Core Insights - Autonomix Medical, Inc. has initiated a Good Laboratory Practice (GLP) preclinical study for its Sensing and RF Ablation System aimed at treating pancreatic cancer pain, marking a significant step towards regulatory approval [1][2][3] - The company is on track to submit an Investigational Device Exemption (IDE) to the FDA, with plans to commence U.S. clinical trials in 2026 if approved [1][3] - Autonomix's technology platform has the potential to address multiple high-need therapeutic areas, including cardiology, resistant hypertension, interventional pain management, and gastrointestinal disorders [4][7] Company Overview - Autonomix is focused on advancing innovative technologies for diagnosing and treating diseases related to the nervous system, utilizing a catheter-based microchip sensing array for enhanced neural signal detection [6][7] - The company's initial development efforts are concentrated on pain management, specifically targeting pancreatic cancer, which currently lacks effective treatment options [7] Research Institute Collaboration - The GLP study is being conducted at CBSET, a leading translational research institute in Massachusetts, known for its high-quality biomedical research services [5]

Financial Performance - Total revenue for 2023 was $36.3 million, a 5% increase compared to $34.7 million in 2022[39] - CytoSorb product sales were $31.0 million in 2023, a 9% increase from $28.6 million in 2022[39] - Q4 2023 total revenue decreased by 8% to $8.7 million compared to $9.4 million in Q4 2022[42] - Q4 2023 CytoSorb sales decreased slightly by 1% to $7.3 million compared to $7.4 million in Q4 2022[42] - The company has $15.6 million in cash as of December 31, 2023, which is expected to fund operations into the fourth quarter of 2024[43] Operational Highlights - Over 228,000 cumulative CytoSorb treatments have been delivered as of the end of 2023, a 17% increase from the end of 2022[9] - International Direct sales experienced strong growth of 27% to $6 million (19% product sales)[23] - The company expects to launch its new PuriFi pump later this year, following the expiration of the distribution agreement with Nikkiso Europe GmbH in September 2023[12] DrugSorb-ATR and STAR-T Trial - The pivotal STAR-T RCT was selected for a Breakout Presentation at the American Association of Thoracic Surgery (AATS) Annual Meeting[13, 17] - The company plans to submit for regulatory approval of DrugSorb-ATR to the U S FDA and Health Canada in the second half of 2024[13, 17] - The initial U S & Canada Total Addressable Market for Brilinta removal is estimated at $325 million, with a potential of $650 million[18, 19] Product Pipeline and Expansion - The company has received ~$50 million in grants, contracts, and other non-dilutive funds since 2003 for its technology[24] - VetResQ, bringing CytoSorb to veterinary medicine, had a limited but successful launch in 2023, with plans for an integrated all-in-one solution in 2024[33] - HemoDefend-BGA aims to create "universal plasma" and has received over $17 million in funding from the U S Department of Defense[37]