Autonomix Medical, Inc. Receives Ethics Committee Authorization for Proof-of-Concept Human Clinical Study Evaluating Proprietary Ablation Technology for Treatment of Pancreatic Cancer Pain
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Insights
The authorization from the Uzbekistan Ethics Committee for Autonomix Medical, Inc. to proceed with a clinical trial is a significant milestone for the company. The trial's primary objective is to assess the efficacy of transvascular radiofrequency (RF) ablation in mitigating pain for pancreatic cancer patients. This is noteworthy as pancreatic cancer is notoriously difficult to treat and pain management remains a critical aspect of patient care. The novel approach of transvascular ablation could potentially offer a less invasive and more targeted pain management strategy compared to systemic pharmacological treatments.
From a medical research perspective, the introduction of a new method for pain alleviation is promising. The current standard of care often involves opioids, which have a high risk of addiction and a host of other side effects. If successful, this technology could shift the paradigm of pain management in oncology, leading to improved patient outcomes and quality of life. The study's design, enrolling 20 subjects with a small additional cohort for procedural familiarization, seems robust and could provide valuable data on both the effectiveness and safety of the procedure.
Investors in the medical device sector should note Autonomix Medical's progress with its innovative catheter-based sensing technology. The commencement of this clinical trial represents a potential growth catalyst for the company. The ability to target a specific unmet medical need, such as non-pharmacologic pain management for pancreatic cancer patients, may position Autonomix favorably in the market upon successful trial outcomes.
Financially, the implications of successful clinical trials are substantial. The technology could capture a significant portion of the pain management market within oncology, traditionally dominated by pharmaceuticals. It's important to monitor the enrollment progress and subsequent data readouts, as these will be critical in determining the company's future revenue potential and impact on its stock valuation. Investors should consider the risks associated with clinical trials, including the possibility of negative outcomes or delays, which could affect the company's financial health and stock performance.
The global pain management devices market is expected to grow, driven by an increasing prevalence of chronic diseases and an aging population. Autonomix's technology could potentially disrupt this market by providing a novel solution for a difficult-to-treat condition. The selection of Uzbekistan as a clinical trial site might reflect strategic market entry considerations or regulatory advantages. It is essential to understand how this choice aligns with the company's overall market strategy and how it may influence the adoption rate of the technology if proven successful.
Market acceptance of new medical technologies is contingent on several factors, including clinical efficacy, cost-effectiveness, ease of use and integration into existing treatment protocols. Assuming positive trial results, Autonomix will need to navigate these factors to successfully commercialize its technology. Additionally, the company's ability to scale production, secure regulatory approvals in other regions and establish partnerships will be critical to its success in capturing market share.
First study ever to evaluate radiofrequency (RF) ablation in a transvascular approach to reduce the pain associated with pancreatic cancer
On track to commence enrollment in Q1 2024
THE WOODLANDS, TX, Feb. 06, 2024 (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 that it has received authorization from the Uzbekistan Ethics Committee to open the clinical trial site for its proof-of-concept human clinical study evaluating the use of transvascular ablation for the treatment of pancreatic cancer pain. The Company is on track to commence enrollment in the first quarter of 2024.
“Our team remains focused on the successful execution of our clinical path forward for this potentially groundbreaking technology. We believe that our technology has the potential to address the significant unmet need for patients with severe, chronic debilitating pain from pancreatic cancer, contributing to an exceptionally difficult quality of life, that currently is not well-treated by pharmacologic approaches. This first-in-man study to treat pancreatic cancer pain will be the very first time that transvascular ablation to reduce the pain associated with this disease has been studied and it is a very important step in validating our clinical and regulatory plans for our technology. We are making solid progress with the study and expect to initiate enrollment imminently,” commented Lori Bisson, Chief Executive Officer of Autonomix.
The primary objective of the proof-of-concept study is to successfully ablate relevant somatic nerves and mitigate pain in patients with pancreatic cancer pain utilizing RF ablation in a transvascular approach to the nerves in the region. Twenty (20) subjects will be enrolled at one clinical trial site in Uzbekistan for the study. Confirmation of suitability will be affirmed by the primary oncology service caring for the patients. Up to 5 additional patients will be included and treated according to protocol to ensure the physician's familiarity with the procedure. However, they will not be included in the analysis of the study objectives. Enrollment is expected to be completed before year-end.
The Company’s catheter-based sensing technology is being developed to do two things: sense neural signals associated with pain or disease and precisely target those nerves for treatment. Autonomix believes this technology is a better alternative to the current approaches commonly used today, 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.
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 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.
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. 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.‘’ Forward-looking statements in this release include, without limitation, the commencement of enrollment in the study in the first quarter of 2024 and the ability of Autonomix to complete enrollment before year-end.
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 final offering statement 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.
Investor and Media Contact
JTC Team, LLC
Jenene Thomas
833-475-8247
autonomix@jtcir.com
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