“We are excited to commence patient enrollment for the PoC human clinical trial, marking a significant milestone in our mission to revolutionize the treatment landscape for diseases involving the nervous system,” stated Lori Bisson, Chief Executive Officer of Autonomix. “Our technology holds promise in addressing the urgent need for effective pain management in patients suffering from pancreatic cancer, a condition known for its severe and often poorly managed pain. We are committed to advancing this innovative approach and look forward to the results of this trial.”

The primary objective of the PoC human clinical trial is to assess the efficacy of transvascular RF ablation in mitigating pain by targeting somatic nerves associated with pancreatic cancer. Twenty (20) subjects will be enrolled at a single clinical trial site, with confirmation of suitability affirmed by the primary oncology service. Additionally, up to 5 additional patients will undergo treatment to ensure physician familiarity with the procedure, although they will not be included in the trial analysis. Enrollment is expected to be completed by the end of 2024.

Expected Upcoming Milestones

• 2024: Completion of ablation device design for clinical use.
• 2025: Development of ablation system and catheter in preparation for human pivotal trial.
• 2025: Launch of combined sensing/ablation clinical trial.
• 2026: De novo submission.
• 2027: Pursuit of FDA clearance.

Autonomix’s catheter-based technology aims to sense neural signals associated with pain or disease and precisely target those nerves for treatment. This innovative approach represents a significant advancement over current methods, which often rely on systemic drugs or blind procedures that may result in inaccurate targeting and collateral damage.

Initially developed to address pancreatic cancer-related pain, Autonomix’s technology offers a promising alternative to existing approaches, providing hope for improved pain management with fewer side effects.