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Autonomix Medical, Inc. Drives Towards U.S. Pivotal Trial with Appointment of Vice President, Regulatory Affairs and Quality
Autonomix MedicalAutonomix Medical(US:AMIX) Newsfilterยท2024-12-19 13:30

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]