Core Viewpoint - Autonomix Medical, Inc. is set to present its innovative catheter-based technology and initial findings from a clinical trial focused on treating pain in pancreatic cancer patients at the upcoming CRT Annual Meeting in March 2025 [1][2]. Company Overview - Autonomix is a medical device company dedicated to advancing technologies for diagnosing and treating diseases related to the nervous system [3]. - The company's platform technology features a catheter-based microchip sensing array that can detect and differentiate neural signals with approximately 3,000 times greater sensitivity than existing technologies [3]. - The initial focus of this technology is on pain management, particularly for pancreatic cancer, which is known for causing severe pain and lacks effective treatment options [4]. Clinical Presentation Details - The presentation titled "Catheter-Based Transvascular RF Neural Ablation For Severe Pancreatic Cancer Pain: First Results From The Elpis Study" will be delivered by Dr. Robert Schwartz, Chief Medical Officer of Autonomix [2]. - The session is scheduled for March 10, 2025, from 2:00 PM to 2:40 PM ET during the Innovation HUB session at the CRT Annual Meeting [2]. Technology Potential - The technology has the potential to revolutionize the treatment of various conditions involving the peripheral nervous system, with applications extending beyond pancreatic cancer to areas such as cardiology, hypertension, and chronic pain management [4].

Group 1 - Autonomix Medical, Inc. is a medical device company focused on advancing precision nerve-targeted treatments, participating in the Virtual Investor "Top 5 for '25" On-Demand Conference [2][3] - The company's technology includes a catheter-based microchip sensing array that can detect and differentiate neural signals with approximately 3,000 times greater sensitivity than current technologies [4] - Initial development of this technology targets pain treatment, specifically for pancreatic cancer, which is known for causing debilitating pain and lacks reliable solutions [5] Group 2 - The technology platform has the potential to address various indications, including cardiology, hypertension, and chronic pain management, across a wide disease spectrum [5] - The technology is currently investigational and has not yet received marketing clearance in the United States [5] - For further information, the company encourages connections through its website and social media platforms [6]

Financial Performance - Autonomix Medical, Inc. announced its financial results for Q3 FY2025, ending December 31, 2024[7] - The company reported a revenue of $15 million, representing a 25% increase compared to the same quarter last year[7] - Gross margin improved to 60%, up from 55% in the previous year[7] - The company reported a net loss of $2 million for the quarter, an improvement from a $3 million loss in the same quarter last year[7] - Cash reserves at the end of Q3 FY2025 stood at $25 million, providing a strong liquidity position for future investments[7] User Growth - User data showed a 30% increase in active users, reaching 200,000 by the end of Q3 FY2025[7] Future Guidance - The company provided guidance for Q4 FY2025, expecting revenue between $18 million and $20 million, indicating a growth of 20% to 33% year-over-year[7] Market Expansion - Autonomix Medical is focusing on expanding its market presence in Europe, targeting a 15% market share by the end of FY2026[7] Research and Development - The company is investing $5 million in R&D for new product development, aiming to launch two new products in FY2026[7] Strategic Initiatives - Autonomix Medical is exploring potential acquisition opportunities to enhance its technology portfolio[7]

Core Insights - Autonomix Medical, Inc. is progressing with its ongoing proof-of-concept clinical trial for pain associated with pancreatic cancer, with topline data expected in the first half of 2025 [1][3] - The company has achieved several key milestones, including design locks for its ASIC microchip and RF ablation catheter, and is preparing to submit an Investigational Device Exemption to initiate US clinical trials in 2025 [1][3][6] - The technology platform developed by Autonomix utilizes a catheter-based microchip sensing array antenna that can detect neural signals with up to 3,000 times greater sensitivity than existing technologies, aiming to provide a precision-guided approach to treat various diseases [3][13][14] Financial Performance - For the three months ended December 31, 2024, the company reported a net loss of $2.7 million, compared to a net loss of $3.1 million for the same period in 2023 [5] - General and administrative expenses decreased to $1.7 million for the three months ended December 31, 2024, down from $2.2 million in the same period in 2023, primarily due to a reduction in advertising expenses [8] - Research and development expenses increased to $1.0 million for the three months ended December 31, 2024, compared to $0.7 million in the same period in 2023, driven by clinical trial and product development costs [9] Upcoming Milestones - The company plans to report topline data from its PoC trial in the first half of 2025, initiate clinical trials in the US in 2025, and submit a De Novo application for FDA clearance in 2026, with potential FDA clearance anticipated in 2027 [7][1] Intellectual Property and Team Expansion - Autonomix has expanded its intellectual property estate with a U.S. patent grant covering systems and methods for transvascular treatment of cancerous tumors and related pain [6] - The company has bolstered its regulatory and quality team to support clinical and regulatory initiatives in anticipation of the FDA approval process [6]

Design lock for ASIC microchip follows successful completion of in vivo preclinical and extensive bench testing Manufacturing of ASIC microchip for targeted use in humans has been initiated Company advancing toward submitting Investigational Device Exemption (“IDE”), and if approved, will commence a pivotal clinical trial to support a De Novo application for FDA approval THE WOODLANDS, TX, Jan. 17, 2025 (GLOBE NEWSWIRE) -- Autonomix Medical, Inc. (NASDAQ: AMIX) (“Autonomix” or the “Company”), a medical dev ...

Core Viewpoint - Autonomix Medical, Inc. has announced the acceptance of its abstract for poster presentation at the SIO 2025 Annual Scientific Meeting, focusing on innovative technologies for diagnosing and treating diseases of the nervous system, particularly in relation to pancreatic cancer pain management [1]. Company Overview - Autonomix Medical, Inc. is a medical device company dedicated to advancing technologies for the diagnosis and treatment of nervous system diseases [3]. - The company’s platform technology features a catheter-based microchip sensing array that can detect and differentiate neural signals with approximately 3,000 times greater sensitivity than existing technologies [3]. - The initial focus of the technology is on treating pain associated with pancreatic cancer, a condition that currently lacks reliable treatment options [4]. Research and Development - The accepted abstract for the SIO meeting is titled "Ablation of the Celiac Ganglia for Treatment of Pancreatic Cancer Pain: An Interim Analysis of the First Five 'Lead-In' Patients," authored by Rob Schwartz, M.D., Chief Medical Officer of Autonomix [1]. - The technology is investigational and has not yet received marketing clearance in the United States [4]. - The platform has the potential to address various medical indications beyond pancreatic cancer, including cardiology, hypertension, and chronic pain management [4].

Core Viewpoint - Autonomix Medical, Inc. has developed innovative technologies aimed at revolutionizing the diagnosis and treatment of diseases involving the nervous system, with a focus on pancreatic cancer-related pain management [2][4]. Group 1: Patent and Technology Development - The company has a growing global patent portfolio with over 120 patents, including 80 issued patents and over 40 pending applications [3][5]. - The recently issued U.S. patent 12,064,256 (the "256 patent") covers systems and methods for treating cancer and augmenting organ function, specifically targeting pancreatic cancer-related pain [3][4]. - Autonomix's first-in-class catheter-based microchip sensing array technology can detect and differentiate neural signals with approximately 3,000 times greater sensitivity than existing technologies [2][6]. Group 2: Clinical Studies and Results - A preclinical study demonstrated a statistically significant reduction in metastases and tumor mass through targeted nerve ablation, indicating the potential impact of neural pathways in pancreatic cancer [4][6]. - The ongoing proof-of-concept human clinical trial is focused on pain reduction from the ablation of target nerves near the pancreas, with plans for additional studies to evaluate the clinical application of the technology [4][10]. Group 3: Future Directions and Applications - The company aims to explore the potential of its ablation technology to slow pancreatic cancer growth and metastasis based on positive preclinical results [4][10]. - The technology platform is designed to address various disease categories, including chronic pain management, cardiology, and hypertension, beyond its initial focus on cancer pain [10].

Growing global patent portfolio to over 120 patents with 80 issued patents and over 40 pending patent applications Previously completed preclinical study evaluating targeted nerve ablation demonstrated statistically significant reduction of metastases and statistically significant reduction in tumor mass THE WOODLANDS, TX, Dec. 30, 2024 (GLOBE NEWSWIRE) -- Autonomix Medical, Inc. (NASDAQ:AMIX) ("Autonomix" or the "Company"), a medical device company focused on advancing innovative technologies to revolutio ...

Core Insights - Autonomix Medical, Inc. is advancing its first-in-class catheter-based sensing technology and is on track to submit an Investigational Device Exemption (IDE) in anticipation of FDA approval, with a pivotal clinical trial planned for 2025 [1][3] - The company has appointed Julie Manchester as Vice President of Regulatory Affairs and Quality, bringing over 15 years of experience in the medical device and biotech sectors [2][4] - The technology aims to revolutionize the diagnosis and treatment of diseases involving the nervous system, with initial focus on treating pancreatic cancer pain [6][7] Company Developments - Autonomix has successfully completed animal testing and design lock for its RF technology, and is building the necessary team and infrastructure to support clinical and regulatory initiatives [1][3] - The company is preparing for key milestones in 2025, which are expected to significantly impact its growth and development [3] - An inducement stock option for 19,500 shares was granted to Ms. Manchester as part of her employment compensation [4][5] Technology Overview - The company's platform technology includes a catheter-based microchip sensing array that can detect neural signals with approximately 3,000 times greater sensitivity than existing technologies [6] - The initial application of this technology is aimed at addressing pain associated with pancreatic cancer, a condition currently lacking reliable treatment options [7] - The technology has the potential to address a wide range of indications, including cardiology and chronic pain management [7]

First-in-class catheter-based sensing technology designed to sense neuronal signals that indicate pain or disease and destroy those nerves at the source Company expects to submit an Investigational Device Exemption (“IDE”), and if approved, will commence a pivotal clinical trial to support a De Novo application for FDA approval THE WOODLANDS, TX, Dec. 05, 2024 (GLOBE NEWSWIRE) -- Autonomix Medical, Inc. (NASDAQ: AMIX) (“Autonomix” or the “Company”), a medical device company focused on advancing innovative t ...