Autonomix Medical, Inc. Granted Approval to Expand Proof-of-Concept Human Clinical Study, Doubling Potential Addressable Market Beyond Pancreatic Cancer Pain
- Ethics Committee approval enables expansion of clinical trials beyond pancreatic cancer to broader visceral cancers
- Initial trial demonstrated significant pain reduction and decreased opioid use in pancreatic cancer patients
- Potential to double addressable market through expansion into additional cancer types
- Technology platform shows versatility for multiple medical applications including cardiology and hypertension
- Clinical trials are being conducted in Uzbekistan rather than major medical markets
- Still in early proof-of-concept phase without regulatory approvals
Insights
Autonomix's clinical trial expansion doubles their market potential beyond pancreatic cancer, building on promising initial results in pain management.
The Ethics Committee authorization from Uzbekistan represents a significant milestone for Autonomix's clinical program. This expansion from their initial proof-of-concept (PoC 1) study allows them to evaluate their nerve ablation technology across a broader spectrum of visceral cancers, potentially doubling their addressable market.
Their platform technology uses a transvascular approach to ablate problematic nerves that transmit cancer pain signals. The initial phase in pancreatic cancer patients reportedly demonstrated three crucial outcomes: significant pain reduction, substantial decreases in opioid use, and meaningful quality of life improvements - the trifecta of success metrics in cancer pain management.
The expanded PoC 2 phase specifically targets additional cancers that signal pain through the Celiac Plexus (including gallbladder, liver, and bile duct cancers) and earlier-stage pancreatic cancers with moderate to severe pain. This strategic approach of targeting the same neural pathway across multiple cancer types represents a classic platform expansion strategy in medical technology.
What's particularly noteworthy is the company's longer-term vision beyond oncology. The technology platform potentially addresses dozens of indications including cardiology, hypertension, and chronic pain management. This suggests a methodical, step-wise clinical development approach - starting with the most severe unmet needs in cancer pain before potentially expanding to larger markets with established treatment alternatives.
Follow-on study (“PoC 2”) builds on initial success in pancreatic cancer pain
Ethics committee authorization supports platform expansion into visceral cancer pain for proprietary ablation technology
Expansion supports Autonomix’s strategy to build long-term value through multi-indication growth
Patient enrollment expected to begin in June 2025
THE WOODLANDS, TX, June 05, 2025 (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 that it has received Ethics Committee authorization from the Ministry of Health of the Republic of Uzbekistan to open the clinical trial site for the follow-on phase to its proof-of-concept human clinical trial (“PoC 2”) evaluating the safety and effectiveness of delivering transvascular energy to ablate relevant problematic nerves and mitigate cancer pain. The Company is on track to commence enrollment in June 2025.
“This next phase of our clinical program represents a meaningful advancement for Autonomix,” said Brad Hauser, CEO of Autonomix. “With Ethics Committee approval, we can now expand our evaluation beyond severe pancreatic cancer pain to include a broader range of visceral cancers. The initial phase of our study in late-stage pancreatic cancer patients delivered promising results, demonstrating significant pain reduction, substantial decreases in opioid use, and meaningful improvements in quality of life. These outcomes reinforce our belief that Autonomix’s technology has the potential to address multiple cancer indications with significant unmet need and transform the standard of care. As we build on this momentum, we see a clear opportunity to create long-term value by unlocking a broader set of impactful clinical applications.”
As previously announced, based on the positive results demonstrated in the initial phase of the Company’s first-in-human proof-of-concept trial (“PoC 1”) in patients with severe pancreatic cancer pain, Autonomix is initiating a follow-on PoC 2 phase in a market expansion opportunity, which has the potential to double the addressable market beyond pancreatic cancer pain by evaluating additional visceral cancers that signal pain through the Celiac Plexus and earlier stage pancreatic cancers with moderate to severe pain.
Autonomix’s technology constitutes a platform with the potential to address dozens of indications, including cardiology, hypertension and chronic pain management, across a wide disease spectrum. The PoC 2 phase will provide a concentrated focus on interventional cancer pain management applications like pancreatic, gall bladder, liver, and bile duct, with potential further expansion in oncology, gastroenterology, and other sectors where the Company has established key opinion leader relationships and emerging preclinical evidence.
For more information about the Company’s technology, please visit autonomix.com.
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 platform system technology includes a catheter-based microchip sensing array that may have the ability to detect and differentiate neural signals with 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 this technology for the treatment of pain, with initial trials focused on pancreatic cancer, a condition that causes debilitating pain and is without a reliable solution. Our technology constitutes a platform to address dozens of potential indications, including cardiology, hypertension and chronic pain management, across a wide disease spectrum. Our technology is investigational and has not yet been cleared for marketing in the United States.
For more information, visit autonomix.com and connect with the Company on X, LinkedIn, Instagram and Facebook.
Forward Looking Statements
Some of the statements in this release are “forward-looking statements,” which involve risks and uncertainties. Forward-looking statements in this press release include, without limitation, the timing of the commencement of the PoC 2 phase of the trial. Such forward-looking statements can be identified by the use of words such as “should,” “might,” “may,” “intends,” “anticipates,” “believes,” “estimates,” “projects,” “forecasts,” “expects,” “plans,” and “proposes.”
Although Autonomix believes that the expectations reflected in these forward-looking statements are based on reasonable assumptions, there are a number of risks and uncertainties that could cause actual results to differ materially from such forward-looking statements. You are urged to carefully review and consider any cautionary statements and other disclosures, including the statements made under the heading “Risk Factors” and elsewhere in the Annual Report on Form 10-K filed with the U.S. Securities and Exchange Commission (“SEC”) on May 31, 2024 and in other filings made by us from time to time with the SEC. Forward-looking statements speak only as of the date of the document in which they are contained and Autonomix does not undertake any duty to update any forward-looking statements except as may be required by law.
Investor and Media Contact
JTC Team, LLC
Jenene Thomas
908.824.0775
autonomix@jtcir.com
FAQ
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