Autonomix Begins Human POC Clinical Trial Targeting Multi-Billion-Dollar Pancreatic Cancer Market

Site initiation completed for first study ever to evaluate radiofrequency (RF) ablation in a transvascular approach to reduce the pain associated with pancreatic cancer

THE WOODLANDS, TX, Feb. 16, 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 completion of its site initiation for its proof-of-concept human clinical study evaluating the use of transvascular RF ablation for the treatment of pancreatic cancer pain.

“We continue to make solid progress with our PoC human clinical study. This study is a very important step in validating our clinical and regulatory plans for our technology and as such our team is dedicated to its successful execution. With the site initiation now complete, we are working to identify and train Principal Investigators for the study and remain on track to commence patient enrollment this quarter,” commented Lori Bisson, Chief Executive Officer of Autonomix.

The primary objective of the proof-of-concept human clinical 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 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 the end of 2024.

Expected Upcoming Milestones

• Q1 CY2024: Principal Investigator selection and agreements
• Q1 CY2024: Commence enrollment in PoC human clinical study evaluating proprietary ablation technology for treatment of pancreatic cancer pain
• 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: FDA clearance