Autonomix Medical, Inc. announced on September 29, 2025, the commencement of a Good Laboratory Practice (GLP) preclinical study for its Sensing and RF Ablation System. This study, required by the FDA, is being conducted at CBSET, a translational research institute.
The GLP study is a set of quality standards that Autonomix is following to ensure the reliability and integrity of its devices. This is a crucial step for meeting regulatory requirements for submitting data to the FDA for Investigational Device Exemption (IDE) clinical trials and eventual product approval.
CEO Brad Hauser stated that the initiation of this study marks a critical milestone in the company's regulatory pathway towards potential approval. Autonomix remains on track to file its IDE and, if approved, commence clinical studies in 2026, further advancing its platform technology for pancreatic cancer pain treatment and other indications.
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