Company developing potential breakthrough technology for the nervous system
Patented two-fold technology that can potentially detect problematic neural signals and ablate nerves in one simple procedure for pain management
Initially targeting multi-billion-dollar pancreatic cancer market
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.
• 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.