Autonomix Medical, Inc. Advances Toward U.S. Clinical Trials in 2025 with Completed Integration of Apex 6 Generator for Transvascular Ablation

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

THE WOODLANDS, TX, March 14, 2025 (GLOBE NEWSWIRE) -- 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.

About Autonomix Medical, Inc.

Autonomix is a medical device company focused on advancing innovative technologies to revolutionize how diseases involving the nervous system are diagnosed and treated. The Company's first-in-class platform system technology includes a catheter-based microchip sensing array that may have the ability to detect and differentiate neural signals with approximately 3,000 times greater sensitivity than currently available technologies. We believe this will enable, for the first time ever, transvascular diagnosis and treatment of diseases involving the peripheral nervous system virtually anywhere in the body.

We are initially developing this technology for the treatment of pain, with initial trials focused on pancreatic cancer, a condition that causes debilitating pain and is without a reliable solution. Our technology constitutes a platform to address dozens of potential indications, including cardiology, hypertension and chronic pain management, across a wide disease spectrum. Our technology is investigational and has not yet been cleared for marketing in the United States.

For more information, visit autonomix.com and connect with the Company on X, LinkedIn, Instagram and Facebook.

Forward Looking Statements

Some of the statements in this release are "forward-looking statements," which involve risks and uncertainties. Forward-looking statements in this press release include, without limitation, the timing of the Company's submission of an IDE, the timing of the commencement of U.S. clinical trials, and the potential of the technology to treat cancerous tumors and the pain associated with pancreatic cancer. Such forward-looking statements can be identified by the use of words such as "should," "might," "may," "intends," "anticipates," "believes," "estimates," "projects," "forecasts," "expects," "plans," and "proposes."

Although Autonomix believes that the expectations reflected in these forward-looking statements are based on reasonable assumptions, there are a number of risks and uncertainties that could cause actual results to differ materially from such forward-looking statements. You are urged to carefully review and consider any cautionary statements and other disclosures, including the statements made under the heading "Risk Factors" and elsewhere in the Annual Report on Form 10-K filed with the U.S. Securities and Exchange Commission (SEC) on May 31, 2024 and in other filings made by us from time to time with the SEC. Forward-looking statements speak only as of the date of the document in which they are contained and Autonomix does not undertake any duty to update any forward-looking statements except as may be required by law.

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