Autonomix Medical, Inc. announced on April 8, 2025, that it has engaged U.S. and international medical experts in interventional radiology and cancer pain. These experts will guide the company's U.S. clinical and regulatory path, ensuring that pre-clinical and clinical studies meet the requirements for an expected FDA De Novo submission in 2026.
The team of medical advisors includes former Society of Interventional Radiology Past Presidents, Dr. Michael Brunner and Dr. Katharine Krol of Health Tech Guidance, Dr. Patricio Polanco of UT Southwestern, and Dr. Nikola Cesarovic of ETH Zürich. This engagement is part of building the necessary infrastructure for potential FDA approval.
CEO Brad Hauser stated that this step is important in preparing for the potential FDA approval of their first-in-class technology. The company remains on track to initiate clinical studies in the U.S. in 2025, with the guidance from these experts expected to provide valuable insights.
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