Final Design Set for Autonomix Medical’s RF Ablation Catheter

Autonomix Medical Inc. has achieved a design lock for its radio frequency (RF) ablation catheter specifically designed to ablate nerves transvascularly in targeted areas.

“There continues to be a much-needed shift in the treatment paradigm for pancreatic cancer patients offering a reduction of pain and improvement in quality of life. Our technology has continued to demonstrate the potential to address this urgent need, and these continued technical achievements enable us to support a labeling indication to commercialize the Autonomix Sensing and RF Ablation System in the United States as a treatment for pancreatic cancer pain,” Autonomix CEO Brad Hauser said. “This design lock represents a meaningful milestone in the advancement of our technology development, placing us another step closer to commencing a pivotal clinical trial, planned in the second half of 2025, and beyond to potential De Novo clearance. The preliminary data from our ongoing first-in-human proof-of-concept study continues to bolster our confidence and demonstrate the potential of our technology to treat chronic pain. We are pleased with the continued progress and look forward to further exploring the potential of our innovative technology.”

With the successful completion of animal testing and design lock for its RF technology, Autonomix Medical expects to submit an Investigational Device Exemption with the U.S. Food and Drug Administration (FDA) and begin a clinical trial in the second half of the year to support an FDA De Novo application. Autonomix is building its team and the infrastructure required to support its clinical and regulatory initiatives in anticipation of the FDA approval process.

The company’s first-in-class technology platform uses a catheter-based microchip sensing array antenna that has the ability to detect and differentiate neural signals with up to 3,000 times greater sensitivity than currently available technologies. Once target nerves are identified, Autonomix uses its proprietary RF technology to ablate nerves, enabling a precision guided sense, treat, and verify approach to addressing a number of disease categories from chronic pain management to hypertension and cardiology. Current approaches, primarily relying on opioids or invasive ethanol injections, can provide only limited relief and may lead to risky side effects.

Autonomix is a medical device company focused on changing the way nervous system diseases are diagnosed and treated. Its 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 approximately 3,000 times greater sensitivity than currently available technologies. Such a solution could enable, for the first time ever, transvascular diagnosis and treatment of diseases involving the peripheral nervous system virtually anywhere in the body.

Autonomix is initially developing this technology for treating pain, with initial trials focused on pancreatic cancer, a condition that causes debilitating pain and is without a reliable solution. Its technology constitutes a platform to address dozens of potential indications, including cardiology, hypertension, and chronic pain management, across a wide disease spectrum. The RF technology is investigational and has not yet been cleared for use in the United States.