Company on track to commence U.S. clinical studies in 2025 to support a De Novo application for FDA approval
THE WOODLANDS, TX, April 08, 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 it has engaged U.S. and international-based medical experts in interventional radiology and cancer pain to guide the Company’s U.S. clinical and regulatory path to ensure pre-clinical and clinical studies meet the needs of the Company’s expected FDA De Novo submission in 2026.
The Company’s medical advisors include former Society of Interventional Radiology Past Presidents, Dr. Michael Brunner and Dr. Katharine Krol of Health Tech Guidance, Dr. Patricio Polanco of UT Southwestern and Dr. Nikola Cesarovic of ETH Zürich.
“We are actively building the team and infrastructure necessary to support our clinical and regulatory initiatives in preparation for the potential FDA approval of our first-in-class technology. The establishment of a team of medical experts to guide the U.S. clinical and regulatory path is an important step in this process, and we are thrilled to be working with highly skilled and accomplished medical professionals,” commented Brad Hauser, CEO of Autonomix. “I am encouraged by the continued progress our team is making. With a growing body of positive data, we are on track to initiate clinical studies in the U.S. in 2025. We believe this step will provide valuable insight and guidance as we continue to progress.”
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 up to 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 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. 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.
Investor and Media Contact
JTC Team, LLC
Jenene Thomas
908.824.0775
autonomix@jtcir.com
