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Autonomix Medical, Inc. Reports Third Quarter Fiscal Year 2025 Financial Results and Provides a Corporate Update
Ongoing proof-of-concept (PoC) clinical trial in pain associated with pancreatic cancer with topline data on track for 1H 2025 Continued solid execution on
About this update from Autonomix Medical, Inc.
[{"type":"text","content":"Ongoing proof-of-concept (PoC) clinical trial in pain associated with pancreatic cancer with topline data on track for 1H 2025 Continued solid execution on milestones with several design locks and key development objectives met in the quarter Company remains on track to submit an Investigational Device Exemption (“IDE”), and if approved, will initiate US clinical trials in 2025 to support a De Novo application for FDA approval THE WOODLANDS, TX, Feb. 13, 2025 (GLOBE NEWSWIRE) -- Autonomix Medical, Inc. (NASDAQ: AMIX) (“Autonomix” or the “Company”), a medical device company focused on advancing precision nerve-targeted treatments, today reported financial results for the third quarter fiscal year 2025 ended December 31, 2024 and provided a corporate update. Quarter Highlights Expanded intellectual property estate with U.S. patent grant covering technology including, but not limited to, systems, methods and devices for transvascular treatment of cancerous tumors and cancer related pain;Bolstered regulatory and quality team to support clinical and regulatory initiatives in anticipation of FDA approval process;Achieved design lock for radio frequency (“RF”) ablation catheter following successful completion of animal testing; andExtended cash runway with $10 million underwritten public offering, before deducting underwriter discounts and other financing expenses, including partial exercise of over-allotment option. “We are making significant progress across multiple fronts and remain fully focused and committed to executing on our strategic priorities. On the clinical front, we remain on track to report topline data from our PoC trial in the first half of 2025 and have made significant progress toward initiating studies in the US in the second half of this year, which will be used in our regulatory filings to obtain a potential clearance for pancreatic cancer pain in 2027. We have achieved design lock for our ASIC microchip and RF ablation catheter, which represent key milestones in the advancement of our innovative technology,” commented Brad Hauser, Chief Executive Officer of Autonomix. “With important key data readouts on the horizon and continued progress toward potential FDA approval, we believe we are positioned for a strong year ahead. We hope to leverage this momentum to drive long-term value for our shareholders.” The Compan...