Full Press Release Details
Design lock for ASIC microchip follows successful completion of in vivo preclinical and extensive bench testing
Manufacturing of ASIC microchip for targeted use in humans has been initiated
Company advancing toward submitting 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, Jan. 17, 2025 (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 it has finalized the design, achieving “design lock”, for its Application Specific Integrated Circuits (ASIC) microchip following the successful completion of in vivo preclinical testing and extensive bench testing, continuing progress toward its U.S. pivotal trial.
“This design lock represents a significant milestone in the advancement of our innovative technology, placing us another step closer to commencing a pivotal clinical trial in the United States, planned in 2025. The ASIC microchip is at the core of our intellectual property portfolio and enables and differentiates our ability to sense the small amplitude of nerve signals through the vasculature. These continued technical achievements should 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.
Mr. Hauser added, “Pain has a significant impact on the lives of patients with pancreatic cancer and there continues to be a much-needed shift in the treatment paradigm for pancreatic cancer patients. Our technology has continued to demonstrate the potential to address this unmet need and offer a reduction of pain and improvement in quality of life for these patients.”
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 the pain associated with pancreatic cancer and the timing of the commencement of a pivotal clinical trial in the United States. 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.
Investor and Media Contact
Tags
Design of ASIC Microchip
U.S. Pivotal Trial in 2025