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Autonomix Medical, Inc. Initiates Good Laboratory Practice (GLP) Study for Sensing and RF Ablation System
Globenewswire· 2025-09-29 13:15
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]
Autonomix Medical, Inc. Demonstrates Sustained Pain Reduction, Quality of Life Gains and 100% Zero Opioid Use in Longer-Term Post Hoc Analysis from PoC 1 Study
Globenewswire· 2025-09-03 12:30
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]
Autonomix Medical, Inc. Exercise of Warrants for $2.5 Million Gross Proceeds
Globenewswire· 2025-07-22 12:30
Core Viewpoint - Autonomix Medical, Inc. has announced agreements for the immediate exercise of existing warrants, allowing the purchase of up to 1,477,596 shares of common stock at a reduced exercise price of $1.723 per share, expected to generate approximately $2.5 million in gross proceeds [1][4]. Group 1: Warrant Exercise and Financial Details - The company has entered into agreements with certain warrant holders for the immediate exercise of outstanding warrants, which were originally issued in November 2024 [1]. - The gross proceeds from the exercise of these warrants are anticipated to be around $2.5 million before placement agent fees [1]. - New unregistered warrants will be issued for the immediate exercise, allowing the purchase of the same number of shares at the same exercise price of $1.723 per share, valid for five and a half years [3]. Group 2: Transaction Closing and Use of Proceeds - The transaction is expected to close on or about July 23, 2025, pending customary closing conditions [4]. - The net proceeds from this offering will be utilized for working capital and general corporate purposes [4]. Group 3: Company Overview and Technology - Autonomix Medical is focused on advancing innovative technologies for diagnosing and treating diseases of the nervous system, utilizing a catheter-based microchip sensing array [7]. - The company is initially developing its technology for pain treatment, particularly targeting pancreatic cancer, and aims to address various conditions across a wide disease spectrum [8].