試驗的主要目標是利用射頻消融術成功地消融相關的體神經並減輕胰腺癌疼痛患者的疼痛，通過血管穿刺該區域的神經。二十（20）名受試者將在一個臨床試驗地點報名參加該試驗。爲患者提供護理的初級腫瘤學服務機構將確認是否合適。最多還將包括5名患者，並根據協議進行治療，以確保醫生熟悉手術。但是，它們將不包括在試驗目標的分析中。招生預計將在2024年底之前完成。
The Company's catheter-based technology is being developed to do two things: sense neural signals associated with pain or disease and precisely target those nerves for treatment. Autonomix believes this technology is a better alternative to the current approaches commonly used today, where doctors either rely on systemic drugs like opioids that lose effectiveness and have unwanted side effects or treat suspected areas blindly in hopes of hitting the right nerves, an approach that is often inaccurate and can miss the target and even cause collateral damage to surrounding parts of the body.
該公司正在開發基於導管的技術來做兩件事：感知與疼痛或疾病相關的神經信號，並精確地靶向這些神經進行治療。Autonomix認爲，這項技術是當今常用的當前方法的更好替代方案，在這些方法中，醫生要麼依賴阿片類藥物等會失去療效併產生不良副作用的全身性藥物，要麼盲目治療疑似區域，希望擊中正確的神經，這種方法通常不準確，可能會錯過靶點，甚至對身體周圍部位造成附帶損害。
The Company is initially developing its technology to address pancreatic cancer-related pain. Current approaches, primarily relying on opioids or invasive ethanol injections, can provide only limited relief and may lead to risky side effects. For more information about the Company's technology, please visit autonomix.com.
該公司最初正在開發應對胰腺癌相關疼痛的技術。目前的方法主要依賴阿片類藥物或侵入性乙醇注射，只能起到有限的緩解作用，並可能導致危險的副作用。有關公司技術的更多信息，請訪問autonomix.com。
譯文內容由第三人軟體翻譯。