THE WOODLANDS, TX — January 12, 2024 – Autonomix Medical, Inc. (“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 successful completion of an animal safety study evaluating the Company’s proprietary ablation technology. All safety inputs for the study were met. No procedure-related side effects have been reported.
The safety study was designed to assess acute safety and feasibility of tissue ablation in a porcine multi-arterial model. Key aspects evaluated during the study included the ability to reach distal artery regions ablation targets using the catheter, perform the ablation steps effectively, and monitor for potential adverse effects in a 3-day observation period following ablation. Findings in the study demonstrated successful energy delivery, with no acute complications using several of the Company’s proprietary ablation catheters.
“We are very pleased with the outcome of this important safety study, and we continue to execute on developing our potentially groundbreaking technology. The successful completion of this preclinical safety study provides us with supportive data as we advance toward our first-in-human clinical study, a catalytic milestone for Autonomix,” commented Lori Bisson, Chief Executive Officer of Autonomix.
Dr. Robert Schwartz, Co-Founder and Chief Medical Officer of Autonomix added, “The nervous system plays a critical part in every key bodily function. There is a critical need for a tool to sense, target and influence neuronal signals safely and reliably that can provide a significant benefit in pain management and other nerve-related disorders across a number of high-value indications. This successful safety animal study gives us optimism moving forward toward eventual clinical application in humans. The study shows promise for safety in transvascular ablation of the nerves in the pancreatic region, which may reduce pain for these patients.”
Based on the successful completion of the ablation animal safety study, the Company is advancing towards its first-in-human clinical study for the use of RF ablation in the reduction of pancreatic cancer pain, which is expected to commence enrollment in Q1 2024.
The Company is initially developing its technology to address pancreatic cancer-related pain. Current approaches, primarily relying on opioids or invasive ethanol injections, can provide only limited relief and may lead to risky side effects. Pancreatic cancer pain, as the first target indication, could offer distinct development benefits that can accelerate Autonomix’s market entry, especially in terms of clinical trials. Achieving “proof-of-concept” in this area could open the door to novel, blockbuster disease treatment and expand the horizons for the Company’s technology.
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 technology platform includes a catheter-based microchip sensing array that has 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 our technology for pancreatic cancer pain and pancreatitis pain, conditions that can cause debilitating pain and need an effective solution. However, our technology constitutes a platform with the potential to address dozens of indications, including in cardiology, renal denervation and chronic pain management across a wide disease spectrum.
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 ability of Autonomix to successfully develop its technology platform on a timely basis. Such forward-looking statements can be identified by the use of words such as ‘’should,‘’ ‘’may,‘’ ‘’intends,‘’ ‘’anticipates,‘’ ‘’believes,‘’ ‘’estimates,‘’ ‘’projects,‘’ ‘’forecasts,‘’ ‘’expects,‘’ ‘’plans,‘’ and ‘’proposes.‘’
Although Autonomix Medical, Inc. (or 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 offering statement filed with the U.S. Securities and Exchange Commission (“SEC”). 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.
The offering will be made only by means of an offering circular. An offering statement on Form 1-A relating to these securities has been filed with the SEC and has become qualified. The securities offered by Autonomix are highly speculative. Investing in shares of Autonomix involves significant risks. The investment is suitable only for persons who can afford to lose their entire investment. Furthermore, investors must understand that such investment could be illiquid for an indefinite period of time. No public market currently exists for the securities, and if a public market develops following the offering, it may not continue.
Autonomix intends to list its securities on a national exchange and doing so entails significant ongoing corporate obligations, including but not limited to disclosure, filing and notification requirements, as well compliance with applicable continued quantitative and qualitative listing standards. For additional information on Autonomix, the offering and any other related topics, please review the registration statement that can be found at the following location EDGAR Entity Landing Page (sec.gov). Additional information concerning Risk Factors related to the offering, including those related to the business, government regulations, intellectual property and the offering in general, can be found in the risk factor section of the Form 1-A offering circular.
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