--News Direct--
By Austin DeNoce, Benzinga
Autonomix Medical (NASDAQ: AMIX) is a cutting-edge medical technology company developing targeted nerve therapies to revolutionize how diseases involving the peripheral nervous system are diagnosed and treated. The company's ongoing proof-of-concept (PoC) human clinical trial is evaluating the safety and efficacy of radiofrequency (RF) ablation in a transvascular approach to reduce pain associated with pancreatic cancer and, to date, has demonstrated extremely compelling results. If successful, Autonomix has the potential to dramatically impact patient well-being and improve quality of life, offering new hope for patients enduring pancreatic cancer pain.
Key Trial Insights
The initial phase of the clinical trial involved five lead in patients who underwent the procedure without complications or significant adverse events. Some 60% of these subjects experienced a significant reduction in pain, with a mean decrease of 6.33 points on the Visual Analogue Scale (VAS) pain scale, dropping from a baseline of 8.0 to 1.67 just seven days post-procedure. Patients also reported quick pain relief, with some feeling better as soon as one day after the procedure.
A detailed look at the data should provide Autonomix with important insight into optimizing the procedure, particularly the catheter entry point, where three of the five patients who benefited with meaningful pain reduction had femoral access to the catheter and the two that did not respond had brachial access.
The primary objective of this PoC trial is to assess the success rate of ablating relevant nerves to mitigate pain in patients with pancreatic cancer using radiofrequency ablation. Secondary objectives include evaluating device- and procedure-related adverse events up to six weeks post-procedure, changes in pain levels and improvements in quality of life from pre- to post-procedure.
Autonomix is proceeding with enrolling an additional 20 subjects to participate in the study and expects to complete enrollment by the end of 2024. The company expects to report topline results from all 20 subjects in the first half of next year.
Clinical Trial Testimonials
According to Autonomix, patients in the responder group reported substantial improvements in their quality of life. On average, these patients noted a 78% enhancement in how they viewed their overall health and a 45% boost in how they viewed their life quality, within seven days of the procedure. This rapid relief is crucial for individuals facing end-of-life situations due to advanced pancreatic cancer, offering them a better quality of life during their remaining time.
Patient testimonials further emphasize the impact of the procedure. Before the procedure, patients can struggle with debilitating pain, which affects their ability to sleep, eat and perform daily activities. Post-procedure, patients experienced immediate, life-changing pain relief and could sleep on their back, return to work and attend social events. Additionally, one patient stated they no longer needed painkillers, and experienced significant improvements in overall health and quality of life. This transformation underscores the procedure's potential to greatly enhance the lives of patients suffering from pancreatic cancer pain.
Technical Approach And Future Plans
Autonomix's technology aims to improve upon current pain management methods, which often rely on systemic drugs like opioids or invasive procedures that can have severe side effects. Autonomix’s catheter-based system is also designed to detect and ablate pain-associated neural signals more accurately. While the current trial focuses on pancreatic cancer-related pain, Autonomix also plans to explore other indications in the future based on these promising results.
A New Dawn In Pain Management
Autonomix’s innovative approach to pain management for pancreatic cancer patients is showing encouraging potential. The initial success of its PoC clinical trial offers a glimpse into a possible future where patients suffering from severe pain can find relief through precise and effective medical technology. As the company gathers more data, the medical community awaits its results, which could revolutionize pain management far beyond just pancreatic cancer pain and have applications across all pain and diseases of the peripheral nervous system.
Featured photo by Alexander Grey on Unsplash
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 technology platform includes a catheter-based microchip sensing array that has the ability to detect and differentiate neural signals with approximately 3,000 times 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 our technology for pancreatic cancer pain, a condition that can cause debilitating pain and needs an effective solution. However, our technology constitutes a platform with the potential to address dozens of indications, including in cardiology, renal denervation and chronic pain management across a wide disease spectrum.
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 completion of patient enrollment in the trial and the Company’s ability to successfully meet the milestones set forth in this press release on a timely basis, if at all. Such forward-looking statements can be identified by the use of words such as ‘should,’ ‘may,’ ‘intends,’ ‘anticipates,’ ‘believes,’ ‘estimates,’ ‘projects,’ ‘forecasts,’ ‘expects,’ ‘plans,’ and ‘proposes.’Although Autonomix Medical, Inc. (or 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 offering circular filed with the U.S. Securities and Exchange Commission (“SEC”) on January 26, 2024. 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.
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