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 ...

Continued efforts to build team and infrastructure required to support clinical and regulatory initiatives in anticipation of the FDA approval process for first-in-class catheter-based sensing technology Company remains on track to submit an Investigational Device Exemption ("IDE"), and if approved, will commence a pivotal clinical trial in 2025 to support a De Novo application for FDA approval THE WOODLANDS, TX , Dec. 19, 2024 (GLOBE NEWSWIRE) -- Autonomix Medical, Inc. (NASDAQ:AMIX) ("Autonomix" or the "C ...

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 ...

THE WOODLANDS, TX, Nov. 25, 2024 (GLOBE NEWSWIRE) -- Autonomix Medical, Inc. (NASDAQ: AMIX) (“Autonomix” or the “Company”), a medical device company focused on advancing precision nerve-targeted treatments, today announced the closing of its previously announced underwritten public offering of common stock units and pre-funded warrant units for aggregate gross proceeds of approximately $10.0 million, prior to deducting underwriting discounts and commissions and offering expenses, which amount includes the p ...

THE WOODLANDS, TX, Nov. 22, 2024 (GLOBE NEWSWIRE) -- Autonomix Medical, Inc. (NASDAQ: AMIX) (“Autonomix” or the “Company”), a medical device company focused on advancing precision nerve-targeted treatments, today announced the pricing of an underwritten public offering of common stock units and pre-funded warrant units for aggregate gross proceeds of approximately $9.0 million prior to deducting underwriting discounts and commissions and offering expenses. The equity offering is comprised of 1,376,287 commo ...

UNITED STATES SECURITIES AND EXCHANGE COMMISSION Washington, D.C. 20549 FORM 8-K CURRENT REPORT Pursuant to Section 13 or 15(d) of the Securities Exchange Act of 1934 Date of Report (Date of earliest event reported): November 11, 2024 Autonomix Medical, Inc. (Exact name of registrant as specified in its charter) Delaware 001-41940 47-1607810 (State or other jurisdiction of incorporation or organization) (Commission File Number) (I.R.S. Employer Identification No.) 21 Waterway Avenue, Suite 300 The Woodlands ...