THE WOODLANDS, TX - Autonomix Medical, Inc. (NASDAQ:AMIX), a medical device company, has announced the completion of site initiation for a new study aimed at treating pain associated with pancreatic cancer through transvascular radiofrequency (RF) ablation. This marks a significant step for the company in validating its clinical and regulatory strategies for its innovative technology.
The proof-of-concept human clinical study will enroll 20 subjects at a single clinical trial site, with an additional 5 patients to be treated for physician familiarization with the procedure but not included in the study's primary analysis. The primary goal is to ablate somatic nerves related to pain using the transvascular RF ablation method. The study is expected to start patient enrollment this quarter, with the aim of completing it before the end of 2024.
Autonomix's technology differs from current pain management approaches, such as opioids or invasive ethanol injections, which may have limited efficacy and significant side effects. The company's catheter-based technology is designed to detect neural signals associated with pain and precisely target nerves for treatment.
The upcoming milestones for Autonomix include selecting Principal Investigators and commencing enrollment for the study within the first quarter of 2024. The company also plans to complete the design of the ablation device intended for clinical use in 2024, develop the ablation system and catheter by 2025, and launch a combined sensing/ablation clinical trial the same year. Autonomix aims for a de novo submission by 2026 and FDA clearance by 2027.
This study is part of Autonomix's broader efforts to develop technologies for diagnosing and treating diseases involving the nervous system. While the current focus is on pancreatic cancer pain, the company's platform has the potential to address various conditions across cardiology, renal denervation, and chronic pain management.
The information in this article is based on a press release statement from Autonomix Medical, Inc.
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