Autonomix Medical, Inc. Granted Approval to Expand Proof-of-Concept Human Clinical Study, Doubling Potential Addressable Market Beyond Pancreatic Cancer Pain

Follow-on study ("PoC 2") builds on initial success in pancreatic cancer pain 

Ethics committee authorization supports platform expansion into visceral cancer pain for proprietary ablation technology

Expansion supports Autonomix's strategy to build long-term value through multi-indication growth

Patient enrollment expected to begin in June 2025

THE WOODLANDS, TX, June 05, 2025 (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 that it has received Ethics Committee authorization from the Ministry of Health of the Republic of Uzbekistan to open the clinical trial site for the follow-on phase to its proof-of-concept human clinical trial ("PoC 2") evaluating the safety and effectiveness of delivering transvascular energy to ablate relevant problematic nerves and mitigate cancer pain. The Company is on track to commence enrollment in June 2025.

"This next phase of our clinical program represents a meaningful advancement for Autonomix," said Brad Hauser, CEO of Autonomix. "With Ethics Committee approval, we can now expand our evaluation beyond severe pancreatic cancer pain to include a broader range of visceral cancers. The initial phase of our study in late-stage pancreatic cancer patients delivered promising results, demonstrating significant pain reduction, substantial decreases in opioid use, and meaningful improvements in quality of life. These outcomes reinforce our belief that Autonomix's technology has the potential to address multiple cancer indications with significant unmet need and transform the standard of care. As we build on this momentum, we see a clear opportunity to create long-term value by unlocking a broader set of impactful clinical applications."

As previously announced, based on the positive results demonstrated in the initial phase of the Company's first-in-human proof-of-concept trial ("PoC 1") in patients with severe pancreatic cancer pain, Autonomix is initiating a follow-on PoC 2 phase in a market expansion opportunity, which has the potential to double the addressable market beyond pancreatic cancer pain by evaluating additional visceral cancers that signal pain through the Celiac Plexus and earlier stage pancreatic cancers with moderate to severe pain.

Autonomix's technology constitutes a platform with the potential to address dozens of indications, including cardiology, hypertension and chronic pain management, across a wide disease spectrum. The PoC 2 phase will provide a concentrated focus on interventional cancer pain management applications like pancreatic, gall bladder, liver, and bile duct, with potential further expansion in oncology, gastroenterology, and other sectors where the Company has established key opinion leader relationships and emerging preclinical evidence.

For more information about the Company's technology, please visit autonomix.com.

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 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 commencement of the PoC 2 phase of the trial. 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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