Company successfully meets key milestone with design lock that integrates and finalizes enhancements to its licensed Apex 6 Radiofrequency (“RF”) Generator

On track for Investigational Device Exemption (“IDE”) submission and, if approved, U.S. clinical trial initiation in 2025 for pancreatic cancer pain

Milestone advances proprietary sensing and ablation catheter technology into a fully integrated transvascular treatment platform

Autonomix Medical, Inc. (NASDAQ: AMIX) (“Autonomix” or the “Company”), a medical device company focused on advancing precision nerve-targeted treatments, today announced it has completed the integration and design enhancements of the Apex 6 Generator into a fully integrated transvascular treatment platform, now rebranded as the Autonomix Sensing and RF Ablation System. The completion of this important milestone allows the Company to remain on track for submitting its IDE application with the U.S. FDA and potentially initiate clinical trials in the United States in 2025.

In July 2024, Autonomix completed its transaction with RF Innovations, Inc., a privately held medical technology company, to license the intellectual property to its Apex 6 Generator, an existing FDA-cleared technology. The Apex 6 Generator aligned with the RF generator specifications required for Autonomix’s Sensing and RF Ablation System and provided a cost effective, de-risked approach to accelerating platform development. Following a rigorous preclinical assessment, the Company has now fully optimized the design for its first-in-class sensing and ablation device.

“There is an urgent need to transform the treatment paradigm for pancreatic cancer patients, offering effective pain relief and improving quality of life,” commented Brad Hauser, CEO of Autonomix. “Our early clinical results have consistently demonstrated the potential to address this unmet medical need, and the successful integration of our RF Generator is a critical step forward. With our IDE submission targeted for 2025, we are closer than ever to bringing this innovation into the clinic and advancing toward potential FDA De Novo clearance. We remain committed to unlocking significant value for both patients and stakeholders as we progress toward commercialization.”

As previously announced, Autonomix is collaborating with RF Innovations’ manufacturing partner, who was incorporated into the Company’s manufacturing supply chain, to facilitate equipment development.

The Company expects to submit an IDE and commence U.S. clinical trials in 2025 to support a labeling indication to commercialize the Autonomix Sensing and RF Ablation System in the U.S. as a treatment for pancreatic cancer pain.