Autonomix Enrolls First Patients in Human Clinical Trial Targeting Multi-Billion-Dollar Pancreatic Cancer Market

First trial to ever evaluate radiofrequency (RF) ablation in a transvascular approach to reduce the pain associated with pancreatic cancer

THE WOODLANDS, TX, March 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 it has commenced patient enrollment for its proof-of-concept (PoC) human clinical trial evaluating the use of transvascular RF ablation for the treatment of pancreatic cancer pain.

“We are pleased to commence enrollment of the PoC human clinical trial and take another step toward validating our clinical and regulatory plans for our technology,” commented Lori Bisson, Chief Executive Officer of Autonomix. “We remain encouraged 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 many find is not well-treated by pharmacologic approaches. Moving forward, we are laser focused on the successful completion of the trial and the advancement of this important technology.”

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.

Expected Upcoming Milestones

• 2024: Complete ablation device design intended for clinical use
• 2025: Complete development of ablation system and catheter in preparation for human pivotal trial
• 2025: Launch combined sensing / ablation clinical trial
• 2026: De novo submission
• 2027: Seek FDA clearance
  

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.