Autonomix Signs Key Clinical Agreements in Preparation to Begin March 2024 Human Clinical Trial

Proof-of-concept (PoC) human clinical trial targeting multi-billion-dollar pancreatic cancer market through transvascular RF ablation

Agreements represent final steps needed in order to commence patient enrollment, expected imminently

THE WOODLANDS, TX, Feb. 29, 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 it has entered into a clinical site agreement with “АКFА MEDLINE" Ltd., for its PoC human clinical trial evaluating the use of transvascular RF ablation for the treatment of pancreatic cancer pain.

Additionally, Autonomix announced the selection of Clinical Accelerator and Qmed, full service Clinical Research Organizations (CROs) specializing in medical devices to support the PoC human clinical trial. Clinical Accelerator will be responsible for managing the clinical operations in country, including recruiting patients, SIV work, and patient treatment records and Qmed will be responsible for managing protocol and trial reporting, as well as managing patient data.

Lori Bisson, Chief Executive Officer of Autonomix commented, “We are pleased to execute these important agreements and final steps towards commencing patient enrollment in our first PoC human clinical trial. We believe each of these firms bring valuable components to our overall clinical advancement and we look forward to working with them closely to bring this trial across the finish line.”

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.