Brad Hauser, CEO of Autonomix Medical, Inc. Outlines Follow-On Expansion Study Expected to Begin in Q2 2025, Potentially Doubling Addressable Market
Rhea-AI Summary
Autonomix Medical (NASDAQ: AMIX) has announced plans to initiate a follow-on expansion study (PoC 2) in Q2 2025, following positive results from their initial proof-of-concept trial (PoC 1) for pancreatic cancer pain treatment. The PoC 2 phase will expand testing to include gall bladder, liver, and bile duct cancers, potentially doubling the company's addressable market.
The PoC 1 trial demonstrated significant pain reduction, decreased opioid use, and improved quality of life in late-stage pancreatic cancer patients. The company's smart catheter technology platform shows promise for various applications, including cardiology, hypertension, and chronic pain management. The technology focuses on delivering transvascular energy to ablate problematic nerves for pain mitigation.
Positive
- PoC 1 trial showed significant pain reduction and decreased opioid use in pancreatic cancer patients
- Expansion to gall bladder, liver, and bile duct cancers doubles the addressable market
- Technology platform has potential applications across multiple sectors including cardiology and hypertension
- Company has established relationships with key opinion leaders
Negative
- Follow-on study (PoC 2) won't begin until Q2 2025
- Results from expanded indications still pending and unproven
Insights
Autonomix's PoC 2 trial expansion doubles addressable market by adding multiple cancer types following successful pancreatic cancer pain results.
Autonomix Medical is strategically expanding its clinical program beyond pancreatic cancer pain to include gall bladder, liver, and bile duct cancers in its upcoming PoC 2 phase trial. This expansion follows positive clinical results from their initial proof-of-concept study where their smart catheter technology demonstrated significant pain reduction, decreased opioid use, and improved quality of life in late-stage pancreatic cancer patients.
The expanded indication set effectively doubles the company's addressable market, representing a substantial commercial opportunity. The technology uses transvascular energy to ablate problematic nerves associated with cancer pain, specifically targeting the Celiac Plexus region. This targeted approach offers a potentially superior alternative to current pain management strategies in these difficult-to-treat conditions.
Beyond this immediate expansion, Autonomix's technology represents a versatile platform with applications across numerous fields including cardiology, hypertension, and chronic pain management. The Q2 2025 initiation timeline for PoC 2 indicates steady progression through their clinical development pathway.
The strategic focus on these specific cancer types leverages existing key opinion leader relationships and builds on preclinical evidence, suggesting a methodical approach to market development. By demonstrating efficacy across multiple cancer types that share neural pain pathways through the Celiac Plexus, Autonomix could establish its technology as a standard intervention for cancer pain management across a broader patient population.
Discussion in Virtual Investor CEO Connect focuses on Company’s planned follow-on market expansion study phase (“PoC 2”) of proof-of-concept trial; Access Here
Additional indications potentially double the addressable market beyond pancreatic cancer pain
Follow-on expansion phase expected to begin in Q2 2025
THE WOODLANDS, TX, May 13, 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 reiterated its plans for a 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. Additionally, the Company announced the release of a Virtual Investor CEO Connect segment discussing the PoC 2 phase. Access the segment here.
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 will initiate the 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. The Company’s PoC 2 phase is on track to commence in the second quarter of 2025.
“We are thrilled with the compelling results of our PoC 1 phase in late-stage pancreatic cancer patients, which demonstrated a significant reduction in pain, substantially decreased opioid use, and showed a meaningful improvement in quality of life for these patients. Building on this success, we are expanding our investigation to include gall bladder, liver, and bile duct cancers— effectively doubling our addressable potential market. This strategic expansion highlights the broad potential of our smart catheter technology and reinforces our commitment to transforming care for patients worldwide,” Brad Hauser, CEO of Autonomix commented.
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
When will Autonomix Medical (AMIX) begin its PoC 2 clinical trial?
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