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THE WOODLANDS, TX - Autonomix Medical, Inc. (NASDAQ: AMIX), a medical device company specializing in technologies for nervous system diseases, has announced plans to start U.S. clinical studies in 2025. With a current market capitalization of just $4 million and a healthy current ratio of 5.31, the company maintains more cash than debt on its balance sheet. This move is part of the company's strategy to secure a De Novo application for FDA approval expected in 2026. According to InvestingPro analysis, the company's financial health score indicates challenges ahead, with rapid cash burn being a key concern.
The company has enlisted the expertise of U.S. and international medical professionals in interventional radiology and cancer pain management. Among the advisors are past presidents of the Society of Interventional Radiology, Dr. Michael Brunner and Dr. Katharine Krol, as well as Dr. Patricio Polanco of UT Southwestern and Dr. Nikola Cesarovic of ETH Zürich.
CEO Brad Hauser expressed confidence in the progress made by the team and the potential impact of their first-in-class platform system technology. This technology includes a catheter-based microchip sensing array that could significantly enhance the sensitivity of neural signal detection and differentiation.
Autonomix's initial focus is on treating pain associated with pancreatic cancer, a condition currently lacking effective solutions. The company's technology is still investigational and has not received marketing clearance in the United States.
This announcement is based on a press release statement, and the company has cautioned that forward-looking statements involve risks and uncertainties. These statements reflect the company's current expectations and are subject to change. Autonomix has also advised reviewing the cautionary statements and disclosures in its Annual Report filed with the SEC.
Investors and media seeking further information can contact Autonomix's representation at JTC Team, LLC.
In other recent news, Autonomix Medical, Inc. announced the completion of a major milestone in its Sensing and RF Ablation System development, which is set to begin clinical trials for pancreatic cancer pain treatment in 2025. This follows the successful integration of the Apex 6 Radiofrequency Generator, acquired from RF Innovations, into their system. The company has also finalized the design of its Application Specific Integrated Circuit (ASIC) microchip, following successful preclinical and bench testing. This microchip is crucial for detecting nerve signals with higher sensitivity than current technologies. Autonomix plans to submit an Investigational Device Exemption to the FDA, aiming for a pivotal clinical trial in the U.S. The company’s technology, still investigational, could potentially be applied to a variety of conditions, including cardiology and chronic pain management. CEO Brad Hauser highlighted the urgent need for improved treatment options for pancreatic cancer patients, expressing optimism about the potential impact on patient quality of life. Autonomix's collaboration with RF Innovations' manufacturing partner is part of its strategy to support equipment development. These developments mark significant steps towards seeking FDA approval and advancing their innovative technology.
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