GLP study marks a key milestone in Autonomix’s path to achieve regulatory approvals
Company remains on track to submit Investigational Device Exemption (“IDE”), and if approved, commence U.S. clinical trials in 2026 to support a De Novo FDA application
THE WOODLANDS, TX, Sept. 29, 2025 — Autonomix Medical, Inc. (NASDAQ: AMIX) (“Autonomix” or the “Company”), a medical device company dedicated to advancing precision nerve-targeted treatments, today announced that it has commenced a Good Laboratory Practice (GLP) preclinical study required by the FDA at CBSET, a state-of-the-art pre-clinical translational research institute, for its Sensing and RF Ablation System as a treatment for pancreatic cancer pain.
This GLP study is a set of quality standards that Autonomix is following to ensure the reliability and integrity of its devices in order to meet regulatory requirements for submitting data to the FDA for IDE clinical trials and product approval.
“The initiation of this study marks a critical milestone in our regulatory pathway towards potential approval. I am incredibly pleased with the progress made to date and with the continued solid execution of our plan. We remain on track to file our IDE and, if approved, commence clinical studies next year,” commented Brad Hauser, CEO of Autonomix.
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. For more information about the Company’s technology, please visit autonomix.com.
CBSET is a state-of-the-art translational research institute located in the greater Boston area of MA. Its mission is to advance biomedical research, through innovative, high-quality services. CBSET combines top-tier research with operational expertise. Since its inception, CBSET has continued to develop technical and scientific acumen through collaborative projects in the medical device, pharmaceutical and academic communities. CBSET’s 40,000 square foot, GLP-compliant, AAALAC- accredited facility includes vivaria, procedure rooms, catheterization / imaging labs, surgical and necropsy suites, histopathology, SEM, and a range of other technologies.
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.
View Autonomix Press Release