Autonomix Medical, Inc. Initiates Good Laboratory Practice (GLP) Study for Sensing and RF Ablation System
Rhea-AI Summary
Autonomix Medical (NASDAQ: AMIX) has initiated a crucial Good Laboratory Practice (GLP) preclinical study for its Sensing and RF Ablation System, targeting pancreatic cancer pain treatment. The study, conducted at CBSET research institute, represents a significant step toward FDA regulatory approvals.
The company remains on track to submit its Investigational Device Exemption (IDE) and, pending approval, begin U.S. clinical trials in 2026 to support a De Novo FDA application. CEO Brad Hauser highlighted this as a critical milestone in their regulatory pathway.
Autonomix's first-in-class technology platform shows potential applications across multiple therapeutic areas, including cardiology, resistant hypertension, interventional pain management, and pulmonary and gastrointestinal disorders.
Positive
- Initiation of FDA-required GLP study marks progress toward regulatory approval
- Company on schedule for IDE submission and potential 2026 clinical trials
- Technology platform has potential applications across multiple therapeutic areas
Negative
- Product still in pre-clinical phase with no guaranteed timeline for FDA approval
- Clinical trials have not yet begun
News Market Reaction 4 Alerts
On the day this news was published, AMIX gained 0.95%, reflecting a mild positive market reaction. Our momentum scanner triggered 4 alerts that day, indicating moderate trading interest and price volatility. This price movement added approximately $59K to the company's valuation, bringing the market cap to $6M at that time.
Data tracked by StockTitan Argus on the day of publication.
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 (GLOBE NEWSWIRE) -- 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.
About CBSET
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.
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 submission of its IDE and, if approved, the timing of the commencement of clinical studies. 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, 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
FAQ
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