Autonomix initiates GLP study for its nerve-targeted treatment, aiming for FDA IDE submission and clinical trials in 2026.
Quiver AI Summary
Autonomix Medical, Inc. has announced the initiation of a Good Laboratory Practice (GLP) preclinical study at CBSET to advance its Sensing and RF Ablation System, aimed at treating pain associated with pancreatic cancer. This study is a crucial step toward meeting FDA regulatory requirements, as the company prepares to submit an Investigational Device Exemption (IDE) application with plans to begin clinical trials in the U.S. in 2026, contingent upon approval. CEO Brad Hauser expressed satisfaction with the company's progress, highlighting the potential of their innovative technology to address various medical conditions beyond cancer pain. Autonomix's platform could revolutionize treatment for a range of diseases involving the nervous system, although the technology is still investigational and not yet marketed in the U.S.
Potential Positives
- Commencement of a GLP preclinical study represents a key milestone towards achieving regulatory approvals for Autonomix's innovative nerve-targeted treatments.
- Company remains on track to submit an Investigational Device Exemption (IDE), potentially paving the way for U.S. clinical trials in 2026.
- The technology developed by Autonomix has potential applications across various therapeutic areas, indicating a broad market reach and significant impact on patient care.
- Cooperation with CBSET, a highly regarded translational research institute, enhances the credibility and quality assurance of the study being conducted.
Potential Negatives
- Company's technology is still investigational and has not yet been cleared for marketing in the United States, indicating potential regulatory hurdles ahead.
- The press release's reliance on forward-looking statements introduces uncertainty regarding the timing and success of future clinical trials and regulatory submissions.
- Risks and uncertainties are explicitly noted, which could imply potential delays or complications in the company's path to approval and market entry.
FAQ
What is the purpose of the GLP study announced by Autonomix?
The GLP study aims to ensure the reliability and integrity of Autonomix's Sensing and RF Ablation System for FDA approval.
When does Autonomix plan to submit its Investigational Device Exemption (IDE)?
Autonomix is on track to submit its IDE for approval in 2026 to commence U.S. clinical trials.
What condition is Autonomix targeting with its new technology?
The technology is initially being developed to treat pancreatic cancer pain.
Where is the GLP study being conducted?
The GLP study is being conducted at CBSET, a leading translational research institute in Massachusetts.
How does Autonomix's technology differ from other current treatments?
Autonomix's platform technology features a microchip sensing array that detects neural signals with greater sensitivity than existing options.
Disclaimer: This is an AI-generated summary of a press release distributed by GlobeNewswire. The model used to summarize this release may make mistakes. See the full release here.
$AMIX Analyst Ratings
Wall Street analysts have issued reports on $AMIX in the last several months. We have seen 1 firms issue buy ratings on the stock, and 0 firms issue sell ratings.
Here are some recent analyst ratings:
- Maxim Group issued a "Buy" rating on 04/29/2025
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Full Release
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.
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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.
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