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
有史以来第一项评估跨血管射频（RF）消融以减轻胰腺癌相关疼痛的试验
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.
德克萨斯州伍德兰兹，2024年3月14日（GLOBE NEWSWIRE）——Autonomix Medical, Inc.（纳斯达克股票代码：AMIX）（“Autonomix” 或 “公司”）是一家专注于推进创新技术以彻底改变涉及神经系统的疾病的诊断和治疗方式的医疗器械公司，今天宣布，其评估经血管使用的概念验证（PoC）人体临床试验的前三例患者手术已安全完成射频消融治疗胰腺癌疼痛。
"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.
“我们很高兴安全地完成了第一批使用射频消融术的患者手术，采用跨血管方法来减轻与胰腺癌相关的疼痛。首席研究员能够将导管导航到目标治疗区域并进行指定的消融手术，没有出现明显的不良事件。Autonomix首席执行官洛里·比森评论说，这些已完成的手术代表了我们的技术和胰腺癌疼痛治疗领域进步的重要里程碑和重要势头，而胰腺癌疼痛的需求仍未得到满足。
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人体临床试验的主要目标是利用射频消融术成功地消融相关的体神经并减轻胰腺癌疼痛患者的疼痛，通过血管穿刺该区域的神经。二十（20）名受试者将在一个临床试验地点报名参加该试验。为患者提供护理的初级肿瘤学服务机构将确认是否合适。最多还将包括5名患者，并根据协议进行治疗，以确保医生熟悉手术。但是，它们将不包括在试验目标的分析中。招生预计将在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.
该公司正在开发基于导管的技术来做两件事：感知与疼痛或疾病相关的神经信号，并精确地靶向这些神经进行治疗。Autonomix认为，这项技术是当今常用的当前方法的更好替代方案，在这些方法中，医生要么依赖阿片类药物等会失去疗效并产生不良副作用的全身性药物，要么盲目治疗疑似区域，希望击中正确的神经，这种方法通常不准确，可能会错过靶点，甚至对身体周围部位造成附带损害。
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.
该公司最初正在开发应对胰腺癌相关疼痛的技术。目前的方法主要依赖阿片类药物或侵入性乙醇注射，只能起到有限的缓解作用，并可能导致危险的副作用。有关公司技术的更多信息，请访问autonomix.com。