Core Insights - Autonomix Medical, Inc. has successfully completed the design lock for its Apex 6 Radiofrequency Generator, integrating enhancements into a fully integrated transvascular treatment platform named the Autonomix Sensing and RF Ablation System, which is on track for Investigational Device Exemption submission and potential U.S. clinical trial initiation in 2025 for pancreatic cancer pain [1][4] Group 1: Company Developments - The integration of the Apex 6 Generator into the Autonomix platform allows for a cost-effective and de-risked approach to accelerate development, following a transaction with RF Innovations, Inc. to license the intellectual property [2] - The company is collaborating with RF Innovations' manufacturing partner to facilitate equipment development, enhancing its manufacturing supply chain [3] Group 2: Market Need and Technology - There is a significant need to transform treatment for pancreatic cancer patients, focusing on effective pain relief and improved quality of life, with early clinical results indicating potential to address this unmet medical need [3] - The technology includes a catheter-based microchip sensing array capable of detecting neural signals with approximately 3,000 times greater sensitivity than current technologies, enabling transvascular diagnosis and treatment of peripheral nervous system diseases [5][6] Group 3: Future Plans - The company plans to submit an IDE and commence U.S. clinical trials in 2025 to support commercialization of the Autonomix Sensing and RF Ablation System for pancreatic cancer pain [4]
Autonomix Medical, Inc. Advances Toward U.S. Clinical Trials in 2025 with Completed Integration of Apex 6 Generator for Transvascular Ablation