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NEWS
Autonomix Medical, Inc. Achieves Design Lock for RF Ablation Catheter Following Successful Completion of Animal Testing, Continuing Progress Toward a U.S. Pivotal Trial in 2025
Thursday, 5th December at 8:30 am
First-in-class catheter-based sensing technology designed to sense neuronal signals that indicate pain or disease and destroy those nerves at the source
Company expects to submit an Investigational Device Exemption ("IDE"), and if approved, will commence a pivotal clinical trial to support a De Novo application for FDA approval
THE WOODLANDS, TX, Dec. 05, 2024 (GLOBE NEWSWIRE) -- Autonomix Medical, Inc. (NASDAQ: AMIX) ("Autonomix" or the "Company"), a medical device company focused on advancing innovative technologies to revolutionize how diseases involving the nervous system are diagnosed and treated, today announced the milestone achievement of design lock for its radio frequency ("RF") ablation catheter specifically designed to ablate nerves transvascularly in targeted areas following the successful completion of animal testing.
"There continues to be a much-needed shift in the treatment paradigm for pancreatic cancer patients offering a reduction of pain and improvement in quality of life. Our technology has continued to demonstrate the potential to address this urgent need, and these continued technical achievements enable us to support a labeling indication to commercialize the Autonomix Sensing and RF Ablation System in the United States as a treatment for pancreatic cancer pain," commented Brad Hauser, CEO of Autonomix. "This design lock represents a meaningful milestone in the advancement of our technology development, placing us another step closer to commencing a pivotal clinical trial, planned in the second half of 2025, and beyond to potential De Novo clearance. The preliminary data from our ongoing first-in-human proof-of-concept study continues to bolster our confidence and demonstrate the potential of our technology to treat chronic pain. We are pleased with the continued progress and look forward to further exploring the potential of our innovative technology."
Thursday, 5th December at 8:30 am
First-in-class catheter-based sensing technology designed to sense neuronal signals that indicate pain or disease and destroy those nerves at the source
Company expects to submit an Investigational Device Exemption ("IDE"), and if approved, will commence a pivotal clinical trial to support a De Novo application for FDA approval
THE WOODLANDS, TX, Dec. 05, 2024 (GLOBE NEWSWIRE) -- Autonomix Medical, Inc. (NASDAQ: AMIX) ("Autonomix" or the "Company"), a medical device company focused on advancing innovative technologies to revolutionize how diseases involving the nervous system are diagnosed and treated, today announced the milestone achievement of design lock for its radio frequency ("RF") ablation catheter specifically designed to ablate nerves transvascularly in targeted areas following the successful completion of animal testing.
"There continues to be a much-needed shift in the treatment paradigm for pancreatic cancer patients offering a reduction of pain and improvement in quality of life. Our technology has continued to demonstrate the potential to address this urgent need, and these continued technical achievements enable us to support a labeling indication to commercialize the Autonomix Sensing and RF Ablation System in the United States as a treatment for pancreatic cancer pain," commented Brad Hauser, CEO of Autonomix. "This design lock represents a meaningful milestone in the advancement of our technology development, placing us another step closer to commencing a pivotal clinical trial, planned in the second half of 2025, and beyond to potential De Novo clearance. The preliminary data from our ongoing first-in-human proof-of-concept study continues to bolster our confidence and demonstrate the potential of our technology to treat chronic pain. We are pleased with the continued progress and look forward to further exploring the potential of our innovative technology."
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