First-in-class catheter-based sensing technology designed to sense neuronal signals that indicate pain or disease and destroy those nerves at the source
Company expects to submit an Investigational Device Exemption ("IDE”), and if approved, will commence a pivotal clinical trial to support a De Novo application for FDA approval
THE WOODLANDS, TX, Dec. 05, 2024 (GLOBE NEWSWIRE) -- Autonomix Medical, Inc. (NASDAQ: AMIX) ("Autonomix” or the "Company”), a medical device company focused on advancing innovative technologies to revolutionize how diseases involving the nervous system are diagnosed and treated, today announced the milestone achievement of design lock for its radio frequency ("RF”) ablation catheter specifically designed to ablate nerves transvascularly in targeted areas following the successful completion of animal testing.
"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,” commented Brad Hauser, CEO of Autonomix. "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 our RF technology, the Company expects to submit an IDE and commence its pivotal clinical trial in the second half of 2025 to support a De Novo application for FDA approval. 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 utilizes 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.
For more information about the Company's technology, please visit autonomix.com.
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 approximately 3,000 times 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 potential of the technology to treat cancerous tumors and the pain associated with pancreatic cancer, to submit and receive approval of an IDE, and to file a De Novo application. 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 31, 2024. Forward-looking statements speak only as of the date of the document in which they are contained and Autonomix does not undertake any duty to update any forward-looking statements except as may be required by law.
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