Autonomix Medical, Inc. announced preliminary positive results from the first five ?lead-in? patients in the Company?s ongoing proof-of-concept (PoC) human clinical trial evaluating the safety and effectiveness of delivering transvascular energy to ablate relevant problematic nerves and mitigate pain in patients with pancreatic cancer pain. The goal of this trial is to assess pain reduction via radiofrequency (RF) ablation.

The Company?s catheter-based microchip sensing array used to detect and differentiate neural signaling was not used in this trial and will be evaluated in future studies. As previously announced, management will host a webcast presentation to discuss the preliminary results June 18, 2024, at 8:30 a.m. ET. The first five patients were enrolled and treated according to protocol in the beginning of the trial to familiarize the Principal Investigator (PI) with the procedure and will not be included in the analysis of the trial objectives.

These first five ?lead-in? patients successfully completed the procedure per protocol with no immediate procedural-related complications or significant adverse events. The primary objective of the PoC human clinical trial is 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 include 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 subjects who have 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 a life expectancy of 3 months or less.

Following the successful completion of the procedure, two subjects have since succumbed to their disease. Both events were expected outcomes and not related to the trial procedure. Summary of Topline Results 7 Days Post-Procedure: 24 hours post-procedure showed an overall mean VAS Pain Score of 2.3 after treating each of the five subjects.

Three patients were treated with femoral access and two were treated with brachial access. Patients treated with brachial access showed no improvement in their pain scores (or worsened) while all patients treated with femoral access positively responded to treatment. The results presented in the charts above are for the three patients in the responder group.

60% of subjects responded with a mean 6.33 reduction of pain on the VAS pain scale (from baseline of 8.0 to 1.67) at 7 days post-procedure. Pain relief was experienced as quick as 1-day post-procedure for the three patients in the responder group. Reduction of pain score occurred simultaneously as the subject?s underlying disease (pancreatic cancer tumor) continued to grow.

This is beneficial for patients who are considered end of life given their advanced stage of disease. Responder patients reported a mean 78% improvement in quality of health at 7 days. Responder patients reported a mean 45% improvement in quality of life at 7 days.

When evaluating the total treated population, including non-responders, the mean reduction in the VAS pain score was a 2.9 point reduction, or 43%, in pain scores reported pre-procedure to day 7. As previously announced, Autonomix has amended the trial protocol to include the gathering of additional information on tumor encroachment on the vessels as well as other key bio-measurements that may correlate with effective nerve ablation. Additionally, the Company has further defined severe pain for inclusion criteria as a 7 or above on the VAS scale as indicated by the patient rather than physician determination. A total of twenty (20) additional subjects will be enrolled in the trial that will be formally included in the trial data results and analysis of trial objectives.

Suitability is determined by the primary oncologist caring for the patients with the treating Principal Investigator confirming eligibility for the trial. Autonomix commenced patient screening under the amended protocol in May 2024 and remains on track to complete enrollment in the PoC human clinical trial by year-end. The Company?s catheter-based technology is being developed to do two things: sense neural signals associated with pain or disease and deliver targeted ablation to those nerves for treatment.

Autonomix believes this technology is a better alternative to the current approaches commonly used where doctors either rely on systemic drugs like opioids that lose effectiveness and have unwanted side effects or treat suspected areas blindly in hopes of hitting the right nerves, an approach that is often inaccurate and can miss the target and even cause collateral damage to surrounding parts of the body. The Company is initially developing its technology to address pancreatic cancer-related pain, with plans for follow-on indications pending the results of the initial data. Current approaches, primarily relying on opioids or invasive ethanol injections, can provide only limited relief and may lead to risky side effects.