THE WOODLANDS, TX — January 4, 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 provided a business overview and highlighted upcoming milestones.
Lori Bisson, Chief Executive Officer of Autonomix, commented, “Autonomix is dedicated to dramatically improving the quality of millions of lives by empowering the nerve-directed treatments of tomorrow. We continue to progress in the development of our groundbreaking technology and believe we have the opportunity to address the significant, pressing need for more effective and targeted solutions to improve the quality of life for patients across a number of high-value indications. We have positioned the Company to achieve transformational corporate and development milestones in 2024.”
The Company’s catheter-based sensing technology is being developed to do two things: sense neural signals associated with pain or disease and precisely target those nerves for treatment. Autonomix believes this technology is a better alternative to the current approaches commonly used today, where doctors either rely on systemic drugs like opioids that lose effectiveness and have unwanted side effects or treat suspected areas blindly in hopes of hitting the right nerves, an approach that is often inaccurate and can miss the target and even cause collateral damage to surrounding parts of the body.
Technology Highlights
- First-in-class electrophysiology technology with 3000 times greater ability (based on non-clinical testing) to detect and differentiate peripheral neural signals than the closest available technology on the market today.
- Extensive IP portfolio consisting of 15 distinct wholly owned patent families and over 100 patents, issued and pending.
- Catheter-deployed microchip converts analog signals from the body to a digital signal that can be sent directly to a computer screen.
- Sensing antenna is sensitive enough to detect signals as low as 0.5 microvolts (as opposed to the 10-15 microvolt minimum detectable by current technology). The unique basket design can locate neural signals in a 3D space for the most precise treatment possible.
- Advancing toward ability to locate, ablate and confirm successful ablation of specific nerves.
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.
Development Program Highlights
- 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 blockbuster diseases, expanding the horizons for the Company’s technology.
- Leveraging a number of cost-efficient advantages, particularly around clinical trial development. The smaller and shorter clinical trials potentially translate to more efficient resource utilization, minimizing overall development costs.
Expected Upcoming Milestones
- 2024: Complete animal safety sensing study
- 2024: Complete establishment of engineering development team
- 2024: Launch of first-in-human study in the reduction of pancreatic cancer pain
- 2024: Complete ablation device design intended for clinical use
- 2025: Complete development of ablation system and catheter in preparation for human pivotal trial
- 2025: Launch combined sensing / ablation clinical trial
- 2026: De novo submission
- 2027: FDA clearance
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.
For more information, visit autonomix.com and connect with the Company on Twitter, LinkedIn 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 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.
Investor Relations Contact
JTC Team, LLC
Jenene Thomas
833-475-8247