Autonomix Medical, Inc. Reports Positive Outcomes in Initial Phase of First-in-Human Proof-of-Concept Trial in Pancreatic Cancer Pain and Initiates Market Expansion Study for Visceral Cancer Pain

Core Insights - Autonomix Medical, Inc. has successfully completed the initial trial phase ("PoC 1") for its innovative pain management technology, demonstrating significant pain reduction in patients with severe pancreatic cancer pain [1][2][5] - The company plans to initiate a follow-on market expansion study ("PoC 2") in Q2 2025, targeting additional visceral cancers and earlier stage pancreatic cancer, potentially doubling the addressable market [1][6][12] Group 1: Trial Results - The PoC 1 trial enrolled 20 patients, achieving clinically meaningful pain reduction with 100% of responders reporting zero opioid use at 7 days post-procedure and 73% remaining opioid-free at 4-6 week follow-up [1][2][8] - Pain relief was statistically significant, with a mean reduction of 3.32 on the Visual Analog Scale (VAS) at 7 days (baseline 7.61 to 4.29), representing a 43.6% improvement, and a mean reduction of 3.95 at 4-6 weeks (baseline 7.95 to 4.00), or 49.7% improvement [8][11] - Responding patients treated via femoral access showed a mean pain reduction of 4.16 at 7 days (baseline 7.81 to 3.65), or 53.3% improvement, and 4.67 at 4-6 weeks (baseline 7.89 to 3.22), or 59.2% improvement [8][11] Group 2: Safety and Quality of Life - The procedure demonstrated a strong safety profile, with no device or procedure-related serious adverse events reported, although there were 8 serious adverse events unrelated to the procedure [8][11] - Patients reported a 76% improvement in global quality of health at 7 days and a 42% improvement at 4-6 weeks post-procedure [8][11] Group 3: Future Directions - The follow-on PoC 2 phase will focus on interventional pain management for additional visceral cancers and earlier stage pancreatic cancer, with an amended trial protocol to gather more data on pain management [6][7][9] - Autonomix's technology platform has the potential to address a wide range of indications beyond cancer pain, including cardiology and chronic pain management [7][12][13]