Autonomix Begins Human POC Clinical Trial Targeting Multi-Billion-Dollar Pancreatic Cancer Market
- Completion of site initiation for a proof-of-concept human clinical study on transvascular RF ablation for pancreatic cancer pain relief.
- Primary objective is to ablate somatic nerves to mitigate pain in patients with pancreatic cancer utilizing RF ablation.
- Twenty subjects will be enrolled at one clinical trial site, with additional patients treated to ensure physician familiarity with the procedure.
- Expected milestones include Principal Investigator selection, commencement of enrollment in the study, completion of ablation device design, development of ablation system and catheter, launch of combined sensing/ablation clinical trial, and FDA clearance by 2027.
- Autonomix's catheter-based technology aims to sense neural signals associated with pain or disease and precisely target nerves for treatment, providing a better alternative to current approaches like opioids or invasive ethanol injections.
- Initial focus on addressing pancreatic cancer-related pain due to limited relief and risky side effects associated with current treatment methods.
- None.
Insights
The initiation of a clinical study by Autonomix Medical, Inc. to evaluate transvascular RF ablation for pancreatic cancer pain represents a significant advancement in pain management for a condition notorious for its debilitating symptoms. The novel approach of targeting somatic nerves via a transvascular route could potentially offer a more precise and less invasive alternative to current treatments, which are often limited in efficacy and can carry substantial risks.
From a research perspective, the success of this proof-of-concept study could pave the way for further development and eventual FDA approval. The meticulous selection of Principal Investigators and the structured timeline for upcoming milestones, including device design completion and pivotal trial preparation, demonstrate a methodical approach to clinical development. The potential for this technology to reduce reliance on opioids, with their associated side effects and risk of addiction, is particularly noteworthy. If successful, Autonomix's technology could disrupt current pain management protocols and offer tangible benefits to patients suffering from pancreatic cancer pain.
The market impact of Autonomix's clinical study could be substantial, given the high unmet need for effective pain management in pancreatic cancer. The company's stock (NASDAQ: AMIX) may experience increased investor interest as milestones are reached and results are reported. The timeline provided for key milestones, including the expected patient enrollment completion and FDA submission, offers investors clear checkpoints to assess the company's progress.
Furthermore, the development of a catheter-based technology that combines sensing and ablation capabilities could position Autonomix favorably in the medical device market. The ability to precisely target nerves associated with pain or disease could differentiate the company's offerings from those of competitors and potentially capture a significant market share in the pain management segment, subject to clinical success and regulatory approvals.
Autonomix's announcement is likely to be scrutinized by investors for its financial implications. The costs associated with conducting clinical studies are significant and the company's ability to manage these expenses while progressing through the regulatory pathway will be critical. The successful completion of the proof-of-concept study could lead to increased funding opportunities or partnerships, which are often crucial for small-cap medical device companies.
It is also important to consider the potential revenue stream that could be generated if the technology gains FDA clearance. Pancreatic cancer is a condition with a high mortality rate and the demand for effective pain management solutions is high. Should the technology prove to be effective and gain market approval, it could lead to a substantial increase in the company's valuation. However, the long regulatory road ahead and the inherent risks of clinical trials mean that investors should weigh these prospects against the risks of developmental delays or unsuccessful trial outcomes.
Site initiation completed for first study ever to evaluate radiofrequency (RF) ablation in a transvascular approach to reduce the pain associated with pancreatic cancer
THE WOODLANDS, TX, Feb. 16, 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 completion of its site initiation for its proof-of-concept human clinical study evaluating the use of transvascular RF ablation for the treatment of pancreatic cancer pain.
“We continue to make solid progress with our PoC human clinical study. This study is a very important step in validating our clinical and regulatory plans for our technology and as such our team is dedicated to its successful execution. With the site initiation now complete, we are working to identify and train Principal Investigators for the study and remain on track to commence patient enrollment this quarter,” commented Lori Bisson, Chief Executive Officer of Autonomix.
The primary objective of the proof-of-concept human clinical 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 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 the end of 2024.
Expected Upcoming Milestones
- Q1 CY2024: Principal Investigator selection and agreements
- Q1 CY2024: Commence enrollment in PoC human clinical study 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: 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 study 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 statement filed with the U.S. Securities and Exchange Commission (“SEC”). 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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