Autonomix Highlights Compelling Patient Testimonial Showing Rapid Pain Relief from First-in-Human Proof-of-Concept Trial in Pancreatic Cancer Pain

Video testimonial demonstrates pain reduction after transvascular nerve ablation, suggesting potential for improving quality of life in late-stage cancer care

THE WOODLANDS, TX, May 05, 2025 (GLOBE NEWSWIRE) -- (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 the release of a new video testimonial from a patient participating in the initial phase of its first-in-human proof-of-concept trial (“PoC 1”) evaluating the safety and effectiveness of delivering transvascular energy to ablate relevant nerves and mitigate pain in patients with severe pancreatic cancer pain. Access the patient testimonial .

“We are deeply grateful to the patients who have shared their experiences with us. Testimonials like this provide meaningful insight into the real-world impact our technology can have, particularly in improving quality of life and reducing dependence on pain medication,” said Brad Hauser, Chief Executive Officer of Autonomix. “Patients with late-stage pancreatic cancer face severe, often unrelenting pain. Data emerging from our ongoing study reinforce the significant burden this pain places on quality of life and point to a clear, unmet need for innovative interventional pain management solutions.”

As previously announced, the Company enrolled twenty (20) patients in PoC 1, including the first five (5) “lead-in” patients. Based on consistent, corresponding evidence that successfully met the trial objectives, the Company determined there was a sufficient number of patients and will conclude its initial phase of the study. Notable findings from the study include statistically significant pain relief as early as 24-hours post procedure, providing patients with rapid relief. Pain reduction across the responding^* patient population remained consistently positive at 7-days and 4-6 weeks post-procedure, with a mean pain reduction of 4.16 on the Visual Analog Scale (“VAS”) (baseline 7.81 to 3.65), or 53.3% improvement at 7-days post-procedure and a mean pain reduction of 4.67 on the VAS pain scale (baseline of 7.89 to 3.22), or 59.2% improvement at 4-6 weeks post-procedure. Responding patients also reported an improved quality of life during end-stage cancer while reducing their use of opioids with 100% of responders* achieving zero opioid use at 7-days post-procedure and 73% of responders remaining opioid free at 4-6 week follow-up. Additionally, the procedure demonstrated a strong safety profile with no device or procedure-related serious adverse events. These promising results have led the Company to expand the protocol into a follow-on PoC 2 phase, now including pain management for additional visceral cancers as well as earlier stage pancreatic cancer patients experiencing moderate to severe pain.

About the Proof-of-Concept Trial

The goal of the first-in-human proof-of-concept trial is to assess pain reduction via RF ablation. The Company’s catheter-based microchip sensing array used to detect and differentiate neural signaling was not used in this trial and will be evaluated in future studies.

The primary objective of the initial phase of the PoC 1 trial was to assess the success rate of ablating relevant nerves to mitigate pain in patients with pancreatic cancer pain utilizing RF ablation in a transvascular approach to the nerves in the region. Secondary objectives included assessing the incidence of device- and procedure-related adverse events up to 4-6 weeks post-procedure; estimating the change in pain levels from pre- to post-procedure; and estimating the change in quality of life from pre- to post-procedure. All patients who had a successful procedure were evaluated at 7-days, 4-6 weeks, and at 3-months post-procedure. All patients entered the study with severe abdominal pain from unresectable pancreatic cancer and had a life expectancy of 3-months or more.

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 and connect with the Company on , , and .

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, the potential of the technology to treat pain associated with pancreatic cancer, and to complete its clinical study in pancreatic cancer pain. 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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^* Responders refer to 16 of the 20 patients who were treated using femoral access responded to treatment. The three (3) patients treated using brachial access showed no improvement in pain scores, representing a key procedural learning.