Autonomix Medical, Inc. 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. 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 familiar 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: First Quarter CY2024: Principal Investigator selection and agreements; First Quarter 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. 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, where doctors either rely on systemic drugs like opioids that lose effectiveness and have unwanted side effects or treat suspected areas; 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. 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.