Core Insights - Autonomix Medical, Inc. is progressing with its ongoing proof-of-concept clinical trial for pain associated with pancreatic cancer, with topline data expected in the first half of 2025 [1][3] - The company has achieved several key milestones, including design locks for its ASIC microchip and RF ablation catheter, and is preparing to submit an Investigational Device Exemption to initiate US clinical trials in 2025 [1][3][6] - The technology platform developed by Autonomix utilizes a catheter-based microchip sensing array antenna that can detect neural signals with up to 3,000 times greater sensitivity than existing technologies, aiming to provide a precision-guided approach to treat various diseases [3][13][14] Financial Performance - For the three months ended December 31, 2024, the company reported a net loss of $2.7 million, compared to a net loss of $3.1 million for the same period in 2023 [5] - General and administrative expenses decreased to $1.7 million for the three months ended December 31, 2024, down from $2.2 million in the same period in 2023, primarily due to a reduction in advertising expenses [8] - Research and development expenses increased to $1.0 million for the three months ended December 31, 2024, compared to $0.7 million in the same period in 2023, driven by clinical trial and product development costs [9] Upcoming Milestones - The company plans to report topline data from its PoC trial in the first half of 2025, initiate clinical trials in the US in 2025, and submit a De Novo application for FDA clearance in 2026, with potential FDA clearance anticipated in 2027 [7][1] Intellectual Property and Team Expansion - Autonomix has expanded its intellectual property estate with a U.S. patent grant covering systems and methods for transvascular treatment of cancerous tumors and related pain [6] - The company has bolstered its regulatory and quality team to support clinical and regulatory initiatives in anticipation of the FDA approval process [6]
Autonomix Medical, Inc. Reports Third Quarter Fiscal Year 2025 Financial Results and Provides a Corporate Update