Core Insights - Autonomix Medical, Inc. has initiated a Good Laboratory Practice (GLP) preclinical study for its Sensing and RF Ablation System aimed at treating pancreatic cancer pain, marking a significant step towards regulatory approval [1][2][3] - The company is on track to submit an Investigational Device Exemption (IDE) to the FDA, with plans to commence U.S. clinical trials in 2026 if approved [1][3] - Autonomix's technology platform has the potential to address multiple high-need therapeutic areas, including cardiology, resistant hypertension, interventional pain management, and gastrointestinal disorders [4][7] Company Overview - Autonomix is focused on advancing innovative technologies for diagnosing and treating diseases related to the nervous system, utilizing a catheter-based microchip sensing array for enhanced neural signal detection [6][7] - The company's initial development efforts are concentrated on pain management, specifically targeting pancreatic cancer, which currently lacks effective treatment options [7] Research Institute Collaboration - The GLP study is being conducted at CBSET, a leading translational research institute in Massachusetts, known for its high-quality biomedical research services [5]

Core Viewpoint - Autonomix Medical, Inc. has initiated a Good Laboratory Practice (GLP) preclinical study for its Sensing and RF Ablation System aimed at treating pancreatic cancer pain, marking a significant step towards regulatory approval and potential clinical trials in the U.S. by 2026 [1][2][3] Company Overview - Autonomix is focused on advancing innovative medical technologies for diagnosing and treating diseases related to the nervous system, utilizing a first-in-class platform technology that includes a catheter-based microchip sensing array [6][7] - The company's technology aims to provide transvascular diagnosis and treatment of peripheral nervous system diseases, with initial development targeting pain management in pancreatic cancer [7] Regulatory Pathway - The GLP study is essential for ensuring the reliability and integrity of Autonomix's devices, which is a prerequisite for submitting data to the FDA for Investigational Device Exemption (IDE) clinical trials [2] - The company is on track to file its IDE application, with plans to commence clinical studies in the following year if approved [3] Technological Potential - Autonomix's technology has the potential to address multiple high-need therapeutic areas, including cardiology, resistant hypertension, interventional pain management, and gastrointestinal disorders [4][6] - The platform is designed to tackle a wide spectrum of diseases, indicating a broad market opportunity for the company [7]

As filed with the Securities and Exchange Commission on September 23, 2025. UNITED STATES SECURITIES AND EXCHANGE COMMISSION Washington, D.C. 20549 FORM S-1 REGISTRATION STATEMENT UNDER THE SECURITIES ACT OF 1933 AUTONOMIX MEDICAL, INC. (Exact Name of Registrant as Specified in Its Charter) (State or Other Jurisdiction of Incorporation or Organization) Delaware 3841 47-1607810 (Primary Standard Industrial Classification Code Number) (I.R.S. Employer Identification Number) 21 Waterway Avenue, Suite 300 The W ...

Core Insights - Autonomix Medical, Inc. is presenting findings from its first-in-human proof-of-concept clinical trial at the 2025 CIRSE Annual Congress in Barcelona, Spain, from September 13-17, 2025 [1] - The presentation will focus on the application of artificial intelligence in interventional radiology, specifically addressing pain mitigation in pancreatic adenocarcinoma through neurolysis via transvascular radiofrequency ablation [2] Company Overview - Autonomix is a medical device company dedicated to advancing technologies for diagnosing and treating diseases of the nervous system, utilizing a catheter-based microchip sensing array for enhanced neural signal detection [4] - The company's initial focus is on treating pain associated with pancreatic cancer, a condition currently lacking reliable treatment options, with potential applications across various medical fields including cardiology and chronic pain management [5] Event Details - The presentation will be led by Marco Bedoya, VP of Research and Development, during the session titled "AI in IR: Machine Learning, SOP and Collaborative Development" on September 15, 2025, from 4:15 PM to 5:15 PM CEST [2]

Core Insights - Autonomix Medical, Inc. has announced positive results from a post hoc analysis of its proof-of-concept human clinical trial ("PoC 1"), highlighting sustained pain reduction, quality of life improvements, and 100% opioid-free outcomes [2][4] Company Overview - Autonomix is a medical device company focused on innovative technologies for diagnosing and treating diseases of the nervous system, utilizing a first-in-class catheter-based microchip sensing array [3] - The technology aims to enable transvascular diagnosis and treatment of peripheral nervous system diseases, potentially applicable across various medical fields [3][4] Technology Development - The initial focus of the technology is on pain management, particularly for pancreatic cancer, which is known for causing severe pain and lacks effective treatment options [4] - The platform technology has the potential to address multiple indications, including cardiology, hypertension, and chronic pain management [4]

As filed with the Securities and Exchange Commission on September 3, 2025. UNITED STATES SECURITIES AND EXCHANGE COMMISSION Washington, D.C. 20549 AMENDMENT NO. 1 FORM S-1 REGISTRATION STATEMENT UNDER THE SECURITIES ACT OF 1933 AUTONOMIX MEDICAL, INC. (Exact Name of Registrant as Specified in Its Charter) | Delaware | 3841 | 47-1607810 | | --- | --- | --- | | (State or Other Jurisdiction of | (Primary Standard Industrial | (I.R.S. Employer | | Incorporation or Organization) | Classification Code Number) | I ...

Core Insights - Autonomix Medical, Inc. has reported long-term data indicating a nearly 66% reduction in pain for patients with severe pancreatic cancer pain, with a mean reduction of 5.08 on the VAS pain scale [1][7] - 100% of responders were opioid-free at the 3-month follow-up, highlighting the potential of the technology as a non-opioid alternative for pain management [2][7] - The company is expanding its proof-of-concept studies to include additional visceral cancers, indicating a broader market opportunity [3][4] Group 1: Study Results - The PoC 1 study demonstrated statistically significant pain relief as early as 24 hours post-procedure, with sustained relief lasting up to five months [3][9] - Responding patients reported a mean 76.5% improvement in global health and a 51.5% improvement in functional ability at 7 days post-procedure [7][9] - The study enrolled 20 patients, with 19 treated successfully, and showed a strong safety profile with no serious adverse events related to the procedure [11][9] Group 2: Technology and Market Potential - Autonomix's technology is a platform that could address various indications, including cardiology and chronic pain management, beyond just cancer pain [4][12] - The follow-on PoC 2 phase aims to evaluate pain management for additional visceral cancers, expanding the potential addressable market significantly [3][4] - The company's catheter-based microchip sensing array technology is designed to detect and differentiate neural signals, which may enhance treatment efficacy [10][12]

Core Insights - Autonomix Medical, Inc. is set to present at the H.C. Wainwright 27th Annual Global Investment Conference from September 8-10, 2025, in New York, NY [1] - The company focuses on innovative technologies for diagnosing and treating diseases of the nervous system, with a first-in-class platform technology that includes a catheter-based microchip sensing array [4][5] - The initial application of this technology is aimed at treating pain associated with pancreatic cancer, a condition currently lacking reliable treatment options [5] Company Overview - Autonomix Medical, Inc. specializes in medical devices that aim to revolutionize the diagnosis and treatment of nervous system diseases [4] - The company's technology is designed to detect and differentiate neural signals with greater sensitivity than existing technologies, enabling transvascular diagnosis and treatment of peripheral nervous system diseases [4] - The investigational technology has not yet received marketing clearance in the United States [5] Conference Participation - Management will be available for in-person one-on-one meetings with qualified investors registered for the conference [2] - A video webcast of the presentation will be available on-demand starting September 8, 2025, at 7:00 AM ET, and will be archived for 90 days [3]

As filed with the Securities and Exchange Commission on August 20, 2025. Registration No. 333- UNITED STATES SECURITIES AND EXCHANGE COMMISSION Washington, D.C. 20549 FORM S-1 REGISTRATION STATEMENT UNDER THE SECURITIES ACT OF 1933 AUTONOMIX MEDICAL, INC. (Exact Name of Registrant as Specified in Its Charter) (State or Other Jurisdiction of Incorporation or Organization) Delaware 3841 47-1607810 (Primary Standard Industrial Classification Code Number) (I.R.S. Employer Identification Number) 21 Waterway Aven ...

Core Insights - Autonomix Medical, Inc. has been granted a new patent, strengthening its position in a multi-billion-dollar market for medical devices targeting cardiovascular, renal, and other high-burden diseases [1][2] Patent and Technology - The newly issued Patent No. 3,697,298 ('298 patent) relates to a medical device that captures and processes physiological signals for real-time monitoring, applicable in various fields including coronary artery mapping and neurotherapy [1][3] - The '298 patent enhances the company's competitive edge by protecting its proprietary technology, which is expected to create diverse revenue streams and expand its global presence [2][3] Technology Platform - Autonomix's technology platform features a catheter-based microchip sensing array that can detect neural signals with greater sensitivity than existing technologies, enabling precision-guided treatment for conditions like chronic pain and hypertension [4][6] - The system includes distributed signal acquisition modules that improve data integrity during neural mapping, with key elements such as miniaturization and noise reduction [3][4] Development Focus - The company is initially focusing on developing its technology for treating pancreatic cancer, a condition associated with severe pain and lacking reliable treatment options [7] - The technology has the potential to address a wide range of indications, including cardiology and chronic pain management, across various disease categories [7]