Microchip-based platform enables real-time nerve mapping and targeted treatment from within the vascular system
Continued progress toward submitting Investigational Device Exemption ("IDE"), and if approved, the commencement of U.S. clinical trials to support a De Novo FDA application
THE WOODLANDS, TX, Aug. 14, 2025 (GLOBE NEWSWIRE) -- Autonomix Medical, Inc. (NASDAQ: AMIX) ("Autonomix" or the "Company"), a medical device company dedicated to advancing precision nerve-targeted treatments, today announced it has advanced its proprietary sensing catheter through a final design review in preparation for human clinical trials. Previous versions had been used in animal models to demonstrate the ability to detect nerve signals. This marks a major step forward on the Company's path toward initiating U.S. clinical studies.
Autonomix's innovative sensing catheter is the first intravascular device of its kind engineered to detect and differentiate nerve signals in real time from inside the vasculature using Autonomix's proprietary microchip-based sensing antenna array. Current technologies require physicians to treat blindly, which can lead to incomplete denervation or overtreatment. Autonomix's sensing catheter aims to offer a powerful new "sense, treat and verify" approach to targeting the nerve, which uniquely gives physicians the ability to detect nerve activity, precisely guide energy delivery, optimize ablation patterns, and confirm that nerve signaling has stopped immediately during the procedure.
"What sets Autonomix's approach apart is the potential of our device to sense and process neural signals directly at the source, enabled by our proprietary microchip array. This sensing catheter is a cornerstone of our platform, designed to help physicians precisely locate target nerves, tailor ablation, and confirm efficacy in real time. Completing this design review milestone reinforces the strength of our development program and brings us closer to delivering safer, more effective treatment options for patients, while advancing value-creating milestones for our shareholders," commented Brad Hauser, CEO of Autonomix. "The ability to map nerve activity in real time has the potential to transform the field of neuromodulation and pain treatment. We believe this represents a paradigm shift in therapeutic electrophysiology, and we look forward to building momentum towards the launch of our clinical trial to support a De Novo FDA submission."
Autonomix's first-in-class technology constitutes a platform with the potential to address dozens of indications in multiple high-need therapeutic areas, including cardiology and resistant hypertension or high blood pressure, interventional pain management, pulmonary and gastrointestinal disorders, and more.
Autonomix is currently executing the operational plan required to submit an IDE and commence U.S. clinical trials 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.
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 U.S. clinical trials and any FDA submission. 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 29, 2025, and from time to time, in our other filings with the SEC. Forward-looking statements speak only as of the date of this press release and Autonomix does not undertake any duty to update any forward-looking statements except as may be required by law.
Investor and Media Contact
JTC Team, LLC
Jenene Thomas
908-824-0775
autonomix@jtcir.com
