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AMIX 資訊
AMIX 事件
Autonomix Medical Completes FDA Pre-Submission Meeting
Autonomix Medical announced the successful completion of a pre-submission meeting with the U.S. Food and Drug Administration, FDA, regarding the Company's recently announced standalone transvascular sensing platform, which is designed to detect and differentiate faint biological signals. "This FDA interaction gives us greater clarity on the work required to pursue an initial U.S. clearance and represents a significant milestone in advancing our proprietary technology toward the U.S. market," said Brad Hauser, Chief Executive Officer of Autonomix. "We believe a focused pathway for the standalone sensing platform allows us to pursue a nearer-term regulatory objective, while we continue to build toward the larger opportunity for our technology. Our goal is to establish the sensing foundation first, then expand toward biosignal interpretation and, over time, procedural guidance."
Autonomix Medical Granted European Patent EP 4 233 700 B1
Autonomix Medical announced the grant of European Patent No. EP 4 233 700 B1, titled "Systems for Assessing Neural Activity in an Eye." "This European patent represents another important step in expanding our global intellectual property footprint," said Brad Hauser, Chief Executive Officer of Autonomix. "As we continue advancing our precision nerve-targeted technology platform, building a broad international patent portfolio remains a key strategic priority. This patent enhances protection for technologies supporting autonomic nervous system assessment and complements our growing portfolio covering precision nerve sensing, mapping and targeted neuromodulation."
Selling Stockholders Plan to Sell Up to 1.07M Shares
This filing relates to the offer and sale from time to time by the selling stockholders of up to 1.07M shares of common stock. The company is not selling any shares under this prospectus and will not receive any of the proceeds from the sale of shares by the selling stockholders.
Autonomix Secures U.S. Patent No. 12,714,780
Autonomix announced the issuance of U.S. Patent No. 12,714,780 by the United States Patent and Trademark Office, or USPTO, titled "Systems and Methods for Regulating Organ and/or Tumor Growth Rates, Function, and/or Development" on August 25. The newly issued patent covers medical systems incorporating a surgical instrument with one or more delivery elements and a controller configured to regulate treatment based, at least in part, on physiological feedback signals from a targeted tissue region or surrounding tissues. The patent specifically covers systems capable of controlling the quantity and delivery of therapeutic fluid based on its distribution within the targeted tissue, as well as systems incorporating imaging and sensing capabilities. Importantly, the issued patent includes applications in which the targeted tissue region comprises a tumor and the therapeutic fluid is configured to effect neural ablation to reduce cancer pain. The patent also covers the use of denervating agents, sympathetic and parasympathetic nerve-specific denervating agents and neuroblocking agents.
Autonomix Medical Completes FDA Preclinical Study
Autonomix Medical announced the successful completion of its Good Laboratory Practice preclinical study, a significant regulatory milestone supporting the company's submission to the FDA. The study was conducted in accordance with FDA Good Laboratory Practice standards and evaluated the safety, functionality and performance of the Autonomix platform across multiple clinically relevant anatomical targets in porcine models. Final histopathology and laboratory analyses support the positive safety and performance outcomes previously reported by the company. Data generated from the study are expected to support Autonomix's FDA submissions and represent an important component of the company's regulatory package as it advances its proprietary technology.
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