Autonomix Signs Key Clinical Agreements in Preparation to Begin March 2024 Human Clinical Trial
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Insights
The commencement of a PoC clinical trial by Autonomix Medical, Inc. for their transvascular RF ablation technology marks a significant milestone in the development of alternative pain management therapies for pancreatic cancer patients. The trial's primary objective is to mitigate pain by ablating somatic nerves through a transvascular approach, which could potentially reduce the reliance on systemic drugs like opioids. Given the opioid crisis and the need for better pain management solutions, this technology could represent a major advancement in the field.
The involvement of specialized CROs such as Clinical Accelerator and Qmed suggests a strategic move to streamline the clinical trial process, which may enhance the efficiency and accuracy of patient data management and trial reporting. This partnership could potentially lead to quicker trial completion and faster progression to subsequent trial phases, which is crucial for gaining FDA clearance.
Investors should note the implications of Autonomix's PoC trial for the stock market. The focus on a multi-billion-dollar market like pancreatic cancer pain treatment indicates a significant commercial opportunity. The successful development and eventual FDA approval of the technology could lead to substantial revenue growth for Autonomix. However, it's important to consider the risks associated with clinical trials, including potential delays or unfavorable results, which could impact the company's financial position and stock performance.
Furthermore, the announcement of expected milestones, including the completion of the ablation device design and the launch of a combined sensing/ablation clinical trial, provides a timeline that investors can monitor. These milestones are critical indicators of the company's progress and can influence investment decisions based on the perceived potential for future growth.
Transvascular RF ablation represents a promising approach to pain management in pancreatic cancer, which is notoriously difficult to treat due to its aggressive nature and the severe pain it causes. The ability to precisely target nerves associated with pain signals while minimizing damage to surrounding tissues could significantly improve the quality of life for patients. This trial's outcome will be closely monitored by the medical community, as it could set a new standard for pain management in oncology and potentially be applied to other types of cancer-related pain.
The trial design, involving only 20 subjects at one clinical site, suggests a focused and controlled approach to evaluating the technology's efficacy. The inclusion of up to 5 additional patients to ensure physician familiarity with the procedure is a prudent step that may contribute to the robustness and reproducibility of the trial results.
Proof-of-concept (PoC) human clinical trial targeting multi-billion-dollar pancreatic cancer market through transvascular RF ablation
Agreements represent final steps needed in order to commence patient enrollment, expected imminently
THE WOODLANDS, TX, Feb. 29, 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 entered into a clinical site agreement with “АКFА MEDLINE" Ltd., for its PoC human clinical trial evaluating the use of transvascular RF ablation for the treatment of pancreatic cancer pain.
Additionally, Autonomix announced the selection of Clinical Accelerator and Qmed, full service Clinical Research Organizations (CROs) specializing in medical devices to support the PoC human clinical trial. Clinical Accelerator will be responsible for managing the clinical operations in country, including recruiting patients, SIV work, and patient treatment records and Qmed will be responsible for managing protocol and trial reporting, as well as managing patient data.
Lori Bisson, Chief Executive Officer of Autonomix commented, “We are pleased to execute these important agreements and final steps towards commencing patient enrollment in our first PoC human clinical trial. We believe each of these firms bring valuable components to our overall clinical advancement and we look forward to working with them closely to bring this trial across the finish line.”
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
- Q1 CY2024: Commence enrollment in PoC human clinical trial evaluating proprietary ablation technology for treatment of pancreatic cancer pain
- 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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