Autonomix Launches FDA-Required GLP Study For Sensing And RF Ablation System In Pancreatic Cancer Pain

Autonomix Medical, Inc. a medical device company focused on precision nerve-targeted therapies, has initiated a Good Laboratory Practice (GLP) preclinical study of its Sensing and RF Ablation System at CBSET, a leading preclinical research institute. The study specifically evaluates its use as a treatment for pain associated with pancreatic cancer.

“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.

This GLP study adheres to FDA-required quality standards, designed to ensure the reliability, accuracy, and regulatory compliance of data submitted for Investigational Device Exemption (IDE) clinical trials and eventual product approval. The results will be a critical step in advancing the device into human studies.

Autonomix’s platform technology is the first of its kind, with broad potential applications beyond pancreatic cancer pain. It may address high unmet needs across therapeutic areas such as resistant hypertension, interventional pain management, cardiology, pulmonary disease, and gastrointestinal disorders.