Autonomix Completes First Three Patient Procedures in Human Clinical Trial Targeting Multi-Billion-Dollar Pancreatic Cancer Market
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Insights
Autonomix Medical's recent announcement regarding the initial success of their proof-of-concept human clinical trial for transvascular RF ablation in treating pancreatic cancer pain is a notable development in the field of medical technology. Pancreatic cancer, known for its poor prognosis and severe pain, often requires intense pain management that can lead to opioid dependency or other side effects. The ability to ablate somatic nerves transvascularly could represent a significant shift in treatment protocols, potentially reducing reliance on systemic drugs.
The transvascular approach, which involves accessing nerves via the vascular system, is less invasive than traditional surgical methods. It also allows for a more targeted treatment, which could reduce side effects and improve patient quality of life. As the trial progresses and more data becomes available, it will be crucial to monitor patient outcomes, including pain reduction and any potential complications. Success in this trial could lead to broader applications of the technology for other types of nerve-related pain management.
The successful completion of initial procedures in Autonomix's clinical trial is a critical milestone that could have financial implications for the company. Investors will be closely watching the progress of this trial, as the development of a new, effective pain management solution for pancreatic cancer patients could open up a significant market opportunity. The current reliance on opioids and invasive procedures indicates a substantial unmet need that Autonomix is aiming to address.
However, it's important to note that the company's technology is still in the early stages of development. The costs associated with research and development, along with the regulatory hurdles ahead, will likely affect the company's financials in the short term. Long-term success will depend on the technology's efficacy, safety profile and the ability to gain regulatory approval and market acceptance. If the trial outcomes are positive, Autonomix could see an increase in its stock value as the market anticipates future revenue streams from the technology.
The introduction of transvascular RF ablation into the treatment landscape for pancreatic cancer pain is a promising advancement. The focus on mitigating pain by targeting specific nerves could improve the overall management of pancreatic cancer symptoms. As an oncology expert, the importance of this trial lies in its potential to provide a new pain management option that could be integrated into the broader cancer care regimen.
Current treatments for pancreatic cancer pain can be quite limited and the side effects of systemic drugs can severely impact a patient's quality of life. The precision of RF ablation could minimize these side effects and provide a more sustainable and effective pain management strategy. Furthermore, the ability to confirm the suitability of the procedure by the primary oncology service ensures that the treatment is tailored to the individual needs of the patient, which is a cornerstone of modern oncology care.
First trial to ever evaluate radiofrequency (RF) ablation in a transvascular approach to reduce the pain associated with pancreatic cancer
THE WOODLANDS, TX, March 14, 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 the safe completion of the first three patient procedures 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 have safely completed the first patient procedures utilizing RF ablation in a transvascular approach to reduce the pain associated with pancreatic cancer. The Principal Investigator was able to navigate the catheter to the target treatment area and perform the specified ablations with no significant adverse events. These completed procedures represent a significant milestone as well as important momentum in the advancement of both our technology and the treatment landscape for pancreatic cancer pain where there remains an unmet need,” commented Lori Bisson, Chief Executive Officer of Autonomix.
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.
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
FAQ
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