Core Insights - Autonomix Medical, Inc. has received Ethics Committee authorization to expand its clinical trials for a proprietary ablation technology aimed at treating visceral cancer pain, building on initial success in pancreatic cancer pain [2][3] - The follow-on phase of the clinical program (PoC 2) is set to begin patient enrollment in June 2025, with the potential to double the addressable market by including additional visceral cancers [2][3][4] Group 1: Clinical Development - The PoC 2 phase will evaluate the safety and effectiveness of delivering transvascular energy to ablate problematic nerves, with a focus on interventional cancer pain management applications [2][4] - Initial trials in late-stage pancreatic cancer patients showed promising results, including significant pain reduction and decreased opioid use, indicating the technology's potential to transform cancer pain management [3][4] Group 2: Market Expansion - The expansion into visceral cancer pain aligns with Autonomix's strategy to create long-term value through multi-indication growth, addressing significant unmet needs in cancer treatment [3][4] - The technology platform has the potential to address various indications beyond cancer, including cardiology and chronic pain management, indicating a broad market opportunity [4][6][7] Group 3: Technology Overview - Autonomix's technology includes a catheter-based microchip sensing array designed to detect and differentiate neural signals with greater sensitivity than existing technologies [6][7] - The investigational nature of the technology means it has not yet been cleared for marketing in the United States, highlighting its developmental stage [7]

Core Insights - Autonomix Medical, Inc. (AMIX) has been granted a U.S. patent for its catheter-based platform that senses and differentiates nerve signals in real-time, marking a significant advancement in neuromodulation technology [1][4] - The patented technology aims to improve treatment precision for chronic conditions such as cancer and pain management, addressing the need for more accurate therapies in modern medicine [2][4] Company Developments - The patent approval strengthens AMIX's long-term business by securing exclusive rights to its nerve-sensing and stimulation technology, positioning the company as a first-mover in a high-demand market [4][6] - AMIX plans to submit an Investigational Device Exemption (IDE) and initiate U.S. clinical trials in 2025, with pancreatic cancer pain as its first commercial indication [10] Market Performance - Following the patent announcement, AMIX shares have remained flat, with a year-to-date decline of 52.1%, compared to the industry’s decline of 7.7% and a slight gain of 0.3% for the S&P 500 [3] - The company currently has a market capitalization of $4.4 million and a price-to-book ratio of 0.5X, significantly lower than the industry average of 2.30X [5] Technology Features - The patented technology includes advanced features such as flexible "microfingers" with built-in sensors for real-time monitoring, enabling a comprehensive approach to nerve treatment [9] - The system allows for the identification and ablation of overactive nerves using a minimally invasive method, offering a promising alternative to traditional treatments [8][9]

Core Viewpoint - Autonomix Medical, Inc. has strengthened its intellectual property position in the nerve-mapping and denervation space with the issuance of U.S. Patent No. 12,257,071, which supports its mission to advance minimally invasive, nerve-focused therapeutics [1][2]. Patent and Technology - The newly issued '071 patent relates to advanced catheter-based systems that combine nerve mapping and radiofrequency (RF) ablation technologies, enhancing precision in treating nerve-related conditions [1][3]. - Key features of the '071 patent include deployable microfingers with embedded sensors for real-time physiological monitoring, the ability to map, stimulate, ablate, and assess nerve activity in a single integrated system, and feedback-driven control of multiple types of procedures [3][4]. - The technology is designed to treat conditions influenced by sympathetic nerve activity, including renal denervation for hypertension, chronic pain syndromes, and various metabolic and neurological disorders [3][4]. Clinical Development and Future Plans - The company plans to submit an Investigational Device Exemption (IDE) and commence U.S. clinical trials in 2025 to support commercialization of the Autonomix Sensing and RF Ablation System as a treatment for pancreatic cancer pain [5][7]. - Autonomix's technology platform aims to revolutionize the diagnosis and treatment of diseases involving the nervous system, with initial trials focused on pancreatic cancer, a condition that causes debilitating pain [6][7]. Market Position and Strategy - The issuance of the patent marks a key milestone in the company's strategy to transform pain management and treat neurological disorders through minimally invasive, catheter-based denervation [2][4]. - The company currently holds over 80 issued patents and 40 pending patent applications, indicating a strong and expanding global patent portfolio [1][2].

Core Viewpoint - Autonomix Medical, Inc. is participating in the Virtual Investor Closing Bell Series to showcase its innovative medical device technology focused on precision nerve-targeted treatments [2][3]. Company Overview - Autonomix Medical, Inc. is a medical device company dedicated to advancing technologies for diagnosing and treating diseases related to the nervous system [5]. - The company's first-in-class platform system technology features a catheter-based microchip sensing array designed to detect and differentiate neural signals with greater sensitivity than existing technologies [5][6]. Technology and Applications - The initial development of the technology is aimed at treating pain, specifically targeting pancreatic cancer, which is known for causing severe pain and lacks reliable treatment options [6]. - The technology has the potential to address a wide range of indications, including cardiology, hypertension, and chronic pain management, across various diseases [6]. Event Details - The event will feature a corporate overview by Brad Hauser, President and CEO, and will include a live Q&A session for investors and interested parties [3][4]. - The live video webcast will be accessible on the company's website, with a replay available for 90 days following the event [4].

Core Insights - Autonomix Medical, Inc. is set to initiate a follow-on phase ("PoC 2") of its proof-of-concept trial, focusing on the safety and effectiveness of transvascular energy delivery to alleviate cancer pain, with the expansion phase expected to start in Q2 2025 [2][3][4] Company Overview - Autonomix is a medical device company dedicated to advancing innovative technologies for diagnosing and treating diseases related to the nervous system [7][8] - The company's technology includes a catheter-based microchip sensing array designed to detect and differentiate neural signals with greater sensitivity than existing technologies [7] Market Expansion - The follow-on PoC 2 phase aims to evaluate additional visceral cancers, potentially doubling the addressable market beyond pancreatic cancer pain, by including gall bladder, liver, and bile duct cancers [3][4] - The initial phase (PoC 1) demonstrated significant pain reduction and decreased opioid use in patients with severe pancreatic cancer pain, leading to the decision to expand the investigation [4][5] Technology and Applications - Autonomix's technology is positioned as a platform capable of addressing various indications, including cardiology, hypertension, and chronic pain management, with a concentrated focus on interventional cancer pain management applications [5][8] - The company has established key opinion leader relationships and emerging preclinical evidence to support further expansion in oncology and gastroenterology sectors [5]

Core Viewpoint - Autonomix Medical, Inc. has released a video testimonial highlighting the effectiveness of transvascular nerve ablation in reducing pain for patients with severe pancreatic cancer, indicating a significant potential to improve quality of life in late-stage cancer care [2][3]. Company Overview - Autonomix Medical, Inc. is a medical device company focused on innovative technologies for diagnosing and treating diseases related to the nervous system [6][7]. - The company is developing a catheter-based microchip sensing array aimed at enhancing the detection and differentiation of neural signals, which may enable transvascular diagnosis and treatment of peripheral nervous system diseases [6][7]. Clinical Trial Insights - The initial phase of the first-in-human proof-of-concept trial (PoC 1) involved 20 patients with severe pancreatic cancer pain, demonstrating statistically significant pain relief as early as 24 hours post-procedure [3][5]. - Pain reduction was measured with a mean improvement of 4.16 on the Visual Analog Scale (VAS), representing a 53.3% improvement at 7 days post-procedure, and a mean reduction of 4.67 on the VAS, indicating a 59.2% improvement at 4-6 weeks post-procedure [3][5]. - 100% of responding patients achieved zero opioid use at 7 days post-procedure, with 73% remaining opioid-free at the 4-6 week follow-up [3][10]. Future Directions - Based on the positive outcomes from PoC 1, the company plans to expand the protocol into a follow-on phase (PoC 2), which will include pain management for additional visceral cancers and earlier-stage pancreatic cancer patients [3][4].

Core Insights - Autonomix Medical, Inc. has successfully completed the initial phase of its first-in-human proof-of-concept trial ("PoC 1") demonstrating clinically meaningful pain reduction in patients with pancreatic cancer pain [1][2] - The company plans to initiate a market expansion study ("PoC 2") targeting additional visceral cancers and earlier stage pancreatic cancer, expected to commence in Q2 2025 [1][2] Company Overview - Autonomix is a medical device company focused on innovative technologies for diagnosing and treating diseases involving the nervous system [3] - The company's platform technology includes a catheter-based microchip sensing array designed to detect and differentiate neural signals with greater sensitivity than existing technologies [3] - The initial development of this technology is aimed at treating pain associated with pancreatic cancer, a condition currently lacking reliable treatment options [4] Future Prospects - The technology has the potential to address a wide range of indications beyond pancreatic cancer, including cardiology, hypertension, and chronic pain management [4] - The investigational technology has not yet received marketing clearance in the United States [4]

Core Insights - Autonomix Medical, Inc. has successfully completed the initial trial phase ("PoC 1") for its innovative pain management technology, demonstrating significant pain reduction in patients with severe pancreatic cancer pain [1][2][5] - The company plans to initiate a follow-on market expansion study ("PoC 2") in Q2 2025, targeting additional visceral cancers and earlier stage pancreatic cancer, potentially doubling the addressable market [1][6][12] Group 1: Trial Results - The PoC 1 trial enrolled 20 patients, achieving clinically meaningful pain reduction with 100% of responders reporting zero opioid use at 7 days post-procedure and 73% remaining opioid-free at 4-6 week follow-up [1][2][8] - Pain relief was statistically significant, with a mean reduction of 3.32 on the Visual Analog Scale (VAS) at 7 days (baseline 7.61 to 4.29), representing a 43.6% improvement, and a mean reduction of 3.95 at 4-6 weeks (baseline 7.95 to 4.00), or 49.7% improvement [8][11] - Responding patients treated via femoral access showed a mean pain reduction of 4.16 at 7 days (baseline 7.81 to 3.65), or 53.3% improvement, and 4.67 at 4-6 weeks (baseline 7.89 to 3.22), or 59.2% improvement [8][11] Group 2: Safety and Quality of Life - The procedure demonstrated a strong safety profile, with no device or procedure-related serious adverse events reported, although there were 8 serious adverse events unrelated to the procedure [8][11] - Patients reported a 76% improvement in global quality of health at 7 days and a 42% improvement at 4-6 weeks post-procedure [8][11] Group 3: Future Directions - The follow-on PoC 2 phase will focus on interventional pain management for additional visceral cancers and earlier stage pancreatic cancer, with an amended trial protocol to gather more data on pain management [6][7][9] - Autonomix's technology platform has the potential to address a wide range of indications beyond cancer pain, including cardiology and chronic pain management [7][12][13]

Core Insights - Autonomix Medical, Inc. is set to present its technology and early proof-of-concept study results at EuroPCR 2025, a leading course in interventional cardiovascular medicine [1][4] - The presentation will focus on a catheter-based transvascular RF neural ablation technique aimed at alleviating severe pain associated with pancreatic cancer [2][6] Company Overview - Autonomix Medical, Inc. specializes in innovative medical device technologies targeting diseases of the nervous system, with a first-in-class platform that includes a catheter-based microchip sensing array [5][6] - The company's technology aims to enhance the detection and differentiation of neural signals, potentially enabling transvascular diagnosis and treatment of peripheral nervous system diseases [5][6] Technology Development - The initial focus of the technology is on treating pain, particularly in pancreatic cancer, which is known for causing severe discomfort and lacks effective treatment options [6] - The platform technology has the potential to address a wide range of indications, including cardiology, hypertension, and chronic pain management [6]

Core Viewpoint - Autonomix Medical, Inc. has received a new patent that enhances its catheter-based technology, indicating significant potential for application and expansion in treating diseases related to the nervous system [1][2]. Patent and Technology Development - The European Patent Office has granted Patent No. 3,226,792, which covers methods and systems for regulating organ and tumor growth, particularly in the field of neuromodulation [1]. - The company has a growing global patent portfolio with over 80 issued patents and 40 pending applications, showcasing its commitment to innovation [1][2]. Applications and Market Potential - The '792 patent includes methods to sense, ablate, and verify neurological traffic related to the prostate and lower urinary tract, potentially addressing conditions such as chronic prostatitis, hypogonadism, nocturia, and erectile dysfunction [3]. - The technology aims to target pain associated with pancreatic cancer by focusing on the celiac plexus, with plans to expand its applications to various peripheral nerve bundles [2][6]. Clinical Trials and Future Plans - The company is preparing to submit an Investigational Device Exemption (IDE) and commence U.S. clinical trials in 2025 for the Autonomix Sensing and RF Ablation System, aimed at treating pancreatic cancer pain [4]. - The technology is positioned as a platform that could address multiple indications across a wide disease spectrum, including cardiology and chronic pain management [6]. Company Overview - Autonomix Medical, Inc. is focused on advancing innovative technologies for diagnosing and treating diseases involving the nervous system, utilizing a catheter-based microchip sensing array for enhanced neural signal detection [5].