Core Viewpoint - Autonomix Medical, Inc. is preparing to commence U.S. clinical studies in 2025 to support a De Novo application for FDA approval of its innovative medical technology aimed at diagnosing and treating diseases of the nervous system [1][3]. Company Overview - Autonomix Medical, Inc. is focused on advancing technologies for the diagnosis and treatment of nervous system diseases, featuring a first-in-class platform system technology that includes a catheter-based microchip sensing array [4]. - The technology is designed to detect and differentiate neural signals with up to 3,000 times greater sensitivity than existing technologies, enabling transvascular diagnosis and treatment of peripheral nervous system diseases [4]. Clinical Development - The company is initially developing its technology for pain treatment, specifically targeting pancreatic cancer, which is known for causing severe pain and lacks reliable treatment options [5]. - The technology has the potential to address a wide range of indications, including cardiology, hypertension, and chronic pain management [5]. Expert Engagement - Autonomix has engaged a team of U.S. and international medical experts in interventional radiology and cancer pain to guide its clinical and regulatory path, ensuring that pre-clinical and clinical studies align with the needs for the FDA De Novo submission expected in 2026 [1][2][3].
Autonomix Medical, Inc. Engages Leading Medical Experts to Guide U.S. Clinical and Regulatory Path in Pancreatic Cancer Pain