Autonomix Medical, Inc. Demonstrates Sustained Pain Reduction, Quality of Life Gains and 100% Zero Opioid Use in Longer-Term Post Hoc Analysis from PoC 1 Study

Rhea-AI Summary

Autonomix Medical (NASDAQ: AMIX) has reported promising longer-term post hoc analysis results from its PoC 1 study evaluating nerve ablation technology for pancreatic cancer pain treatment. The study demonstrated significant pain reduction of 65.6% (mean 5.08 reduction on VAS pain scale) in responding patients.

Key highlights include 100% opioid-free status among responders at 3-month follow-up, and substantial improvements in quality of life metrics: 76.5% improvement in global health, 51.5% improvement in functional ability, and 50.4% improvement in symptom management. Following these positive results, Autonomix has initiated PoC 2 phase to expand into additional visceral cancers, potentially doubling their addressable market.

Positive

• Significant pain reduction of 65.6% in responding patients
• 100% of responders were opioid-free at 3-month follow-up
• Notable quality of life improvements with 76.5% improvement in global health
• Expansion of addressable market through PoC 2 phase to include additional visceral cancers
• Technology platform shows potential for multiple indications beyond cancer pain

Negative

• Small sample size with only 6-7 responding patients in the analysis
• Results limited to post hoc analysis of responders only

Insights

Medical Device & Clinical Trials Expert

Autonomix's nerve ablation device shows promising durability with 66% pain reduction and zero opioid use in pancreatic cancer patients after 3 months.

The longer-term post hoc analysis from Autonomix's PoC 1 study delivers compelling clinical evidence supporting their nerve-targeted treatment technology. The 5.08-point reduction on the VAS pain scale (from 7.75 to 2.67) represents a 65.6% improvement in pain scores, which exceeds the threshold typically considered clinically meaningful in pain studies. Most remarkably, 100% of responders remained opioid-free at the 3-month follow-up, which is extraordinary for pancreatic cancer patients who typically rely heavily on opioid medications.

The quality-of-life improvements are equally impressive with 76.5% improvement in global health, 51.5% in functional ability, and 50.4% in symptom management. These comprehensive improvements suggest the technology addresses the multidimensional impact of cancer pain, not just the pain intensity alone.

The statistical significance of the results (p<0.001 at 24 hours and p<0.005 at 3-5 months) indicates these findings are unlikely due to chance. However, it's important to note the small sample size (n=6-7 responders) and the post hoc nature of the analysis, which introduces potential selection bias. The distinction between responders versus the total enrolled population suggests not all patients benefited equally.

The expansion into PoC 2 to include additional visceral cancers signaling pain through the Celiac Plexus represents a strategic move to potentially double their addressable market. The technology platform approach with applications across multiple indications (cardiology, hypertension, chronic pain) provides multiple pathways for commercial success, reducing the risk profile compared to single-indication devices.

New longer-term post hoc analysis results of responders (n=6)¹ showed long-lasting, durable pain reduction of nearly 66%, or a mean 5.08 reduction on the VAS pain scale, in patients with severe pancreatic cancer pain

100% of responders (n=7) ¹ showed zero opioid use at their 3-month post-procedure follow-up²

Quality of life markers further improved including sleep quality, energy level and ability to lead normal daily and leisure time activities and reduced tension, vomiting and constipation

THE WOODLANDS, TX, Sept. 03, 2025 (GLOBE NEWSWIRE) -- Autonomix Medical, Inc. (NASDAQ: AMIX) (“Autonomix” or the “Company”), a medical device company dedicated to advancing precision nerve-targeted treatments, today announced new longer-term post hoc data from its initial trial phase of its first-in-human study proof-of-concept evaluating the safety and effectiveness of delivering transvascular energy to ablate relevant problematic nerves and mitigate pain in patients with severe pancreatic cancer pain.

“These longer-term data build on the compelling results from PoC 1 and appear to show the sustained benefit our technology can deliver to patients with severe cancer pain. Importantly, 100 percent of responders were opioid-free three months post-procedure, reinforcing the potential of our approach as a non-opioid alternative for a highly opioid-dependent population. The durability of effect and quality-of-life improvements further support the value proposition of our platform as we expand into additional visceral cancer pain indications in PoC 2 and beyond,” commented Brad Hauser, CEO of Autonomix.

Results from the PoC 1 study demonstrated both statistically significant pain relief as early as 24-hours post-procedure (p<0.001) and sustained pain relief lasting as far out as three to five months post-procedure² (p<0.005), offering both immediate and lasting pain mitigation in patients with pancreatic cancer pain.

Notable Longer-Term Post Hoc Analysis Findings from the PoC 1 Phase

• Responding patients (n=6)¹ reported a mean 5.08 pain reduction on the VAS pain scale (baseline of 7.75 to 2.67), or 65.6% improvement.
• Among responders (N=7)¹, 100% of patients were opioid free at their 3-month post-procedure follow-up which highlights the potential for a non-opioid alternative in a highly opioid-reliant disease.
• Responding patients (N=6)¹ experienced remarkable improvement in global health (mean 76.5% improvement), functional ability (mean 51.5% improvement), and symptom management (mean 50.4% improvement), demonstrating the procedure addresses more than just pain and has the potential to improve day-to-day living during end-stage cancer.
  

As previously announced, based on the positive results demonstrated in PoC 1, Autonomix has initiated a follow-on PoC 2 phase in a market expansion opportunity that will double 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.

For more information about the Company’s technology, please visit autonomix.com.

About the Proof-of-Concept Study

The goal of the first-in-human proof-of-concept study is to assess pain reduction via RF ablation. The Company’s catheter-based microchip sensing array used to detect and differentiate neural signaling was not used in this study and will be evaluated in future studies.

The primary objective of the study’s PoC 1 phase was to assess the success rate of ablating relevant nerves to mitigate pain in patients with pancreatic cancer pain utilizing RF ablation in a transvascular approach to the nerves in the region. Secondary objectives included assessing the incidence of device- and procedure-related adverse events up to 4-6 weeks post-procedure; estimating the change in pain levels from pre- to post-procedure; and estimating the change in quality of life from pre- to post-procedure. All patients who had a successful procedure were evaluated at 7 days, 4-6 weeks, and at 3 months post-procedure. All patients entered the study with severe abdominal pain from unresectable pancreatic cancer and had a life expectancy of 3 months or more.

The Company enrolled twenty (20) patients in PoC 1, including the first five (5) “lead-in” patients. Based on consistent, corresponding evidence that successfully met the trial objectives, the Company determined there was a sufficient number of patients and concluded its initial phase of the study. Notable findings from the study included statistically significant pain relief as early as 24-hours post-procedure, providing patients with rapid relief. Pain reduction remained consistently positive at 7 days and 4-6 weeks post-procedure. Patients also reported an improved quality of life during end-stage cancer while reducing their use of opioids, and the procedure demonstrated a strong safety profile. These promising results led the Company to expand the protocol into a follow-on PoC 2 phase, now including pain management for additional visceral cancers as well as earlier stage pancreatic cancer patients experiencing moderate to severe pain.

Notable Topline Statistics and Key Learnings from the PoC 1 Phase (N=20)

• All patients entered the study with severe abdominal pain from unresectable pancreatic cancer and a life expectancy of 3 months or more.
• 19 of 20 enrolled patients were treated, and each assessed as successful catheter placement in the celiac trunk. One (1) patient was enrolled and not treated due to unsuccessful catheter placement because of an existing celiac trunk stenosis (narrowing of the vessel).
• There were no device or procedure-related serious adverse events. As to be expected with surgical procedures in seriously ill patient populations, there were 8 serious adverse events (6 subjects succumbed to their disease before the 4-6 week follow up, which were not related to the procedure, and 2 events resulting in hospitalization also unrelated to the procedure) and 14 adverse events (including 8 events of expected arterial constrictions due to spasms and temporary artery occlusion).
• 16 patients were treated using femoral access and three (3) patients using brachial access. 100% of patients (16) with femoral access responded to treatment, while the three (3) patients with brachial access showed no improvement in pain scores, representing a key procedural learning.
• Across the total population (mITT – n=19), pain relief occurred as early as 24 hours post-procedure. At 7 days post-procedure, there was a mean pain reduction of 3.32 on the Visual Analog Scale (“VAS”) (baseline 7.61 to 4.29), or 43.6% improvement. At 4-6 weeks post-procedure, there was a mean pain reduction of 3.95 on the VAS pain scale (baseline of 7.95 to 4.00), or 49.7% improvement.
• Responding femoral patients (n=16) represented 84% of treated patients with a mean pain reduction of 4.16 on the VAS pain scale (baseline of 7.81 to 3.65), or 53.3% improvement, at 7 days post-procedure. At 4-6 weeks post-procedure, there was a mean 4.67 reduction on the VAS pain scale (baseline of 7.89 to 3.22), or 59.2% improvement.
• At 7 days post-procedure, responding femoral patients reported a 76% improvement in global quality of health, a 33% improvement in functional quality of life and a 37% improvement in symptomatic quality of life. At 4-6 weeks post-procedure, responding femoral patients reported a 42% improvement in global quality of health, a 28% improvement in functional quality of life and a 29% improvement in symptomatic quality of life.
• 100% of responding patients were able to go to zero opioid use at 7 days post-procedure, while 73% of responding patients were at zero opioid use at 4-6 weeks post-procedure.
• Three responding patient VAS scores, one responding patient quality of life score and one responding patient opioid status were not reported at the 4–6-week post-procedure follow-up due to the inability to travel given the natural progression of their disease and will be recorded as missing data in the final report. 
  

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 potential of the technology to treat cancerous tumors and the pain associated with pancreatic cancer and other visceral cancers. 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 29, 2025, and from time to time, our other filings 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

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¹ Of the 16 PoC 1 responding patients, a total of eight responders succumbed to their disease before the 3-month post-procedure follow-up which was attributed to disease progression and not related to the procedure. Two responding patient VAS and quality of life scores and one responding patient opioid status were not reported at the 3-month post-procedure follow-up due to the inability to travel given the natural progression of their disease and will be recorded as missing data in the final report. 
² As to be expected in seriously ill patient populations, the 3-month post-procedure follow up ranged from three to five months due to disease progression and the patient’s inability of the patient to travel.

FAQ

What were the key results of Autonomix Medical's (NASDAQ: AMIX) PoC 1 study for pancreatic cancer pain?

The study showed a 65.6% pain reduction (mean 5.08 reduction on VAS scale) in responding patients, with 100% of responders becoming opioid-free at 3-month follow-up.

How effective was AMIX's nerve ablation technology in improving quality of life for pancreatic cancer patients?

The technology demonstrated significant improvements in responding patients: 76.5% in global health, 51.5% in functional ability, and 50.4% in symptom management.

What is the statistical significance of Autonomix Medical's pain relief results?

The study showed statistically significant pain relief as early as 24-hours post-procedure (p<0.001) and sustained relief up to 3-5 months post-procedure (p<0.005).

What are Autonomix Medical's plans for expanding their technology beyond pancreatic cancer?

Through PoC 2 phase, AMIX is expanding into additional visceral cancers affecting the Celiac Plexus, including gallbladder, liver, and bile duct cancers, potentially doubling their addressable market.

How many patients responded to Autonomix Medical's treatment in the PoC 1 study?

The post hoc analysis included 6-7 responding patients, with 6 patients analyzed for pain reduction and 7 patients analyzed for opioid use.