Autonomix Medical, Inc. Treats First Patient in Follow-On Market Expansion Phase (“PoC 2”) of Proof-of-Concept Human Clinical Study

Rhea-AI Summary

Autonomix Medical (NASDAQ:AMIX) has announced the enrollment and treatment of its first patient in the follow-on phase of its proof-of-concept human clinical trial (PoC 2). This expansion follows positive results from the initial PoC 1 study in patients with severe pancreatic cancer pain.

The PoC 2 phase aims to double the potential addressable market by evaluating the company's nerve ablation technology in additional visceral cancers that signal pain through the Celiac Plexus, as well as earlier stage pancreatic cancers with moderate to severe pain. The technology involves delivering transvascular energy to ablate problematic nerves for pain mitigation.

The company's platform technology has potential applications across multiple indications, including cardiology, hypertension, and chronic pain management. The current PoC 2 phase specifically focuses on interventional cancer pain management applications in areas such as pancreatic, gall bladder, liver, and bile duct cancers, with possibilities for further expansion in oncology and gastroenterology sectors.

Positive

• Expansion into additional cancer indications doubles the potential addressable market
• Positive results demonstrated in initial PoC 1 study for pancreatic cancer pain
• Technology platform has potential to address multiple indications beyond cancer pain
• Established relationships with key opinion leaders in target medical sectors

Negative

• None.

Insights

Medical Device and Clinical Trial Expert

Autonomix's expansion into additional cancer pain indications doubles their market opportunity while building on positive early clinical results.

Autonomix's announcement represents a significant advancement in their clinical development strategy. The company has initiated their follow-on market expansion phase (PoC 2) of their proof-of-concept study, enrolling and treating the first patient for cancer pain beyond pancreatic indications. This expansion leverages the positive results already demonstrated in their initial clinical phase (PoC 1) that focused specifically on pancreatic cancer pain.

The strategic importance of this development is two-fold: First, it doubles their potential addressable market by including additional visceral cancers that signal pain through the Celiac Plexus as well as earlier-stage pancreatic cancers with moderate to severe pain. Second, it validates their platform technology approach, confirming their ability to potentially address multiple indications with the same core technology.

This expansion aligns with Autonomix's broader vision of developing their transvascular nerve ablation technology as a versatile platform that could eventually target dozens of indications across cardiology, hypertension, and chronic pain management. The company is wisely focusing initially on interventional cancer pain management applications where they've established key opinion leader relationships and have preclinical evidence.

For a medical device company at this stage, successfully expanding clinical applications demonstrates both clinical validation of their core technology and prudent commercial strategy execution. The market will be watching closely for forthcoming clinical data from both study phases to further validate the technology's efficacy and safety profile across these expanded indications.

Expansion of study into additional indications doubles the potential addressable market beyond pancreatic cancer pain

PoC 2 phase builds on early success and positive results demonstrated in PoC 1 in patients with severe pancreatic cancer pain, supporting multi-indication growth strategy

THE WOODLANDS, TX, June 30, 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 the first patient has been enrolled and treated in 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.

“We’re executing on a bold vision to expand the reach of our technology beyond pancreatic cancer pain and into a broader range of high-need visceral cancer indications,” said Brad Hauser, CEO of Autonomix. “The start of patient treatment in our PoC 2 study represents a major milestone that reinforces our momentum and marks a critical step toward unlocking substantial clinical and commercial potential. We believe this expansion strengthens our value proposition and positions us to deliver meaningful impact for patients while creating long-term value for shareholders. We look forward to sharing further updates as clinical data become available.”

As previously announced, based on the positive results demonstrated in the initial phase of the Company’s first-in-human proof-of-concept study (“PoC 1”) in patients with severe pancreatic cancer pain, Autonomix has initiated a follow-on PoC 2 phase in a market expansion opportunity, which doubles the potential 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.

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 results 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, 2025 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

What is the significance of Autonomix Medical's PoC 2 trial announcement?

The PoC 2 trial represents a significant expansion of Autonomix's (NASDAQ:AMIX) clinical program, doubling the potential addressable market by including additional visceral cancers beyond pancreatic cancer pain.

What medical conditions does Autonomix Medical's technology target?

Autonomix's technology targets pain management in various cancers including pancreatic, gall bladder, liver, and bile duct cancers, with potential applications in cardiology, hypertension, and chronic pain management.

How does Autonomix Medical's pain management technology work?

The technology works by delivering transvascular energy to ablate problematic nerves that signal pain through the Celiac Plexus, particularly focusing on cancer-related pain management.

What were the results of Autonomix Medical's PoC 1 trial?

While specific data points weren't disclosed, the company reported positive results in the initial PoC 1 trial for patients with severe pancreatic cancer pain, which led to the expansion into PoC 2.

What are the future expansion plans for Autonomix Medical's technology?

Beyond the current focus on cancer pain management, Autonomix plans to expand into oncology, gastroenterology, cardiology, hypertension, and chronic pain management applications.