Autonomix Medical completes design enhancements for the Apex 6 RF Generator, advancing clinical trial plans for pancreatic cancer pain treatment.
Quiver AI Summary
Autonomix Medical, Inc. has announced a significant achievement with the completion of the design lock for its Apex 6 Radiofrequency Generator, which has been fully integrated into the Autonomix Sensing and RF Ablation System. This milestone is crucial for the company as it prepares to submit its Investigational Device Exemption (IDE) application to the U.S. FDA, with the aim of starting clinical trials for pancreatic cancer pain treatment in 2025. The Apex 6 Generator, licensed from RF Innovations, enhances the company’s platform, facilitating the development of a first-in-class catheter-based system that aims to address the urgent need for effective pain relief in pancreatic cancer patients. CEO Brad Hauser expressed optimism about the potential of their technology to transform treatment paradigms, while the company continues to collaborate with manufacturing partners to advance commercialization efforts.
Potential Positives
- Successful integration and design enhancements of the Apex 6 Radiofrequency Generator into a fully integrated transvascular treatment platform represents a significant milestone for the company's technology development.
- On track for Investigational Device Exemption submission and potential clinical trial initiation in 2025, indicating progress toward bringing innovative treatments to market.
- Focus on addressing unmet medical needs for pancreatic cancer patients demonstrates the company's commitment to improving patient quality of life and could attract stakeholder interest in commercialization prospects.
Potential Negatives
- Company's technology remains investigational and has not yet been cleared for marketing in the United States, indicating a lack of guaranteed market access.
- Forward-looking statements about the timeline for IDE submission and clinical trials carry inherent risks and uncertainties that could lead to delays or failures, which may impact investor confidence.
- Company's focus on pancreatic cancer, a condition with high morbidity and mortality, could raise scrutiny regarding the viability and ethical implications of its treatment approach.
FAQ
What milestone has Autonomix Medical recently achieved?
Autonomix Medical has successfully completed the integration and design enhancements of its Apex 6 Radiofrequency Generator.
What is the purpose of the Autonomix Sensing and RF Ablation System?
The system aims to provide a transvascular treatment platform for pancreatic cancer pain relief.
When does Autonomix plan to submit its Investigational Device Exemption (IDE) application?
The company is on track to submit its IDE application in 2025.
What technology does Autonomix focus on advancing?
Autonomix focuses on developing innovative technologies for diagnosing and treating diseases involving the nervous system.
What is the intended use of the Apex 6 Generator?
The Apex 6 Generator is to be utilized in the Autonomix Sensing and RF Ablation System for pancreatic cancer treatment.
Disclaimer: This is an AI-generated summary of a press release distributed by GlobeNewswire. The model used to summarize this release may make mistakes. See the full release here.
$AMIX Hedge Fund Activity
We have seen 0 institutional investors add shares of $AMIX stock to their portfolio, and 18 decrease their positions in their most recent quarter.
Here are some of the largest recent moves:
- RENAISSANCE TECHNOLOGIES LLC removed 16,690 shares (-100.0%) from their portfolio in Q3 2024, for an estimated $200,079
- MARINER, LLC removed 5,619 shares (-100.0%) from their portfolio in Q4 2024, for an estimated $21,127
- GEODE CAPITAL MANAGEMENT, LLC removed 4,481 shares (-100.0%) from their portfolio in Q4 2024, for an estimated $16,848
- HRT FINANCIAL LP removed 3,053 shares (-100.0%) from their portfolio in Q4 2024, for an estimated $11,479
- PNC FINANCIAL SERVICES GROUP, INC. removed 1,837 shares (-100.0%) from their portfolio in Q4 2024, for an estimated $6,907
- CWM, LLC removed 1,000 shares (-100.0%) from their portfolio in Q4 2024, for an estimated $3,760
- VIRTU FINANCIAL LLC removed 756 shares (-100.0%) from their portfolio in Q4 2024, for an estimated $2,842
To track hedge funds' stock portfolios, check out Quiver Quantitative's institutional holdings dashboard.
Full Release
Company successfully meets key milestone with design lock that integrates and finalizes enhancements to its licensed Apex 6 Radiofrequency (“RF”) Generator
On track for Investigational Device Exemption (“IDE”) submission and, if approved, U.S. clinical trial initiation in 2025 for pancreatic cancer pain
Milestone advances proprietary sensing and ablation catheter technology into a fully integrated transvascular treatment platform
THE WOODLANDS, TX, March 14, 2025 (GLOBE NEWSWIRE) --
Autonomix Medical, Inc.
(NASDAQ: AMIX) (“Autonomix” or the “Company”), a medical device company focused on advancing precision nerve-targeted treatments, today announced it has completed the integration and design enhancements of the Apex 6 Generator into a fully integrated transvascular treatment platform, now rebranded as the Autonomix Sensing and RF Ablation System. The completion of this important milestone allows the Company to remain on track for submitting its IDE application with the U.S. FDA and potentially initiate clinical trials in the United States in 2025.
In July 2024, Autonomix completed its transaction with RF Innovations, Inc., a privately held medical technology company, to license the intellectual property to its Apex 6 Generator, an existing FDA-cleared technology. The Apex 6 Generator aligned with the RF generator specifications required for Autonomix’s Sensing and RF Ablation System and provided a cost effective, de-risked approach to accelerating platform development. Following a rigorous preclinical assessment, the Company has now fully optimized the design for its first-in-class sensing and ablation device.
“There is an urgent need to transform the treatment paradigm for pancreatic cancer patients, offering effective pain relief and improving quality of life,” commented Brad Hauser, CEO of Autonomix. “Our early clinical results have consistently demonstrated the potential to address this unmet medical need, and the successful integration of our RF Generator is a critical step forward. With our IDE submission targeted for 2025, we are closer than ever to bringing this innovation into the clinic and advancing toward potential FDA De Novo clearance. We remain committed to unlocking significant value for both patients and stakeholders as we progress toward commercialization.”
As previously announced, Autonomix is collaborating with RF Innovations’ manufacturing partner, who was incorporated into the Company’s manufacturing supply chain, to facilitate equipment development.
The Company expects to submit an IDE and commence U.S. clinical trials in 2025 to support a labeling indication to commercialize the Autonomix Sensing and RF Ablation System in the U.S. as a treatment for pancreatic cancer pain.
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 platform system technology includes a catheter-based microchip sensing array that may have 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 this technology for the treatment of pain, with initial trials focused on pancreatic cancer, a condition that causes debilitating pain and is without a reliable solution. Our technology constitutes a platform to address dozens of potential indications, including cardiology, hypertension and chronic pain management, across a wide disease spectrum. Our technology is investigational and has not yet been cleared for marketing in the United States.
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 Company’s submission of an IDE, the timing of the commencement of U.S. clinical trials, and the potential of the technology to treat cancerous tumors and the pain associated with pancreatic cancer. Such forward-looking statements can be identified by the use of words such as “should,” “might,” “may,” “intends,” “anticipates,” “believes,” “estimates,” “projects,” “forecasts,” “expects,” “plans,” and “proposes.”
Although 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 Annual Report on Form 10-K filed with the U.S. Securities and Exchange Commission (SEC) on May 31, 2024 and in other filings made by us from time to time with the 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
908.824.0775
autonomix@jtcir.com
This article was originally published on Quiver News, read the full story.
The views and opinions expressed herein are the views and opinions of the author and do not necessarily reflect those of Nasdaq, Inc.
