THE WOODLANDS, Texas — Autonomix Medical, Inc. a medical device company focused on advancing innovative technologies to revolutionize how diseases involving the nervous system are diagnosed and treated, today announced successful completion of an animal safety study evaluating the Company’s proprietary ablation technology. All safety inputs for the study were met. No procedure-related side effects have been reported.
The safety study was designed to assess acute safety and feasibility of tissue ablation in a porcine multi-arterial model. Key aspects evaluated during the study included the ability to reach distal artery regions ablation targets using the catheter, perform the ablation steps effectively, and monitor for potential adverse effects in a 3-day observation period following ablation. Findings in the study demonstrated successful energy delivery, with no acute complications using several of the Company’s proprietary ablation catheters.
“We are very pleased with the outcome of this important safety study, and we continue to execute on developing our potentially groundbreaking technology. The successful completion of this preclinical safety study provides us with supportive data as we advance toward our first-in-human clinical study, a catalytic milestone for Autonomix,” commented Lori Bisson, Chief Executive Officer of Autonomix.
Dr. Robert Schwartz, Co-Founder and Chief Medical Officer of Autonomix added, “The nervous system plays a critical part in every key bodily function. There is a critical need for a tool to sense, target and influence neuronal signals safely and reliably that can provide a significant benefit in pain management and other nerve-related disorders across a number of high-value indications. This successful safety animal study gives us optimism moving forward toward eventual clinical application in humans. The study shows promise for safety in transvascular ablation of the nerves in the pancreatic region, which may reduce pain for these patients.”
Based on the successful completion of the ablation animal safety study, the Company is advancing towards its first-in-human clinical study for the use of RF ablation in the reduction of pancreatic cancer pain, which is expected to commence enrollment in Q1 2024.
The Company is initially developing its technology to address pancreatic cancer-related pain. Current approaches, primarily relying on opioids or invasive ethanol injections, can provide only limited relief and may lead to risky side effects. Pancreatic cancer pain, as the first target indication, could offer distinct development benefits that can accelerate Autonomix’s market entry, especially in terms of clinical trials. Achieving “proof-of-concept” in this area could open the door to novel, blockbuster disease treatment and expand the horizons for the Company’s technology.
About Autonomix Medical, Inc.
Autonomix is a medical device company focused on advancing innovative technologies to revolutionize how diseases involving the nervous system are diagnosed and treated. The Company’s first-in-class technology platform includes a catheter-based microchip sensing array that has the ability to detect and differentiate neural signals with approximately 3,000 times greater sensitivity than currently available technologies. We believe this will enable, for the first time ever, transvascular diagnosis and treatment of diseases involving the peripheral nervous system virtually anywhere in the body.
We are initially developing our technology for pancreatic cancer pain and pancreatitis pain, conditions that can cause debilitating pain and need an effective solution. However, our technology constitutes a platform with the potential to address dozens of indications, including in cardiology, renal denervation and chronic pain management across a wide disease spectrum.
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