Autonomix Enrolls First Patients in Human Clinical Trial Targeting Multi-Billion-Dollar Pancreatic Cancer Market
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Insights
The initiation of a proof-of-concept clinical trial for transvascular RF ablation by Autonomix Medical represents a significant step in the field of pain management for pancreatic cancer patients. The study's primary goal is to alleviate the severe pain that often accompanies this disease, which is notoriously difficult to treat with conventional pharmacological methods. If successful, this could lead to a paradigm shift in how pain is managed in cancer patients, potentially reducing reliance on opioids, which are fraught with issues such as addiction and decreased efficacy over time.
From a medical research perspective, the innovative approach of using a catheter-based system to target neural signals associated with pain could offer a more precise and less invasive alternative to current methods. This specificity not only aims to improve patient outcomes but also to minimize the side effects and complications associated with broader systemic treatments or invasive procedures. The technology's dual capability to sense and ablate neural signals is particularly noteworthy, as it suggests a level of precision in diagnosis and treatment that could greatly enhance the quality of life for patients suffering from intractable pain.
For investors, the commencement of patient enrollment in Autonomix's clinical trial is a critical milestone that could have a substantial impact on the company's valuation. As the trial progresses, positive results could act as a catalyst for the stock, attracting investor interest and potentially leading to an increase in the company's market capitalization. However, investors should also be aware of the inherent risks associated with clinical trials, including the possibility of negative outcomes or delays that could adversely affect the stock.
The projected timeline leading to a de novo FDA submission by 2026 and subsequent clearance by 2027 provides a clear roadmap for the technology's development and regulatory approval process. Should the technology prove effective and gain FDA clearance, Autonomix could capture a significant market share in the pain management sector, particularly for cancer-related pain, which remains an area with substantial unmet medical needs.
From a market perspective, the development of Autonomix's catheter-based RF ablation technology taps into the growing demand for innovative pain management solutions that move away from opioid dependency. The increasing prevalence of pancreatic cancer and the associated pain management challenges present a substantial market opportunity for Autonomix. If the technology is commercially successful, it could disrupt the current pain management market, especially for cancer-related pain and set a new standard for similar treatments.
It is important to monitor the competitive landscape, as other companies may also be developing alternative pain management therapies. Autonomix's ability to differentiate its product through the dual sensing and ablation capabilities could, however, provide a competitive edge. The outcomes of this trial will be instrumental in determining the technology's market viability and potential for adoption by healthcare providers.
First trial to ever evaluate radiofrequency (RF) ablation in a transvascular approach to reduce the pain associated with pancreatic cancer
THE WOODLANDS, TX, March 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 it has commenced patient enrollment for its proof-of-concept (PoC) human clinical trial evaluating the use of transvascular RF ablation for the treatment of pancreatic cancer pain.
“We are pleased to commence enrollment of the PoC human clinical trial and take another step toward validating our clinical and regulatory plans for our technology,” commented Lori Bisson, Chief Executive Officer of Autonomix. “We remain encouraged 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 many find is not well-treated by pharmacologic approaches. Moving forward, we are laser focused on the successful completion of the trial and the advancement of this important technology.”
The primary objective of the PoC human clinical trial 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 for the trial. 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 trial objectives. Enrollment is expected to be completed before the end of 2024.
Expected Upcoming Milestones
- 2024: Complete ablation device design intended for clinical use
- 2025: Complete development of ablation system and catheter in preparation for human pivotal trial
- 2025: Launch combined sensing / ablation clinical trial
- 2026: De novo submission
- 2027: Seek FDA clearance
The Company’s catheter-based 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.
The Company is initially developing its technology to address pancreatic cancer-related pain. Current approaches, primarily relying on opioids or invasive ethanol injections, can provide only limited relief and may lead to risky side effects. 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. 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.
Investor and Media Contact
JTC Team, LLC
Jenene Thomas
833-475-8247
autonomix@jtcir.com
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