Autonomix Medical Completes Pre-Submission Meeting With FDA For Its Transvascular Sensing Platform

Autonomix Medical, Inc. (NASDAQ: AMIX ) ("Autonomix" or the "Company"), a medical device company dedicated to advancing precision nerve-targeted treatments, today 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. The FDA interaction provided important guidance regarding Autonomix’s proposed regulatory strategy, validation activities and anticipated submission pathway for the Company’s standalone sensing platform. Based on feedback received, the Company believes it has identified a Class II regulatory pathway that would use an already-cleared reference device to support a substantial-equivalence strategy for its standalone sensing platform. Subject to successful completion of development and validation activities, and FDA review, Autonomix is targeting potential U.S. clearance in approximately 15 months.