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Autonomix Medical, Inc. Receives Ethics Committee Authorization for Proof-of-Concept Human Clinical Study Evaluating Proprietary Ablation Technology for Treatment of Pancreatic Cancer Pain
First study ever to evaluate radiofrequency (RF) ablation in a transvascular approach to reduce the pain associated with pancreatic cancer On track to
About this update from Autonomix Medical, Inc.
[{"type":"text","content":"First study ever to evaluate radiofrequency (RF) ablation in a transvascular approach to reduce the pain associated with pancreatic cancer On track to commence enrollment in Q1 2024 THE WOODLANDS, TX, Feb. 06, 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 that it has received authorization from the Uzbekistan Ethics Committee to open the clinical trial site for its proof-of-concept human clinical study evaluating the use of transvascular ablation for the treatment of pancreatic cancer pain. The Company is on track to commence enrollment in the first quarter of 2024. “Our team remains focused on the successful execution of our clinical path forward for this potentially groundbreaking technology. We believe that our technology has the potential to address the significant unmet need for patients with severe, chronic debilitating pain from pancreatic cancer, contributing to an exceptionally difficult quality of life, that currently is not well-treated by pharmacologic approaches. This first-in-man study to treat pancreatic cancer pain will be the very first time that transvascular ablation to reduce the pain associated with this disease has been studied and it is a very important step in validating our clinical and regulatory plans for our technology. We are making solid progress with the study and expect to initiate enrollment imminently,” commented Lori Bisson, Chief Executive Officer of Autonomix. The primary objective of the proof-of-concept study 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 in Uzbekistan for the study. 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 study objectives. Enrollment is expected to be completed before year-end. The Company’s catheter-ba...